title: Preliminary results of a phase I/II clinical trial of paclitaxel and carboplatin in non-small cell lung cancer.
abstract: Forty-nine patients with non-small cell lung cancer were treated in a study designed to establish the maximum tolerated dose of outpatient paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), given by 3-hour infusion, combined with a fixed dose of carboplatin (area under the concentration-time curve [AUC] = 6, Calvert method). The study population included 31 men and 18 women with previously untreated, unresectable stage III or IV non-small cell lung cancer. Patients had a median age of 62 years (age range, 46 to 81 years) and a median Southwest Oncology Group performance status of 1 (range, 0 to 2). With six to 10 patients treated at each dose level, paclitaxel was given at a starting dose of 150 mg/m2, and doses were escalated by 25-mg/m2 increments. The carboplatin dose was fixed at an AUC of 6. Paclitaxel 250 mg/m2 was established as the maximum tolerated dose of this combination, and severe (grade 3) sensory neuropathy was defined as the dose-limiting toxicity. Objective responses were documented in 26 of 42 patients with objectively measurable disease, for an overall response rate of 62%. Although these data are preliminary, this regimen appears to be efficacious and cost-effective, and warrants further study. Paclitaxel 225 mg/m2 combined with carboplatin (AUC = 6) every 3 weeks is recommended for follow-up phase II and III clinical trials.
authors.affiliation: Department of Medical Oncology, University of Southern California/Kenneth Norris Jr Comprehensive Cancer Center, Los Angeles 90033, USA.
authors.forename: R B
authors.initials: RB
authors.lastname: Natale
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000633:toxicity; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000633:toxicity; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D016190:Carboplatin; D017239:Paclitaxel