joedangor

Joe Dangor @joedangor

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Mayo Clinic Cancer Center

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mayoclinic.org

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Activity by Joe Dangor @joedangor

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Mon, Aug 8 at 1:30pm EDT by @joedangor · View  

Research led by Mayo Clinic Establishes Mortality Risk for Refractory Celiac Disease Patients

researcher examining specimen at microscopeROCHESTER, Minn — An international research team led by Mayo Clinic has developed a first-of-its-kind model to predict mortality in patients suffering from celiac disease (CD).

The study, headed by Alberto Rubio-Tapia, M.D., Mayo Clinic gastroenterologist, established a five-year survival estimate for patients suffering from refractory celiac disease, a rare and most severe form of the disorder.

“Celiac disease is characterized by intestinal damage induced by the ingestion of gluten in susceptible individuals,” the study states. “Gluten-free diet is an effective therapy for most patients.”

Gluten is a protein found in common grains, including wheat, rye and barley. The protein can cause a reaction that damages the lining of the small intestine in CD sufferers. For the small percentage of patients still experiencing moderate to severe symptoms after cutting gluten from their diet, it’s important to establish a baseline mortality risk — the purpose of this research — to help manage care.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

The study followed 232 multinational patients with refractory CD through seven treatment centers in the U.S., Europe and South America. The median age of subjects was 53 years old and 64 percent were women.

Over a five-year follow-up period, 51 of the patients (22 percent) died, with refractory CD listed as the most common cause of death. Variables, including age of the patient when diagnosed, serum albumin protein levels and presence of specific abnormal lymphocytes, were weighted to calculate the five-year mortality estimate.

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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Wed, Aug 3 at 8:45am EDT by @joedangor · View  

Mayo Researchers Identify Unique Breast Microbiome and Bacterial Differences Between Healthy and Cancerous Tissue

medical or chemistry science background with a microscopeROCHESTER, Minn. — A team of Mayo Clinic researchers has identified evidence of bacteria in sterilely-obtained breast tissue and found differences between women with and without breast cancer. The findings are published in the Aug. 3 issue of Scientific Reports.

“Our research found that breast tissue samples obtained in the operating room under sterile conditions contain bacterial DNA, even when there is no sign of infection. Furthermore, we identified significant differences in the breast tissue microbiome of women with cancer versus women without cancer,” says Tina Hieken, M.D., a breast surgical oncologist at Mayo Clinic. “Our work confirmed the presence of a distinct breast tissue microbiome and that it is different than the microbiome of the overlying breast skin.”

According to the National Cancer Institute, a microbiome is a collection of microorganisms and viruses that live in a specific environment in the human body.

Dr. Hieken says, globally, breast cancer accounts for nearly one quarter of all cancers and is the leading cause of cancer death among women. She says that while there are established risk factors for breast cancer, at least 70 percent of breast cancer cases occur in women of average risk, and current prediction models are poor at identifying risk for individual women.

“Differences in the microbiome have been implicated in cancer development at a variety of body sites including stomach, colon, liver, lung and skin,” says co-investigators Amy Degnim, M.D. a breast surgical oncologist at Mayo Clinic. “There is mounting evidence that changes in the breast microbiome may be implicated in cancer development and the aggressiveness of cancer and that eliminating dangerous microorganisms or restoring normal microbiota may reverse this process,” adds Nick Chia, Ph.D., a microbiome researcher at Mayo Clinic.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, [email protected]

Dr. Hieken says it remains unclear whether small shifts in microbial communities, the presence of a virulent pathogenic strain or the absence of a beneficial one might be responsible for promoting the development of cancer in the breast microbiome. However, she says the findings of this study will spur further research to identify potential causes of breast cancer development and new microbial-based prevention therapies.

Co-authors are:

Tina Hieken, M.D.
Jun Chen, Ph.D.
Tanya Hoskin, M.S.
Marina Walther-Antonio, Ph.D.
Stephen Johnson
Sheri Ramaker
Jian Xiao, Ph.D.
Derek Radisky, Ph.D.
Keith Knutson, Ph.D.
Krishna Kalari, Ph.D.
Janet Yao
Larry Baddour, M.D.
Nicholas Chia, Ph.D.
Amy Degnim, M.D.

All co-authors are from Mayo Clinic.

The authors wish to thank the women who participated in this study and Michelle Neseth for her administrative support. The study was supported by grants from the American Society of Breast Surgeons Foundation, The Fraternal Order of Eagles Cancer Research Fund, the Mayo Clinic Department of Surgery Research Unit and Mayo Center for Individualized Medicine.

About  the Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the clinical trial referral office at 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Thu, Jul 28 at 1:20pm EDT by @joedangor · View  

Removing Healthy Breast Discouraged for Low-Risk Women With Unilateral Breast Cancer

back of a woman in pink bra with one strap removed representing mastectomy
A position paper issued today by the American Society of Breast Surgeons (ASBrS) recommends against contralateral prophylactic mastectomy (CPM) for average-risk women with breast cancer in one breast. The ASBrS statement published as a pair of manuscripts in the Annals of Surgical Oncology addresses the growing trend to remove the healthy breast in women undergoing mastectomy for breast cancer.

“Contralateral prophylactic mastectomy is a growing trend that has generated significant discussion among physicians, patients, breast cancer advocates and media,” says Judy Boughey, M.D., a Mayo Clinic breast surgeon and lead author of the position statement. “Our group examined and summarized the data, and developed guidelines about the appropriateness of prophylactic surgery. Our goal was to provide a framework for physicians to discuss CPM with patients. It is important for patients to understand that CPM does not improve their cancer outcome and understand the pros, cons and alternatives to CPM.”

Dr. Boughey is available for interviews.
MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, [email protected]

ASBrS recommends that, for each patient, surgeons make a clear recommendation for or against CPM from a medical standpoint. In addition, the procedure generally should be discouraged in average-risk women whose chance of developing breast cancer in the opposite breast is 0.1 percent to 0.6 percent per year. ASBrS recommends counseling for breast conservation for all medically appropriate patients and the use of tumor-shrinking or reconstructive approaches to help facilitate breast conservation, when appropriate.

The ASBrS papers acknowledge that the patient’s values and preferences should be an important part of a shared decision-making process. The document provides a detailed template for these discussions, which it highly recommends surgeons follow.

Read the manuscripts here:
http://link.springer.com/article/10.1245%2Fs10434-016-5443-5
http://link.springer.com/article/10.1245%2Fs10434-016-5408-8

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Wed, Jul 27 at 10:05am EDT by @joedangor · View  

Updated Testing Guidelines Make More Women Eligible for Herceptin, yet Benefit Uncertain

Immunohistochemistry for HER2 shows positive membrane staining in this infiltrating ductal carcinoma.ROCHESTER, Minn. — Changes to HER2 testing guidelines for breast cancer in 2013 significantly increased the number of patients who test HER2-positive, according to a new study by Mayo Clinic researchers published in the Journal of Clinical Oncology. Cancers that have an excess of HER2 protein or extra copies of the HER2 gene are called HER2-positive and can be treated with drugs like Herceptin that target HER2. HER2 stands for human epidermal growth factor receptor 2.

Mayo Clinic researchers found that the number of HER2-positive breast cancers doubled after testing guidelines were changed by the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) in 2013. “The new guidelines were established to reduce the number of equivocal cases, where HER2 status is uncertain, but we found that they did just the opposite,” says senior study author Robert Jenkins, M.D., Ph.D., the Ting Tsung and Wei Fong Chao Professor of Individualized Medicine Research and Professor of Laboratory Medicine and Pathology at Mayo Clinic. “The number of equivocal cases went up, resulting in additional testing and a much larger number of women with cancers ultimately labeled as HER2-positive.

