Omission of day 2 of antiemetic medications is a cost saving strategy for improving chemotherapy-induced nausea and vomiting control: results of a randomized phase III trial.
Author(s): Lajolo PP, de Camargo B, del Giglio A
Affiliation(s): Department of Internal Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.
Publication date & source: 2009-02, Am J Clin Oncol., 32(1):23-6.
OBJECTIVES: Nausea and vomiting are important symptoms observed in cancer patients. In a previous study, we showed that delayed chemotherapy-induced nausea and vomiting control could be potentially improved by skipping the administration of a 5-hydroxytryptamine 3 (5-HT3) antagonist on day 2. We report here a trial confirming our previous findings. MATERIALS AND METHODS: A phase III randomized placebo-controlled trial was conducted in which patients received intravenously ondansetron 16 mg, dexamethasone 20 mg, and ranitidine 50 mg before highly/moderately emetogenic chemotherapy (day 1). Starting on day 2, all patients received metoclopramide 10 mg per oral every 8 hours (days 2, 3, and 4), dexamethasone 8 mg daily (days 2 and 3), and ranitidine 150 mg every 12 hours (days 2 and 3). Patients were randomized to receive either granisetron 0.5 mg per oral (days 2 and 3) (group A) or placebo instead of granisetron on day 2 and granisetron 0.5 mg on days 3 and 4 (group B). RESULTS: Seventy-three patients were enrolled. Groups were similar regarding clinical characteristics, despite better control during the acute phase of chemotherapy-induced nausea and vomiting in group A (P = 0.04). Complete delayed protection from nausea and vomiting (DCPNV) from day 2 to 5 was similar in both groups (30% vs. 32%; P = 0.5). Analyzing DCPNV by logistic regression multivariate analyses, acute complete protection from nausea and vomiting (P = 0.001) and study group (P = 0.06) were independently associated with DCPNV. Selecting patients who achieved acute complete protection from nausea and vomiting, we observed that group B had a superior DCPNV (85% vs. 50%, P = 0.02). CONCLUSION: DCPNV can be improved just by skipping day 2 of 5-HT3-antagonists. Future studies should compare this inexpensive strategy with NK1-antagonists or second generation 5-HT3-antagonists.