title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Assistance Publique - Hôpitaux de Marseille, Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Centre d'Investigation Clinique, Marseille, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Barlesi
authors.affiliation: Respiratory Pathology Department, Centre Hospitalier Universitaire Saint Antoine, AP-HP, Paris, France.
authors.forename: Christos
authors.initials: C
authors.lastname: Chouaid
authors.affiliation: Respiratory Pathology Department, Centre Hospitalier, Creil, France.
authors.forename: Jacky
authors.initials: J
authors.lastname: Crequit
authors.affiliation: Respiratory Pathology Department, Centre Hospitalier, Draguignan, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Le Caer
authors.affiliation: Respiratory Pathology Department, Hôpital Universitaire Arnaud de Villeneuve, Montpellier, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Pujol
authors.affiliation: Respiratory Pathology Department, HIA Sainte Anne, Toulon, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Legodec
authors.affiliation: Respiratory Pathology, Centre Hospitalier Universitaire, Limoges, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Vergnenegre
authors.affiliation: Pulmonology, Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Le Treut
authors.affiliation: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Assistance Publique - Hopitaux de Paris, Paris, France.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Fabre-Guillevin
authors.affiliation: Department of Public Health and Biostatistics, Faculty of Medicine, Aix Marseille University, Assistance Publique - Hôpitaux de Marseille, Marseille, France.
authors.forename: Anderson
authors.initials: A
authors.lastname: Loundou
authors.affiliation: Self-Perceived Health Assessment Research Unit (EA3279), Aix Marseille University, Marseille, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Auquier
authors.affiliation: Self-Perceived Health Assessment Research Unit (EA3279), Aix Marseille University, Marseille, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Simeoni
authors.affiliation: 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.
authors.forename: Pascal A
authors.initials: PA
authors.lastname: Thomas
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology / Q000523:psychology / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077143:Docetaxel; D005260:Female; D005602:France; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011013:Pneumonectomy / Q000009:adverse effects / Q000401:mortality; D011788:Quality of Life; D011795:Surveys and Questionnaires; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D002945:Cisplatin; D000093542:Gemcitabine
keywords: Adjuvant chemotherapy; Non-small-cell lung cancer; Quality of life