Abstract
Rationale: Concomitant RT-CT demonstrated survival advantage for stage III NSCLC. A few phase II studies comparing induction to consolidation RT-CT cannot allow definitive conclusion. The ELCWP designed a phase III trial with survival as primary endpoint.
Methods: Previously untreated locally advanced unresectable non metastatic NSCLC were centrally randomised. CT consisted of P (60 mg/m²) and D (75 mg/m²) every 3 weeks. During RT-CT, P and D were given both at 20 mg/m² weekly for up to 6 cycles. Radiotherapy consisted in a 5fx/week schedule, 2Gy per fx for a total dose of 66Gy. Due to poor accrual, a futility analysis was performed and the trial was prematurely closed.
Results: From 01/2007 to 10/2013, 125 patients were randomised. There was no imbalance between arms for the main patients' characteristics. Median survival times were, respectively in the induction and the consolidation arms, 22.7 months (95% CI 16.0-39.2) and 19.5 months (95% CI 11.5-27.0). Hazard ratio was 0.89 (95% CI 0.56-1.40). Response rates and median PFS were 51% (95% CI 37%-64%) and 7.4 months (95% CI 6.2-11.7) in the induction RT-CT arm and 57% (95% CI 44%-70%) and 10.2 months (95% CI 8.1-15.0) in the consolidation RT-CT arm. Induction RT-CT was associated with more leucopenia (p = 0.002) and stomatitis (p = 0.03).
Conclusion: In this prematurely closed phase III trial, we are confirming the results from our individual data meta-analysis (Radiother Oncol 111 suppl 1, p34, 2014) concluding to the absence of any detectable difference between induction and consolidation RT-CT.
- Copyright ©ERS 2015
