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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Friday, October 14, 2022
Adding the novel CDK4/6 inhibitor dalpiciclib to the aromatase inhibitors letrozole or anastrozole in the first-line setting significantly prolonged progression-free survival in patients with hormone receptor–positive, HER2-negative advanced breast cancer, with manageable toxicities, according to results of the phase III DAWNA-2 trial. The assessment of this randomized, double-blind study, which included 456 patients from 42 centers in China, was presented during the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract LBA16) by Binghe Xu, MD, PhD, of Peking Union Medical College, Beijing, and colleagues. Progression-free survival per investigator was the primary endpoint.
Dalpiciclib joins palbociclib, ribociclib, and abemaciclib, the authors noted, as the fourth CDK4/6 inhibitor to demonstrate a survival benefit in hormone receptor–positive, HER2-negative advanced breast cancer (with letrozole or anastrozole in untreated disease or with fulvestrant in pretreated disease).
Patients were randomly assigned 2:1 to receive dalpiciclib (n = 303) or placebo (n = 153) plus letrozole or anastrozole; they could have any menopausal status. With median follow-up times of 21.7 and 21.4 months in the dalpiciclib and placebo arms, respectively, progression-free survival was significantly better with dalpiciclib: median, 30.6 months (95% confidence interval; [CI] = 30.6 months to not reached) versus 18.2 months (95% CI = 16.5–22.5 months), with a hazard ratio of 0.51 and a one-sided P < .0001. “Progression-free survival benefit with dalpiciclib was evident regardless of menopausal status, and overall response rate and duration of response per investigator also favored the dalpiciclib group,” stated Dr. Xu and co-investigators.
No neutropenia or leukopenia occurred in the placebo group, but they were the most frequent grade ≥ 3 adverse effects in the dalpiciclib group, occurring in 85.8% and 66.6%, respectively. Serious adverse events occurred in 11.9% and 6.5% of the dalpiciclib and placebo groups, respectively, and 4.0% and 2.0% discontinued any treatment because of adverse effects.
Disclosure: The study authors’ disclosure information can be found at cslide.ctimeetingtech.com.
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