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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.

journal_name

Jpn J Clin Oncol

journal_title

Japanese journal of clinical oncology

authors

Ohe Y,Niho S,Kakinuma R,Kubota K,Matsumoto T,Ohmatsu H,Goto K,Kunitoh H,Saijo N,Nishiwaki Y

doi

10.1093/jjco/hye019

keywords:

subject

Has Abstract

pub_date

2001-03-01 00:00:00

pages

100-6

issue

eissn

0368-2811

issn

1465-3621

journal_volume

pub_type

临床试验,杂志文章

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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.