Concurrent chemotherapy and short course radiotherapy in patients with stage IIIA to IIIB non-small cell lung cancer not eligible for radical treatment: results of a randomized phase II study.

摘要

INTRODUCTION: The optimal treatment for patients with stage IIIA to IIIB non-small cell lung cancer (NSCLC) not eligible for surgery and definitive chemoradiotherapy is unknown. The aim of this study was to evaluate concurrent chemotherapy and palliative radiotherapy. METHODS: Patients with stage IIIA to IIIB NSCLC with tumor >8 cm and/or forced expiratory volume < or =40%, performance status 0 to 2, and tumor-related chest symptoms were randomly assigned to arm A: radiotherapy alone (30 Gy/10 fractions) or arm B: chemoradiotherapy (two cycles of cisplatin and vinorelbine followed by radiotherapy together with third cycle). Primary end point was response rate, the power of the study was 90%, and the significance level was p = 0.1. RESULTS: A total of 99 patients were eligible for response, overall survival, and progression-free survival evaluation. Median age was 66 years (45-78 years). Response rate was 27% versus 53%, p = 0.08; median overall survival was 9.0 versus 12.9 months, p = 0.0342; and median progression-free survival was 4.7 versus 7.3 months, p = 0.046, in arm A versus arm B, respectively. There were no deaths during treatment in arm A and six deaths in arm B; no hematological G3 to G4 toxicities in arm A and 14 toxicities in arm B. Symptom control was high and similar in both arms. CONCLUSIONS: Upfront chemotherapy combined with palliative radiotherapy (30 Gy) is a promising treatment option in the subpopulation of patients with stage IIIA to IIIB NSCLC not amenable for definitive chemoradiotherapy and deserves further investigation.