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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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Tue, Feb 28 at 1:01pm EDT by @joedangor · View  

Mayo Clinic to participate in live celebrity broadcast to promote need to increase colorectal cancer screening rates

Colon cancer polyp illustrationROCHESTER, Minn. – Mayo Clinic has joined Fight Colorectal Cancer, the American Cancer Society, and the National Colorectal Cancer Roundtable to highlight the need to increase colorectal cancer screening rates and raise awareness during Colorectal Cancer Awareness Month. The groups are collaborating on a live web broadcast from the Hard Rock Café in Times Square in New York City on Wednesday, March 1, from 1 to 3 p.m. EST. The Facebook Live broadcast will include Katie Couric, actor Luke Perry, country music artist Craig Campbell and professional racecar driver Scott Lagasse Jr. The celebrities will share their personal connections to colorectal cancer alongside survivors and medical professionals.

"Colorectal cancer is the second-leading cause of cancer deaths when men and women are combined, but the disease can often be prevented or detected early through screening," says Mayo Clinic gastroenterologist Paul Limburg, M.D., who will participate in the live broadcast. Dr. Limburg encourages people to discuss colorectal cancer screening with their physicians. He 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.

Dr. Limburg will interview celebrity participants on the “Blue Carpet” from 1 to 1:30 p.m. EST in a live broadcast on Mayo Clinic’s Facebook page. The formal program, which begins at 2 p.m. EST, will be streamed from the Countdown to 2018 site and on the Fight Colorectal Cancer Facebook page.

The live broadcast also will highlight the organizers' shared goal that 80 percent of eligible adults 50 years or older get screened annually for colorectal cancer by 2018.

The National Colorectal Cancer Roundtable launched the 80% by 2018 campaign in 2014, and, today, more than 1,300 organizations across the country have pledged to support this public health goal.

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About Fight Colorectal Cancer
Fight Colorectal Cancer is a national nonprofit advocacy organization fighting for a cure. It was founded in 2005 by Nancy Roach, a nationally recognized patient advocate who witnessed the need for colorectal cancer advocacy after her mother-in-law’s diagnosis. The organization plays an important role in rallying colorectal cancer advocates to action. Fight Colorectal Cancer is known for activism and patient empowerment throughout patient, academic, political, scientific, medical and nonprofit communities. With a mission focused on advocacy, research, patient education and awareness, the organization serves advocates in every state of the U.S. and many countries around the world. To learn more, visit fightcrc.org.

About the American Cancer Society
The American Cancer Society is a global grass-roots force of 2 million volunteers saving lives in every community. As the largest voluntary health organization, the society's efforts have contributed to a 23 percent decline in cancer death rates in the U.S. since 1991 and a 50 percent drop in smoking rates. The society is finding cures as the nation's largest private, not-for-profit investor in cancer research, ensuring people facing cancer have the help they need and continuing the fight for access to quality health care, lifesaving screenings and more. For more information, to get help, or to join the fight, call the society anytime at 1-800-227-2345 (toll-free), or visit cancer.org.

About the National Colorectal Cancer Roundtable
The National Colorectal Cancer Roundtable was established by the American Cancer Society and the Centers for Disease Control and Prevention in 1997. The roundtable is a national coalition of public, private and voluntary organizations whose mission is to advance colorectal cancer control efforts by improving communication, coordination and collaboration among health agencies, medical-professional organizations and the public. The ultimate goal of the roundtable is to increase the use of proven colorectal cancer screening tests among the entire population for whom screening is appropriate. Visit nccrt.org for more information.

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/.

MEDIA CONTACT
Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

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Wed, Feb 8 at 10:00am EDT by @joedangor · View  

Mayo Clinic researchers quantify immune cells associated with future breast cancer risk

Concept of biochemistry with dna molecule on blue backgroundROCHESTER, Minn. – Researchers from Mayo Clinic have quantified the numbers of various types of immune cells associated with the risk of developing breast cancer. The findings are published in a study in Clinical Cancer Research.

"This is the first study to quantify the numbers of various immune cell types in breast tissue and whether they are associated with later breast cancer risk," says the study's lead author, Amy Degnim, M.D., a breast surgeon at Mayo Clinic. "Our findings provide evidence that the immune system may have an important role in promoting or inhibiting breast cancer development in its very earliest stages." In addition, Dr. Degnim says the findings provide researchers with greater confidence that immune-related approaches to breast cancer prevention, such as vaccines, may be useful.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

Dr. Degnim and her colleagues studied quantitative differences in immune cell types between normal breast tissue from donors and breast tissue from donors with benign breast disease, a non-cancerous lump or thickening of breast tissue. They designed a breast tissue matched case control study using samples from the Susan G. Komen for the Cure Tissue Bank and women diagnosed with benign breast disease at Mayo Clinic who subsequently developed cancer or remained cancer-free.

