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Adjuvant Alectinib vs. Chemotherapy in ALK-Positive Non–Small-Cell Lung Cancer
Mutations in the anaplastic lymphoma kinase (ALK) gene occur in about 5% of patients with non–small-cell lung cancer (NSCLC). These patients are more likely than those with other types of NSCLC to be aged ≤55 years, to be never smokers, and to develop central nervous system (CNS) metastases. Alectinib is currently approved for the first-line treatment of advanced ALK-positive NSCLC.
The industry-supported, international, open-label, phase 3 ALINA trial assessed the efficacy and safety of 24 months of adjuvant alectinib versus platinum-based chemotherapy in 257 patients with completely resected stage IB to IIIA ALK-positive NSCLC. The primary endpoint was disease-free survival (DFS). Patients were randomized to receive oral alectinib (600 mg twice daily) for 24 months or chemotherapy (cisplatin and vinorelbine, gemcitabine, or pemetrexed) for four 21-day cycles.
Treatment with alectinib reduced the risk of recurrence or death by 76% (hazard ratio, 0.24; 95% CI, 0.13–0.45; P<0.001) compared with adjuvant chemotherapy alone. The alectinib group also had a 78% improvement in central nervous system DFS (HR, 0.22; 95% CI, 0.08–0.58).
Alectinib was well tolerated with no new safety signals. Adverse events led to alectinib dose reduction in 25.8% of patients and to early discontinuation of adjuvant alectinib therapy in 5.5%.
Comment
A number of questions remain. Given that adjuvant chemotherapy has been shown to improve overall survival in resected NSCLC, an attractive strategy might be to intensify chemotherapy and then treat with alectinib. In addition, it is unclear if 2 years of alectinib is the appropriate duration of therapy. Results from the trial are still immature, and overall survival has not yet been reported. However, the substantial improvement in DFS makes this adjuvant alectinib a new standard for patients with resected ALK-positive NSCLC and underscores the need for molecular testing in NSCLC, regardless of stage.
Citation(s)
Author:
Wu Y-L et al.
Title:
Alectinib in resected ALK-positive non–small-cell lung cancer.
Source:
N Engl J Med
2024
Apr
11; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
Jyoti D. Patel, MD, FASCO