Harold Burstein, MD, PhD, FASCO
Jame Abraham, MD, FACP
Harold Burstein, MD, PhD, FASCO, Associate Professor of Medicine at Dana-Farber Cancer Institute, Boston, and Jame Abraham, MD, FACP, Director of the Breast Oncology Program at Taussig Cancer Institute and Co-Director of the Cleveland Clinic Comprehensive Breast Cancer Program, commented on what both called an “impressive” improvement in survival.
CDK4/6 inhibitors are being widely used in breast cancer, especially in postmenopausal patients, based on proof that they delay the time to disease progression and they double the effectiveness of endocrine therapy, Dr. Burstein said. “This important study now shows that these benefits translate into a significant survival benefit for estrogen receptor–positive metastatic breast cancer,” he commented.
Dr. Burstein noted that although ribociclib is the first CDK4/6 inhibitor to show proof of a survival advantage, palbociclib also showed a trend toward a survival benefit in postmenopausal patients in PALOMA-2.1 “I think the MONALEESA-7 data, on top of the palbociclib data, are making us think that for this class of drug, there’s a real survival signal,” he offered.
Dr. Burstein added that MONALEESA-7 is also important because it focuses “on a group of young women—patients who have historically been understudied—showing that they, too, benefit from this class of drugs in a remarkable way.” The findings also bust the myth that outcomes are always worse in younger women “Their outcomes look very similar,” he noted.
Agreeing with Dr. Hurvitz’s remarks at the press briefing, Dr. -Abraham foresees more clinicians now opting for ribociclib. “The biggest question now is whether we are all going to switch to ribociclib, as it’s the only drug with survival data. We’ve been using palbociclib for a long time, and our comfort level is high with that. I think clinicians will become more open to considering the newer drug,” he told The ASCO Post.”
“Now, when I sit with a 45-year-old patient and I’m thinking about a CDK4/6 inhibitor, I will tell her we have survival data for ribociclib, and probably we can give it a try,” he said.
Dr. Burstein suggested, as well, that the achievement of this survival advantage might expand use of the drug worldwide. “I think the demonstration of a robust survival difference adds to a value proposition for products like ribociclib,” Dr. Burstein commented. “Hopefully, these data will enable access to this product for more women around the world, particularly in health-care systems that assess value rigorously as part of their decisions regarding national access to drugs.” ■
DISCLOSURE: Drs. Abraham and Burstein reported no conflicts of interest.
1. Turner NC, Slamon DJ, Ro J, et al: Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med 379:1926-1936, 2018.
The first statistically significant overall survival benefit has been shown for a cyclin-dependent kinase (CDK) 4/6 inhibitor plus endocrine therapy as first-line treatment of advanced breast cancer. The results are from the phase III MONALEESA-7 trial, which evaluated ribociclib plus endocrine...