Translational lung cancer research · 2026
Adjuvant alectinib versus crizotinib in completely resected ALK-positive non-small-cell lung cancer: a real-world retrospective cohort study.
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Yang Yitao, Liang Shenhua, Liu Ruihe, Tian Jiayuan, Luo Xingyu, Ma Guowei
Аннотация
BACKGROUND: Following the phase III ALINA trial, adjuvant alectinib has become an important option for completely resected anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC). However, the adjuvant role of crizotinib remains uncertain, and real-world data directly comparing adjuvant alectinib with crizotinib are limited. We compared their efficacy, central nervous system (CNS) control, and safety in this setting.
METHODS: This single-center retrospective cohort study included 48 patients with R0-resected stage IA-IIIB ALK-positive NSCLC who underwent surgery between April 2012 and October 2023. Patients received alectinib 600 mg twice daily (n=26) or crizotinib 250 mg twice daily (n=22) after surgery. The primary endpoint was the 3-year disease-free survival (DFS) rate. Survival outcomes were estimated using the Kaplan-Meier method, and unadjusted hazard ratios (HRs) were calculated using Cox regression. Safety was evaluated by treatment-related adverse events.
RESULTS: At a median follow-up of 84.6 months, alectinib was associated with longer DFS than crizotinib, with median DFS not reached versus 28.23 months, a 3-year DFS rate of 91.4% versus 41.4%, and an unadjusted HR of 0.20 [95% confidence interval (CI): 0.08-0.47]. Brain metastasis-free survival (BMFS) also favored alectinib, with 3-year BMFS rates of 95.2% versus 74.8% and an HR of 0.16 (95% CI: 0.05-0.56). Most adverse events were grade 1-2; no grade ≥3 adverse events occurred with alectinib, compared with 27.3% with crizotinib.
CONCLUSIONS: In this real-world cohort of patients with completely resected ALK-positive NSCLC, adjuvant alectinib was associated with longer DFS, improved BMFS, and a more favorable safety profile than crizotinib. These findings are broadly consistent with the benefit of adjuvant alectinib observed in the phase III ALINA trial and support alectinib as the preferred adjuvant ALK-tyrosine kinase inhibitor (TKI) option over crizotinib. Further validation in larger multicenter real-world or prospective studies is warranted.
METHODS: This single-center retrospective cohort study included 48 patients with R0-resected stage IA-IIIB ALK-positive NSCLC who underwent surgery between April 2012 and October 2023. Patients received alectinib 600 mg twice daily (n=26) or crizotinib 250 mg twice daily (n=22) after surgery. The primary endpoint was the 3-year disease-free survival (DFS) rate. Survival outcomes were estimated using the Kaplan-Meier method, and unadjusted hazard ratios (HRs) were calculated using Cox regression. Safety was evaluated by treatment-related adverse events.
RESULTS: At a median follow-up of 84.6 months, alectinib was associated with longer DFS than crizotinib, with median DFS not reached versus 28.23 months, a 3-year DFS rate of 91.4% versus 41.4%, and an unadjusted HR of 0.20 [95% confidence interval (CI): 0.08-0.47]. Brain metastasis-free survival (BMFS) also favored alectinib, with 3-year BMFS rates of 95.2% versus 74.8% and an HR of 0.16 (95% CI: 0.05-0.56). Most adverse events were grade 1-2; no grade ≥3 adverse events occurred with alectinib, compared with 27.3% with crizotinib.
CONCLUSIONS: In this real-world cohort of patients with completely resected ALK-positive NSCLC, adjuvant alectinib was associated with longer DFS, improved BMFS, and a more favorable safety profile than crizotinib. These findings are broadly consistent with the benefit of adjuvant alectinib observed in the phase III ALINA trial and support alectinib as the preferred adjuvant ALK-tyrosine kinase inhibitor (TKI) option over crizotinib. Further validation in larger multicenter real-world or prospective studies is warranted.