Combination chemotherapy with carboplatin, docetaxel, and gemcitabine in advanced non-small-cell lung cancer: A phase II study

Purpose: To evaluate the efficacy and toxicity of the combination of carbop latin, docetaxel, and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC), Patients and Methods: Forty-five chemotherapy-naive patients with NSCLC wer e treated on an out-patient basis with carboplatin area under the curve 5 i ntravenous (IV) and gemcitabine 800 mg/m(2) IV on day 1 and docetaxel 75 mg /m(2) IV and gemcitanine 800 mgg/m(2) IV on day 8. Granulocyte colony-stimu lating factor (150 ug/m(2) subcutaneously) was given prophylactically from day 3 to day 6 and day 10 to day 16. Chemotherapy was repeated every 4 week s, patients were evaluated for response every two cycles of treatment Results: The median age of the patients was 58 years (range, 24 to 75 years ). The performance status was 0 for 16 patients, 1 for 17 patients, and 2 f or 12 patients, Nine patients (20%) herd stage IIIB disease, and 36 (80%) h ad stage IV; histology was mainly squamous cell carcinoma (51.2% of patient s) that was poorly differentiated (37.8%). All 45 patients were assessable for toxicity, and 41 were assessable for response, On an intent-to-treat an alysis, the objective response rate was 46.5% (21 our of 45 patients; 95% c onfidence interval [CI], 31.7% to 62.5%), Of the 45 patients, four (8.8%] a chieved a complete response (95% CI, 2.5% to 21.2%); 17 (37.7%) achieved a partial response (95% CI, 23.8% to 53.5%); seven (15.5%) had stable disease ; and 14 (31.1%) had progressive disease, The median survival time was 13.5 months, and the actuarial 1-year survival rate was 51.11%. The median dura tion of response was 7.6 months, and the rime to tumor progression was 8.1 months, Grade 3/4 anemia and thrombocytopenia occurred in 17.7% and 28.8% o f patients, respectively. Twenty-one patients (46.6%) developed grade 3/4 n eutropenia, and six patients (13.3%) were complicated with fever, Alopecia was universal. Grade 3 diarrhea occurred in four patients (8.8%); grade 3/4 neurotoxicity occurred in 10 patients (22.2%); and grade 2/3 allergic reac tion occurred in three patients (16.6%), There were no treatment-related de aths. Six patients (13.3%) required a dose reduction, two of which required two reductions. Conclusions: The combination of carboplatin, docetaxel, and gemcitabine is an effective regimen for the treatment of chemotherapy-naive patients with advanced NSCLC, causing only moderate toxicity, J Clin Oncol 17:3816-3821. (C) 1999 by American Society of Clinical Oncology.