Denis Moro-Sibilot1, Clarisse Audigier-Valette2, Patrick Merle3, Elisabeth Quoix4, Pierre-Jean Souquet5, Fabrice Barlesi6, Christos Chouaid7, Olivier Molinier8, Jaafar Bennouna9, Armelle Lavolé10, Julien Mazières11, Anne-Claire Toffart12, Alexandra Langlais13, Franck Morin13, Gérard Zalcman14. 1. Department of Thoracic Oncology, Pole Thorax Vaisseaux, CHU Grenoble and INSERM U 823, CS10217, Grenoble, France. Electronic address: DMoro.pneumo@chu-grenoble.fr. 2. Department of Pneumology, Hôpital Sainte Musse, Toulon, France. 3. Department of Pneumology-Thoracic Oncology, CHU Hôpital Gabriel Montpied, Clermont-Ferrand, France. 4. Department of Pneumology, Nouvel hôpital civil, Hôpitaux universitaires de Strasbourg, Strasbourg, France. 5. Department of Pneumology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France. 6. Aix Marseille Université, Assistance Publique Hôpitaux de Marseille, Multidisciplinary Oncology and Therapeutic Innovation Unit, Hôpital Nord, Centre d'investigation clinique, Marseille, France. 7. Department of Pneumology, Centre hospitalier intercommunal de Créteil, Créteil, France. 8. Pneumology, Centre Hospitalier, Le Mans, France. 9. Institut de Cancérologie de l'Ouest, Saint-Herblain, France. 10. Pneumology, AP-HP Hôpital Tenon, Paris, France. 11. Pneumology, CHU, Toulouse, France. 12. Department of Thoracic Oncology, Pole Thorax Vaisseaux, CHU Grenoble and INSERM U 823, CS10217, Grenoble, France. 13. French Cooperative Thoracic Intergroup (IFCT), Paris, France. 14. Department of Pneumology and Thoracic Oncology, CHU Caen, Côte de Nacre, Caen, France.
Abstract
INTRODUCTION: This study compared the efficacy of docetaxel alone vs. docetaxel plus cisplatin/carboplatin in resected NSCLC patients relapsing after preoperative, adjuvant, or perioperative platinum-based chemotherapy. MATERIALS AND METHODS: Patients were randomly assigned to receive docetaxel plus cisplatin/carboplatin (Arm A) or docetaxel alone (Arm B). Primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate at 6 weeks, toxicity, quality of life, and overall survival (OS). RESULTS:From November 2007 to August 2012, 88 patients were enrolled. Due to an unexpectedly slow accrual, the trial was prematurely stopped. Adding platinum to docetaxel caused a non-significant increase in PFS. Median PFS was 8.0 months (95% CI: 5.3-10.4) for Arm A vs. 5.6 months (95% CI: 4.0-7.3) for Arm B (HR: 0.71, 95% CI: 0.45-1.1, p=0.15). Median OS was 16.0 months (95% CI: 10.1-23.9) for Arm A vs. 12.4 months (95% CI: 8.2-19.6) for Arm B. In pre-planned subgroup analyses, a time to recurrence ≥12 months and non-squamous histology favorably influenced OS (HR: 0.51, 95% CI: 0.29-0.91, p=0.02 and HR: 0.54, 95% CI: 0.33-0.91, p=0.02, respectively). There were no unexpected adverse events, and Grade 3-4 toxicity was comparable in both groups. CONCLUSIONS: Our study failed to demonstrate significant PFS improvement with the docetaxel-platinum doublet compared to single-agent docetaxel. The 3.6-month improvement in OS with the cisplatin-based doublet proves, however, appealing and merits further investigation.
RCT Entities:
INTRODUCTION: This study compared the efficacy of docetaxel alone vs. docetaxel plus cisplatin/carboplatin in resected NSCLCpatients relapsing after preoperative, adjuvant, or perioperative platinum-based chemotherapy. MATERIALS AND METHODS:Patients were randomly assigned to receive docetaxel plus cisplatin/carboplatin (Arm A) or docetaxel alone (Arm B). Primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate at 6 weeks, toxicity, quality of life, and overall survival (OS). RESULTS: From November 2007 to August 2012, 88 patients were enrolled. Due to an unexpectedly slow accrual, the trial was prematurely stopped. Adding platinum to docetaxel caused a non-significant increase in PFS. Median PFS was 8.0 months (95% CI: 5.3-10.4) for Arm A vs. 5.6 months (95% CI: 4.0-7.3) for Arm B (HR: 0.71, 95% CI: 0.45-1.1, p=0.15). Median OS was 16.0 months (95% CI: 10.1-23.9) for Arm A vs. 12.4 months (95% CI: 8.2-19.6) for Arm B. In pre-planned subgroup analyses, a time to recurrence ≥12 months and non-squamous histology favorably influenced OS (HR: 0.51, 95% CI: 0.29-0.91, p=0.02 and HR: 0.54, 95% CI: 0.33-0.91, p=0.02, respectively). There were no unexpected adverse events, and Grade 3-4 toxicity was comparable in both groups. CONCLUSIONS: Our study failed to demonstrate significant PFS improvement with the docetaxel-platinum doublet compared to single-agent docetaxel. The 3.6-month improvement in OS with the cisplatin-based doublet proves, however, appealing and merits further investigation.
Authors: Vitor F Vasconcellos; Guilherme N Marta; Edina Mk da Silva; Aecio Ft Gois; Tiago B de Castria; Rachel Riera Journal: Cochrane Database Syst Rev Date: 2020-01-13