title: Phase I study of biweekly paclitaxel and carboplatin for frail patients with advanced non-small cell lung cancer.
abstract: OBJECTIVE
  The aim of this phase I study was to determine the maximum tolerated dose (MTD) and to evaluate the toxicity of the biweekly paclitaxel and carboplatin combination chemotherapy in frail patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Seventeen unresectable and previously untreated NSCLC patients participated in this study. Frail patients (>80 years old with PS 0-1 and adequate organ functions, or <80 years old with PS 2 or <80 with PS 0-1 and one inadequate organ function of bone marrow, liver, or kidney) of NSCLC were enrolled in this study. Both paclitaxel and carboplatin were administered on day 1 and repeated biweekly. The starting dose of paclitaxel 120 mg/m2 and carboplatin was AUC 3 /d on day 1 every 2 weeks for 4 to 8 cycles.
  
  
  RESULTS
  Seventeen frail patients received a total of 1 to 10 cycles. The major hematologic toxicity was neutropenia. Nonhematologic toxicities, including numbness and constipation, were generally mild and reversible. The MTD of paclitaxel were determined as 140 mg/m2. The recommended phase II study dose of paclitaxel was determined as 120 mg/m2 with area under the curve 3 biweekly for 1 day. An objective response was observed in 8 of 17 patients (47%) with frail patients.
  
  
  CONCLUSIONS
  The combination chemotherapy of biweekly paclitaxel and carboplatin appears to be tolerable and sufficiently effective in frail patients with NSCLC. A phase II trial is underway.
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan. nyanagi@med.gunma-u.ac.jp
authors.forename: Noriko
authors.initials: N
authors.lastname: Yanagitani
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tsuchiya
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Kaira
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sunaga
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Tsuchiya
authors.forename: Koji
authors.initials: K
authors.lastname: Sato
authors.forename: Satoru
authors.initials: S
authors.lastname: Watanabe
authors.forename: Shiro
authors.initials: S
authors.lastname: Nomura
authors.forename: Shuzo
authors.initials: S
authors.lastname: Sakai
authors.forename: Ryusei
authors.initials: R
authors.lastname: Saito
authors.forename: Masatomo
authors.initials: M
authors.lastname: Mori
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000188:drug therapy* / Q000473:pathology*; D017322:Clinical Trials, Phase II as Topic; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D016330:Frail Elderly; D006801:Humans; D007958:Leukocyte Count; D008175:Lung Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000633:toxicity; D018579:Patient Selection; D010976:Platelet Count
chemical_list: D016190:Carboplatin; D017239:Paclitaxel