Obstetrics and gynecology · 1994
Ondansetron and metoclopramide fail to prevent vomiting secondary to ultra-high-dose cisplatin-carboplatin chemotherapy.
Клиническое исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Fanning J, Hilgers R D
Аннотация
OBJECTIVE: To determine the severity of emesis caused by ultra-high-dose cisplatin-carboplatin chemotherapy and to compare the antiemetic efficacy of an ondansetron regimen and a metoclopramide regimen.
METHODS: Forty consecutive patients with stage III or IV epithelial ovarian cancer or advanced or recurrent endometrial cancer were treated with ultra-high-dose cisplatin-carboplatin chemotherapy. No patient had received prior chemotherapy. Chemotherapy consisted of intravenous (IV) cisplatin 70 mg/m2 and IV carboplatin 100 mg/m2 administered on days 1 and 8 every 28 days for five cycles, representing a total monthly organoplatin dose of 207 mg/m2. Patients were randomized to receive metoclopramide, diphenhydramine, prochlorperazine, and lorazepam; or ondansetron, dexamethasone, prochlorperazine, and lorazepam. Patients were blinded and there was no crossover. The metoclopramide dose was 2 mg/kg IV every 2 hours x 3, and the ondansetron dose was 0.15 mg/kg IV every 4 hours x 3.
RESULTS: All 40 patients developed vomiting; 21 (52%) developed severe vomiting and seven (17%) required home IV therapy (grade 4). Eight patients (40%) receiving the metoclopramide regimen developed severe vomiting, compared to 13 (65%) in the ondansetron group (P = .50). Two patients (10%) in the metoclopramide group developed grade 4 vomiting, compared to five (25%) in the ondansetron group (P = .45). Except for sedation and amnesia, there were no significant side effects associated with either regimen.
CONCLUSION: Neither regimen was effective in preventing high-dose cisplatin-carboplatin-induced emesis, and the ondansetron regimen did not appear to be superior.
METHODS: Forty consecutive patients with stage III or IV epithelial ovarian cancer or advanced or recurrent endometrial cancer were treated with ultra-high-dose cisplatin-carboplatin chemotherapy. No patient had received prior chemotherapy. Chemotherapy consisted of intravenous (IV) cisplatin 70 mg/m2 and IV carboplatin 100 mg/m2 administered on days 1 and 8 every 28 days for five cycles, representing a total monthly organoplatin dose of 207 mg/m2. Patients were randomized to receive metoclopramide, diphenhydramine, prochlorperazine, and lorazepam; or ondansetron, dexamethasone, prochlorperazine, and lorazepam. Patients were blinded and there was no crossover. The metoclopramide dose was 2 mg/kg IV every 2 hours x 3, and the ondansetron dose was 0.15 mg/kg IV every 4 hours x 3.
RESULTS: All 40 patients developed vomiting; 21 (52%) developed severe vomiting and seven (17%) required home IV therapy (grade 4). Eight patients (40%) receiving the metoclopramide regimen developed severe vomiting, compared to 13 (65%) in the ondansetron group (P = .50). Two patients (10%) in the metoclopramide group developed grade 4 vomiting, compared to five (25%) in the ondansetron group (P = .45). Except for sedation and amnesia, there were no significant side effects associated with either regimen.
CONCLUSION: Neither regimen was effective in preventing high-dose cisplatin-carboplatin-induced emesis, and the ondansetron regimen did not appear to be superior.