title: Phase I studies of cisplatin and docetaxel administered by three consecutive weekly infusions for advanced non-small cell lung cancer in elderly and non-elderly patients.
abstract: BACKGROUND
  To determine the maximum tolerated dose and recommended dose of cisplatin and docetaxel administered by three consecutive weekly infusions in both non-elderly (< or =74 years) and elderly (> or =75 years) patients, we conducted two independent phase I studies for nonelderly and elderly patients with non-small cell lung cancer.
  
  
  METHODS
  Between April 1998 and September 1999, 26 non-elderly (median, 54 years; range, 44-73 years) and 12 elderly (median, 76 years; range, 75-80 years) patients with non-small cell lung cancer were entered in these studies. The eligibility criteria of both cohorts were identical except for age. Chemotherapy consisted of cisplatin 25 mg/m2 and an escalated dose of docetaxel on days 1, 8 and 15 every 4 weeks. The initial dose of docetaxel was 20 mg/m2 and it was increased by 5 mg/m2 at each dose level.
  
  
  RESULTS
  In the non-elderly and elderly cohorts, up to 45 or 25 mg/m2 of docetaxel, respectively, were administered. Dose-limiting toxicities were neutropenia, liver damage, pneumonia and omission of treatment on day 15 by leukopenia and refusal in the non-elderly cohort; pneumonia and omission of treatment on day 15 by refusal due to fatigue/asthenia or fever in the elderly cohort. We considered the recommended doses for phase II studies were cisplatin 25 mg/m2 and docetaxel 35 mg/m2 on days 1, 8 and 15 for non-elderly patients and cisplatin 25 mg/m2 and docetaxel 20 mg/m2 on days 1, 8 and 15 for elderly patients. Seven of 26 (27%) and seven of 12 (58%) patients achieved a partial response, median survival times were 8.7 and 7.2 months and 1 year survival rates were 27 and 27% in the non-elderly and elderly cohorts, respectively.
  
  
  CONCLUSIONS
  Further evaluation of this combination chemotherapy is warranted for both nonelderly and elderly patients with non-small cell lung cancer but the dose of docetaxel should be lower for elderly than non-elderly patients.
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. yohe@ncc.go.jp
authors.forename: Y
authors.initials: Y
authors.lastname: Ohe
authors.forename: S
authors.initials: S
authors.lastname: Niho
authors.forename: R
authors.initials: R
authors.lastname: Kakinuma
authors.forename: K
authors.initials: K
authors.lastname: Kubota
authors.forename: T
authors.initials: T
authors.lastname: Matsumoto
authors.forename: H
authors.initials: H
authors.lastname: Ohmatsu
authors.forename: K
authors.initials: K
authors.lastname: Goto
authors.forename: H
authors.initials: H
authors.lastname: Kunitoh
authors.forename: N
authors.initials: N
authors.lastname: Saijo
authors.forename: Y
authors.initials: Y
authors.lastname: Nishiwaki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016019:Survival Analysis; D043823:Taxoids
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel; D002945:Cisplatin