What’s New in Breast Cancer Research and Treatment?

Criterium’s Academic Breast Cancer Consortium (ABRCC) is comprised of 15 renowned academic and community sites in North America, conducting translational research in Breast Cancer studies for major pharmaceutical companies who are working on the most current clinical trials for advanced treatments of breast cancer. While 2020 was a year dominated by COVID-19 news and tragedy, breast cancer research and breakthroughs can’t wait for COVID to “go away” – and research in this area continues on full-speed. Our ABRCC researchers reflect on 2020 and look ahead to 2021 with renewed hope.

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Podcast: ‘You Have to Personalize the Miracles’

For November’s Lung Cancer Awareness Month, Heather Smith and Melissa Turner share the stories of their cancer journeys. The women took very different routes to the CU Cancer Center and the world-renowned lung cancer care of Ross Camidge, MD. On this episode of the CU Anschutz 360 podcast, learn why they love everything about Dr. Camidge’s practice, especially the fact that he makes them laugh.

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Following NCCN Guidelines for Metastatic Breast Cancer Results in Lower Costs for Patients

Research from the O’Neal Comprehensive Cancer Center at UAB finds patients treated outside of NCCN Guidelines recommendations had significantly higher direct costs.

A new study from the O’Neal Comprehensive Cancer Center at University of Alabama at Birmingham (UAB), published in the October 2019 issue of JNCCN—Journal of the National Comprehensive Cancer Network, finds that direct costs for metastatic breast cancer (MBC) patients increase dramatically when their treatment differs from recommendations in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Previous studies have found that guideline discordant care results in higher health care costs overall1, but this is the first study to look specifically at the cost burden for patients.

“We thought that it was important to explore potential differences in out-of-pocket costs, since financial toxicity is a growing issue among patients with metastatic breast cancer,” explained Courtney P. Williams, MPH, Division of Hematology and Oncology, O’Neal Comprehensive Cancer Center at UAB. “We found about one in five women received an anticancer treatment that wasn’t listed within the NCCN Guidelines. Those women were responsible for higher out-of-pocket costs—including deductibles, coinsurance, and copayments—in the year following their metastatic breast cancer diagnosis than those receiving an anticancer treatment listed within the guidelines. This finding is especially important for older patients, which made up about 75 percent of our sample, since financial and psychological distress could be worse for patients living on a fixed income.”

The retrospective study used the SEER-Medicare database to look at patient costs for 3,709 women diagnosed with MBC between 2007 and 2013 who survived at least a year after diagnosis. Treatment regimens were matched to the version of the NCCN Guidelines® for Breast Cancer that were available at the exact treatment date. The definition of guideline-concordant care varied depending on date due to NCCN’s frequent guideline updates.

The median patient cost for the year post-diagnosis was $5,171 for care that fit within contemporary NCCN Guidelines, versus $7,421 for care that deviated from them. Both overtreatment and undertreatment—as defined by the guidelines—ultimately resulted in higher patient costs.

“The observation that out-of-pocket costs may be greater for guideline discordant care is important for both patients and physicians to understand, especially when many guideline discordant treatments may not improve clinical outcomes,” commented Matthew P. Goetz, MD, Mayo Clinic Cancer Center, Member of the NCCN Guidelines Panel for Breast Cancer, who was not involved in this study. “Clinical trials should be prioritized as a way to offer patients access to new drugs/treatments that might not otherwise be available to them, while limiting out-of-pocket expenses.”

Non-approved use of bevacizumab accounted for the highest increase in patient expenses, and was also associated with worse outcomes. The article cited this fact as a “cautionary tale for physicians who add novel agents without proven benefit to treatment regimens,” and argued that it might be better to provide no treatment, than to provide a “guideline-discordant treatment associated with mild but persistent and bothersome adverse events.”

“NCCN Guidelines exist to provide recommendations based on scientific evidence and expert opinion,” said Williams. “Although there will always be circumstances where off-guideline treatment is warranted, physicians should aim to comply with current guidelines for the safety of the patient, both physically and psychologically, as well as to decrease adverse outcomes such as financial toxicity.”

To read the entire study, visit JNCCN.org. Complimentary access to “Guideline Discordance and Patient Cost Responsibility in Medicare Beneficiaries with Metastatic Breast Cancer” is available until January 10, 2020.

About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. By defining and advancing high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers around the world.

