ASCO (American Society of Clinical Oncology) is a professional organization representing physicians of all oncology sub-specialties who care for people with cancer. ASCO’s mission is to conquer cancer through research, education, and promotion of the highest quality patient care. ASCO’s vision is a world where cancer is prevented or cured, and every survivor is healthy.
Members meet annually at the ASCO Annual Meeting. It offers informative educational and scientific sessions that highlight the latest in cancer care treatments. This year’s meeting was June 1st-5th, 2018 in Chicago, Illinois.
Debra Patt, MD MPH MBA
Executive Vice President, Policy and Strategic Initiatives, Texas Oncology
Chair, Breast Cancer, US Oncology Pathways Task Force
Director, Analytics, McKesson Specialty Health
Director of Breast Health, Division of Women’s Health, Dell Medical School
We appreciate Dr. Patt for sharing highlights from this year’s annual meeting:
While every year I hate to miss the wonderful Art Bra Austin event, I am returning from the ASCO 2018 meeting where groundbreaking research is being presented, almost making it seem like cancer progress only occurs in June.
For breast cancer patients, we have new information that will be helpful to you. The two biggest studies reported that are useful to our breast cancer patients are TAILORX and PERSEPHONE.
TAILORX evaluated women with early stage, node negative, ER positive and HER2 negative to determine if women with intermediate Oncotype DX recurrence scores between 11-25 would benefit from adjuvant chemotherapy. The short answer is that women in the intermediate recurrence score did not benefit from adjuvant chemotherapy with 9 years follow up. This study tells us that women with ER+ HER2 negative and lymph node negative patients that have Oncotype Dx recurrence scores 1-25 can safely avoid chemotherapy. Women less than 50 years of age did have slightly different results, and this may be because younger women are inherently at higher risk for recurrence or because of the ovarian suppression that occurs during chemotherapy can provide some additional benefit. The other point that is interesting in this study is that about 75% of these patients are MINDACT low risk, meaning that these patients are inherently lower risk and would be recommended to safely avoid chemotherapy from the Mammaprint assay as well.
The take home point is increasing comfort with de-escalation in treatment and continued support for requiring less chemotherapy for risk reduction in patients with lower risk cancers.
The PERSEPHONE trial is a trial in women with localized HER2 amplified breast cancer sought to understand if patients who have chemotherapy for risk reduction have improved benefit with 12 months instead of 6 months of adjuvant trastuzumab (Herceptin.) As we know, 12 months of adjuvant trastuzumab is the standard of care in the United States today. The Disease Free Survival was 89% in both arms at 4 years demonstrating equivalent efficacy in both arms of this study. In the 12 months of trastuzumab arm, 8% of patients experienced cardiac toxicity while in the 6 months of trastuzumab arm only 4% experienced cardiac toxicity.
It is surprising that the cardiac toxicity in both arms is higher than we would expect. However, the take home point again is that we can safely de-escalate therapy in many women with HER2 amplified tumors. Additional considerations is that this trial occurred without consideration for pertuzumab (Perjeta) and neratinib (Nerlynx) –both that offer benefit in terms of risk reduction in women with higher risk HER2 amplified breast cancers.
There were also many studies looking at the utility of using cell free DNA through the GRAIL studies. This in particular is exciting, but not yet ready for prime time in breast cancer or as a screening tool. There is also some risk in cell free DNA assays as if they are done at the incorrect time, they can be more likely to amplify genomic alterations that are not clinically meaningful with the consequence of physicians acting on targets that should not be actionable and not acting on targets that may be actionable. As you consider the role of these tests in your care, be sure to understand when they can be helpful and when they are more likely to provide misinformation.
The theme of the conference was precision medicine- hitting the target. Many targeted and immunotherapies were discussed. In particular, low prevalence mutations with selective targets. Many trials have approached a precision medicine strategy in aggregate with “basket” trials like TAPUR, Match, Quilt, and others. The structure of these trials is to randomize patients to therapeutic strategies based on somatic genomic alterations within their tumor types. Some early match trials reported in breast cancer that partnered a precision medicine strategy to consider clinical trial enrollment. This year these studies in breast cancer were disappointing, but the jury is still out as we need to understand better if we are hitting the right target and if we are hitting the right target with the right drug. This will take time. There were successes in other tumor types for low prevalence mutations and highly successful therapeutic interventions that give us great hope for engaging in this strategy. While we saw the NTRK fusion story last year reporting incredible response rates and fast tracked for FDA approval and the RET story this year received with the same enthusiasm. Stacking together these low prevalence mutations in aggregate, will get us better answers for more people.
In the last week, on May 30th, President Trump also signed in to legislation a “Right to Try” bill. While this bill does permit clinicians and patients to use some drugs that have not completed the FDA approval process, the bill does not require doctors to prescribe these drugs, does not mandate manufacturers to supply these drugs, and does not require third party payers to pay for these drugs. In general, it is in the best interest of patients when they make evidence based choices about their care with their doctors within the protections offered by the FDA.