title: Phase 2 study of S-1 plus carboplatin in patients with advanced non-small cell lung cancer.
abstract: We conducted a phase II study of S-1 and carboplatin combination regimen in the treatment of patients with advanced non-small cell lung cancer (NSCLC). Chemotherapy-naïve patients with advanced NSCLC were treated with S-1 and carboplatin. S-1 was administered orally twice daily for 14 days and carboplatin AUC 5 on day 1 of each cycle, and this was repeated every 4 weeks. Twenty-nine patients were enrolled in this study. The main grade 3 or 4 toxicities observed during the first cycle were neutropenia (10.3%), thrombocytopenia (41%), and transaminase elevation. Objective responses were seen in 9 patients (response rate 31.0%). The median survival time and median progression-free survival were 16.0 months (95% CI, 12.1-19.0 months) and 4.5 months (95% CI, 3.2-6.1 months), respectively. Hematological adverse events reaching grade 3 or 4 were neutropenia (10.3%), anemia (3.4%), and thrombocytopenia (3.4%). No febrile neutropenia was detected. Nonhematological toxicities were also mild. Although grade 3 infection was observed in 1 patient, the patient improved without intervention. The combination of S-1 plus carboplatin is an active and well-tolerated regimen for the treatment of patients with advanced NSCLC. Further investigations are required to confirm our results in randomized trials.
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Showa-machi, Maebashi, Gunma 371-8511, Japan. kkaira1970@yahoo.co.jp
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Kaira
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sunaga
authors.forename: Noriko
authors.initials: N
authors.lastname: Yanagitani
authors.forename: Hisao
authors.initials: H
authors.lastname: Imai
authors.forename: Mitsuyoshi
authors.initials: M
authors.lastname: Utsugi
authors.forename: Yasuki
authors.initials: Y
authors.lastname: Iwasaki
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Shimizu
authors.forename: Hironobu
authors.initials: H
authors.lastname: Iijima
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Tsurumaki
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Tomizawa
authors.forename: Takeshi
authors.initials: T
authors.lastname: Hisada
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Ishizuka
authors.forename: Ryusei
authors.initials: R
authors.lastname: Saito
authors.forename: Masatomo
authors.initials: M
authors.lastname: Mori
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / 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; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D013921:Thrombocytopenia / Q000209:etiology
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D016190:Carboplatin