title: Phase I/II study of S-1 plus carboplatin in patients with advanced non-small cell lung cancer.
abstract: The objective of this phase I/II study was to determine the recommended dose (RD) of S-1 and carboplatin (CBDCA), and to evaluate the efficacy and safety of this combination in the treatment of patients with advanced non-small cell lung cancer (NSCLC). Chemotherapy-naïve patients were treated with S-1 given orally on days 1-14, and CBDCA infused intravenously on day 1, repeated every 3 weeks. RD was AUC5 of CBDCA and 80 mg/m(2) of S-1. Nineteen patients were treated at the RD. The overall response was 30.8% (95% confidence interval: 17.1-58.3%). The response rate in the RD was 36.8% (95% CI: 16.3-61.6%). The median overall survival time was 11.1 months (95% CI: 8.1-15.3 months) and the median progression-free survival time was 5.0 months (95% CI: 3.6-6.0 months). Major grades 3-4 toxicities were thrombocytopaenia (47%), anaemia (26%) and infection (16%). This is the first report to show promising activity of this combination in phase II, including survival data and manageable toxicity, especially in outpatients receiving treatment for advanced NSCLC.
authors.affiliation: Outpatients Treatment Center, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan. ketamura@ncc.go.jp
authors.forename: Kenji
authors.initials: K
authors.lastname: Tamura
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Ozaki
authors.forename: Tatsuhiko
authors.initials: T
authors.lastname: Kashii
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.forename: Masashi
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Kaoru
authors.initials: K
authors.lastname: Matsui
authors.forename: Takashi
authors.initials: T
authors.lastname: Shibata
authors.forename: Takayasu
authors.initials: T
authors.lastname: Kurata
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D016190:Carboplatin