title: A phase II study of the docetaxel-carboplatin chemotherapy regimen in advanced non-small-cell lung cancer.
abstract: The efficacy of the docetaxel-carboplatin combination chemotherapy was studied in various phase II studies. Based on these data we aimed to test the regimen in previously untreated patients with advanced advanced non-smoking lung cancer (NSCLC) with docetaxel 80 mg/m2 a standard dose of carboplatin at AUC = 5, in an attempt to define the efficacy and tolerability of the combination in an open-label phase II study. Patients with histologically confirmed advanced NSCLC stage IIIB and IV were candidates for the present study. Docetaxel was administered at 80 mg/m2 over 1 h by intravenous (IV) infusion followed by carboplatin AUC = 5 in 30 min IV infusion, both on day 1, and recycled every 21 days. Sixty patients received 263 courses of therapy in total; 231/263 (88%) were administered according to the planned doses, and 48/60 (80%) patients received chemotherapy without decrement of the dose; 32/263 (12%) of the courses were administered with a 10%-30% dose reduction. Complete responses (CR) were seen in 5 patients (8.3%) and partial responses (PR) in 16 patients (26.7%) for an overall response rate of 35%. Median duration of response was 7.5 months [95% confidence interval (CI)-7.1-7.9], time to progression (TIP) 11.5 months (95% CI-8.2-14.8), median overall survival (OS) 15.0 months (95% CI-10.8-19.2). One-year survival was 61.7%. Toxicity was acceptable; it was calculated according to the administered cycles and was mainly neutropenia: grade 3, 9% and grade 4, 2%; anemia: grade 3, 8%; nausea and vomiting: grade 3, 8%. The outpatient regimen of docetaxel-carboplatin is effective with acceptable toxicity in patients with advanced NSCLC.
authors.affiliation: Medical Oncology Unit, Department of Pathophysiology, Laikon General Hospital, Athens University School of Medicine, 115 21, Athens, Greece. tsavaril@otenet.gr
authors.forename: Nicolas
authors.initials: N
authors.lastname: Tsavaris
authors.forename: Christos
authors.initials: C
authors.lastname: Kosmas
authors.forename: Elias
authors.initials: E
authors.lastname: Skopelitis
authors.forename: Kostantinos
authors.initials: K
authors.lastname: Gennatas
authors.forename: Alexandra
authors.initials: A
authors.lastname: Zorbala
authors.forename: Paris
authors.initials: P
authors.lastname: Papas
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Gouveris
authors.forename: George
authors.initials: G
authors.lastname: Antypas
authors.forename: Sofia
authors.initials: S
authors.lastname: Rokana
authors.forename: George
authors.initials: G
authors.lastname: Tzelepis
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* / Q000401:mortality; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin