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The New England Journal of MedicineAlectinib in Resected ALK-Positive Non–Small-Cell Lung Cancer

Enhanced Disease-Free Survival in ALK-Positive NSCLC with Alectinib

In a pivotal phase 3 trial, adjuvant alectinib demonstrated significant improvement in disease-free survival rates compared to traditional platinum-based chemotherapy in patients with resected ALK-positive non-small-cell lung cancer (NSCLC). This landmark study underscores the potential of targeted therapies to redefine post-surgical outcomes, offering a promising alternative to conventional chemotherapy regimens.

Key Points:

  • The study involved a global, phase 3, open-label, randomized trial focusing on patients with completely resected, ALK-positive NSCLC at stages IB (tumors ≥4 cm), II, or IIIA.
  • Patients were randomly assigned to receive either oral alectinib (600 mg twice daily for 24 months) or traditional intravenous platinum-based chemotherapy administered over four 21-day cycles.
  • The primary endpoint of the study was disease-free survival, with a secondary focus on central nervous system (CNS) disease–free survival, overall survival, and safety profiles.
  • After two years, the alectinib group showed a disease-free survival rate of 93.8% in patients with stage II or IIIA disease, significantly higher than the 63.0% observed in the chemotherapy group (hazard ratio for disease recurrence or death, 0.24; 95% CI, 0.13 to 0.45; P<0.001).
  • In the intention-to-treat population, the rates were similarly high with alectinib at 93.6% compared to 63.7% for chemotherapy (hazard ratio, 0.24; 95% CI, 0.13 to 0.43; P<0.001).
  • Alectinib also offered a clinically meaningful advantage in CNS disease-free survival with a hazard ratio of 0.22 (95% CI, 0.08 to 0.58) for CNS disease recurrence or death.
  • Overall survival data were still immature at the time of reporting, with further analysis required.
  • Safety profiles for alectinib did not reveal any unexpected adverse effects, suggesting good tolerability and manageable safety in comparison to traditional chemotherapy.

“Among patients with resected ALK-positive NSCLC, adjuvant alectinib not only significantly improved disease-free survival but also enhanced CNS disease-free outcomes, marking a substantial advancement in the management of this cancer subtype.”

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