title: Docetaxel versus docetaxel plus gemcitabine as front-line treatment of patients with advanced non-small cell lung cancer: a randomized, multicenter phase III trial.
abstract: To compare the overall survival (OS) of patients with advanced non-small cell lung (NSCLC) treated with either docetaxel plus gemcitabine or single-agent docetaxel. Chemotherapy-naive patients with advanced/metastatic NSCLC were randomly assigned to receive either DG [n=157; gemcitabine 1100mg/m(2) on days 1 and 8], docetaxel 75mg/m(2) on day 8 or D [n=155; docetaxel 100mg/m(2) on day 1] every 3 weeks. A total of 312 patients were evaluable for toxicity and response. A predefined interim intention-to-treat analysis showed significantly longer median OS (p=0.037) in favor of the DG regimen (9.4 months versus 8.3 months for DG and D regimens, respectively), resulting in the premature termination of the study. The DG regimen was also associated with a significantly higher response rate compared to D (26.8% versus 11.6%, p<0.001). TTP were 3.5 and 2.3 months for the DG and D regimen, respectively (p=0.054). Although there were two treatment-related deaths in the DG arm, the toxicity profiles of the two regimens were comparable. The DG regimen was associated with a significantly better quality of life. The efficacy of the docetaxel plus gemcitabine combination is superior to single-agent docetaxel in chemonaive patients with advanced NSCLC.
authors.affiliation: The Hellenic Oncology Research Group (HORG), Athens, Greece. georgsec@med.uoc.gr
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Androulakis
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.forename: Dora
authors.initials: D
authors.lastname: Hatzidaki
authors.forename: Kostas
authors.initials: K
authors.lastname: Syrigos
authors.forename: Aris
authors.initials: A
authors.lastname: Polyzos
authors.forename: Athina
authors.initials: A
authors.lastname: Agelidou
authors.forename: Ioannis
authors.initials: I
authors.lastname: Varthalitis
authors.forename: Nikoalos
authors.initials: N
authors.lastname: Ziras
authors.forename: Maria
authors.initials: M
authors.lastname: Agelidou
authors.forename: Vassilis
authors.initials: V
authors.lastname: Chandrinos
authors.forename: Ioannis
authors.initials: I
authors.lastname: Boukovinas
authors.forename: Alexandra
authors.initials: A
authors.lastname: Geroyianni
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavroudis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000523:psychology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine