Is neoadjuvant chemoradiotherapy a feasible strategy for stage IIIA-N2 non-small cell lung cancer? Mature results of the randomized IFCT-0101 phase II trial.

Locally advanced non-small cell lung cancers share a risk of both local and systemic recurrence and justifies a therapeutic strategy combining focal and systemic treatment. In resectable stage IIIA-N2 tumors, peri-operative chemotherapy significantly increases survival rates. Chemoradiotherapy, which is the standard treatment of non-resectable locally advanced tumors, may have a role as an induction treatment to reduce locoregional recurrence rates. In the present phase II trial, we aimed at comparing standard induction chemotherapy (arm A: cisplatin and gemcitabine) with 2 different regimens of induction chemoradiotherapy (total dose: 46 Gy) including third-generation cytotoxic agents (arm B: cisplatin and vinorelbine; arm C: carboplatin and paclitaxel) in patients with resectable stage IIIA-N2 NSCLC, using feasibility of the whole strategy, including surgery, as a primary endpoint. A total of 46 patients were included. Response rate was significantly higher after induction chemoradiotherapy vs. chemotherapy (87% vs. 57%, p=0.049). A total of 44 patients underwent operation. The feasibility rate of the proposed therapeutic strategy was 89% for the whole cohort, 93% in arm A (induction chemotherapy with cisplatin and gemcitabine), 88% in arm B (induction chemoradiotherapy with cisplatin and vinorelbine), and 87% in arm C (induction chemoradiotherapy with carboplatin and paclitaxel) (p=0.857). Overall median, 1-year, and 3-year survival were 30 months, 87%, and 43%, respectively. Induction chemoradiotherapy with modern treatment regimens is highly feasible and may show promises in the current and future developments of multimodal therapeutic strategies in locally advanced NSCLC. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

RCT Entities:   Population Interventions Outcomes