Efficacy and safety of adjuvant ensartinib in stage I ALK-positive NSCLC patients: a retrospective, multicenter study
Menée en Chine à partir de données portant sur 393 patients atteints d'un cancer du poumon non à petites cellules ALK+ de stade I, cette étude rétrospective évalue l'efficacité, du point de vue de la survie sans maladie, et la toxicité d'un traitement adjuvant par ensartinib
Background: The role of adjuvant ensartinib in patients with stage I ALK-positive non-small cell lung cancer (NSCLC) with high-risk pathological features remains unclear. This multicenter retrospective study aimed to evaluate the efficacy and safety of adjuvant ensartinib in this population.
Methods: A total of 393 patients with completely resected stage I ALK-positive NSCLC were included from five centers in China between March 2017 and March 2026. Patients were categorized into the ensartinib group (n = 63) and the observation group (n = 330). Inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were employed to balance baseline characteristics. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety.
Results: After IPTW, baseline characteristics were well balanced between groups. The ensartinib group showed a higher 3-year DFS rate compared with the observation group (100% vs. 90.2%;P = 0.014). In patients with high-risk pathological features (micropapillary or solid subtypes or complex glandular pathological subtypes
≥
10%, mucinous adenocarcinoma, or spread through air spaces), the 3-year DFS was 100% in the ensartinib group versus 86.5% in the observation group (P = 0.016). No significant difference in OS was observed between groups. Adverse events occurred in 87.3% of patients in the ensartinib group, all of which were grade 1–2, with rash being the most common adverse event (85.7%).
Conclusion: Exploratory analyses suggested an association between adjuvant ensartinib and favorable DFS outcomes in stage I ALK-positive NSCLC patients exhibiting high-risk pathological features. A favorable safety profile was also observed. For patients without high-risk factors, the benefit of adjuvant ensartinib remains to be further clarified. These findings are hypothesis-generating and support further prospective evaluation of risk-adapted adjuvant ALK-TKI therapy in stage I ALK-positive NSCLC.
Lung Cancer , résumé, 2026