According to Breastcancer.org, more than 10 percent of women will develop breast cancer in their lifetime. In the U.S. alone, the American Cancer Society estimates there will be more than 246,000 new cases of invasive breast cancer diagnosed this year, along with 61,000 new cases of noninvasive breast cancer. All newly diagnosed breast cancers are tested for human epidermal growth factor receptor 2 (HER2), a molecule that promotes the growth of cancer cells. HER2-positive cancers tend to be more aggressive and spread more quickly than other breast cancers.

Dr. Jenkins says the development of drugs like trastuzumab (Herceptin) and lapatinib (Tykerb) that target HER2 have greatly improved the prognosis of patients with HER2-positive breast cancer, but it is not clear what level of HER2 is needed on cancer cells for these targeted therapies to be effective. Therefore, he says, it is critical that clinicians accurately determine the HER2 status of a particular cancer. HER2 testing is performed using two methods: immunohistochemistry, which detects how much of the HER2 protein is present on cancer cells, and fluorescence in-situ hybridization (FISH), which measures how many copies of the HER2 gene are inside each cell.

The U.S. Food and Drug Administration (FDA) approved the first HER2 testing guidelines for determining eligibility for HER2-directed therapy for breast cancer in 1998. The American Society of Clinical Oncology/College of American Pathologists published a new set of guidelines in 2007 (AC2007), which were updated in 2013 (AC2013). The latest guidelines changed the cut-off for equivocal and positive cases.

Dr. Jenkins and his colleagues hypothesized that the new criteria outlined in AC2013 would lead to an increase in the number of breast cancers that test HER2-positive. They analyzed FISH results for 2,851 breast cancer cases referred to the Mayo Clinic Cytogenetics Laboratory for FISH testing between November 2013 and October 2014, and then compared the prevalence of HER2 FISH amplification using the three guidelines.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

In their analysis, the researchers found a near doubling in the proportion of HER2 FISH-positive cases interpreted using AC2013 (23.6 percent), compared to the FDA criteria (13.1 percent) or AC2007 (11 percent). The Mayo researchers previously reported a 13 percent HER2-positivity rate using the FDA criteria in their clinical practice in 2000, and that rate had remained constant until the implementation of AC2013. Since the implementation of AC2013, an additional 10-15 percent of women with breast cancer are considered eligible for HER2-directed therapies, even though it is unknown if they would benefit from addition of HER2-directed treatments.

“Women who receive false positive results are not only exposed to the risks of HER2-directed therapies, but they also miss out on the treatments that could be effective against their cancer. That is counter to the goal of personalized medicine, which is to give the right drug to the right patient at the right time,” says Dr. Jenkins. “Given the medical, financial and psychosocial aspects of these targeted therapies, it is prudent that we prospectively identify the most optimal candidates for treatment.”

Dr. Jenkins says that the recent National Surgical Adjuvant Breast and Bowel Project B-47 trial could provide insight into whether the additional patients labeled as HER2-positive by AC2013 actually will benefit from HER2-directed therapies. Ultimately, he says, the decision to use such targeted therapies should be taken only after carefully considering the risks and benefits by patients and their physicians, as well as any additional information that can be gleaned from other HER2 tests results, including immunohistochemistry.

Co-authors are:

  • Mithun Vinod Shah, M.D. Ph.D., Mayo Clinic
  • Anne Wiktor, Mayo Clinic
  • Reid Meyer, Mayo Clinic
  • Kathleen Tenner, Mayo Clinic
  • Karla Ballman, Ph.D.
  • Stefan Green, Mayo Clinic
  • William Sukov, M.D., Mayo Clinic
  • Rhett Ketterling, M.D., Mayo Clinic
  • Edith Perez, M.D., Mayo Clinic

The study was supported by grants from the National Cancer Institute of the National Institutes of Health.

About the Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the clinical trials referral office at 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Tue, Jul 26 at 11:00am EDT by @joedangor · View  

Stereotactic Radiosurgery may be Best for Patients with Metastatic Brain Tumors

MRI Scan of brain
ROCHESTER, Minn. — Patients with three or fewer metastatic brain tumors who received treatment with stereotactic radiosurgery (SRS) had less cognitive deterioration three months after treatment than patients who received SRS combined with whole brain radiation therapy (WBRT). These findings are according to the results of a federally funded, Mayo Clinic-led, multi-institution research study published today in the Journal of the American Medical Association.

“Metastatic brain tumors are unfortunately common in patients with cancer,” says Paul Brown, M.D., a radiation oncologist at Mayo Clinic and the lead author of the study. Dr. Brown says that, while SRS gives physicians the opportunity to treat tumors and spare healthy brain tissue, a combination of SRS plus WBRT has been shown to help control growth of metastatic brain tumors. “The concern is that WBRT also damages cognitive function,” says Dr. Brown. “That is why we have been studying the use of SRS alone.”

Researchers enrolled 213 patients between February 2002 and December 2013, and randomly assigned them to treatment with SRS alone (111) or SRS followed by WBRT (102). Researchers found less cognitive deterioration at three months in patients treated with SRS alone. Quality of life (QOL) was also higher at three months among patients treated with SRS alone. There was no significant difference in functional independence at three months between treatment groups. Median overall survival was 10.4 months for patients treated with SRS alone and 7.4 months for patients treated with SRS and WBRT.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, [email protected]

“This is the first large-scale clinical trial to evaluate this patient population with a comprehensive battery of cognitive and QOL instruments,” Dr. Brown says. “WBRT has often been offered early in the disease course for patients with metastatic brain tumors, but, because of this trial, we know the negative impact of WBRT on both quality of life and cognitive function is significant. With these trial findings, we expect practice will shift, reserving WBRT for patients with more extensive disease in the brain.”

Mayo Clinic co-authors are:

  • Kurt Jaeckle, M.D.
  • Jane Cerhan, Ph.D.
  • Bruce Pollock, M.D.
  • Evanthia Galanis, M.D.
  • Jan Buckner, M.D.
  • Karla Ballman, Ph.D.

Other co-authors are:

  • Anthony Asher, M.D., Carolinas Healthcare System
  • Elana Farace, Ph.D., Penn State Hershey Medical Center
  • Xiomara Carrero, B.S., Alliance Statistics and Data Center
  • Keith Anderson, M.S., Alliance Statistics and Data Center
  • Fred Barker II, M.D., Massachusetts General Hospital
  • Richard Deming, M.D., Mercy Medical Center
  • Stuart Burri, M.D., Levine Cancer Institute
  • Cynthia Ménard, M.D., Princess Margaret Cancer Center
  • Caroline Chung, M.D., Princess Margaret Cancer Center
  • Volker Stieber, M.D. Novant Health Forsyth Medical Center

The trial was conducted by the NCCTG (Alliance for Clinical Trials in Oncology) in collaboration with other cooperative groups, including the Radiation Therapy Oncology Group, and was supported by grants U10CA180821, U10CA180882, CA076001, CA025224, RTOG U10CA21661, and NRG U10CA180868 from the National Cancer Institute.

About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the clinical trial referral office at 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Wed, Jun 29 at 11:15am EDT by @joedangor · View  

Everolimus R-CHOP Combination Safe for Treating Diffuse Large B-Cell Lymphoma

Close up of IV drip for patient and Infusion pump in hospital.ROCHESTER, Minn. — The targeted therapy everolimus may be safely combined with R-CHOP for new, untreated diffuse large B-cell lymphoma according to the results of a pilot study by Mayo Clinic researchers published in the Lancet Haematology. R-CHOP is a combination of drugs used to treat lymphoma. The combination includes rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone.

“There is an unmet need to develop new therapies based on R-CHOP to try to increase the cure rate for diffuse large B-cell lymphoma,” says Patrick Johnston, M.D., Ph.D., a hematologist at Mayo Clinic and lead author. “This pilot study suggests that adding mTOR inhibitors to standard therapy could improve outcomes, though it needs to be validated in a larger clinical trial.”