Reprint by permission PRNewswire; Image courtesy of Pixabay Free License CC0

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Dr. John S. Macdonald Honored at 2018 Luminary Awards

John S. Macdonald, MD, is the Senior Medical Advisor for AGICC (Academic GI Cancer Consortium) and the consolidated Oncology Consortia of Criterium groups, including: AMyC (Academic Myeloma Consortium), ATOMIC (Academic Thoracic Oncology Medical Investigators Consortium) and ABRCC (Academic Breast Cancer Consortium). He is a leading supporter and advocate of the Translational Research methodology.

Dr. Macdonald was one of a few select honorees at The Ruesch Center for the Cure of Gastrointestinal Cancers Annual Luminary Awards on November 30th, 2018.

Dr. Macdonald successfully developed and led the Comprehensive Cancer Center at St. Vincent’s in New York City between 1997 and 2007. He is widely recognized as an industry and academic expert in gastrointestinal oncology and has written and lectured on the advantages of translational research. In addition to his responsibilities at Saint Vincent’s, Dr. Macdonald served as Chief of Medical Oncology there, and as the Lynn Wood Neag Endowed Professor of Medicine at the New York Medical College. He is acknowledged as a leading educator in Medical Oncology. 

Macdonald pioneered the use of chemoradiation after surgical resection of gastric cancers. This treatment regimen, aptly named the “Macdonald Regimen,” has helped turn the idea of a cure into a reality for thousands of patients with gastric cancers. This has also paved the way for the development of new treatment options for gastric cancers.  “[Macdonald] is a groundbreaking researcher, dedicated educator, and outstanding clinician,” said Sunnie Kim, MD, of the Ruesch Center for the Cure of Gastrointestinal Cancers, prior to presenting Macdonald with his award. “He has changed the lives of countless patients with some of the deadliest cancers.”

Dr. Macdonald has authored over 400 articles, abstracts and book chapters and has been both published in, and editor of, many prestigious medical journals. Macdonald has received numerous awards and distinctions, including being named among Good Housekeeping’s Best 300 Doctors in America and, over a seven-year period, New York magazine’s Best Doctors in New York.

Visit the website to see Dr. Macdonald’s profile and all the Consortia groups.

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Finding New Treatments for Breast Cancer with Brain Metastases

As if Breast Cancer or Brain Cancer alone were not enough to combat — patients with both now?have new hope in light of fledgling research that is showing progress.

Once breast cancer metastasizes into other areas of the body, particularly the brain, it becomes much more dangerous. And while the National Cancer Institute spends more than $500 million dollars per year on breast cancer research, only two to five percent of this funding goes to study how the disease spreads.

A clinical trial is open nationwide through the Academic Breast Cancer Consortium (ABRCC), giving access to an exciting novel drug therapy combination. The tucatinib, palbocilib and letrozole trial is coordinated by ABRCC and currently open for enrollment at the University of Colorado Cancer Center; University of Texas Health and Science Center in San Antonio, TX; Stony Brook University, NY; University of Arizona, Tucson, AZ; and University of New Mexico, Albuquerque, NM and will also be accruing patients at Northwestern University, Chicago, IL.

There are three well-established predictive markers of breast cancer. They are estrogen receptors (ER), progesterone receptors (PR), and the growth factor receptor HER2, these receptors may be blocked with targeted drugs to stop cancer growth. Breast cancers lacking these three markers are referred to as ?triple-negative? but clinicians and scientists are quickly learning more about cancers that have all three receptors, which are often called ?triple-positive.? There are treatments against each target individually, but when multiple drivers are present, as in ?triple-positive? breast cancer, blocking one often results in cancer nimbly switching to driving its growth with the other two.

The study combines tucatinib, which inhibits HER2, with letrozole targeting ER and PR hormone receptors, and the drug palbociclib, which targets CDK proteins that help cancer cells rush through the process of replication. The three had not been tried together until Elena Shagisultanova, MD, PhD, a breast cancer specialist at UCH, hypothesized there could be a way to target all three drivers at the same time with better results than targeting combinations of any two.

?When metastatic cancer spreads to the brain, it can be especially challenging,? says Dr Peter Kabos, the National Medical Director of the Academic Breast Cancer Consortium (ABRCC) and the Kabos Research Lab for Breast Cancer at UC Denver. ?Many medications aren?t effective in the brain, but exciting early clinical trial data for tucatinib shows that it may be one of the drugs that can penetrate the blood-brain barrier to combat brain metastases.

