Phase II study of docetaxel in the treatment of patients with advanced non-small cell lung cancer in routine daily practice

The purpose of this study was to evaluate the efficacy and safety of doceta xel as first- and second-line chemotherapy for advanced non-small cell lung cancer (NSCLC) under routine clinical conditions. Two hundred and three pa tients with advanced NSCLC received docetaxel 100 mg/m(2) (1-h intravenous infusion) every 3 weeks, with oral corticosteroid pie-medication, of whom 1 73 were eligible. Median age was 60 (29-78) years and median Karnofsky perf ormance status was 80% (60-100). A total of 77% of patients had metastatic disease. 33% had bone metastases and 18% had liver metastases. The treatmen t 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 popula tion (8.7 months and 38%, respectively, for patients receiving first-line t reatment and 7.2 months and 27%, respectively, for patients receiving secon d-line treatment). Neutropenia, grade 3 and 4, occurred in 57% of the cycle s and 5% of patients experienced febrile neutropenia. Alopecia (62% of pati ents). neuro-sensory symptoms (32%), asthenia (28%). diarrhea (22%). nausea (22%) and nail disorders (20%) were the most common non-hematological adve rse effects. A total of 33% of patients suffered fluid retention. despite t he use of corticosteroid pre-medication. but this was only severe in 1.5% o f patients. It was possible to confirm the efficacy of docetaxel as a singl e agent for first- and second-line chemotherapy in a large patient populati on treated in a community setting. (C) 2000 Elsevier Science Ireland Ltd. A ll rights reserved.