FRIDAY, April 12, 2024 (HealthDay News) -- Adjuvant alectinib improves disease-free survival compared with platinum-based chemotherapy among patients with resected ALK-positive non-small cell lung cancer (NSCLC), according to a study published in the April 11 issue of the New England Journal of Medicine.
Yi-Long Wu, M.D., from the Guangdong Lung Cancer Institute in Guangzhou, China, and colleagues conducted a global, phase 3, open-label, randomized trial involving patients with completely resected, ALK-positive NSCLC of stage IB, II, or IIIA. Participants were randomly assigned to receive oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles (130 and 127 patients, respectively).
The researchers found that the percentage of patients alive and disease-free was 93.8 and 63.0 percent in the alectinib and chemotherapy groups, respectively, at two years, among patients with stage II or IIIA disease (hazard ratio for disease recurrence or death, 0.24), and 93.6 and 63.7 percent, respectively, in the intention-to-treat population (hazard ratio, 0.24). A clinically meaningful benefit with respect to central nervous system disease-free survival was seen in association with alectinib versus chemotherapy (hazard ratio, 0.22). The overall survival data were immature. There were no unexpected safety findings.
"The disease-free survival benefit was seen consistently across prespecified subgroups, including those defined according to disease stage, race, sex, and smoking status," the authors write.
The study was funded by F. Hoffmann-La Roche, the manufacturer of alectinib.
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