比较两种联合化疗方案（六甲密胺-环磷酰胺-氟尿嘧啶-甲氨蝶呤方案与顺铂-六甲密胺-氟尿嘧啶-甲氨蝶呤-泼尼松方案）治疗晚期卵巢癌的随机试验。

Randomised trial comparing two combination chemotherapy regimens (Hexa-CAF vs CHAP-5) in advanced ovarian carcinoma.

作者信息

Neijt J P, ten Bokkel Huinink W W, van der Burg M E, van Oosterom A T, Vriesendorp R, Kooyman C D, van Lindert A C, Hamerlynck J V, van Lent M, van Houwelingen J C

出版信息

Lancet. 1984 Sep 15;2(8403):594-600. doi: 10.1016/s0140-6736(84)90594-4.

DOI:10.1016/s0140-6736(84)90594-4

PMID:6147640

Abstract

186 patients with advanced epithelial ovarian carcinoma were treated with either a combination of hexamethylmelamine, cyclophosphamide, methotrexate, and 5-fluorouracil (Hexa-CAF) or cyclophosphamide and hexamethylmelamine alternating with doxorubicin and a 5-day course of cisplatin (CHAP-5). Treatment with CHAP-5 resulted in more complete remissions as determined by laparatomy or peritoneoscopy (p = 0.004), better overall response (p = 0.0001), and longer overall survival and progression-free survival (p less than 0.002). Therapy, histological grade, and Karnofsky index were reliable predictors of overall response, whereas therapy, FIGO-stage, and size of residual tumour before chemotherapy were independent predictors for complete remission and for prolonged survival. Peripheral neurotoxicity was a major problem in patients assigned to the CHAP-5-group and was likely to be due to the simultaneous administration of hexamethylmelamine and cisplatin. The CHAP-5 regimen is one of the most effective regimens for the initial treatment of ovarian cancer.

摘要

186例晚期上皮性卵巢癌患者接受了六甲蜜胺、环磷酰胺、甲氨蝶呤和5-氟尿嘧啶联合方案（六甲蜜胺-环磷酰胺-甲氨蝶呤-5-氟尿嘧啶方案，Hexa-CAF）或环磷酰胺与六甲蜜胺交替联合多柔比星及5天疗程顺铂的方案（CHAP-5方案）治疗。根据剖腹手术或腹腔镜检查结果，CHAP-5方案治疗导致更多的完全缓解（p = 0.004）、更好的总体缓解率（p = 0.0001）以及更长的总生存期和无进展生存期（p < 0.002）。治疗方式、组织学分级和卡诺夫斯基指数是总体缓解的可靠预测因素，而治疗方式、国际妇产科联盟（FIGO）分期和化疗前残余肿瘤大小是完全缓解和延长生存期的独立预测因素。外周神经毒性是CHAP-5组患者的一个主要问题，可能是由于同时使用六甲蜜胺和顺铂所致。CHAP-5方案是卵巢癌初始治疗中最有效的方案之一。