Researchers found that, compared to normal breast tissue, breast tissue with benign breast disease had greater numbers of several types of immune cells, especially dendritic cells and macrophages that work together to create an immune response, says Dr. Degnim. She says women who later developed breast cancer showed lower amounts of antibody-producing immune cells, known as B cells, in their breast tissue, which supports the hypothesis that the immune system may play an important role in early breast cancer development.

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About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, 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).

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, Jan 18 at 1:00pm EDT by @joedangor · View  

Mayo Clinic enrolls first patient in phase 1 study of orally delivered capsule to treat recurrent Clostridium difficile infection

Illustration of Human Digestive SystemROCHESTER, Minn. – Mayo Clinic announced today that it has enrolled the first patient in a phase one study of a unfrozen oral capsule formulated to treat Clostridium difficile infection.

The capsule is formulated to rehabilitate the human gut microbiome delivering a broad spectrum of live microbes into the patient's intestinal tract. The gut microbiome hosts trillions of microbes that live in harmony with their human host and perform processes vital for health.

“New therapies are urgently needed to prevent recurrent C-diff, a debilitating, costly and potentially life-threatening infection," says Sahil Khanna, M.B.B.S., a gastroenterologist at Mayo Clinic and principal investigator on the study. He says the study will enroll approximately 20 patients in a prospective, two-arm, phase-one, safety assessment and dosing study at Mayo Clinic’s Rochester campus.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

“C-diff infections are an increasingly difficult-to-resolve intestinal infection that cause about 29,000 deaths annually in the U.S.,” says Dr. Khanna.

Dr. Khanna says potential advantages to providing an oral capsule for treatment that is stable at room temperature include flexibility in dosing and at-home treatment. Currently, patients seeking treatment must travel to a medical center for a fecal transplant procedure that involves the placement of live microbes into the patient's body in a procedure similar to a colonoscopy.

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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, Jan 11 at 11:02am EDT by @joedangor · View  

Mayo Clinic Cancer Center endorses updated HPV vaccine recommendations

a health care provider with gloves on giving a person an injection in the upper armROCHESTER, Minn. — Mayo Clinic Cancer Center today joined with 69 National Cancer Institute-designated cancer centers in issuing a joint statement supporting updated HPV vaccination guidelines from the Centers for Disease Control and Prevention (CDC).

"The HPV vaccine is a proven way to prevent certain types of cancer, but it's not being used widely enough," says Robert Diasio, M.D., director of the Mayo Clinic Cancer Center. "We want people to know this is an opportunity to prevent cancer and save lives."

According to the CDC, incidence rates of HPV-associated cancers have continued to rise, with approximately 39,000 new HPV-associated cancers now diagnosed each year in the U.S. Although HPV vaccines can prevent most cervical, anal, oropharyngeal (middle throat) and other genital cancers, vaccination rates remain low across the U.S. Just 41.9 percent of girls and 28.1 percent of boys complete the recommend vaccine series.

The new guidelines from the CDC recommend that children 11―12 should receive two doses of the HPV vaccine at least six months apart. Adolescents and young adults older than 15 years should continue to complete the three-dose series.

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.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

"As a gynecologic oncologist, I care for women with cervical cancer, a cancer caused almost exclusively by HPV infection," says Jamie Bakkum-Gamez, M.D., of Mayo Clinic. "Preventing this cancer, which can be done by vaccinating against HPV, will protect women from the morbidity and lethality of the cancer and its therapy. The extensive cancer treatments that are needed to treat cervical cancer eliminate fertility, cause permanent tissue damage and don’t promise a cancer cure." Dr. Bakkum-Gamez says the best defense against cancers caused by HPV is to vaccinate girls and boys against HPV according to the new guidelines.

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About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, 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).

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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Mon, Jan 9 at 8:47am EDT by @joedangor · View  

Mayo Clinic researchers identify new potential treatment for cancer metastasis

Cancer cell in human bodyROCHESTER, Minn. — Breast cancer metastasis, the process by which cancer spreads, may be prevented through the new use of a class of drugs already approved by the U.S. Food and Drug Administration. Mayo Clinic researchers have identified that a key drug target, CDK4/6, regulates a cancer metastasis protein, SNAIL, and drugs that inhibit CDK 4/6 could prevent the spread of triple-negative breast cancer. This is the finding of a paper published online in the Dec. 9 issue of the journal Nature Communications. CDK4/6 inhibitors are approved for treating estrogen positive breast cancer, but not triple-negative breast cancer.

