Aditya Bardia, MD, MPH, Director of Breast Cancer Research and Associate Professor at Harvard Medical School, and attending physician at Mass General Cancer Center, Boston, commented on the RIGHT Choice trial. Based on this study, he noted, few patients should be excluded from treatment with ribociclib plus endocrine therapy. Traditionally, the recommendation has been to consider combination chemotherapy for patients with visceral crisis, but this dogma was challenged by the RIGHT Choice trial.
Aditya Bardia, MD, MPH
“The RIGHT Choice is an important trial,” Dr. Bardia said in an interview with The ASCO Post. “It evaluated chemotherapy vs endocrine therapy plus a CDK4/6 inhibitor as first-line therapy for patients with “visceral crisis.” At this time, the mainstay of management in the first-line setting is endocrine therapy plus a CDK4/6 inhibitor except for patients with visceral crisis, for whom chemotherapy is recommended. The study showed that ribociclib plus endocrine therapy was superior, more than doubling the progression-free survival. In addition, ribociclib and endocrine therapy had lower toxicity than chemotherapy.”
The investigators’ definition of “visceral crisis” included patients with a significant disease burden or pain, “showing that endocrine therapy plus ribociclib works well in that setting, and it can work quickly,” he said. “The reason chemotherapy is used is to get a prompt response in a patient who is symptomatic or has a high disease burden, because endocrine therapy alone can take time. However, in this study combination therapy, endocrine therapy and ribociclib was utilized, and the time to response was similar to chemotherapy—that’s key for patients who have a lot of disease.”
Dr. Bardia noted that there is difference between visceral crisis and visceral dysfunction. Patients who received ribociclib plus endocrine therapy in the clinical trial met treatment criteria for ribociclib. Patients who have visceral dysfunction such as high bilirubin or elevated creatinine, who do not meet treatment criteria with ribociclib were not evaluated in this study, and thus might still need chemotherapy. Hopefully, future studies could evaluate nonchemotherapy options for patients with visceral dysfunction also and address an unmet need for this subgroup.”
DISCLOSURE: Dr. Bardia has served as a consultant to and has received research funding for Pfizer, Novartis, Genentech, Merck, Radius Health/Menarini, Immunomedics/Gilead Sciences, Sanofi, Daiichi Sankyo, AstraZeneca, and Eli Lilly.
According to findings from the phase II RIGHT Choice trial, many premenopausal patients with metastatic hormone receptor–positive, HER2-negative breast cancer experiencing visceral crisis are best treated with first-line ribociclib plus endocrine therapy rather than with chemotherapy.1