WCLC 2025 - Posters & ePosters-P1.07.49 Limited Impact of Adjuvant Chemotherapy in Alk-Positive Stage II-III Adenocarcinoma: A Multicenter CReGYT-03 ALK Study

P1.07.49 Limited Impact of Adjuvant Chemotherapy in Alk-Positive Stage II-III Adenocarcinoma: A Multicenter CReGYT-03 ALK Study

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This multicenter retrospective study (CReGYT-03 ALK) evaluated the impact of cytotoxic adjuvant chemotherapy (ACT) on patients with stage II-III lung adenocarcinoma in Japan, focusing on differences by ALK fusion gene status. Among 1028 patients resected from 2011 to 2018 without EGFR mutations, 793 who underwent anatomical lung resection with mediastinal lymph node dissection were analyzed. ALK positivity was identified in 7% (58/793).<br /><br />Inverse probability weighting adjusted for confounders such as age, sex, smoking status, performance status, and pathological stage was used to compare recurrence-free survival (RFS) and overall survival (OS) between patients who did or did not receive ACT.<br /><br />In ALK-negative patients (93% of cohort), ACT was associated with significantly improved RFS and OS. Hazard ratios after weighting were 0.612 (95% CI: 0.483-0.774) for RFS and 0.720 (95% CI: 0.603-0.860) for OS, indicating a benefit of ACT.<br /><br />Conversely, in ALK-positive patients, ACT showed limited efficacy. Survival analyses could not estimate hazard ratios due to insufficient events or no meaningful difference between ACT and observation groups. Patient characteristics were balanced after weighting, but ACT did not translate into clear survival advantages within the ALK-positive subgroup.<br /><br />This finding aligns with recent shifts in postoperative management after the 2024 approval of alectinib as adjuvant therapy specifically for ALK-positive NSCLC, replacing cytotoxic chemotherapy. The study highlights that cytotoxic ACT's benefit is limited in ALK-positive stage II-III adenocarcinoma, supporting tailored adjuvant treatment based on molecular profiling.<br /><br />Despite limitations inherent to retrospective design, these results suggest precision medicine should guide adjuvant therapy, reserving cytotoxic chemotherapy mainly for ALK-negative patients and considering targeted therapies such as alectinib for ALK-positive cases after complete resection.

Asset Subtitle

Akira Hamada

Meta Tag

Speaker Akira Hamada

Topic Early-Stage Non-small Cell Lung Cancer

Keywords

ALK fusion gene

adenocarcinoma

adjuvant chemotherapy

cytotoxic chemotherapy

lung cancer

stage II-III

inverse probability weighting

recurrence-free survival

overall survival

alectinib