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Japanese Journal of Clinical Oncology 31:100-106 (2001)
© 2001 Foundation for Promotion of Cancer Research

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

Yuichiro Ohe1,2, Seiji Niho1, Ryutaro Kakinuma1, Kaoru Kubota1, Taketoshi Matsumoto1, Hironobu Ohmatsu1, Koichi Goto1, Hideo Kunitoh2, Nagahiro Saijo2 and Yutaka Nishiwaki1,+

1Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba and 2Department of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan

Background: To determine the maximum tolerated dose and recommended dose of cisplatin and docetaxel administered by three consecutive weekly infusions in both non-elderly (<=74 years) and elderly (>=75 years) patients, we conducted two independent phase I studies 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 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 non-elderly and elderly patients with non-small cell lung cancer but the dose of docetaxel should be lower for elderly than non-elderly patients.

+ For reprints and all correspondence: Yuichiro Ohe, Department of Internal Medicine, National Cancer Center Hospital, 1–1 Tsukiji 5-chome, Chuo-ku, Tokyo 104-0045, Japan. E-mail: yohe@ncc.go.jp


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