“Metastasis is a hallmark of cancer and a leading cause of cancer death,” says the study's senior author, Zhenkun Lou, Ph.D., of Mayo Clinic. “Despite great progress in cancer therapy, the prevention of cancer metastasis is still an unfulfilled challenge.”

For this study, Dr. Lou and his colleagues focused on triple-negative breast cancer, which is difficult to treat, because it does not exhibit receptors for estrogen, progesterone or the HER-2/neu gene, which are targets for many current breast cancer treatments.

“Prior published data suggested that CDK 4/6 inhibitors were not effective in reducing the growth rates of estrogen receptor negative breast cancer,” says Dr. Lou. “Our data confirmed that, while the rate of growth of triple-negative breast cancer was not affected by CDK 4/6 inhibitors, this class of drugs was able to significantly inhibit the spread of triple-negative breast cancer to distant organs when tested in multiple different triple-negative breast cancer models, including patient-derived xenografts.” Patient-derived xenographs involve the implantation of tumor tissue into an immunodeficient mouse which becomes an avatar to help identify which drug or drug combinations are most likely to be effective for an individual cancer patient.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

Dr. Lou cautions that more research is necessary, however. If his findings are corroborated, it would be an important discovery that could expand the use of CDK 4/6 inhibitors to prevent the metastasis of many other cancers that exhibit a high level of the SNAIL protein.

“These findings may provide a new treatment for the prevention of cancer metastasis,” says study co-author Matthew Goetz, M.D., an oncologist and co-leader of the Women’s Cancer Program at Mayo Clinic. “Mayo Clinic is now developing new studies that will focus on the role of CDK 4/6 inhibitors and their potential to inhibit cancer metastasis in women with triple-negative breast cancer who are at highest risk for cancer metastasis.”

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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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Dec 12, 2016 by @joedangor · View  

Enzyme that regulates DNA repair may offer new precision treatments for breast and ovarian cancer

Digital illustration DNA structureROCHESTER, Minn. — Researchers at Mayo Clinic have identified an enzyme called UCHL3 that regulates the BRCA2 pathway, which is important for DNA repair. Results of this research are published online in Genes & Development.

“DNA encodes the blueprints for our body, and DNA repair is a fundamental mechanism to prevent the accumulation of mutations in DNA and human disease,” says senior author Zhenkun Lou, Ph.D., a molecular pharmacologist at Mayo Clinic.

“The BRCA2 pathway is important for DNA repair, and mutation of the BRCA2 gene is linked to increased cancer risk, especially breast cancer and ovarian cancer.”

Dr. Lou says UCHL3 is highly expressed in some cancers, and mutated or deleted in other cancers. Cancer cells with high UCHL3 expression are resistant to chemotherapy; whereas, cancer cells with low UCHL3 are more sensitive to chemotherapy. Therefore, the expression of UCHL3 could be a guide to develop more precise cancer therapy.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

“UCHL3 could be a potential therapeutic target to overcome resistance to chemotherapy in cancer cells that have a high level of UCHL3,” Dr. Lou says. He says UCHL3 gene also could be developed into a biomarker in the clinic to guide precision medicine.

“While more research is needed, our studies may provide a novel therapeutic venue to treat women’s cancer and thereby contribute to the health and welfare of women,” says Dr. Lou.

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About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, 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).

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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Dec 7, 2016 by @joedangor · View  

Mayo Clinic research helps refine role of gene variants in breast cancer risk

a graphic illustrating the concept of breast cancer genomicsROCHESTER, Minn. — Inherited pathogenic variants in protein coding genes BARD1 and RAD51D increase a woman’s likelihood of developing breast cancer, according to research conducted at Mayo Clinic and presented today at the 2016 San Antonio Breast Cancer Symposium. Pathogenic variants are changes in DNA that have a negative impact on a gene’s ability to function properly.

“The BARD1 and RAD51D genes, have been included in clinical testing panels to determine breast cancer risk,” says Fergus Couch, Ph.D., a geneticist at Mayo Clinic and lead author of the study. “However, the genes were identified as 'breast cancer' genes through very small studies, so there has never been strong evidence indicating that they are important in driving breast cancer risk.”