The everolimus, R-CHOP combination was well-tolerated by patients with no dose-limiting toxicity reached within the planned dose escalation. The vast majority of patients (96 percent) achieved an overall response, and all responders achieved a complete metabolic response to the treatment. The findings indicate that drugs targeting the P13K-mTOR pathway — a cascade of molecules involved in cell growth and survival — add benefit when combined with standard R-CHOP therapy.

Johnston_Patrick_B_16MY[1]

Lymphoma is the sixth most common cancer in the U.S., and diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma. The standard accepted treatment for DLBCL is a combination R-CHOP delivered in a 21-day cycle for six cycles. However, this regimen typically cures only approximately 60 percent of patients.

Dr. Johnston and his colleagues scoured the scientific literature in search of ways to improve the cure rate. Two lines of evidence pointed toward targeting the P13K-mTOR pathway. First, numerous studies have demonstrated the importance of this pathway in the pathogenesis of DLBCL cells in the laboratory. Second, clinical studies have documented the single-agent efficacy of everolimus (an mTOR inhibitor) in relapsed DLBCL. Therefore, Mayo Clinic researchers decided to test a regimen that combined the standard R-CHOP with everolimus.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, [email protected]

They conducted a phase 1 and feasibility study in 24 patients with new, previously untreated DLBCL in the Alliance for Clinical Trials in Oncology, a National Cancer Institute cooperative group. Patients received everolimus for 14 days in combination with R-CHOP-21. A large proportion of patients achieved an overall response (96 percent) and a complete metabolic response as assessed by positron emission tomography imaging (96 percent). No relapses with DLBCL occurred and all patients achieved the predictive milestone of being event-free at 12 months from enrollment. The treatment was well-tolerated, and the most common adverse events were hematological in nature, such as grade 4 neutropenia (75 percent) and grade 3 febrile neutropenia (21 percent).

“This study is the first to integrate a P13K-mTOR agent with standard RCHOP,” says Dr. Johnston. “The encouraging outcome results and toxicity profile of this new regimen, along with the worldwide availability of everolimus, make it potentially applicable to the large population of DLBCL patients.”

Co-authors are:

  • Betsy LaPlant
  • Ellen McPhail, M.D.
  • Thomas M. Habermann, M.D.
  • David J. Inwards, M.D.
  • Ivana M. Micallef, M.D.
  • Joseph P. Colgan, M.D.
  • Grzegorz S. Nowakowski, M.D.
  • Stephen M. Ansell, M.D., Ph.D.
  • Thomas E. Witzig, M.D.

The study was supported by grants from the National Cancer Institute of the National Institutes of Health.

About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the clinical trial referral office at 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Fri, Jun 17 at 12:39pm EDT by @joedangor · View  

Task Force Cancer Screening Recommendations Now Include Stool DNA Test

cologuard kit photo

ROCHESTER, Minn. -- The United States Preventive Services Task Force has issued its final colorectal cancer screening recommendations for 2016. The Task Force assigns an overall “A” grade to colorectal cancer (CRC) screening in people ages 50-75, and fully recommends several screening exams that now includes Cologuard, the stool DNA test codeveloped by Mayo Clinic and Exact Sciences.

“The task force decision to include Cologuard will make this accurate and noninvasive new colorectal cancer screening option available to millions of people who may be unable or unwilling to undergo colonoscopy,” says David Ahlquist, M.D., a gastroenterologist at Mayo Clinic and co-inventor of the test. “This decision will help save lives.”

The task force recommendations also recognize the use of Cologuard every three years, in keeping with the recommendation of the American Cancer Society and the coverage interval established by the Centers for Medicare and Medicaid Services.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, [email protected]

Colorectal cancer is the second leading cause of cancer death among men and women. According to the American Cancer Society, more than 134,000 people will develop colorectal cancer in 2016, and more than 49,000 will die of the disease.

In August 2014, Mayo Clinic became the first health care organization to offer Cologuard. The Cologuard technology platform was codeveloped by Exact Sciences Corp. and Mayo Clinic as part of a broad, exclusive collaboration.

Dr. Ahlquist and Mayo Clinic have a financial interest in Cologuard. Neither Mayo Clinic nor Dr. Ahlquist receives royalties for Cologuard tests ordered for Mayo Clinic patients by Mayo Clinic physicians.

About Exact Sciences
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, follow Exact Sciences on [email protected], or on Facebook.

About Cologuard
Cologuard was approved by the U.S. Food and Drug Administration in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society, and stool-DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Falsepositives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard,visit http://www.CologuardTest.com. Rx Only.

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

 

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joedangor

Thu, May 26 at 11:00am EDT by @joedangor · View  

Surrogate Endpoints Poor Proxy for Survival in Cancer Drug Approval Process

a person holding a glass of water and a handful of medication pillsROCHESTER, Minn. — Surrogate endpoints used to support the majority of new cancer drugs approved in the U.S. often lack formal study, according to the authors of a study published in the June issue of Mayo Clinic Proceedings. This analysis questions whether the U.S. Food and Drug Administration (FDA) is adhering to standards that demand that surrogates be “reasonably likely to predict” or “established” to be used to grant approvals.

“In cancer clinical trials, surrogate endpoints, such as tumor shrinkage or slowed tumor growth, may be used as proxies for outcomes that matter to patients — living longer or better — in order to gain earlier approval of new drugs,” says lead author Vinay Prasad, M.D., M.P.H. a hematologist at Oregon Health & Sciences University.

Dr. Prasad and co-author Chul Kim, M.D. M.P.H., a researcher at the National Institutes of Health, studied 55 drugs approved on the basis of a surrogate endpoint by the FDA between January 2009 and December 2014. Twenty-five drugs received accelerated (provisional) approval, and 30 drugs received traditional (full) approval. Surrogates used for accelerated approval should be “reasonably likely to predict” living longer, while surrogates used for traditional approvals should be “established,” according to prior guidance from the FDA.

Yet, the authors could not find any formal analyses of the strength of the surrogate-survival correlation for 14 drugs (56 percent) that received accelerated approval and 11 drugs (37 percent), which received traditional approval. For drugs receiving accelerated approval, a level 1 analysis (the most robust analysis) had been performed on only four drugs. For drugs receiving traditional approval, a level 1 analysis had been performed on 15, with only three finding a strong correlation.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

“The present study suggests that the use of surrogate endpoints for drug approval often lacks formal empirical verification,” says Dr. Prasad.

In a commentary also published in the June issue of Mayo Clinic Proceedings, Vincent Rajkumar, M.D., a Mayo Clinic hematologist, writes that the study by Drs. Prasad and Kim is “the product of a time-consuming, thoughtful, and careful study.” He says their findings “may lead one to think that the FDA is more lenient and is willing to approve oncologic drugs more readily than ever before.”

But, he cautions that there are many aspects in the interpretation of those data that one must be wary of, and placing more requirements may impede progress in drug development and the speed of approval. He says that the current FDA approval process has achieved an optimal balance between the need for speed, so patients with cancer have early access to promising new drugs, and the need for safety, so harmful or useless drugs don’t enter the market. At the same time, he warns against further relaxation of the current standards.

Dr. Prasad acknowledges that the FDA may have unpublished studies used to justify these surrogates. “If so, I would urge the FDA to publish these studies to allow independent researchers to judge their work,” he says. “If the surrogates are valid that would be great news. But, if there are limitations to the analyses, it would benefit patients to know.” He says the FDA has previously published such analyses.

About Mayo Clinic Proceedings
Mayo Clinic Proceedings is a monthly peer-reviewed medical journal that publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research, and clinical epidemiology. Mayo Clinic Proceedings is sponsored by the Mayo Foundation for Medical Education and Research as part of its commitment to physician education. It publishes submissions from authors worldwide. The journal has been published for more than 80 years and has a circulation of 130,000. Articles are available at http://www.mayoclinicproceedings.org/.

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Mon, May 23 at 6:00am EDT by @joedangor · View  

Knowledge of Positive Cologuard Test Improves Colonoscopy Performance, Mayo Clinic Study Shows

Cologuard stool DNA screening boxSAN DIEGO – An endoscopist’s knowledge of a positive Cologuard test improves colonoscopy performance, according to a poster presentation at last week’s Digestive Disease Week conference.

