ABSTRACT
BACKGROUND: To assess the effect and toxicity of low-dose paclitaxel in patients with metastatic or recurrent gastric cancer with measurable lesions as first-line chemotherapy. METHODS: Patients with measurable metastatic or recurrent gastric cancer were eligible in this study. Paclitaxel and cisplatin were intravenously infused for 3h, at a dose of each 135 mg/m2 and 60 mg/m2, every 3 weeks and then this regimen was repeated until intolerable toxicity or disease progression. Objective tumor responses, duration of response, time to disease progression, and toxicity profile were evaluated in this study. RESULTS: Total 31 patients were enrolled in this study between May 2001 and January 2004. Sixteen patients had ECOG performance status (PS) 1, eleven had PS 2 and four had PS 3. A total of 122 cycles (median 3, range 1~12) were administered. Eleven (35%, 11/31) objective partial responses (PR) were observed and the remaining 19 patients showed stable (9 patients, 30%) and progressive disease (11 patients, 35%). The response rate was 35% (95% confidence interval, 18~51%). The estimated median survival was 8.1 months, median response duration was 5.3 months and median progression-free survival was 3.3 months. Severe toxicities were uncommon. There were 14 episodes (11.5%) of grade 3-4 neutropenia. Grade 3 nausea and vomiting occurred in 4%. Grade 3 peripheral neuropathy occurred in 3.3%. CONCLUSION: This low dose paclitaxel regimen (135 mg/m2) showed comparable results with previously published high-dose paclitaxel regimen (175~250 mg/m2) used in metastatic or recurrent gastric cancer and the toxicity was minimal.