Dr. Couch and his colleagues studied data from 65,000 women with breast cancer to obtain risk estimates associated with 21 cancer predisposition genes from testing panels. They found that pathogenic variants in certain genes, such as BARD1 and RAD51D, caused moderately increased risks of breast cancer. These researchers also confirmed the involvement of the ATM, CHEK2 and PALB2 genes in breast cancer. They also found that the RAD50 and MRE11A genes did not increase risks of breast cancer.

“Our findings are important, because genes that do not increase risk of breast cancer can now be ignored and potentially removed from clinical testing panels,” Dr. Couch says. “I am hopeful this work will lead to much better interpretation of results from clinical, hereditary [and] genetic testing.”

Dr. Couch's research included data supplied by Ambry Genetics. Dr. Couch has no relevant financial disclosures.

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About Mayo Clinic Cancer Center
As a leading institution funded by the National Cancer Institute, 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).

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/.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

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Oct 17, 2016 by @joedangor · View  

Pregabalin may lessen pain from irritable bowel syndrome, Mayo Clinic study finds

Multi-racial man with stomach painROCHESTER, Minn. — A pilot study by researchers at Mayo Clinic has found that patients suffering from pain related to irritable bowel syndrome (IBS) may benefit from taking pregabalin, a neuro-pain inhibitor commonly used to treat fibromyalgia. The results of the study were presented today at the annual meeting of the American College of Gastroenterology in Las Vegas.

“There currently are limited treatment options available to fight the abdominal pain associated with IBS,” says Yuri Saito Loftus, M.D., the study's author. “We theorized that pregabalin could potentially be helpful.”

Dr. Saito-Loftus and her colleagues followed 85 patients with IBS who reported high levels of abdominal pain. These patients ranged in age from 18 to 70 years. The placebo-controlled study lasted 12 weeks. Patients who received pregabalin reported significant improvement in pain management, compared to those who received a placebo. Preliminary data also showed improvement in other IBS symptoms, including bloating and diarrhea.

Dr. Saito Loftus cautions that, because the study is small, the results are not definitive. “Our study does provide preliminary evidence that pregabalin may be an additional treatment option for patients with IBS who have failed other treatment options, but more research is needed,” Dr. Saito Loftus says.

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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/.

MEDIA CONTACT:
Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, 
newsbureau@mayo.edu

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Oct 12, 2016 by @joedangor · View  

Mayo Clinic and Massachusetts Institute of Technology receive grant to support physical sciences-oncology center

computer display of a brain scanROCHESTER, Minn. — Mayo Clinic and the Massachusetts Institute of Technology (MIT) have been awarded a five-year, $9.7 million grant from the National Cancer Institute (NCI) to support a Physical Sciences-Oncology Center (PS-OC). Researchers hope to learn more about the physical parameters that limit drug delivery into brain tumors and use this information to build models that will help physicians better predict how the body will distribute a particular drug to brain tumors and help them select the best drug to treat each patient based on their unique tumor.

Mayo Clinic and MIT are among 10 institutions selected to participate in the NCI Physical Sciences-Oncology Network. The network supports innovative ideas that blend perspectives and approaches from the physical sciences, engineering, and cancer research, with the goal of improving the understanding of cancer biology and oncology.

“The most common types of malignant brain tumors — brain metastases originating from cancers outside of the brain, and glioblastoma — have regions that are protected from most drugs,” says co-principal investigator Jann Sarkaria, M.D., of Mayo Clinic. “Low-level drug exposure in these regions can promote drug resistance and that may be why there have been no new effective drug treatments for brain tumors in more than a decade.”

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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 clinical trial referral office at 1-855-776-0015 (toll-free).

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/.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

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Oct 5, 2016 by @joedangor · View  

Mayo Clinic researchers map prostate cancer relapse using C-11 choline PET and MRI

Image of prostate and C-11 choline PET scan
ROCHESTER, Minn. – A team of Mayo Clinic researchers has, for the first time, successfully mapped patterns of prostate cancer recurrence, following surgery. Using C-11 choline PET imaging and multiparametric MRI, researchers found an anatomically diverse pattern of recurrence, which may help optimize treatment of patients whose prostate cancer returns after surgery. The research findings are published today in the Journal of Urology.

“This study has important implications for men who have a rising prostate-specific antigen (PSA) test, also known as biochemical recurrence, after radical prostatectomy for prostate cancer,” says Jeffrey Karnes, M.D., a urological surgeon at Mayo Clinic. “In men with biochemical recurrence, determining where the disease has recurred is quite challenging, especially when the PSA level is low.”