Cologuard is an at-home, stool-DNA colorectal cancer screening test that has been approved by the U.S. Food and Drug Administration. This test, available by prescription only, is reimbursed by Medicare and covered by an increasing number of commercial health care plans.

Researchers from Mayo Clinic compared results of colonoscopies following a positive result from Cologuard (unblinded) with colonoscopies performed by those who were not aware of the Cologuard result (blinded).  Unblinded endoscopists found polyps or hemorrhagic lesions 83 percent of the time and precancerous polyps in 70 percent of patients, compared to 68 and 53 percent of blinded endoscopists, respectively.

“Endoscopist knowledge of a positive Cologuard result appears to enhance colonoscopy quality, based on observed differences in number of detected lesions, total adenomas, detection of inconspicuous or flat lesions, and withdrawal times.” says David Johnson, M.D., a gastroenterologist at Mayo Clinic’s Rochester campus. “This increase in yield could translate into more true-positive and fewer false-negative results than estimated from blinded pre-approval studies.” The study also showed that unblinded endoscopists spent 46 percent more time and found twice as many polyps per colonoscopy.

The blinded group included a portion of the Cologuard-positive patients who participated in the DeeP-C clinical study, which was published in the April 2014 New England Journal of Medicine. The DeeP-C study evaluated Cologuard’s performance in nearly 10,000 patients. Cologuard was found to be 92 percent sensitive in detecting colorectal cancer with 87 percent specificity.

MEDIA CONTACT:
Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, 
[email protected]

In August 2014, Mayo Clinic became the health care organization to offer Cologuard. The Cologuard technology platform was co-developed by Exact Sciences Corp. and Mayo Clinic as part of a broad, exclusive collaboration.

David Ahlquist, M.D., a Mayo Clinic gastroenterologist is co-inventor of the test.

Dr. Ahlquist and Mayo Clinic have a financial interest in Cologuard. Neither Mayo Clinic nor Dr. Ahlquist receives royalties for Cologuard tests ordered for Mayo patients by Mayo physicians.

About Exact Sciences
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, follow Exact Sciences on [email protected], or on Facebook.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society, and stool-DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer.

Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False-positives and false- negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit http://www.CologuardTest.com. Rx Only.

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

 

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joedangor

Tue, May 10 at 6:01pm EDT by @joedangor · View  

Mayo Clinic Studies at 2016 American Urological Association Meeting

Dr. Landon Trost performing urology surgeryROCHESTER, Minn. — Mayo Clinic physicians will present findings on several studies at the 2016 American Urological Association Annual Meeting, to be held May 6-10 in San Diego. They will be available to discuss their research and findings with reporters covering the conference. Some of the studies to be presented include: 

“Risk Factors for Postoperative Complications in Patients Undergoing Partial Nephrectomy”

Embargoed until Monday, May 9, at 1 p.m. EDT

Mayo Clinic urologists have completed a comprehensive institutional review of all patients undergoing a partial nephrectomy between 2001 and 2012.

“Partial nephrectomy has become the treatment of choice for many renal masses. This approach provides a safe and effective way for surgeons to remove localized tumors, while preserving the remainder of the kidney,” says the study’s lead author Harras Zaid, M.D., a fellow in urologic oncology at Mayo Clinic. “Even though practice patterns have changed over the past decade with increased use of partial nephrectomy and newer minimally invasive technologies, research into outcomes has lagged, especially research identifying predictors of postoperative complications.”

Dr. Zaid and his colleagues evaluated logistic regression models to assess predictors of postoperative complications within 30 days of surgery. They identified 1,763 patients who underwent 1,773 partial nephrectomies between 2001 and 2012.

Factors associated with higher rates of early complication included being male, having one kidney, renal insufficiency, and a higher Charlson comorbidity score. The Charlson comorbidity index categorizes a patient’s conditions based on standardized measures. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.

Dr. Zaid says these data may help inform patient counseling prior to partial nephrectomy and help select high-risk candidates for observation or percutaneous ablative procedures.

“Tranexamic Acid May Reduce Need for Blood Transfusion in Patients Undergoing Open Radical Cystectomy”

Embargoed until Friday, May 6, at 1 p.m. EDT

Surgeons at Mayo Clinic instituted a change in clinical practice in April 2013 for certain patients undergoing open radical cystectomy to study whether tranexamic acid might improve outcomes by reducing perioperative blood transfusions.

“About 60 percent of patients undergoing open radical cystectomy receive blood transfusions, which has been associated with poor outcomes, increased risks of disease recurrence and mortality,” says Harras Zaid, M.D., the study’s lead author. “Tranexamic acid is an antifibrinolytic agent that promotes blood clotting by preventing clots from breaking down and may eliminate the need for blood transfusions.”

For the study, patients undergoing radical cystectomy received an intraoperative, intravenous bolus of tranexamic acid followed by continuous infusion. Patients with a history of venous thromboembolism or those who received coronary stents a year prior to their surgery did not receive tranexamic acid.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, [email protected]

Researchers defined perioperative blood transfusion as occurring during surgery or within postoperative hospitalization and defined venous thromboembolism as occurring within 30 days of surgery.

Using these definitions, they recorded and compared outcomes to a matched cohort of patients who received radical cystectomy at Mayo Clinic prior to the change in clinical practice.

Researchers studied 103 patients who underwent radical cystectomy at Mayo Clinic between April 2013 and July 2015 and received tranexamic acid. For analysis these patients were matched 1-to-2 to historic controls based on age, preoperative hemoglobin, receipt of neoadjuvant chemotherapy, and stage of cancer. Researchers found that use of intraoperative tranexamic acid associated with a significant reduction in perioperative blood transfusions (31.1 percent versus 57.5 percent, p<0.001) and did not increase the risk of venous thromboembolism.

“Artificial Urinary Sphincter Improves Outcomes for Men with Stress Incontinence”

Embargoed until Tuesday, May 10 at 3:30 p.m. EDT

Men who underwent primary artificial urinary sphincter implantation to treat stress incontinence had improved long-term outcomes according to the results of a 28-year study by Mayo Clinic urologists. “Recognition of long-term success is important for preoperative patient counseling,” says the study’s lead author Brian Linder, M.D., a urologist at Mayo Clinic.

Researchers identified 1802 male patients with stress urinary incontinence that underwent artificial urinary sphincter placement from 1983 to 2011. Of the 1082 study participants, 60 percent were men who received primary implantations. This group comprised the study cohort.

Researchers conducted patient follow-up through office examination, operative reports and written or telephone correspondence. They also evaluated multiple clinical and surgical variables for potential association with treatment failures that were defined as any secondary surgery.

Researchers found no patient-related risk factors that were independently associated with an increased risk of secondary surgery. Secondary-surgery free survival was 90 percent at 1 year, 74 percent at 5 years, 57 percent at 10 years, and 41 percent at 15 years. Patients who received implants had a median age of 71 and median follow-up of 4.1 years. Overall, 31 percent of patients underwent a secondary surgery, including 89 for device infection or erosion, 131 for device malfunction, 89 for urethral atrophy and 29 for pump malposition or tubing complications.

“Proton Pump Inhibitor Use May Increase Complications Following Radical Prostatectomy”

Embargoed until Monday, May 9, at 3:30 p.m. EDT

Recent studies have shown an association between proton pump inhibitor (PPI) use and adverse outcomes including dementia, chronic kidney disease, fractures, and increased mortality following hospital discharge. At the same time, there is little literature regarding the effects of PPIs on surgical outcomes. Urologists at Mayo Clinic sought to assess the impact of PPI use on outcomes following radical prostatectomy.

