Hiroki Hara1, Shigenori Kadowaki2,3, Masako Asayama1, Akira Ooki1, Toko Yamada1, Takako Yoshii1, Kensei Yamaguchi1,4. 1. Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan. 2. Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan. skadowaki@aichi-cc.jp. 3. Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan. skadowaki@aichi-cc.jp. 4. Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Abstract
BACKGROUND: There are few chemotherapeutic options for advanced gastric cancer with severe disseminated peritoneal metastases, which are usually accompanied by ascites. Bolus 5-fluorouracil (5-FU) plus leucovorin therapy has been widely used against gastrointestinal malignancies, with resulting mild toxicities. METHODS: We retrospectively analyzed the efficacy and safety of first-line chemotherapy with bolus 5-FU plus l-leucovorin in 30 advanced gastric cancer patients who had massive ascites and/or inadequate oral intake. This therapy consisted of 5-FU (600 mg/m2 IV bolus) plus l-leucovorin (250 mg/m2 2-h IV infusion) administered on a 6 weeks on/2 weeks off schedule. RESULTS: Among all the patients, 26 (87%) were unable to eat and 12 (40%) had massive ascites. Major grade 3 or 4 adverse events were neutropenia (17%), nausea (7%), fatigue (7%), and diarrhea (3%); no treatment-related deaths were observed. The median progression-free survival and overall survival (OS) were 2.4 months [95% confidence interval (CI), 0.6-4.1] and 6.0 months (95% CI, 2.1-9.9), respectively. Objective improvement in oral intake was seen in 7 patients (27%). Improvement in ascites occurred in 9 (39%) of 23 patients. In multivariate analyses, the presence of both massive ascites and inadequate oral intake was significantly associated with worse OS (hazard ratio, 5.25; 95% CI, 1.61-17.1). The median OS for patients (n = 22) without this factor was 7.2 months (95% CI, 4.2-10.3). CONCLUSION: Our study suggests that bolus 5-FU plus l-leucovorin therapy is feasible and has clinical activity as palliative therapy in patients with severe peritoneal metastases from gastric cancer.
BACKGROUND: There are few chemotherapeutic options for advanced gastric cancer with severe disseminated peritoneal metastases, which are usually accompanied by ascites. Bolus 5-fluorouracil (5-FU) plus leucovorin therapy has been widely used against gastrointestinal malignancies, with resulting mild toxicities. METHODS: We retrospectively analyzed the efficacy and safety of first-line chemotherapy with bolus 5-FU plus l-leucovorin in 30 advanced gastric cancerpatients who had massive ascites and/or inadequate oral intake. This therapy consisted of 5-FU (600 mg/m2 IV bolus) plus l-leucovorin (250 mg/m2 2-h IV infusion) administered on a 6 weeks on/2 weeks off schedule. RESULTS: Among all the patients, 26 (87%) were unable to eat and 12 (40%) had massive ascites. Major grade 3 or 4 adverse events were neutropenia (17%), nausea (7%), fatigue (7%), and diarrhea (3%); no treatment-related deaths were observed. The median progression-free survival and overall survival (OS) were 2.4 months [95% confidence interval (CI), 0.6-4.1] and 6.0 months (95% CI, 2.1-9.9), respectively. Objective improvement in oral intake was seen in 7 patients (27%). Improvement in ascites occurred in 9 (39%) of 23 patients. In multivariate analyses, the presence of both massive ascites and inadequate oral intake was significantly associated with worse OS (hazard ratio, 5.25; 95% CI, 1.61-17.1). The median OS for patients (n = 22) without this factor was 7.2 months (95% CI, 4.2-10.3). CONCLUSION: Our study suggests that bolus 5-FU plus l-leucovorin therapy is feasible and has clinical activity as palliative therapy in patients with severe peritoneal metastases from gastric cancer.
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