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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Monday, August 7, 2023
An article published in The Lancet Oncology reported findings on the safety and efficacy of the CDK4/6 inhibitor dalpiciclib plus letrozole or anastrozole in patients with hormone receptor–positive, HER2-negative advanced breast cancer. Binghe Xu, MD, of Peking Union Medical College, Beijing, China, and colleagues focused on patients with advanced breast cancer who had no previous systemic therapy in the advanced setting. In fact, the median progression-free survival was significantly longer with dalpiciclib than without.
“In patients with hormone receptor–positive breast cancer, overactivity of the CDK4/6 pathway is common, and CDK4/6 inhibitors have shown promise in overcoming resistance to endocrine therapy…,” stated Dr. Xu and colleagues.
A total of 456 eligible patients with pathologically confirmed hormone receptor–positive, HER2-negative untreated advanced breast cancer were included in the phase III DAWNA-2 trial. Patients were randomly assigned (2:1) to receive oral dalpiciclib (150 mg/day for 3 weeks, followed by 1 week off) or matching placebo plus endocrine therapy: either 2.5 mg of letrozole or 1 mg of anastrozole orally once daily, continuously. The primary endpoint was investigator-assessed progression-free survival. Additionally, safety was analyzed in all patients who received at least one treatment dose.
The median follow-up was 21.6 months at data cutoff (June 2022). Findings revealed that the median progression-free survival was significantly longer with dalpiciclib than without (30.6 months vs. 18.2 months). Adverse events of grade 3 or 4 were reported in 90% of the 302 patients in the dalpiciclib group and 12% of the 153 patients in the placebo group. The most common adverse events of grade 3 or 4 with dalpiciclib were neutropenia and leukopenia.
Disclosure: For full disclosures of the study authors, visit thelancet.com.
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