“PPIs are available both over the counter and with a prescription, and are used to treat gastro esophageal reflux disorder (GERD) and peptic ulcer disease,” says Dr. Westerman, the study’s lead author Mary Westerman, M.D., a urology fellow at Mayo Clinic. “PPI use has risen dramatically over the past 20 years. Currently, PPIs are the fourth most prescribed class of medication in the U.S., so it’s important to know their impact on surgical outcomes.”

Researchers identified 9,338 patients who underwent radical prostatectomy at Mayo Clinic from 2001 to 2012. PPI use was defined as having taken a PPI within 90 days preceding surgery.

Overall, 372 (4 percent) of men were taking a PPI at the time of surgery. The median postoperative follow-up was 7.3 years, during which time 81(0.9 percent) of men died of prostate cancer. Men taking a PPI were older (63 years, compared to 61.5 years) and had higher BMIs. They also were more likely to have a higher Charlson comorbidity index score, indicating an increased risk of mortality, at the time of radical prostatectomy. Finally, at the time of radical prostatectomy, patients using PPIs had more pathologically advanced disease and an increased risk of complications.

“More research is needed to determine whether PPI use is a surrogate for decreased overall health or frailty, or if PPIs result in physiologic changes, predisposing patients to more complications,” says Dr. Westerman. “It is clear that patients taking PPIs were older, less healthy and had higher risk of disease and their use of PPIs was independently associated with a higher overall complication rate following radical prostatectomy.”

“Amateur Athletes Who Use Steroids Experience Side Effects Both on and Off Testosterone”

Embargoed until Tuesday, May 10, at 3:30 p.m. EDT

Since the 1980s, illicit use of androgenic and anabolic steroids has spread from elite athletes into the general population. Despite the high level of steroid use among amateur athletes, little is known about this population. Mayo Clinic researchers sought to identify and characterize patterns of anabolic-androgenic steroids (AAS) in a cohort of this population. “Current estimates are that 1 million to 3 million amateur athletes use steroids in the U.S.,” says the study’s lead author, Mary Westerman, M.D., a urology fellow at Mayo Clinic.

Researchers issued an anonymous, self-administered questionnaire between February 2015 and June 2015. Links to the survey, hosted on SurveyMonkey, were posted on message boards of websites popular among AAS users. Researchers analyzed 37 questions for the study.

The majority of the 231 respondents who met inclusion were white males, over 25, employed with above average incomes and formal education beyond high school. Ninety-three percent began using AAS after 18, and 81 percent reported using more than 400 mg of testosterone per week. Factors associated with longer duration of use included higher incomes, increased testosterone dosages, being over 35, being married and being self-employed. Seventy-seven percent had routine lab tests, and 38 percent reported having laboratory abnormalities at some point. Nearly all respondents experienced subjective side effects on and off testosterone.

“The population of AAS users is disparate from other drug abusers,” says Dr. Westerman. “Lab abnormalities and side effects are common in this population, and health care professionals should take this into account when counseling these patients.”

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Thu, May 5 at 2:34pm EDT by @joedangor · View  

Protein may Predict Response to Immunotherapy in Patients with Metastatic Melanoma

Researcher processing dermatology specimenROCHESTER, Minn. — A protein called Bim may hold the clue to which patients may be successful on immunotherapy for metastatic melanoma, according to the results of a study by Mayo Clinic researchers led by senior author Haidong Dong, M.D., Ph.D., and published online in the May 5 edition of JCI Insight.

“Immune checkpoint therapy with PD-1 blockade has emerged as an effective treatment for many advanced cancers,” says the study’s lead author, Roxana Dronca, M.D., an oncologist at Mayo Clinic. “However, only a fraction of patients achieve durable responses to immunotherapy and, to date, we have had no means of predicting which patients are most likely to benefit.”

PD-1 blockade is a type of immunotherapy that helps make cancer cells more vulnerable to attack by T cells in the body’s immune system by blocking the activity of a molecule called PD-1. PD-1 prevents T cells from recognizing and attacking cancer cells.

Dr. Dronca and her colleagues found a higher frequency of immune cells, called T cells, that expressed the protein Bim among patients who responded to immunotherapy for metastatic melanoma than among patients who were treated immunotherapy but whose disease had progressed.

“Our previous research demonstrated that Bim is a downstream signaling molecule in the PD-1 signaling pathway, and that levels of Bim reflect the degree of PD-1 interaction with its ligand PD-L1,” says Dr. Dong.

A signaling pathway is a group of molecules in a cell that work together to control one or more cell functions, such as cell division or cell death.

“We hypothesized that the increased frequency of CD8+PD-1+Bim+T cells in patients who respond to immunotherapy reflects an increased number of target T cells for PD-1 blockade with pembrolizumab, which may explain the positive clinical outcomes in these patients,” Dr. Dong says.

“A great advantage of this approach lies in the ease of serial peripheral blood testing, compared with repeated invasive tissue biopsies,” says Dr. Dronca. “We are currently validating these results in a larger prospective cohort of patients with metastatic melanoma and in patients with lung cancer using multiple serial peripheral blood samples and standardized tumor assessment.”

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected].

For the study, Dr. Dronca and her colleagues collected peripheral blood from patients at the initiation immunotherapy (baseline) and again at the time of first radiographic tumor assessment (12 weeks). They collected additional samples at each subsequent radiographic tumor evaluation for patients continuing on immunotherapy.

“The potential discovery of a way to predict a patient’s response to pembrolizumab would help inform clinical decision-making,” said Dr. Dronca. “It would not only help clinicians identify which patients would be most likely to benefit from the drug, but also prevent patients not likely to respond to the therapy from being exposed to unnecessary toxicities and costs.”

The study was supported by funds from the Cancer Research Institute, the National Cancer Institute grants R21, CA197878, CTSA, KL2 TR000136, and, in part, by the National Institutes of Health/National Institute of Allergy and Infectious Diseases grants R01 AI095239 and K12CA090628. Researchers also received funding from the Mayo Clinic Center for Individualized Medicine Biomarker Discovery Program.

About the Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the Mayo Clinic Cancer Center clinical trials office at 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Tue, Apr 19 at 11:35am EDT by @joedangor · View  

Aspirin Use May Help Prevent Bile Duct Cancer

Small white aspirin pills spilling out of a glass jarROCHESTER, Minn. — A team of current and former Mayo Clinic researchers has discovered that aspirin use is associated with a significantly reduced risk of developing bile duct cancer, also called cholangiocarcinoma. The results are published in Hepatology.

“Our study found that individuals who took aspirin had a more than a two-and-a-half to three-and-a-half-fold lesser chance of developing bile duct cancer, compared to individuals who did not take aspirin,” says Lewis Roberts, M.B. Ch.B., Ph.D., the study’s senior author and a gastroenterologist and hepatologist at Mayo Clinic.

Bile duct cancer is an uncommon cancer that forms in the slender tubes (bile ducts) that carry digestive fluid through the liver. The disease occurs mostly in people over 50 and can cause symptoms, such as yellowing of the skin and eyes, intense itchiness of the skin, and white stools. Bile duct cancer is an aggressive type of cancer that progresses quickly and is difficult to treat.

“We know that continuous unremitting inflammation is one of the main factors that promotes cancer of the bile ducts,” Dr. Roberts says. “Aspirin, with it’s an anti-inflammatory properties, may reduce the risk of bile duct cancer by lessening inflammation through inhibition of an enzyme called cyclo-oxygenase (COX), which is known to promote inflammation.”

In addition to the COX enzyme pathway, Dr. Roberts says other studies have shown that aspirin blocks additional cell-signaling cascades that promote cancer development. “The evidence has been accumulating that regular, long-term use of aspirin is associated with a decreased risk of a number of different cancer types, particularly gastrointestinal cancers,” he says.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

But, it is not certain that aspirin is safe to use for cancer prevention. Dr. Roberts and his colleagues say additional confirmatory studies are needed before aspirin can be recommended for use in preventing bile duct cancer. Future plans will include population-based studies designed to confirm the associations of aspirin with decreased risk of developing bile duct cancer and clinical trials of aspirin in people at high risk for developing bile duct cancer.

Data for the study was gathered from the Mayo Clinic Hepatobiliary Neoplasia registry, the Mayo Clinic Biobank and and the Rochester Epidemiology Project.

Co-authors are:

  • Jonggi Choi
  • Hassan Ghoz
  • Benyam Addissie
  • William Harmsen
  • Terry Therneau
  • Janet Olson
  • Thoetchai Peeraphatdit
  • Esha Baichoo
  • Roongruedee Chaiteerakij

About the Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the Mayo Clinic Cancer Center clinical trials office at 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Wed, Apr 6 at 2:14pm EDT by @joedangor · View  

Radiation Therapy Chemotherapy Combination Improves Survival in Adults with Low-Grade Brain Cancer

computer display of a brain scanROCHESTER, Minn. — Patients with a low-grade type of brain tumor called glioma who received radiation therapy plus a chemotherapy regimen, including procarbazine, lomustine and vincristine (PCV), experienced a longer progression-free survival and overall survival than patients who received radiation therapy alone, according to the results of the clinical trial, Radiation Therapy Oncology Group (RTOG) 9802 published in the April 7 issue of the New England Journal of Medicine.

“This is the first phase III trial to demonstrate conclusively a treatment-related survival benefit for patients with grade 2 glioma,” says Jan Buckner, M.D., the study’s lead author. Dr. Buckner is an oncologist and chair of the Department of Oncology at the Mayo Clinic Cancer Center in Rochester, Minnesota.

“Our early results, reported at a median patient follow-up of 5.9 years, showed that radiation therapy plus PCV chemotherapy was associated with a statistically significant prolongation of median progression-free survival, but not with overall survival. However, additional follow-up demonstrated an improvement in overall survival as well for these patients,” Dr. Buckner says.

Between October 1998 and June 2002, 251 patients with low-grade glioma were enrolled in the RTOG 9802 trial. Patients enrolled were at high risk, compared to other patients with low-grade glioma, because they were 40 or older, or had a less-than-complete surgical removal of their tumor.

Patients were randomized to 1 of 2 trial arms, radiation therapy plus six cycles of PCV chemotherapy or radiation therapy alone. Before treatment, researchers conducted a pathology review on tumor samples and prepared for samples for correlative laboratory studies to assess mutational status and identify prognostic variables.

At a median follow-up time of 11.9 years, 67 percent of enrolled patients were identified as having tumor progression, and 55 percent of patients had died. Patients in the radiation therapy plus PCV chemotherapy arm had longer median survival times, compared with those in the trial arm who received radiation therapy alone (13.3 versus 7.8 years, respectively; p=0.003). Median progression- free survival time for patients receiving radiation therapy plus PCV chemotherapy versus radiation therapy alone was 10.4 years and 4.0 years, respectively. Ten-year, progression-free survival and overall survival rates for patients in the radiation therapy plus PCV chemotherapy arm versus those in the radiation therapy alone arm were 51 percent versus 21 percent and 60 percent versus 40 percent, respectively.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

For progression-free survival and overall survival distributions, a difference between treatment arms became apparent only after two to four years following randomization. The favorable prognostic variables researchers identified for progression-free and overall survival included the radiation plus PCV chemotherapy arm and oligodendroglioma histology.

As expected, treatment toxicity was greater in the PCV chemotherapy arm and consistent with patients receiving multiagent chemotherapy regimens. The most common toxicities were fatigue, anorexia, nausea and vomiting, which were mostly grade 1−2 in severity with the exception of grade 3−4 neutropenia.

“Our results indicate that initial radiation therapy followed by PCV is necessary to achieve longer survival in patients with grade 2 glioma and that salvage therapy at relapse after radiation therapy alone is less effective,” says Dr. Buckner. “It has also been hypothesized that other genetic alterations may be responsible for a small subset of patients whose glial brain tumors are chemotherapy-resistant. However, radiation therapy plus PCV appears to represent the most effective treatment identified to date for the majority of patients with grade 2 glioma,” Dr. Buckner says.

While grade 2 glioma constitute only 5 percent to 10 percent of all brain tumors, they are responsible for progressive neurologic symptoms and premature death in nearly all patients diagnosed with this type of brain tumor.

“RTOG 9802 involves a network of investigators across the U.S. and Canada working through the National Cancer Institute’s National Clinical Trials Network,” says Dr. Buckner. “This trial could only have been conducted through a publicly funded national clinical trials network.”

Funding for the trial was provided by the National Cancer Institute, and the trial was conducted by investigators at institutions participating in the Radiation Therapy Oncology Group, the Alliance for Clinical Trials in Oncology, the Eastern Cooperative Oncology Group and the Southwest Oncology Group.

About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the Mayo Clinic Cancer Center clinical trials office at 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Wed, Feb 24 at 12:28pm EDT by @joedangor · View  

Mayo Clinic to Live-Stream Colonoscopy Promoting Cancer Screening Awareness

Facebook horizontal

ROCHESTER, Minn. — Mayo Clinic will live-stream a colonoscopy on the mobile app Periscope on Tuesday, March 1, at 8:30 a.m. EST. The broadcast is part of Mayo Clinic’s ongoing collaboration with Fight Colorectal Cancer to raise awareness of the importance of colorectal cancer screening. March is Colorectal Cancer Awareness Month.

Mayo Clinic’s first LIVE procedure broadcast #ScopeScope

“We’ve worked with Fight Colorectal Cancer on its One Million Strong campaign for the last three years to highlight the importance of appropriate screening,” says Lee Aase, director of the Mayo Clinic Social Media Network. “Our previous promotions included live patient events, a music video and a social media campaign. As we discussed plans for our 2016 promotion, I received a reminder for my colonoscopy, so we decided to take this opportunity to demystify the process by live-streaming the procedure on Periscope.”

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs,
507-284-5005,
 [email protected]

Intestinal polyps

The procedure, which will be broadcast on Mayo Clinic’s Periscope channel using the #ScopeScope hash tag, will be supplemented by additional commentary and interaction on Mayo Clinic’s Twitter account. Aase also will document the process leading up to his colonoscopy from his personal Twitter and Periscope accounts.

“About 50,000 Americans die from colorectal cancer each year, even though it is among the most treatable cancers when caught early,” says Mayo Clinic gastroenterologist Paul Limburg, M.D., Dr. Limburg encourages people to discuss colorectal cancer screening with their physicians. Dr. Limburg says that, in addition to colonoscopy, there are noninvasive screening options such as Cologuard a stool DNA test that patients can do at home and mail in for analysis. Cologuard was co-developed by Mayo Clinic and Exact Sciences. “The bottom line is the best screening test is the one that gets done,” says Dr. Limburg.

Journalists: Sound bites with Dr. Limburg are available in the downloads.

 

About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call 1-855-776-0015 (toll-free).

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org 

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joedangor

Wed, Feb 3 at 5:00pm EDT by @joedangor · View  

Investigating Surgery for Women at High Risk of Breast and Ovarian Cancer

mother fighting breast cancer with her young daughter sitting outside leaning against a wooden fence
ROCHESTER, Minn. — In a review article published in the Feb. 4 issue of the New England Journal of Medicine, a pair of Mayo Clinic Cancer Center researchers provide an in-depth look at the issues associated with the care of women in families with hereditary breast and ovarian cancer syndrome who have not yet developed cancer themselves. The article addresses optimal risk assessment for breast and ovarian cancers, the usefulness of risk-reducing surgery, side effects of these procedures, alternative strategies for cancer prevention and the best ways to help with the decision-making process.

“Women whose families have been marked by excess breast and ovarian cancer are at higher risk of developing those diseases over their lifetime,” says lead author and Mayo Clinic oncologist Lynn Hartmann, M.D. “Although these women can reduce their risk considerably through preventive mastectomies and or the removal of their fallopian tubes and ovaries, these procedures come with their own complications and psychosocial effects.”

