Efficacy of palonosetron for prevention of chemotherapy induced nausea and vomiting in patients with stomach cancer receiving FOLFOX4 regimen
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대한내과학회
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대한내과학회 추계학술발표논문집 2011년, 제2011권 제1호, 288(총1쪽)
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    Background: Palonosetron, a unique second generation 5-HT3RA, has demonstrated superiority in preventing both acute and delayed emesis when compared with the first-generation 5-HT3RAs. The aim of this trial was to assess the efficacy and the safety of a single dose of palonosetron in patients with stomach cancer receiving moderately emetogenic chemotherapy, FOLFOX4 regimen. Methods: Patients received a single intravenous bolus of palonosetron (0.25 mg) before administration of oxaliplatin. Nausea and vomiting were evaluated over 7-day period. Also the adverse effects were reported. Complete response (CR) was defined as no vomiting without use of rescue medication during overall phase (0-168h) and complete control (CC) was defined as CR and only mild nausea. The primary endpoint was CR during overall study period. Efficacy and toxicity was compared to our immediate historical cohort 108 patients treated with ondansetron. Results: Between March and September 2010, we enrolled 48 patients with histologically confirmed stomach cancer scheduled to receive FOLFOX4 regimen. More than half of the patients had not received any previous chemotherapy (66.7%) and all of patients had stage IV disease. Complete response rate during overall phase was 54.2% (palonosetron, ITT cohort) and 38.9% (ondansetron, histologic cohort). The proportion of patient with a CC during the acute phase (0-24h) was significantly higher in the ITT cohort [44 of 48 patients (91.6%)] than in the histologic cohorts [81 of 108 patients (75.0%)]. All adverse events induced by palonosetron were mild, especially patients had no gastrointestinal adverse events like diarrhea, constipation. Conclusion: Palonosetron is a very effective antiemetic drug for the prevention of nausea and vomiting in patients with stomach cancer receiving FOLFOX4 chemotherapy. It is meaningful result because study population consist of very homogenous stomach cancer patients group and there`s few side effect of gastrointestinal system.
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