title: Phase I/II study of docetaxel and S-1, an oral fluorinated pyrimidine, for untreated advanced non-small cell lung cancer.
abstract: The purpose of this phase I/II study is to evaluate a new combination chemotherapy consisting of docetaxel and S-1 as front-line therapy for patients with untreated advanced non-small cell lung cancer (NSCLC). The treatment included docetaxel on day 1 and oral S-1 at a fixed dose of 40mg/m(2) administered twice daily on days 1-14 and repeated every 3 weeks. In phase I, docetaxel at escalating doses of 40 (level 0), 50 (level 1) and 60mg/m(2) (level 2) was administered starting from level 1. Because only one patient among the 6-patient cohort at level 1 and no patient among the 3-patient cohort at level 2 experienced defined dose-limiting toxicity (DLT), level 2 was determined as the recommended dose. In phase II, 60 patients were treated at the recommended dose for median 3 cycles, and the overall response rate was 30% (95% confidence interval [CI], 18.9-43.2%), and the median overall and progression-free survival times were 15.2 (95% CI: 10.5-17.7) and 4.9 (95% CI: 3.5-5.6) months, respectively. The most frequent toxicities experienced were neutropenia, febrile neutropenia and appetite loss; all toxicities were however well manageable. The present regimen showed a potent activity with mild toxicity in untreated NSCLC.
authors.affiliation: Department of Respirology (B2), Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan. takiguchi@faculty.chiba-u.jp
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takiguchi
authors.forename: Yuji
authors.initials: Y
authors.lastname: Tada
authors.forename: Akihiko
authors.initials: A
authors.lastname: Gemma
authors.forename: Shoji
authors.initials: S
authors.lastname: Kudoh
authors.forename: Mitsunori
authors.initials: M
authors.lastname: Hino
authors.forename: Kozo
authors.initials: K
authors.lastname: Yoshimori
authors.forename: Akinobu
authors.initials: A
authors.lastname: Yoshimura
authors.forename: Keiichi
authors.initials: K
authors.lastname: Nagao
authors.forename: Hisanobu
authors.initials: H
authors.lastname: Niitani
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000503:physiopathology; D018450:Disease Progression; D000077143:Docetaxel; D004338:Drug Combinations; D054796:Drug Dosage Calculations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid