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)

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Abstract
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 survival (OS), in the trimodality arm. (PASCO 2003) With longer follow-up (≥2.5 yrs per pt), new analyses of primary endpoints PFS and OS were conducted. Methods: Pts with PS 0–1 and T1–3, pN2, M0 NSCLC were randomized if resection was technically feasible. All received cisplatin 50 mg/m2 d1, 8, 29, 36 and etoposide 50 mg/m2 d1–5, d29–33 (PE) and RT to 45 Gy starting day 1. Arm 1 had resection if no progression (PD), then PE X2; Arm 2 completed RT to 61 Gy with PE X2. Intent to treat analyses used Kaplan-Meier estimates, log-rank tests and Cox multivariate models; exploratory analyses used logistic regression. All CI are 95% and p-values, 2-sided. Results: 396 eligible pts were enrolled (Arm 1, 202; Arm 2, 194; well-balanced on all factors). Treatment-related deaths: Arm 1, 16 (7.9%), of which 10 ...

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