title: A phase II study of combination chemotherapy with docetaxel and carboplatin for patients with advanced or metastatic non-small cell lung cancer.
abstract: BACKGROUND
  The aim of this phase II study was to evaluate the efficacy of combination chemotherapy consisting of docetaxel and carboplatin in patients with inoperable non-small cell lung cancer (NSCLC).
  
  
  METHODS
  For this multicenter phase II study, the eligibility criteria included histologically or cytologically proven inoperable NSCLC, measurable lesions, Eastern Cooperative Oncology Group performance status (PS) 0-2, adequate organ and bone marrow functions, and written informed consent. Patients received 60 mg/m2 of docetaxel and carboplatin (target AUC 5.5) on day 1 every 3 weeks until disease progression. The primary end-point of this study was response rate and the secondary end-points were toxicities, time to progression and overall survival.
  
  
  RESULTS
  A total of 40 patients were enrolled and 39 patients were eligible. A complete response and partial response were observed in 1 and 13 patients, respectively. An objective response rate was 35.9% (95% confidential interval [CI] 20.8-51.0%). The median time to progression was 5.2 months and the median overall survival was 12.0 months. The 1- and 2-year survival rates were 53.8% and 25.1%, respectively. The major toxicities were leukocytopenia and neutropenia. Grade 3 or 4 thrombocytopenia was rare and non-hematological toxicities were generally mild. Grade 3 non-hematological toxicities were observed in 6 patients (2 with nausea and vomiting, 1 with diarrhea, 1 with elevated transaminase levels, 1 with allergic reaction and 1 with edema). No grade 4 non-hematological toxicities were observed.
  
  
  CONCLUSIONS
  Docetaxel and carboplatin combination chemotherapy was well tolerated and active in Japanese patients with advanced or metastatic NSCLC.
authors.affiliation: Respiratory Medicine, Kanazawa University Hospital, Takara-machi 13-1, Kanazawa, Ishikawa, Japan. kasa1237@med3.m.kanazawa-u.ac.jp
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kasahara
authors.forename: Hideharu
authors.initials: H
authors.lastname: Kimura
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Shibata
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Araya
authors.forename: Takashi
authors.initials: T
authors.lastname: Sone
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Oribe
authors.forename: Shiho
authors.initials: S
authors.lastname: Furusho
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kita
authors.forename: Hiroki
authors.initials: H
authors.lastname: Shirasaki
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Oribe
authors.forename: Yuzo
authors.initials: Y
authors.lastname: Yoshimi
authors.forename: Akihito
authors.initials: A
authors.lastname: Ueda
authors.forename: Hideki
authors.initials: H
authors.lastname: Tachibana
authors.forename: Hiromoto
authors.initials: H
authors.lastname: Shintani
authors.forename: Masayuki
authors.initials: M
authors.lastname: Mizuguchi
authors.forename: Kohichi
authors.initials: K
authors.lastname: Nishi
authors.forename: Masaki
authors.initials: M
authors.lastname: Fujimura
authors.forename: Shinji
authors.initials: S
authors.lastname: Nakao
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin