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

Background: To determine the maximum tolerated dose and recommended dose of cisplatin and docetaxel administered by three consecutive weekly infusions in both non-elderly (less than or equal to 74 years) and elderly (greater than or equal to 75 years) patients, we conducted two independent phase I s tudies for non-elderly 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 y ears) patients with non-small cell lung cancer were entered in these studie s. The eligibility criteria of both cohorts were identical except for age. Chemotherapy consisted of cisplatin 25 mg/m(2) and an escalated dose of doc etaxel on days 1, 8 and 15 every 4 weeks. The initial dose of docetaxel was 20 mg/m(2) and it was increased by 5 mg/m(2) at each dose level. Results: In the non-elderly and elderly cohorts, up to 45 or 25 mg/m(2) of docetaxel, respectively, were administered. Dose-limiting toxicities were n eutropenia, 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 eld erly cohort. We considered the recommended doses for phase II studies were cisplatin 25 mg/m(2) and docetaxel 35 mg/m(2) on days 1, 8 and 15 for non-e lderly patients and cisplatin 25 mg/m(2) and docetaxel 20 mg/m(2) on days 1 , 8 and 15 for elderly patients. Seven of 26 (27%) and seven of 12 (58%) pa tients 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 eld erly cohorts, respectively. Conclusions: Further evaluation of this combination chemotherapy is warrant ed for both non-elderly and elderly patients with non-small cell lung cance r but the dose of docetaxel should be lower for elderly than non-elderly pa tients.