Randomized controlled trial of resection versus radiotherapy after induction chemotherapy in stage IIIA-N2 XXXX .

@entity1 @entity1149 @entity902 @entity55
BACKGROUND: Induction chemotherapy before surgical resection increases survival compared with surgical resection alone in @entity1 with stage IIIA-N2 @entity1149 ( @entity1149 ). We hypothesized that, following a response to induction chemotherapy, surgical resection would be superior to thoracic radiotherapy as locoregional therapy. METHODS: Selected @entity1 with histologic or cytologic proven stage IIIA-N2 @entity1149 were given three cycles of @entity902 -based induction chemotherapy. Responding @entity1 were subsequently randomly assigned to surgical resection or radiotherapy. Survival curves were estimated using Kaplan-Meier analyses from time of randomization. RESULTS: Induction chemotherapy resulted in a response rate of 61% (95% confidence interval [CI] = 57% to 65%) among the 579 eligible @entity1 . A total of 167 @entity1 were allocated to resection and 165 to radiotherapy. Of the 154 (92%) @entity1 who underwent surgery, 14% had an exploratory thoracotomy, 50% a radical resection, 42% a pathologic downstaging, and 5% a pathologic complete response; 4% died after surgery. Postoperative radiotherapy was administered to 62 (40%) of @entity1 in the surgery arm. Among the 154 (93%) irradiated @entity1 , overall compliance to the radiotherapy prescription was 55%, and grade 3/4 acute and late esophageal and pulmonary toxic effects occurred in 4% and 7%; one @entity1 died of radiation @entity55 . Median and 5-year overall survival for @entity1 randomly assigned to resection versus radiotherapy were 16.4 versus 17.5 months and 15.7% versus 14%, respectively (hazard ratio = 1.06, 95% CI = 0.84 to 1.35). Rates of progression-free survival were also similar in both groups. CONCLUSION: In selected @entity1 with pathologically proven stage IIIA-N2 @entity1149 and a response to induction chemotherapy, surgical resection did not improve overall or progression-free survival compared with radiotherapy. In view of its low morbidity and mortality, radiotherapy should be considered the preferred locoregional treatment for these @entity1 .