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

In the article Dr. Hartmann and co-author, Noralane Lindor, M.D., a pathologist and genetics expert, argue for greater support for women grappling with complex and emotionally charged decisions, and more research to devise improved treatment approaches for hereditary breast and ovarian cancer syndrome.

“Most of the research thus far examined whether or not these procedures could actually prevent cancer and to what extent,” says Dr. Hartmann. “Now that we have evidence of the efficacy of the surgeries, there has been a shift toward looking at the psychological impact of these procedures on women. The studies that have been done thus far indicate that most women are satisfied with the choice that they make, but more research is needed to figure out how we can help them sort through their options in the most helpful manner.”

Journalists: Sound bites with Dr. Hartmann are available in the downloads.

Each year, more than 200,000 women in the U.S. are diagnosed with breast cancer, and more than 20,000 are diagnosed with ovarian cancer. Women who have hereditary breast and ovarian cancer syndrome have had either (or both) disease arise over and over again in their family tree. Mutations in BRCA1 and BRCA2 are the most common genetic defects in these women, though they are still responsible for only a minority of cases.

Women who carry BRCA1 and BRCA2 mutations are often lumped under the single heading BRCA1/2, as if they face the same risks and are susceptible to the same types of cancer. However, Drs. Hartmann and Lindor explain that the diseases spawned by mutations in these two genes can be very different. BRCA1 carriers face an average cumulative risk of 67 percent for breast cancer and 45 percent for ovarian cancer by age 80. For BRCA2 carriers, those average cumulative risks are 66 percent and 12 percent, respectively.

Most of the breast cancers that develop in BRCA1 carriers are high-grade, “triple-negative” breast cancers (negative for estrogen receptor, progesterone receptor and HER-2). In contrast, breast cancers in BRCA2 carriers are mostly ER-positive, like those seen in the general population. Dr. Hartmann says these differences have significant prognostic and treatment ramifications for these women, because risk-reducing medications are available for women with ER-positive disease but not for those with ER-negative disease.

In addition, ovarian cancer typically strikes earlier and with greater frequency in BRCA1 carriers than in BRCA2 carriers. Current guidelines recommend that BRCA1 and BRCA2 carriers who are done having children have their ovaries and fallopian tubes removed — through a procedure known as a salpingo-oophorectomy — between the ages of 35 and 40 years. The authors believe that women who are BRCA2 carriers can delay this procedure until they are 45 years of age, since their risk of ovarian cancer by 50 years of age is only one percent.

“Many of the studies we discuss were published recently, so we are taking advantage of the increased knowledge of the types of cancers that these women develop and the ages at which they occur to suggest how we can change our thinking around their management,” says Dr. Hartmann. “It is part of medicine today to try to individualize recommendations whenever possible.”

For women with strong family histories of breast and ovarian cancers in whom mutations in the BRCA genes are not present, consideration of testing rarer, less well-understood genes is now an option. Dr. Lindor says that women with mutations discovered in non-BRCA genes or those with no known mutations identified in their family at all face even more difficult decisions when it comes to clinical care as individual cancer risks and treatment benefits are often challenging to define.

To improve recommendations for high-risk women, Drs. Hartmann and Lindor propose future studies that investigate how women weigh their options and studies that follow the short- and long-term psychosocial and medical effects of women’s decisions to undergo surgery, take risk-reducing medications, or pursue surveillance. 

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About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call the Mayo Clinic Cancer Center clinical trials office at 1-855-776-0015 (toll-free).

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayoclinic or http://newsnetwork.mayoclinic.org.

 

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joedangor

Wed, Jan 27 at 11:00am EDT by @joedangor · View  

Mayo Clinic Cancer Center Endorses HPV Vaccination to Prevent Cancer

pills, needle, medicine for HPV Vaccine

Rochester, MINN. — Mayo Clinic Cancer Center has joined 68 other top cancer centers that have issued a statement urging for increased HPV vaccination to prevent cancer.

“The HPV vaccine is one of the bright spots in our work to prevent cancer,” says Robert Diasio, M.D., director of the Mayo Clinic Cancer Center. “Unfortunately, it is a tool that is being grossly underutilized, and we need to get the word out that this is an opportunity to save lives.”

According to the Centers for Disease Control and Prevention (CDC), HPV infections are responsible for approximately 27,000 new cancer diagnoses each year in the U.S. Several vaccines are available that can prevent most cervical, anal, oropharyngeal (middle throat) and other genital cancers; however, vaccination rates remain low across the U.S., with under 40 percent of girls and just over 21 percent of boys receiving the recommended three doses.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected]

Research shows there are a number of barriers to overcome to improve vaccination rates, including a lack of strong recommendations from physicians and parents not understanding that this vaccine protects against several types of cancer.

Experts from the National Cancer Institute (NCI), the CDC, American Cancer Society and more than half of the NCI-designated cancer centers met at a summit in Houston in November 2015 to discuss strategies for overcoming these barriers. The following statement was a major recommendation resulting from discussions at the summit:

NCI-designated cancer centers urge HPV vaccination for the prevention of cancer

Approximately 79 million people in the United States are currently infected with a human papillomavirus (HPV) according to the Centers for Disease Control and Prevention (CDC), and 14 million new infections occur each year. Several types of high-risk HPV are responsible for the vast majority of cervical, anal, oropharyngeal (middle throat) and other genital cancers. The CDC also reports that each year in the U.S., 27,000 men and women are diagnosed with an HPV-related cancer, which amounts to a new case every 20 minutes. Even though many of these HPV-related cancers are preventable with a safe and effective vaccine, HPV vaccination rates across the U.S. remain low.

Together we, the National Cancer Institute (NCI)-designated Cancer Centers, recognize these low rates of HPV vaccination as a serious public health threat. HPV vaccination represents a rare opportunity to prevent many cases of cancer that is tragically underused. As national leaders in cancer research and clinical care, we are compelled to jointly issue this call to action.

According to a 2015 CDC report, only 40 percent of girls and
21 percent of boys in the U.S. are receiving the recommended three doses of the HPV vaccine. This falls far short of the goal
of 80 percent by the end of this decade, set forth by the U.S. Department of Health and Human Service’s Healthy People 2020 mission. Furthermore, U.S. rates are significantly lower than those of countries such as Australia (75 percent), the United Kingdom (84-92 percent) and Rwanda (93 percent), which have shown that high vaccination rates are currently achievable.

The HPV vaccines, like all vaccines used in the U.S., passed extensive safety testing before and after being approved by the U.S. Food and Drug Administration (FDA). The vaccines have a safety profile similar to that of other vaccines approved for adolescents in the U.S. Internationally, the safety of HPV vaccines has been tested and approved by the World Health Organization’s Global Advisory Committee on Vaccine Safety.

CDC recommends that boys and girls receive three doses of HPV vaccine at ages 11 or 12 years. The HPV vaccine series can be started in preteens as early as age 9 and should be completed before the 13th birthday. The HPV vaccine is more effective the earlier it is given; however, it is also recommended for young women until age 26 and young men until age 21.

The low vaccination rates are alarming given our current ability to safely and effectively save lives by preventing HPV infection and its associated cancers. Therefore, the 69 NCI-designated Cancer Centers urge parents and health care providers to protect the health of our children through a number of actions:

  • We encourage all parents and guardians to have their sons and daughters complete the 3-dose HPV vaccine series before the 13th birthday, and complete the series as soon as possible in children aged 13 to 17. Parents and guardians should talk to their health care provider to learn more about HPV vaccines and their benefits.
  • We encourage young men (up to age 21) and young women (up to age 26), who were not vaccinated as preteens or teens, to complete the 3-dose HPV vaccine series to protect themselves against HPV.
  • We encourage all health care providers to be advocates for cancer prevention by making strong recommendations
for childhood HPV vaccination. We ask providers to join forces to educate parents/guardians and colleagues about the importance and benefits of HPV vaccination. 
HPV vaccination is our best defense in stopping HPV infection in our youth and preventing HPV-related cancers in our communities. The HPV vaccine is CANCER PREVENTION. More information is available from the CDC.

