Fabrice Barlesi1, Christos Chouaid2, Jacky Crequit3, Hervé Le Caer4, Jean-Louis Pujol5, Julien Legodec6, Alain Vergnenegre7, Jacques Le Treut8, Elizabeth Fabre-Guillevin9, Anderson Loundou10, Pascal Auquier11, Marie-Claude Simeoni11, Pascal A Thomas12. 1. Assistance Publique - Hôpitaux de Marseille, Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Centre d'Investigation Clinique, Marseille, France. 2. Respiratory Pathology Department, Centre Hospitalier Universitaire Saint Antoine, AP-HP, Paris, France. 3. Respiratory Pathology Department, Centre Hospitalier, Creil, France. 4. Respiratory Pathology Department, Centre Hospitalier, Draguignan, France. 5. Respiratory Pathology Department, Hôpital Universitaire Arnaud de Villeneuve, Montpellier, France. 6. Respiratory Pathology Department, HIA Sainte Anne, Toulon, France. 7. Respiratory Pathology, Centre Hospitalier Universitaire, Limoges, France. 8. Pulmonology, Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France. 9. Department of Medical Oncology, Hôpital Européen Georges Pompidou, Assistance Publique - Hopitaux de Paris, Paris, France. 10. Department of Public Health and Biostatistics, Faculty of Medicine, Aix Marseille University, Assistance Publique - Hôpitaux de Marseille, Marseille, France. 11. Self-Perceived Health Assessment Research Unit (EA3279), Aix Marseille University, Marseille, France. 12. Department of Thoracic Surgery, Aix Marseille University, Assistance Publique - Hôpitaux de Marseille, Marseille, France pathomas@ap-hm.fr pascal-alexandre.thomas@mail.ap-hm.fr.
Abstract
OBJECTIVES:Adjuvant chemotherapy with vinorelbine plus cisplatin (VC) improves survival in resected non-small-cell lung cancer (NSCLC), but has negative impact on quality of life (QoL). In advanced NSCLC, gemcitabine plus cisplatin (GC) and docetaxel plus cisplatin (DC) exhibit comparable efficacy, with possibly superior QoL compared to VC. This trial investigated these regimens in the adjuvant setting. METHODS:Patients with Stage IB to III NSCLC were eligible following standardized surgery. Overall, 136 patients were included, with 67 and 69 assigned to the GC and DC arms, respectively. Cisplatin (75 mg/m(2), Day [D] 1) plus gemcitabine (1250 mg/m(2), D1 and D8) or docetaxel (75 mg/m(2) D1) were administered for three cycles. Primary end-point was QoL (EORTC QLQ-C30), with the study designed to detect a 10-point difference between arms. Overall survival, safety and cost were secondary end-points. RESULTS: No between-group imbalance was observed in terms of patient characteristics. At inclusion, global health status (GHS) scores (/100) were 63.5 and 62.7 in GC and DC, respectively (P = 0.8), improving to 64.5 and 65.4 after 3 months (P = 0.8). No significant difference in functional or symptoms scores was observed between the arms except for alopecia. Grade 3/4 haematological and non-haematological toxicities were found in 33.8 and 21.7% (P = 0.11), and 33.8 and 26.1% (P = 0.33) of patients, in GC and DC, respectively. At 2 years, 92.9 and 89.8% of patients remained alive in GC and DC, respectively (P = 0.88). CONCLUSIONS: DC and GC adjuvant chemotherapies for completely resected NSCLC were well tolerated and appear free of major QoL effects, and are therefore representing candidates for comparison with the standard VC regimen.
RCT Entities:
OBJECTIVES: Adjuvant chemotherapy with vinorelbine plus cisplatin (VC) improves survival in resected non-small-cell lung cancer (NSCLC), but has negative impact on quality of life (QoL). In advanced NSCLC, gemcitabine plus cisplatin (GC) and docetaxel plus cisplatin (DC) exhibit comparable efficacy, with possibly superior QoL compared to VC. This trial investigated these regimens in the adjuvant setting. METHODS:Patients with Stage IB to III NSCLC were eligible following standardized surgery. Overall, 136 patients were included, with 67 and 69 assigned to the GC and DC arms, respectively. Cisplatin (75 mg/m(2), Day [D] 1) plus gemcitabine (1250 mg/m(2), D1 and D8) or docetaxel (75 mg/m(2) D1) were administered for three cycles. Primary end-point was QoL (EORTC QLQ-C30), with the study designed to detect a 10-point difference between arms. Overall survival, safety and cost were secondary end-points. RESULTS: No between-group imbalance was observed in terms of patient characteristics. At inclusion, global health status (GHS) scores (/100) were 63.5 and 62.7 in GC and DC, respectively (P = 0.8), improving to 64.5 and 65.4 after 3 months (P = 0.8). No significant difference in functional or symptoms scores was observed between the arms except for alopecia. Grade 3/4 haematological and non-haematological toxicities were found in 33.8 and 21.7% (P = 0.11), and 33.8 and 26.1% (P = 0.33) of patients, in GC and DC, respectively. At 2 years, 92.9 and 89.8% of patients remained alive in GC and DC, respectively (P = 0.88). CONCLUSIONS:DC and GC adjuvant chemotherapies for completely resected NSCLC were well tolerated and appear free of major QoL effects, and are therefore representing candidates for comparison with the standard VC regimen.