title: Phase I/II trial of docetaxel and carboplatin as a first-line therapy in patients with stage IV non-small-cell lung cancer.
abstract: A phase I/II study was conducted to determine the maximum-tolerated dose, the safety and tolerability, and the clinical efficacy of carboplatin and docetaxel in combination in patients with stage IV non-small-cell lung cancer. Patients with measurable, previously untreated, good performance status, and stage IV non-small-cell lung cancer were eligible. Increasing doses of docetaxel were given in combination with a fixed dose of carboplatin except at level 5. Cycles were repeated every four weeks. Seventy-seven patients were registered. In phase I, 27 patients were entered at five different dose levels. A docetaxel dose of 60 mg/m(2) and carboplatin area under the concentration time curve 6 was recommended for phase II, and an additional 50 patients were entered at this level for a total of 56 patients. Grade 3/4 neutropenia was the most common adverse event and occurred in 70% of the patients. Two patients had febrile neutropenia. Fifty-six patients were assessable for response; 21 partial responses were observed for an overall response rate of 37.5%. The median time to tumor progression was 4.0 months (range, 1.0-21.0 months), and the median survival was 12.9 months (range, 0.4-51.3 months). The one-year survival rate was 46.4%. The combination of docetaxel 60 mg/m(2) and carboplatin area under the concentration time curve 6 is feasible and effective in patients with stage IV non-small-cell lung cancer.
authors.affiliation: Division of Respiratory Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai, Showa-ku, Nagoya 466-8550, Japan.
authors.forename: Kensuke
authors.initials: K
authors.lastname: Kataoka
authors.forename: Ryujiro
authors.initials: R
authors.lastname: Suzuki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Taniguchi
authors.forename: Yasunobu
authors.initials: Y
authors.lastname: Noda
authors.forename: Joe
authors.initials: J
authors.lastname: Shindoh
authors.forename: Syuichi
authors.initials: S
authors.lastname: Matsumoto
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Watanabe
authors.forename: Kousuke
authors.initials: K
authors.lastname: Honda
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Suzuki
authors.forename: Kenji
authors.initials: K
authors.lastname: Baba
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Imaizumi
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Kume
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Kenzo
authors.initials: K
authors.lastname: Takagi
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin