Abstract
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 were randomized (167 to S and 166 to TRT), having the following characteristics: median age 62 years; male 74%; squamous/non-squamous: 39/61%; T1/2/3: 12/72/15%. In 151 operated pts, the following rates were observed: exploratory thoracotomy: 14%; radical resection: 50%; pathological downstaging: 40%; operative mortality: 4%; PORT 27% up to now. Among 153 irradiated TRT pts, median total treatment time was 43 days (15–60). CT- scan planning was used in 92%. The median total dose delivered to the normal mediastinum/IF was 40/60 Gy, respectively. Currently, 278 events have occurred after a median duration of follow-up of 58 months. Final analysis of OS and PFS will be submitted by March 25. Conclusions: Study partially supported by NCI Grants 5U10CA11488–24 through 5U10CA11488–34. No significant financial relationships to disclose.
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