title: Phase I and II trials of vinorelbine with carboplatin for patients 75 years of age or older with previously untreated non-small-cell lung cancer.
abstract: BACKGROUND
  The safety and efficacy of platinum-based combination chemotherapy for elderly patients with advanced non-small-cell lung cancer (NSCLC) remains unclear. We conducted phase I and phase II trials of a combination of vinorelbine and carboplatin for patients ≥75 years of age and with advanced NSCLC.
  
  
  METHODS
  Previously untreated patients (≥75 years of age) with stage IIIB or IV NSCLC were enrolled. Based on a 4-week cycle, vinorelbine was given on days 1 and 8, and carboplatin was given on day 1. Dose-limiting toxicity was defined as grade 4 hematologic toxicity that lasted 4 days or more, febrile neutropenia; grade 3 or worse nonhematologic toxicities; or the omission of vinorelbine administration on day 8 in the first cycle.
  
  
  RESULTS
  Thirteen patients were enrolled in phase I. dose-limiting toxicity was grade 4 neutropenia that lasted 4 days or more, observed in 2 of 4 patients at level 4. Phase II study used the dose of level 3 (20 mg/m(2) vinorelbine, area under the curve of 4 mg/mL/min carboplatin). Forty-two patients were enrolled. The response rate was 14.6% of 41 assessable patients (95% CI, 3.8-25.4). The median time to progression was 98 days (95% CI, 61-135 days), and the median survival time was 366 days (95% CI, 321-411 days). All toxicities were mild and manageable.
  
  
  CONCLUSIONS
  Use of 20 mg/m(2) vinorelbine on days 1 and 8, followed by carboplatin area under the curve of 4 mg/mL/min on day 1 every 4 weeks warrants a phase III study for elderly patients with advanced NSCLC.
authors.affiliation: Department of Respiratory Medicine, Nagasaki Municipal Medical Center, Nagasaki, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takatani
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Nakamura
authors.forename: Seiji
authors.initials: S
authors.lastname: Nagashima
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Soda
authors.forename: Akitoshi
authors.initials: A
authors.lastname: Kinoshita
authors.forename: Minoru
authors.initials: M
authors.lastname: Fukuda
authors.forename: Masaaki
authors.initials: M
authors.lastname: Fukuda
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Soejima
authors.forename: Takashi
authors.initials: T
authors.lastname: Kasai
authors.forename: Katsumi
authors.initials: K
authors.lastname: Nakatomi
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Iida
authors.forename: Mikio
authors.initials: M
authors.lastname: Oka
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Tsukamoto
authors.forename: Shigeru
authors.initials: S
authors.lastname: Kohno
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018287:Carcinoma, Large Cell / Q000188:drug therapy* / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D011379:Prognosis; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D016190:Carboplatin; D000077235:Vinorelbine