A randomized trial comparing adjuvant chemotherapy with gemcitabine plus cisplatin with docetaxel plus cisplatin in patients with completely resected non-small-cell lung cancer with quality of life as the primary objective

Fabrice Barlesi (1) , Christos Chouaid (2) , Jacky Crequit (3) , Hervé Le Caer (4) , Jean Louis Pujol (5, 6) , Julien Legodec (7) , Alain Vergnenegre (8) , Jacques Le Treut (9) , Elizabeth Fabre-Guillevin (10) , Anderson Loundou (11) , Pascal Auquier (11) , Marie-Claude Simeoni (11) , Pascal A. Thomas (12)

1 Hôpital Nord [CHU - APHM]
2 CHU Saint-Antoine [AP-HP]
3 Respiratory Pathology Department
4 Respiratory Pathology Department
5 IRCM - U1194 Inserm - UM - Institut de Recherche en Cancérologie de Montpellier
6 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
7 Respiratory Pathology Department
8 Service de Pathologie respiratoire et allergologie [CHU Limoges]
9 Service de Pneumologie
10 HEGP - Hôpital Européen Georges Pompidou [APHP]
11 SPMC - Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants
12 Departement de chirurgie thoracique et des maladies de l'oesophage [Hôpital Nord - APHM]

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.

Mots clés: Quality of life; Adjuvant chemotherapy; Non-small-cell lung cancer; QUESTIONNAIRE QLQ-C30; CLINICAL-TRIALS; PHASE-III; CARCINOMA; ONCOLOGY; SURGERY; SCORES; IB

Domaines: Cancer

Fabrice Barlesi, Christos Chouaid, Jacky Crequit, Hervé Le Caer, Jean Louis Pujol, et al.. A randomized trial comparing adjuvant chemotherapy with gemcitabine plus cisplatin with docetaxel plus cisplatin in patients with completely resected non-small-cell lung cancer with quality of life as the primary objective. Interactive Cardiovascular and Thoracic Surgery, 2015, ⟨10.1093/icvts/ivv050⟩. ⟨hal-01207949⟩