Phase II study assessing the benefit of cisplatin re-introduction (stop-and-go strategy) in patients with advanced non-squamous non-small cell lung cancer: the IFCT-1102 BUCiL study (a Better Use of Cisplatin in Lung cancer).

Introduction: This single-arm phase II trial aimed to evaluate a stop-and-go strategy with cisplatin-based chemotherapy and bevacizumab in advanced non-squamous non-small cell lung cancer (NSCLC).
Methods: Patients were initially treated with three cycles of pemetrexed, cisplatin plus bevacizumab (sequence 1) followed by bevacizumab maintenance and after progression, re-introduction of three cycles of pemetrexed, cisplatin plus bevacizumab (sequence 2) and pemetrexed plus bevacizumab maintenance. The primary endpoint was the proportion of patients with advanced non-squamous NSCLC receiving the complete sequence 2 without platinum dose reduction (hypothesis ≥75%).
Results: 120 patients with performance status ≤1 were included. Of 113 patients evaluable for efficacy, 65 (57.5%) entered in sequence 2 and 56 (86%) received the three planned cycles including 37 (56.9%, 95% CI 45.1 to 73.6) without platinum dose reduction. The median progression-free survival 1 (PFS1; inclusion to progression 1) was 5.6 months (95% CI 5.0 to 6.3) and median PFS2 (progression 1 to progression 2) was 6.8 months (95% CI 5.8 to 8.8). The median disease control duration (PFS1+PFS2; n=65) was 12.4 months (95% CI 11.2 to 14.9). The median overall survival was 17.7 months (95% CI 13.1 to 21.6) and 20.5 months (95% CI 16.9 to 26.9) for patients reaching the sequence 2 (n=65).
Conclusion: Although the stringent primary endpoint was not met, this stop-and-go strategy with platinum-based chemotherapy plus bevacizumab continuation beyond progression compares favourably with standard schedule, deserving to be further studied in advanced non-squamous NSCLC.
Competing Interests: Competing interests: JB: advisory board for Roche, Bristol-Myers Squibb, Boehringer-Ingelheim and Astra-Zeneca. FB: personal fees for Astra-Zeneca, Bristol-Myers Squibb, Boehringer-Ingelheim, Clovis Oncology, Eli Lilly Oncology, F Hoffmann–La Roche Ltd, Novartis, Merck, MSD, Pierre Fabre and Pfizer. JC: participation to boards of experts for Lilly, Roche, Astra-Zeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Pfizer and Novartis. OM: advisory board for Roche. EQ: advisory board for Novartis, Abbvie and Roche; travel meeting grant and honoraria for Boehringer-Ingelheim; travel meeting grant for Pfizer, Amgen and Lilly. JR: personal fees for Pierre Fabre, Bayer and Novartis. P-JS: grants and non-financial support for Roche and Lilly.