According to Dr. Karnes, in the U.S., approximately 30 percent of patients who have had an initial prostate cancer surgically excised will suffer a recurrence and seek treatment. “Current imaging tests like conventional bone and CT scans are not sensitive enough to identify sites of recurrence, especially when the PSA value is lower than 10,” he says.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, newsbureau@mayo.edu

Dr. Karnes says the combination of C-11 choline PET scanning and multiparametric MRI, helps physicians accurately identify sites of recurrence at an average PSA of 2. More importantly, he says, “This type of staging allows us to identify sites of recurrent disease that can be potentially treated either surgically or with radiation.”

Dr. Karnes and his team also were able to describe patterns of prostate cancer recurrence. They found that nearly two-thirds of men in the study had recurrence limited to the pelvis, which potentially can be targeted for radiation therapy.

Co-authors are:

Ilya Sobol, M.D.

Harras Zaid, M.D.

Rimki Haloi

Lance Mynderse, M.D.

Adam Froemming, M.D.

Val Lowe, M.D.

Brian Davis, M.D., Ph.D.

Eugene Kwon, M.D.

All authors are from Mayo Clinic

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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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Sep 27, 2016 by @joedangor · View  

Mayo Clinic physicians present research findings at 2016 ASTRO Annual Meeting

Cancer radiotherapyROCHESTER, Minn. — Mayo Clinic physicians will present findings at the 2016 American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting Sept. 25-28 in Boston. Key Mayo Clinic-led studies include: 

Radiosurgery, not whole-brain radiotherapy should be the standard of care following surgical resection of metastatic brain tumors

Embargoed until Sunday, Sept. 25, at 3:15 p.m. EDT

Radiosurgery to the surgical cavity following surgery to remove metastatic brain tumors is effective in killing residual cancer and results in fewer cognitive problems and better quality of life than whole-brain radiotherapy, according to the results of a phase III, multi-institutional, cooperative group study presented today at the 2016 ASTRO annual meeting.

“This trial confirms radiosurgery to the surgical cavity is a viable treatment and should be one of the standards of care after resection of brain metastases,” says lead author Paul Brown, M.D. a radiation oncologist at Mayo Clinic. “We found no difference in survival whether a patient receives postoperative radiosurgery or whole-brain radiotherapy; however, radiosurgery avoids the cognitive damage caused by whole-brain radiotherapy and other unpleasant side effects, such as hair loss, fatigue and skin redness.” Dr. Brown adds that recovery after radiosurgery is typically shorter than with whole-brain radiotherapy, so patients can restart systemic therapies such as chemotherapy sooner.

 

Effective treatments for mouth sores caused by radiation therapy

Embargoed until Sunday, Sept. 25, at 3:15 p.m. EDT

Pain from oral mucositis, or mouth sores, in patients receiving radiation therapy for cancers of the head and neck was significantly reduced by an oral rinse of doxepin and an oral rinse containing diphenhydramine, lidocaine and antacids, known as Magic Mouthwash, compared to a placebo. These were the findings of a three-arm, multi-institution, randomized, double blind, placebo-controlled, phase III trial, led by Robert Miller, M.D., a radiation oncologist at Mayo Clinic. Dr. Miller presented his findings at today at the 2016 ASTRO annual meeting.

“We published a study in 2012 showing that an oral rinse of doxepin reduced oral mucositis-related pain, compared to placebo,” says Dr. Miller. “However, there were no large randomized controlled trials studying the potential benefits of Magic Mouthwash.”

Dr. Miller and his colleagues studied 275 patients between November 2014 and May 2016 and found that pain related to oral mucositis was significantly less following both doxepin and Magic Mouthwash rinses versus placebo. They also found that both doxepin and magic mouthwash rinses were well tolerated by patients.

 

Researchers identify specific sites of prostate cancer recurrence following radiation therapy using C-11 choline positron emission tomography scanning

Embargoed until Tuesday, Sept. 27, at 4:45 p.m. EDT

A team of Mayo Clinic researchers have used C-11 choline positron emission tomography scanning (CholPET) to identify anatomic patterns of prostate cancer recurrence in patients who have a rising prostate-specific antigen level (PSA) after having received radiation therapy to treat their cancer. Researchers found that most recurrences were localized to the pelvis (prostate and or surrounding tissue). Using these data, they were able to generate a tool that estimates the risk of recurrence outside of the pelvis. This information may be an aid in clinical decision -making.

