Phase II study of low-dose paclitaxel and cisplatin as second-line therapy in 5-fluorouracil and platinum pretreated gastric cancer

Abstract

4194 Background: Paclitaxel has shown promising activity as a single agent in gastric cancer and has synergism with cisplatin in human gastric cancer cell lines. This study was performed to evaluate the efficacy and toxicity of an outpatient regimen composed of low-dose paclitaxel and cisplatin in patients with metastatic or relapsed gastric cancer who had progressed disease during or after treatment with 5-fluorouracil (5-FU) and platinum compounds. Methods: Patients with documented progression on or within 6 months of 5-FU and platinum-based chemotherapy were enrolled. As second-line treatment, paclitaxel 145 mg/m2 was administered intravenously over 3 hours, followed by cisplatin 60 mg/m2 on day 1 every 3 weeks in the outpatient setting. Results: Between October 2002 and June 2004, 28 patients (25 male and 3 female) were enrolled. As first-line treatment, 24 patients received 5-FU/cisplatin and 4 patients received 5-FU/oxaliplatin/leucovorin. Median age was 62.5 years. Of these patients, 8 (29%) had partial responses. Six (21%) had stable disease and 12 (43%) had progressive disease. Two patients (7%) were not evaluable because of early drop-out from this study due to treatment-related toxicities. With the median follow-up duration of 10.5 months, the median time to progression (TTP) in all patients was 2.9 months (95% confidence interval [CI]: 1.9∼3.9 months) and the TTP in responders was 4.3 months (95% CI: 3.1∼5.5 months). The median overall survival was 9.1 months (95% CI: 7.0∼11.2 months). The most common hematologic toxicity was grade 1∼2 anemia (43%). Grade 3 leucopenia developed in 7% and no other grade 3∼4 hematologic toxicity or neutropenic sepsis were observed. The most common non-hematologic toxicities were peripheral neuropathy (32%) and emesis (25%). One case (4%) of grade 4 emesis and 2 cases (7%) of grade 3 peripheral neuropathy were developed; 2 (7%) patients were dropped out from this study due to toxicities. No other grade 3∼4 non-hematological toxicities were observed. Conclusions: As second-line treatment, low-dose paclitaxel and cisplatin chemotherapy in the outpatient setting was active and had acceptable toxicities. No significant financial relationships to disclose.