title: Phase II study of docetaxel in the treatment of patients with advanced non-small cell lung cancer in routine daily practice.
abstract: The purpose of this study was to evaluate the efficacy and safety of docetaxel as first- and second-line chemotherapy for advanced non-small cell lung cancer (NSCLC) under routine clinical conditions. Two hundred and three patients with advanced NSCLC received docetaxel 100 mg/m2 (1-h intravenous infusion) every 3 weeks, with oral corticosteroid pre-medication, of whom 173 were eligible. Median age was 60 (29-78) years and median Karnofsky performance status was 80% (60-100). A total of 77% of patients had metastatic disease, 33% had bone metastases and 18% had liver metastases. The treatment was second-line or more for 72 patients (35%). Overall response rates in the eligible population were 19.7% [95% CI, 12.5-23.0] for both treatments, 22.6% for first-line treatment and 13.8% for second-line treatment. Median survival was 8.3 months and 1-year survival was 35% for the overall population (8.7 months and 38%, respectively, for patients receiving first-line treatment and 7.2 months and 27%, respectively, for patients receiving second-line treatment). Neutropenia, grade 3 and 4, occurred in 57% of the cycles and 5% of patients experienced febrile neutropenia. Alopecia (62% of patients), neuro-sensory symptoms (32%), asthenia (28%), diarrhea (22%), nausea (22%) and nail disorders (20%) were the most common non-hematological adverse effects. A total of 33% of patients suffered fluid retention, despite the use of corticosteroid pre-medication, but this was only severe in 1.5% of patients. It was possible to confirm the efficacy of docetaxel as a single agent for first- and second-line chemotherapy in a large patient population treated in a community setting.
authors.affiliation: Helsinki University Central Hospital, Haartmaninkatu 4, FIN 00290, Helsinki, Finland.
authors.forename: K
authors.initials: K
authors.lastname: Mattson
authors.forename: L
authors.initials: L
authors.lastname: Bosquee
authors.forename: G
authors.initials: G
authors.lastname: Dabouis
authors.forename: A
authors.initials: A
authors.lastname: Le Groumellec
authors.forename: J L
authors.initials: JL
authors.lastname: Pujol
authors.forename: S
authors.initials: S
authors.lastname: Marien
authors.forename: R
authors.initials: R
authors.lastname: Stupp
authors.forename: J Y
authors.initials: JY
authors.lastname: Douillard
authors.forename: B
authors.initials: B
authors.lastname: Brägas
authors.forename: J
authors.initials: J
authors.lastname: Berille
authors.forename: R
authors.initials: R
authors.lastname: Olivares
authors.forename: T
authors.initials: T
authors.lastname: Le Chevalier
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016019:Survival Analysis; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel