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Japanese Journal of Clinical Oncology 33:626-630 (2003)
© 2003 Foundation for Promotion of Cancer Research

Study of Paclitaxel and Dose Escalation of Cisplatin in Patients with Advanced Non-small Cell Lung Cancer

Hirokazu Watanabe, Noboru Yamamoto, Tomohide Tamura, Tatsu Shimoyama, Katsuyuki Hotta, Akira Inoue, Masahiro Sawada, Yoshiko Akiyama, Hitoshi Kusaba, Hiroshi Nokihara, Ikuo Sekine, Hideo Kunitoh, Yuichiro Ohe, Tetsuro Kodama and Nagahiro Saijo+

Division of Internal Medicine, National Cancer Center Hospital, Tokyo, Japan

Background: We conducted a dose-finding and feasibility study in which we administered a fixed dose 3-h infusion of paclitaxel and an escalating dose of cisplatin in Japanese patients with advanced non-small cell lung cancer.

Methods: Chemotherapy consisted of fixed dose (210 mg/m2) paclitaxel given over 3 h on day 1 and an escalating dose of cisplatin on day 2, every 3–4 weeks. The dose of cisplatin was 40 mg/m2 at level 1, 60 mg/m2 at level 2 and 80 mg/m2 at level 3.

Results: Between October 1999 and February 2001, 24 patients were enrolled and 58 cycles were administered. The major hematological toxicities were leukopenia and neutropenia. Grade 4 neutropenia developed in 83.3%, 66.7% and 83.3% of patients at the dose levels of 1, 2 and 3, respectively. The major non-hematological toxicities consisted of alanine aminotransferase (ALT) elevation and peripheral neuropathy. Grade 3 ALT elevation was observed in two of the 12 patients at level 3, but both recovered within 3 days. The peripheral neuropathy was sensory-dominant and frequent, and it was almost tolerable. The maximum tolerated dose was not identified even at the highest dose of paclitaxel (210 mg/m2) and cisplatin (80 mg/m2) administered in the study. The recommended dose was determined to be paclitaxel 210 mg/m2 on day 1 and cisplatin 80 mg/m2 on day 2, every 3–4 weeks. Seven partial responses were observed in the 24 patients.

Conclusions: The combination of paclitaxel 210 mg/m2 and cisplatin 80 mg/m2 was found to be a well-tolerated active regimen in Japanese patients with advanced non-small cell lung cancer.

+ For reprints and all correspondence: Tomohide Tamura, Division of Internal Medicine, National Cancer Center Hospital, 5–1–1, Tsukiji Chuo-ku, Tokyo 104-0045, Japan. E-mail: ttamura{at}ncc.go.jp


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