“Management of recurrent prostate cancer after radiation therapy depends on accurately identifying the site of the recurrent disease,” says William Parker, M.D., a urologic oncology resident at Mayo Clinic. “We found that CholPET identified the site of recurrence in 87 percent of patients who had a rising PSA after radiation therapy, most of whom had disease that could potentially benefit from further salvage therapy. Our findings underscore the importance of advanced imaging in tailoring a treatment plan for patients who have a rising PSA following primary radiation therapy.”

 

C-11 choline positron emission tomography (PET) scanning useful in locating prostate cancer recurrence following surgery and radiation therapy.

Embargoed until Tuesday, Sept. 27 4:45 pm ET

Using C-11 choline positron emission tomography, Mayo Clinic investigators observed very few sites of prostate cancer recurrence within prostate bed of patients who had previously undergone prostatectomy followed by either salvage or adjuvant radiotherapy. This is the finding of a study presented today at the 2016 ASTRO annual meeting by Jaden Evans, M.D., a radiation oncology resident at Mayo Clinic.

“C-11 Choline PET scanning is a useful means of evaluating sites of prostate cancer recurrence following radiation therapy,” says Dr. Evans. "It provides an opportunity to improve our ability to locate disease recurrence and hopefully an earlier stage in disease progression when the burden of disease is lower."

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284 5005, newsbureau@mayo.edu

Researchers studied more than 2800 patients with prostate cancer who were scanned using CholPET between 2008 and 2015. 391 patients had previously received either definitive, adjuvant, salvage or palliative radiotherapy. Of these patients, researchers identified 41 patients who had undergone prostatectomy followed by prostate bed only radiotherapy and who subsequently experienced a biochemical relapse with at least one site of recurrence identified by CholPET.

Researchers examined sites of recurrence with respect to radiation fields and patient anatomy. Researchers noted that the majority of recurrence sites occurred in lymph nodes outside of the previously irradiated field.

“Perhaps our most compelling observation in this cohort was very few in-field sites of recurrence,” says Dr. Evans. “We interpret these findings as evidence that post-prostatectomy radiotherapy is effective.”

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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 clinical trial referral office at 1-855-776-0015 (toll-free).

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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Sep 7, 2016 by @joedangor · View  

The Mayo Clinic Cancer Center participates in NCI-MATCH clinical trial

Scientists examined DNA gel that is used in genetics, medicine, biology, pharma research and forensics.ROCHESTER, Minn. — The Mayo Clinic Cancer Center has announced it is participating in the National Cancer Institute’s Molecular Analysis for Therapy Choice clinical trial, also known as NCI-MATCH or study EAY131. The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive cancer center with locations in Rochester, Minnesota, Phoenix, Arizona, and Jacksonville, Florida. All three locations are participating.

“NCI-MATCH is a phase II precision medicine trial that seeks to determine whether matching certain drugs or drug combinations in adults whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of their cancer type,” says Robert Diasio, M.D., director of the Mayo Clinic Cancer Center. “We are proud to participate in this unique cancer treatment trial because it is the largest, most scientifically rigorous precision medicine cancer trial to date.”

Precision medicine refers to the tailoring of treatment based on the characteristics of each individual. Treatment focuses on molecular abnormalities instead of the organ site of the cancer.

For more information on NCI-MATCH, contact the Mayo Clinic Cancer Center clinical trial referral office at 1-855-776-0015 (toll-free). For information on additional participating sites, visit the NCI website.

About NCI-MATCH
NCI-MATCH was co-developed by the National Cancer Institute, part of the National Institutes of Health and the ECOG-ACRIN Cancer Research Group, one of five NCI National Clinical Trials Network groups.

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/.

MEDIA CONTACT: Joe Dangor, Mayo Clinic Public Affairs, 507-284-5005, newsbureau@mayo.edu

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joedangor

Aug 8, 2016 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, newsbureau@mayo.edu

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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joedangor

Aug 3, 2016 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, newsbureau@mayo.edu

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

Jul 28, 2016 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, newsbureau@mayo.edu

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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joedangor

Jul 27, 2016 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, newsbureau@mayo.edu

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

Jul 26, 2016 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, newsbureau@mayo.edu

“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

Jun 29, 2016 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, newsbureau@mayo.edu

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

Jun 17, 2016 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, newsbureau@mayo.edu

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 Twitter @ExactSciences, 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

May 26, 2016 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, newsbureau@mayo.edu

“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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