Study of paclitaxel and dose escalation of cisplatin in patients with advanced non-small cell lung cancer.

Abstract:

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/m(2)) 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/m(2) at level 1, 60 mg/m(2) at level 2 and 80 mg/m(2) 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/m(2)) and cisplatin (80 mg/m(2)) administered in the study. The recommended dose was determined to be paclitaxel 210 mg/m(2) on day 1 and cisplatin 80 mg/m(2) on day 2, every 3-4 weeks. Seven partial responses were observed in the 24 patients. CONCLUSIONS:The combination of paclitaxel 210 mg/m(2) and cisplatin 80 mg/m(2) was found to be a well-tolerated active regimen in Japanese patients with advanced non-small cell lung cancer.

journal_name

Jpn J Clin Oncol

authors

Watanabe H,Yamamoto N,Tamura T,Shimoyama T,Hotta K,Inoue A,Sawada M,Akiyama Y,Kusaba H,Nokihara H,Sekine I,Kunitoh H,Ohe Y,Kodama T,Saijo N

doi

10.1093/jjco/hyg116

keywords:

subject

Has Abstract

pub_date

2003-12-01 00:00:00

pages

626-30

issue

12

eissn

0368-2811

issn

1465-3621

journal_volume

33

pub_type

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