A randomized trial of radical surgery (S) versus thoracic radiotherapy (TRT) in patients (pts) with stage IIIA-N2 non-small cell lung cancer (NSCLC) after response to induction chemotherapy (ICT) (EORTC 08941)

LBA7015 Background: The optimal locoregional treatment -TRT or S- following systemic ICT of pts with stage IIIA-N2 NSCLC is unclear. 5-year survival rate in uncontrolled series of either modality varies between 5–25%. Methods: Selected pts with histological or cytological proven stage IIIA-N2 NSCLC were given 3 cycles of platinum-based ICT. Responding pts were then randomized between S: radical resection with lymph node dissection and optional postoperative radiotherapy (PORT), or TRT: at least 40 Gy in 2 Gy daily fractions on the mediastinum with a boost to at least 60 Gy on the involved field (IF). In order to observe an increase of 5-year overall survival (OS) from 15 (TRT) to 25% (S), 292 events out of 358 randomized pts had to be observed (log rank test, power 80%, type I error 5%). Secondary endpoints were progression free survival (PFS) and toxicity. Results: ICT achieved an average response rate of 61.5% (95%CI: 57.6–65.5) among the 572 registered pts who started protocol treatment. Of these, 333 ...