PURPOSE: To determine the antitumor activity and toxicity of paclitaxel administered as a three-hour infusion and to estimate the incidence of hypersensitivity reactions using a short-course prophylaxis regimen in patients with advanced gastric cancer. PATIENTS AND METHODS: Sixty patients with advanced measurable gastric cancer and performance status 0 to 2, who had received at most one prior chemotherapy regimen, were treated with paclitaxel 210 mg/m2 over three hours following a short-course premedication with dexamethasone, diphenhydramine and ranitidine administered 30 min prior to the delivery of paclitaxel. Cycles were repeated every three weeks. Twenty-six patients (43%) had received prior chemotherapy for metastatic disease and six patients had received adjuvant chemotherapy. The response rate to prior chemotherapy was 50% (13 of 26). RESULTS: Objective responses were observed in 14 of 60 patients (23%; 95% confidence interval (95% CI): 13%-36%). Six of twenty-eight (21%) patients with no prior chemotherapy and 7 of 26 (27%) previously treated patients for metastatic disease developed a PR. There were no complete responses. The median duration of response was 152 days. The study treatment was well tolerated. Twenty-two of sixty patients (37%) experienced grade 3 or 4 neutropenia, which was the most common and serious toxicity. Grade 3 peripheral neuropathy occurred in one patient. Hypersensitivity reactions were observed in only nine patients (15%) and were all grade 1. CONCLUSIONS: A three-hour infusion of paclitaxel is both an active and safe treatment for gastric cancer using the short-course premedication schedule. Paclitaxel appears to be non-cross resistant to other active agents for gastric cancer.
PURPOSE: To determine the antitumor activity and toxicity of paclitaxel administered as a three-hour infusion and to estimate the incidence of hypersensitivity reactions using a short-course prophylaxis regimen in patients with advanced gastric cancer. PATIENTS AND METHODS: Sixty patients with advanced measurable gastric cancer and performance status 0 to 2, who had received at most one prior chemotherapy regimen, were treated with paclitaxel 210 mg/m2 over three hours following a short-course premedication with dexamethasone, diphenhydramine and ranitidine administered 30 min prior to the delivery of paclitaxel. Cycles were repeated every three weeks. Twenty-six patients (43%) had received prior chemotherapy for metastatic disease and six patients had received adjuvant chemotherapy. The response rate to prior chemotherapy was 50% (13 of 26). RESULTS: Objective responses were observed in 14 of 60 patients (23%; 95% confidence interval (95% CI): 13%-36%). Six of twenty-eight (21%) patients with no prior chemotherapy and 7 of 26 (27%) previously treated patients for metastatic disease developed a PR. There were no complete responses. The median duration of response was 152 days. The study treatment was well tolerated. Twenty-two of sixty patients (37%) experienced grade 3 or 4 neutropenia, which was the most common and serious toxicity. Grade 3 peripheral neuropathy occurred in one patient. Hypersensitivity reactions were observed in only nine patients (15%) and were all grade 1. CONCLUSIONS: A three-hour infusion of paclitaxel is both an active and safe treatment for gastric cancer using the short-course premedication schedule. Paclitaxel appears to be non-cross resistant to other active agents for gastric cancer.
Authors: Min Kyoung Kim; Kyung Hee Lee; Myung Soo Hyun; Young Rok Do; Hong Suk Song; Won Sik Lee; Keon Uk Park; Jin Ho Baek; Jong Gwang Kim Journal: Cancer Res Treat Date: 2005-12-31 Impact factor: 4.679