The trial is funded by the Pfizer ASPIRE Award in Breast Cancer Research. Cascadian Therapeutics and Pfizer are providing the study drugs tucatinib and palbociclib. For more information about trial eligibility and participation, contact brad.mackay@ucdenver.edu or emily.berens@ucdenver.edu

Article excerpted with permission from the University of Colorado Cancer Center blog — for the complete story, click here.

ABRCC Consortia MD Elena Shagisultanova Targets Treatment-Resistant Breast Cancer

Metastatic triple-positive breast cancer frequently resists treatments. Scientists at the University of Colorado Cancer Center are testing a unique combination of medications to change that.

Growth of breast cancer cells is often propelled by one of three receptors ? estrogen receptors (ER), progesterone receptors (PR) or the growth factor receptor called HER2. Treatments exist targeting each of these receptors individually. However, when all three receptors are present ? this ?triple-positive? breast cancer ? blocking any single receptor is not enough. ?Treatments that block hormonal (estrogen and progesterone) receptors may be not very effective because tumor cells may use HER2 receptor to grow. The drugs that block HER2 receptors may not work as well because the cells will use hormonal receptors to survive. Chemotherapy works against triple-positive breast cancers, however, it has multiple side effects. Previous clinical trials have been largely unsuccessful in defining a well-tolerated targeted drug combination that blocks all avenues for growth of triple-positive breast tumors.

?Under the current guidelines, patients with triple-positive metastatic breast cancer have two options as a first line of treatment and neither is a great option,? says Elena Shagisultanova, MD, PhD, investigator at the CU Cancer Center and assistant professor in the University of Colorado School of Medicine?s Division of Medical Oncology. ?One approach is to start an anti-hormonal pill, which is generally non-toxic. However, the response usually lasts only three to four months. The other choice is to start chemotherapy combined with HER-2 targeted agents. This option is effective, but it has multiple side effects.?

Shagisultanova is the principal investigator on the multi-institutional trial.? It is also?an investigator-initiated trial which allows physician/scientists to test treatments that their hands-on experience in the lab and clinic indicate may offer meaningful results. Shagisultanova believes she and CU Cancer Center colleagues may have another option: a regimen using three pills, each targeting a different pathway of the disease. The?trial combines tucatinib, which inhibits HER2, with letrozole targeting hormone receptors, and the CDK4/6 inhibitor palbociclib.

?We think hormone receptor and HER-2 signals are coming together to help cancer cells resist treatment,? says Shagisultanova. ?The CDK4/6 inhibitor palbociclib can block these converging signals in the nucleus. We believe that if we can inhibit the signaling deeper in the tumor cell using this triple blockade, patients will have longer lives and better quality of life.? ?Tucatinib, palbociclib and letrozole tend to have different side-effects, leading Shagisultanova to believe the triple combination of targeted agents will be well- tolerated.

Early clinical trials often exclude patients whose cancer has already metastasized to the brain, in large part due to the inability of anti-cancer drugs to penetrate the blood-brain barrier to reach the disease in the central nervous system. However, because tucatinib has proven effective in shrinking HER2-positive breast tumors that have spread to the brain, patients with brain metastases are, in fact, included in the current trial.

?Metastatic disease in the brain is one of the most dangerous complications of triple-positive breast cancer. If we can prevent development of brain metastases, or effectively treat metastatic disease in the brain, it will improve the lives of many patients,? Shagisultanova says.? ?There are many challenges in designing and delivering clinical trials,? says Christopher Lieu, MD, CU Cancer Center?s deputy associate director for clinical research. Lieu also leads CU Cancer Center?s efforts in further developing an Investigator-Initiated Trials Committee.

?We are fortunate at CU Cancer Center to have innovative clinicians who are analyzing data to find novel and innovative strategies to target malignancies that are in serious need of better therapies,? Lieu adds.? ?Trials like this one are critical in moving cancer science forward and finding effective, non-toxic therapies.?

This trial is currently open for enrollment at the ABRCC Consortia Academic sites of: University of Colorado Cancer Center, Northwestern University, Chicago, IL; University of Texas Health and Science Center in San Antonio, TX; Stony Brook University, NY; University of Arizona, Tucson, AZ, and University of New Mexico, Albuquerque, NM.

The trial is funded by the Pfizer ASPIRE Award in Breast Cancer Research. Cascadian Therapeutics and Pfizer are providing the study drugs tucatinib and palbociclib.

