Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 1993
Ondansetron versus ondansetron, dexamethasone, and chlorpromazine in the prevention of nausea and vomiting associated with multiple-day cisplatin chemotherapy.
Клиническое исследованиеКлиническое исследование III фазыСтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАПоддержка службы здравоохранения СШАНазвание и аннотация: Перевод в очереди
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Fox S M, Einhorn L H, Cox E, Powell N, Abdy A
Аннотация
PURPOSE: This study is designed to evaluate the effectiveness of ondansetron alone (OND) or in combination with 2 days of dexamethasone and 5 days of chlorpromazine (ODC) in the prevention of emetic episodes in patients receiving multiple-day cisplatin.
PATIENTS AND METHODS: Forty-four patients receiving 20 or 40 mg/m2 of cisplatin daily for 4 to 5 days plus etoposide (VP-16) alone or in combination with bleomycin or ifosfamide were randomized to receive three doses of OND (0.15 mg/kg 30 minutes before and 4 and 8 hours after cisplatin) versus the identical OND regimen plus dexamethasone 8 mg before cisplatin and 4 mg 4 and 8 hours later on days 1 and 2, plus chlorpromazine 50 mg every 4 hours for four doses per day. Patients were chemotherapy-naive, had a Karnofsky performance status > or = 60, and were not receiving nonstudy antiemetics.
RESULTS: Nineteen of 22 patients (86%) on ODC had fewer than three emetic episodes throughout the study period, compared with 10 of 22 (46%) on OND (P = .009), and 55% of patients on ODC had no emetic episodes, compared with 32% on OND (P = .22). The ODC arm had fewer treatment failures (5%) than the OND arm (32%). The mean nausea ratings per visual analog scale were 15.0 for OND and 5.5 for ODC (P = .046). Headache was less frequent with ODC versus OND (14% and 41%, respectively, P = .09).
CONCLUSION: ODC was superior to OND with respect to therapeutic efficacy and decreased headaches. Both OND and ODC were more effective on days 1 and 2, rather than days 4 and 5, suggesting tachyphylaxis, anticipatory nausea, or delayed nausea from the first few days of cisplatin combination chemotherapy.
PATIENTS AND METHODS: Forty-four patients receiving 20 or 40 mg/m2 of cisplatin daily for 4 to 5 days plus etoposide (VP-16) alone or in combination with bleomycin or ifosfamide were randomized to receive three doses of OND (0.15 mg/kg 30 minutes before and 4 and 8 hours after cisplatin) versus the identical OND regimen plus dexamethasone 8 mg before cisplatin and 4 mg 4 and 8 hours later on days 1 and 2, plus chlorpromazine 50 mg every 4 hours for four doses per day. Patients were chemotherapy-naive, had a Karnofsky performance status > or = 60, and were not receiving nonstudy antiemetics.
RESULTS: Nineteen of 22 patients (86%) on ODC had fewer than three emetic episodes throughout the study period, compared with 10 of 22 (46%) on OND (P = .009), and 55% of patients on ODC had no emetic episodes, compared with 32% on OND (P = .22). The ODC arm had fewer treatment failures (5%) than the OND arm (32%). The mean nausea ratings per visual analog scale were 15.0 for OND and 5.5 for ODC (P = .046). Headache was less frequent with ODC versus OND (14% and 41%, respectively, P = .09).
CONCLUSION: ODC was superior to OND with respect to therapeutic efficacy and decreased headaches. Both OND and ODC were more effective on days 1 and 2, rather than days 4 and 5, suggesting tachyphylaxis, anticipatory nausea, or delayed nausea from the first few days of cisplatin combination chemotherapy.