THURSDAY, Feb. 10, 2022 (HealthDay News) -- For patients with previously untreated stage II or III triple-negative breast cancer, the rate of event-free survival is higher for those receiving neoadjuvant pembrolizumab combined with chemotherapy versus neoadjuvant chemotherapy alone, according to a study published in the Feb. 10 issue of the New England Journal of Medicine.
Peter Schmid, M.D., Ph.D., from Queen Mary University of London, and colleagues randomly assigned patients with previously untreated stage II or III triple-negative breast cancer in a 2:1 ratio to receive neoadjuvant therapy with four cycles of pembrolizumab or placebo every three weeks plus paclitaxel and carboplatin, followed by pembrolizumab or placebo plus doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide (four cycles). Patients received adjuvant pembrolizumab or placebo every three weeks (up to nine cycles) after definitive surgery. Overall, 784 patients were assigned to pembrolizumab-chemotherapy and 390 were assigned to placebo-chemotherapy. The median follow-up was 39.1 months at this fourth planned interim analysis.
In the fourth planned interim analysis, the researchers found that at 36 months, the estimated event-free survival was 84.5 and 76.8 percent in the pembrolizumab-chemotherapy and placebo-chemotherapy groups, respectively (hazard ratio for event or death, 0.63). Adverse events mainly occurred during the neoadjuvant phase and were consistent with established safety profiles for pembrolizumab and chemotherapy.
"The results of this trial support the use of pembrolizumab plus platinum-, taxane-, and anthracycline-containing neoadjuvant chemotherapy, followed by adjuvant pembrolizumab after surgery, as a treatment regimen for patients with high-risk, early triple-negative breast cancer," the authors write.
The study was supported by Merck Sharp and Dohme, a subsidiary of Merck, the manufacturer of pembrolizumab.
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