About Mayo Clinic Cancer Center
As a leading institution funded by the NCI, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call 1-855-776-0015 (toll-free).

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About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org.  

 

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joedangor

Tue, Jan 26 at 12:19pm EDT by @joedangor · View  

Smokers Who Quit More Than 15 Years Ago Need Screening

xray of lungs filled with tobacco cigarettes
ROCHESTER, Minn.  — Expanding lung cancer screening to include people who quit smoking more than 15 years ago could detect more cases and further reduce associated mortality, according to a study by Mayo Clinic researchers published in the Journal of Thoracic Oncology.

“A decline in smoking rates has been, and continues to be, a critical step to reduce lung cancer risk and deaths,” says the study’s lead author Ping Yang, M.D., Ph.D., an epidemiologist at Mayo Clinic Cancer Center. “But, it also means that fewer people have benefited from early detection of lung cancer, because more patients don’t qualify for low-dose CT scans.” The current lung cancer screening criteria set by the U.S. Preventive Services Task Force (USPSTF) recommends CT screening for adults between the ages of 55 and 80 who have smoked at least one pack a day for 30 years and are still smoking, or have quit within 15 years.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected] 

In a study published in JAMA in 2015, Dr. Yang and her colleagues found that two-thirds of patients in the U.S. with newly diagnosed lung cancer would not meet the current USPSTF screening criteria, suggesting a need to adjust the definition of patients at high risk.

In the current study, Dr. Yang and her colleagues set out to identify which specific populations of individuals are at risk, but are being missed by the current lung cancer screening criteria. Researchers retrospectively tracked two groups of people with lung cancer: a hospital cohort made up of 5,988 individuals referred to Mayo Clinic and a community cohort consisting of 850 residents of Olmsted County, Minnesota.

They found that, compared to other risk categories, patients who quit smoking for 15 to 30 years accounted for the greatest percentage of patients with lung cancer who didn’t qualify for screening. The newly defined high-risk group constituted 12 percent of the hospital cohort and 17 percent of the community cohort.

“We were surprised to find that the incidence of lung cancer was proportionally higher in this subgroup, compared to other subgroups of former cigarette smokers,” says Dr. Yang. “The common assumption is that after a person has quit for so many years, the lung cancer rate would be so low that it wouldn’t be noticeable. We found that assumption to be wrong. This suggests we need to pay attention to people who quit smoking more than 15 years ago, because they are still at high risk for developing lung cancer.”

Equally important, the current study found that expanding the criteria for CT screening would not significantly add to the number of false-positive cases and would save more lives with an acceptable amount of radiation exposure and cost. Dr. Yang and her colleagues showed that expanding the criteria to include this risk category could add 19 percent more CT examinations for detecting 16 percent more cases. They calculated the expansion would result in minimal increases in false-positive results (0.6 percent), over diagnosis (0.1 percent), and radiation-related lung cancer deaths (4 percent).

"Lung cancer rates are dropping, because smoking is decreasing, but that doesn’t mean that our current screening parameters are good enough,” Dr. Yang says. “It is understandable, because the relative importance of risk factors changes over time. We need to adjust screening criteria periodically, so we can catch more lung cancers in a timely fashion. Based on our data, which are more recent and come from a well-defined population, I think that we should take action to screen this group, which is at high risk of developing the disease.”

She recommends additional research to confirm if similar trends are being seen in populations beyond Olmsted County Minnesota.  If confirmed, she recommends that policymakers consider changing the lung cancer screening guidelines to include people who quit smoking more than 15 years ago. She also recommends that policymakers continue to re-examine lung cancer screening criteria to account for changes in groups that are most at risk.

Co-authors are:

  • Jason Wampfler, Mayo Clinic,
  • Shawn Stoddard, Mayo Clinic
  • David Midthun, M.D., Mayo Clinic
  • Yi Wang, M.D., Wenzhou Medical University, China
  • Dong Xie, M.D., Ph.D., Shanghai Pulmonary Hospital, China
  • Jun She, M.D., Ph.D., Shanghai Respiratory Institute, Fudan University, China

The study was supported by National Institutes of Health grants R03 CA77118, R01 CA80127 and R01 CA84354; by the Rochester Epidemiology Project grant R01 AG034676 and by grants from the National Institute on Aging and Mayo Clinic.

About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call 1-855-776-0015 (toll-free).

###

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayoclinic or http://newsnetwork.mayoclinic.org.

 

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joedangor

Mon, Jan 18 at 11:56am EDT by @joedangor · View  

Mayo Clinic Accepts Funds For Cancer Research from Telethon

Dr. Robert Diasio, on stage with ceremonial check from the 2015 5th District Eagles Cancer Telethon.Robert Diasio, M.D., director of the Mayo Clinic Cancer Center (center) joined leaders from the Masonic Cancer Center at the University of Minnesota and the Hormel Institute to jointly accept proceeds from the 2015 5th District Eagles Cancer Telethon. The presentation took place at the 2016 5th District Eagles Cancer Telethon on Saturday, January 16 at the Mayo Civic Center in Rochester, Minn.

Now in its 62nd year, the 5th District Eagles Cancer Telethon is a non-profit charity dedicated to raising funds to support cancer research in Minnesota. It is the longest locally run telethon in the United States with support coming from Eagles members and the public throughout southeastern Minnesota and beyond. For more information visit: http://www.eaglescancertelethon.org/

About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, the Mayo Clinic Cancer Center conducts basic, clinical and population science research, translating discoveries into improved methods for prevention, diagnosis, prognosis and therapy. For information on cancer clinical trials, call 1-855-776-0015 (toll-free).

###

About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or http://newsnetwork.mayoclinic.org/.

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joedangor

Nov 11, 2015 by @joedangor · View  

Prior Oral Contraceptive Use Associated with Better Outcome for Ovarian Cancer Patients

ROCHESTER, Minn. — Patients who develop ovarian cancer appear to have better outcomes if they have a history of oral contraceptive use, according to a study by Mayo Clinic researchers published in the current issue of the journal BMC Cancer.

woman holding pills shutterstock_322434785“Multiple studies from a variety of sources have indicated that oral contraceptives are associated with a reduced risk of ovarian cancer, one of the most deadly cancers in women,” says Aminah Jatoi, M.D., an oncologist at Mayo Clinic and co-lead author of the study. “However, few studies have explored the connection between the pill and outcomes in patients who ultimately develop the disease.”

In their study, Dr. Jatoi and co-author Ellen L. Goode, Ph.D., an epidemiologist at Mayo Clinic, examined the outcomes of ovarian cancer patients who were seen at Mayo Clinic from 2000 through 2013. Each patient was given a risk factor questionnaire about prior oral contraceptive use. Of the 1,398 patients who completed the questionnaire, 827 responded that they had previously taken birth control pills.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected] 

Journalists: Sound bites with Dr. Jatoi are available in the downloads.

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joedangor

Oct 28, 2015 by @joedangor · View  

Guidelines on Sharing Individual Genomic Research Findings with Family

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Recommendations balance research participant privacy with family need for health information

ROCHESTER, MINN. – A blue-ribbon project group funded by the National Institutes of Health has published the first consensus guidelines on how researchers should share genomic findings in research on adults and children with other family members. The recommendations, published in the Journal of Law, Medicine & Ethics, offer direction on sharing information before and after the death of an individual research participant.

“These recommendations will have an impact on future human subject protection policies when genetic research is performed,” says Gloria Petersen, Ph.D. of Mayo Clinic, who co-authored the guidelines with Susan Wolf, J.D., of the University of Minnesota, and Barbara Koenig, Ph.D. of the University of California, San Francisco.

The authors say the explosive growth of genomic research has led to tough questions about what to do with the resulting information. Should researchers share an individual’s private results with family members who may share that genetic risk? The question often pits individual privacy against family need.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, [email protected] 

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