Scandinavian phase III trial of neoadjuvant chemotherapy in NSCLC stages IB-IIIA/T3

Abstract

7146 Background: Neoadjuvant chemotherapy before surgery for NSCLC has previously shown somewhat promising results, but all prior randomised studies included also patients (pts) with N2-disease or stage IIIB. The aim was thus to evaluate the impact of neoadjuvant chemotherapy for early stage disease (stages IB - IIIA/T3). Methods: Pts had histologically verified NSCLC stages IB, IIA, IIB, and IIIA/T3 based on CT-scan and negative mediastinoscopy, and were randomised to 3 courses of Paclitaxel 225 mg/m2 and Carboplatin AUC 6 day 1 q 3 weeks followed by surgery (regimen A) or immidiate surgery (regimen B). Chest radiotherapy 60 Gy were administered in case of incomplete resection. Survival was primary end-point. It was required to randomise totally 280 pts to detect an 15% increment in 5-year survival rate with a two-sided type I error of 5% and 80% power. The study was stopped prematurely due to slow patient recruitment. Results: 44 pts with a median age of 66 years were randomised to regimen A and 46 with median age 62 years to regimen B from November 1998 to October 2004. There were no differences with respect to performance status, gender, histology, LDH, or stage groups between the treatment regimens. In regimen A, 46% achieved a partial response to the neoadjuvant chemotherapy. Microscopically complete resection was achieved in 79% and 70% in regimen A and B, respectively. Median survival and 5-year survival rates were 34.4 months and 36% compared to 22.5 months and 24% in regimen A and B, respectively (not significant). Conclusions: No statistically significant differences were noted in this prematurely closed trial, but median survival was increased by one year and 5-year survival rate increased by 12% for pts receiving neoadjuvant chemotherapy, suggesting that a beneficial effect can not be ruled out. Follow-up and survival update continues. No significant financial relationships to disclose.