title: Combination chemotherapy with carboplatin, docetaxel, and gemcitabine in advanced non-small-cell lung cancer: a phase II study.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of the combination of carboplatin, docetaxel, and gemcitabine in patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Forty-five chemotherapy-naive patients with NSCLC were treated on an out-patient basis with carboplatin area under the curve 5 intravenous (IV) and gemcitabine 800 mg/m(2) IV on day 1 and docetaxel 75 mg/m(2) IV and gemcitabine 800 mg/m(2) IV on day 8. Granulocyte colony-stimulating 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 weeks. 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 for 12 patients. Nine patients (20%) had stage IIIB disease, and 36 (80%) had stage IV; histology was mainly squamous cell carcinoma (51.2% of patients) that was poorly differentiated (37.8%). All 45 patients were assessable for toxicity, and 41 were assessable for response. On an intent-to-treat analysis, the objective response rate was 46. 5% (21 out of 45 patients; 95% confidence interval [CI], 31.7% to 62. 5%). Of the 45 patients, four (8.8%) achieved 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 duration of response was 7.6 months, and the time to tumor progression was 8.1 months. Grade 3/4 anemia and thrombocytopenia occurred in 17.7% and 28.8% of patients, respectively. Twenty-one patients (46.6%) developed grade 3/4 neutropenia, 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 reaction occurred in three patients (16.6%). There were no treatment-related deaths. 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.
authors.affiliation: 1Department of Medical Oncology, METAXAS Memorial Cancer Hospital, Piraeus, Greece. depectasides@usa.net
authors.forename: D
authors.initials: D
authors.lastname: Pectasides
authors.forename: A
authors.initials: A
authors.lastname: Aspropotamitis
authors.forename: A
authors.initials: A
authors.lastname: Halikia
authors.forename: A
authors.initials: A
authors.lastname: Visvikis
authors.forename: F
authors.initials: F
authors.lastname: Antoniou
authors.forename: A
authors.initials: A
authors.lastname: Kalantaridou
authors.forename: N
authors.initials: N
authors.lastname: Karvounis
authors.forename: S
authors.initials: S
authors.lastname: Batzios
authors.forename: A
authors.initials: A
authors.lastname: Athanassiou
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives; D043823:Taxoids; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine