Barrenetxea G, Schneider J, Centeno M M, Romero H, de la Rica M, Rodríguez-Escudero F J
Departamento de Ginecología y Obstetricia, Universidad del Pais Vasco,Hospital de Cruces, Baracaldo, Spain.
Cancer Chemother Pharmacol. 1996;38(5):471-5. doi: 10.1007/s002800050513.
The objective of the present study was to examine the problem of the control of nausea and vomiting induced by non-cisplatin containing cyclophosphamide-based chemotherapy regimens in breast cancer patients. This was randomized, double-blind, parallel-group and placebo-controlled study comparing the efficacy of three antiemetic therapeutic regimens (ondansetron for 3 days, ondasetron plus metoclopramide, and ondansetron given in a single dose) in breast cancer patients receiving cyclophosphamide-based chemotherapy regimens on an outpatient basis. Both the primary and the secondary efficacy were measured. The primary efficacy variable was the number of emetic episodes (considering early and delayed emesis). The secondary efficacy variable measured was the quality of life. Two-by-two tables using the chi-square test and relative-risk concept were elaborated for statistical analysis. There was no difference between high-dose ondansetron and ondansetron plus metoclopramide among patients given CMF (cyclophosphamide, methotrexate, 5-fluorouracil). The single-dose ondansetron regimen showed the worst results. In patients given an FEC regimen (cyclophosphamide, epirubicin, 5-fluorouracil) the antiemetic efficacy was best for the high-dose ondansetron regimen, followed by the ondansetron plus metoclopramide regimen, and was worst for single-dose ondansetron administration. Despite the use of different antiemetic schedules, nausea and emesis are significant problems in patients receiving cyclophosphamide-based chemotherapy. Their adequate control should be the aim of any antiemetic approach.
本研究的目的是探讨乳腺癌患者中基于环磷酰胺的非顺铂化疗方案所致恶心和呕吐的控制问题。这是一项随机、双盲、平行组和安慰剂对照研究,比较了三种止吐治疗方案(3天使用昂丹司琼、昂丹司琼加甲氧氯普胺、单次剂量使用昂丹司琼)在门诊接受基于环磷酰胺化疗方案的乳腺癌患者中的疗效。测量了主要疗效和次要疗效。主要疗效变量是呕吐发作次数(包括早期和延迟呕吐)。测量的次要疗效变量是生活质量。使用卡方检验和相对风险概念的二乘二表用于统计分析。在接受CMF(环磷酰胺、甲氨蝶呤、5-氟尿嘧啶)的患者中,高剂量昂丹司琼与昂丹司琼加甲氧氯普胺之间没有差异。单次剂量昂丹司琼方案显示出最差的结果。在接受FEC方案(环磷酰胺、表柔比星、5-氟尿嘧啶)的患者中,高剂量昂丹司琼方案的止吐疗效最佳,其次是昂丹司琼加甲氧氯普胺方案,单次剂量使用昂丹司琼的疗效最差。尽管使用了不同的止吐方案,但恶心和呕吐在接受基于环磷酰胺化疗的患者中仍是重要问题。对其进行充分控制应是任何止吐方法的目标。