Tailoring maintenance chemotherapy upon response to induction chemotherapy as compared with pemetrexed continuation maintenance in advanced non-squamous NSCLC patients: Results of the IFCT-GFPC-1101 multicenter randomized phase III trial. (February 2022)

• Record Type: Journal Article
• Authors: Souquet, Pierre-Jean; Audigier-Valette, Clarisse; Molinier, Olivier; Cortot, Alexis; Margery, Jacques; Moreau, Lionel; Gervais, Radj; Barlesi, Fabrice; Pichon, Eric; Zalcman, Gérard; Dumont, Patrick; Girard, Nicolas; Poudenx, Michel; Mazières, Julien; Cadranel, Jacques; Debieuvre, Didier; Dauba, Jérôme; Langlais, Alexandra; Morin, Franck; Moro-Sibilot, Denis; Westeel, Virginie; Pérol, Maurice
• Is Part Of: Lung cancer. Volume 164(2022)
• Page Start: 84
• Page End: 90
• Publication Date: 2022-02
• Subjects: Non-small cell lung cancer -- Pemetrexed -- Gemcitabine -- Maintenance; Lungs -- Cancer -- Periodicals; Lung Neoplasms -- Abstracts; Lung Neoplasms -- Periodicals; Poumons -- Cancer -- Périodiques; Lungs -- Cancer; Periodicals; Electronic journals; Electronic journals; 616.99424
• DOI: 10.1016/j.lungcan.2021.11.014
• Languages: English
• ISSNs: 0169-5002

Abstract

Highlights: Adapting maintenance according to response to chemo (SD/OR) doesn't improve survival. Doublet with G or P, have equivalent efficacy in contrast to the JMDB trial. Chemo remains the reference in case of contra-indication/failure of immunotherapy. Toxicities of the two doublets are quite similar during induction/maintenance phase. Abstract: Background: Benefit from maintenance in advanced non-squamous non-small cell lung cancer (NS-NSCLC) might favor switch maintenance after disease stabilization (SD) and continuation after objective response (OR). This trial assessed a maintenance strategy conditioned by response to cisplatin-gemcitabine (CG) with G continuation for patients with OR or switch to pemetrexed (P) for patients with SD as compared with a control arm based on the Paramount regimen. Methods: Eligibility criteria: age 18–70 years, ECOG PS 0–1, untreated stage IV NS-NSCLC without EGFR or ALK alteration, ineligibility to bevacizumab. Patients were randomized 1:1 to receive either CG (4 cycles) followed by G maintenance in case of OR followed by P at progression, or switch to P for patients with SD, or 4 cycles of CP followed by P (control arm). Primary endpoint: overall Survival. Results: Between 2012 and 2016, 932 patients were randomized (CG: 467, CP: 465) with well-balanced characteristics. 257 patients (56.7%) in the CG arm received maintenance (G: 142, P: 113) versus 277 patients (59.7%) in the CP arm. Median number of maintenance cycles was 5 for G and P (CG induction) and 4 for P (CP induction). OS adjusted HR was 0.97 (95% CI 0.84, 1.13; p = 0.71) with a median of 10.9 months (CG) versus 10.4 (CP). HR for PFS was 0.95 (95% CI 0.83, 1.09; p = 0.45) with a median of 4.8 months for CG versus 4.5 for CP. Safety profile was as expected. Conclusions: Adapting maintenance strategy according to response to induction chemotherapy does not improve patient outcome. Clinical trial information: NCT01631136.