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Cancer Deaths Decline Again in US

Death rates from cancer in the United States dropped again between 2014 and 2015, continuing a downward trend that began in 1991 and has meant 2.4 million fewer deaths.

Advances in early detection and treatment, along with a drop in smoking, are believed to be responsible for much of the 26 percent drop since 1991, said the findings in the American Cancer Society’s comprehensive annual report. “This new report reiterates where cancer control efforts have worked, particularly the impact of tobacco control,” said Otis W. Brawley, chief medical officer of the American Cancer Society.

“A decline in consumption of cigarettes is credited with being the most important factor in the drop in cancer death rates.”? However, he noted that “tobacco remains by far the leading cause of cancer deaths today, responsible for nearly three in 10 cancer deaths.”

Overall, the US cancer death rate reached a peak of 215.1 per 100,000 population in 1991, and has declined to 158.6 per 100,000 in 2015.

Deaths from lung cancer made a 45 percent decline among men and 19 percent among women.? Cancers of the breast, prostate and colon and rectum are also down steeply. The report forecasts about 1.7 million new cancer cases and 609,640 cancer deaths in the United States in 2018. “Over the past decade, the overall cancer incidence rate was stable in women and declined by about two percent per year in men,” it said.

While progress is evident, stark racial disparities remain. The cancer death rate in 2015 was 14 percent higher in blacks than in whites, down from a peak of 33 percent in 1993.

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Displayed with permission from AFP, usage courtesy of RePubHub license; Image courtesy of Pixabay by alisea_30 under CC0 License.

New Report: Breast Cancer Fatalities Plummet 40%

The American Cancer Society says women face a one-in-eight chance of getting breast cancer and more than 40,600 will succumb this year in the U.S. from the disease.

But improved treatments and early detection are producing promising results, because fatalities from the cancer have dropped almost 40 percent between 1989 and 2015.? That, according to a new report released by ACS, saved some 322,600 lives.? While breast cancer rates increased from 1975 to 1989, the study notes, the fatality rates have dramatically decreased, dropping an actual 39 percent over that period.

The results confirm a steady downward trend over recent years.? Advances in chemotherapy regimens that were developed in the 1980s, the introduction of new drugs like tamoxifen and Herceptin, and early detection through mammograms have reduced the likelihood of breast cancer patients dying from the disease, the report notes.

Breast cancer is the most common cancer diagnosed among U.S. women and is the second leading cause of cancer death among women after lung cancer, according to ACS.? The American Cancer Society publishes the “Breast Cancer Statistics” report every two years to track the latest trends in breast cancer incidence, mortality, survival and screening by race/ethnicity in the United States, as well as state variations in these measures.

The report reveals that black women continue to have higher breast cancer death rates than whites nationally. “Non-Hispanic white and non-Hispanic black women have higher breast cancer incidence and death rates than women of other race/ethnicities; Asian/Pacific Islander (API) women have the lowest incidence and death rates,” the report states. “Although the overall breast cancer incidence rate during 2010 through 2014 was slightly lower in non-Hispanic black women than in non-Hispanic white, the breast cancer death rate during 2011 through 2015 was 42 percent higher in NHB women than in NHW women.”

The report also links the physiology of black and white women to the discrepancy, noting that black women do not benefit from the development of tamoxifen because they are less inclined to have the type of breast cancer known as “estrogen-receptor positive” that the drug alleviates.? In addition, black women are twice as likely as white women to develop “triple negative breast cancer,” which can be more difficult to treat, the report noted.

But the black-white disparity is stabilizing.? There were no significant differences in breast cancer death rates between black and white women in seven states, according to the study, while Massachusetts, Connecticut, and Delaware had similar rates, suggesting equitable breast cancer outcomes are feasible.

“A large body of research suggests that the black-white breast cancer disparity results from a complex interaction of biologic and nonbiologic factors, including differences in stage at diagnosis, tumor characteristics, obesity, other health issues, as well as tumor characteristics, particularly a higher rate of triple negative cancer,” lead author of the report, Carol DeSantis said.? “But the substantial geographic variation in breast cancer death rates,” she continued, “confirms the role of social and structural factors, and the closing disparity in several states indicates that increasing access to health care to low-income populations can further progress the elimination of breast cancer disparities.”

By Alicia Powe, Displayed with permission from WND via RePubHub; Chart Courtesy of Nat’l Center for Health Statistics/CDC

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