Accelerated hypofractionated radiotherapy plus chemotherapy for inoperable locally advanced non-small-cell lung cancer: Final results of a prospective phase-II trial with a long-term follow-up

BackgroundConcurrent chemotherapy and radiation using conventional fractionation is the standard treatment for inoperable, locally advanced non-small-cell lung cancer (NSCLC). We tested accelerated hypofractionated radiotherapy (AHR) and chemotherapy for the treatment of locally advanced NSCLC.MethodsEligible patients with locally advanced NSCLC were treated with induction chemotherapy (cisplatin and docetaxel), followed by AHR using tomotherapy and consolidation chemotherapy. The prescribed doses were 30Gy/5 daily fractions at the reference isodose (60-70%) to the tumor, and 25Gy/5 daily fractions to the clinically involved lymph nodes. The primary end-point was response rate (RR); the secondary end-points were acute and late side-effects, local progression-free survival (PFS), metastasis-free survival (MFS) and overall survival (OS). This trial closed before the first planned interim analysis due to poor accrual.ResultsFrom January 2009 to January 2012, 17 of the 23 enrolled patients were evaluable. Treatment yielded an overall RR of 82%. Median follow-up was 87months (range: 6-87), local PFS was 19.8months (95% CI 9.7 - not reached), MFS was 9.7months (95% CI 5.8-46.0) and OS was 23months (95% CI 8.4-48.4). 70% of patients experienced acute G4 neutropenia, 24% G4 leukopenia, 24% G3 paresthesia, 4% G3 cardiac arrythmia, 4% underwent death after chemotherapy. Late toxicity was represented by 24% dyspnea G3.ConclusionsAHR combined with chemotherapy is feasible with no severe side-effects, and it appears highly acceptable by patients.Trial registrationThis study is registered with the EudractCT registration 2008-006525-14. Registered on 9 December 2008.