Phase III study of concurrent chemotherapy and radiotherapy (CT/RT) vs CT/RT followed by surgical resection for stage IIIA(pN2) non-small cell lung cancer (NSCLC): Outcomes update of North American Intergroup 0139 (RTOG 9309)

摘要: 7014 Background: Surgery after CT/RT remains controversial for patients (pts) with stage IIIA(pN2) NSCLC. Initial analyses of INT 0139 showed significantly better progression-free survival (PFS), but not overall (OS), in the trimodality arm. (PASCO 2003) With longer follow-up (≥2.5 yrs per pt), new primary endpoints PFS and OS were conducted. Methods: Pts PS 0–1 T1–3, pN2, M0 NSCLC randomized if resection was technically feasible. All received cisplatin 50 mg/m2 d1, 8, 29, 36 etoposide d1–5, d29–33 (PE) RT to 45 Gy starting day 1. Arm 1 had no progression (PD), then PE X2; 2 completed 61 X2. Intent treat used Kaplan-Meier estimates, log-rank tests Cox multivariate models; exploratory logistic regression. CI are 95% p-values, 2-sided. Results: 396 eligible pts enrolled (Arm 1, 202; 2, 194; well-balanced on all factors). Treatment-related deaths: 16 (7.9%), which 10 ...