A prospective randomized clinical trial of melphalan and cis-platinum versus hexamethylmelamine, adriamycin, and cyclophosphamide in advanced ovarian cancer.
A prospective randomized clinical trial of melphalan and cis-platinum versus hexamethylmelamine, adriamycin, and cyclophosphamide in advanced ovarian cancer.
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一项关于美法仑和顺铂与六甲基三聚氰胺、阿霉素和环磷酰胺治疗晚期卵巢癌的前瞻性随机临床试验。
DOI：
10.1016/0090-8258(83)90082-3
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发表时间：
1983
影响因子：
4.7
通讯作者：
Wharton,JT
中科院分区：
文献类型：
--
作者：
Edwards,CL;Herson,J;Gershenson,DM;Copeland,LJ;Wharton,JT
从 1978 年 5 月到 1980 年 11 月，169 名先前未经治疗的晚期上皮性卵巢癌患者参加了一项前瞻性随机临床试验，比较六甲基三聚氰胺、阿霉素和环磷酰胺 (HAC) 的组合与美法仑和顺铂的组合。 11 名患者被排除在分析之外，另外 5 名患者被排除在反应分析之外。在 153 名可评估缓解的患者中，有 47 名（即 30.7%）完全缓解（全部通过手术确定）、6 名部分缓解和 100 名无缓解。 HAC 组的缓解率为 31%，马法兰-铂组的缓解率为 37.8%。总体回应率为34.6%。残余肿瘤直径（小于或大于 2 厘米）对反应产生统计学显着影响 — 47.8% vs 24.4%。在 47 名完全缓解者中，有 7 名（即 14.9%）复发，中位缓解时间为 44 个月以上。在 158 名可评估生存的患者中，90 名患者死亡，中位生存时间为 27.9 个月（HAC = 26.4 个月，马法兰铂 = 29.6 个月）。年龄、FIGO分期、组织学分级和残留疾病均对生存时间产生显着影响。二线治疗在治疗失败时没有任何益处。马法兰-铂组的血液学毒性更大。两组的胃肠道毒性都很严重。其他毒性较小且罕见。
From May 1978 until November 1980, 169 previously untreated patients with advanced epithelial ovarian cancer were entered into a prospective randomized clinical trial comparing the combination of hexamethylmelamine, Adriamycin, and cyclophosphamide (HAC) to a combination of melphalan andcis-platinum. Eleven patients were excluded from analysis and another 5 patients were excluded from response analysis. Of 153 patients evaluable for response, there were 47, or 30.7%, complete responders (all determined surgically), 6 partial responders, and 100 nonresponders. The response rate for the HAC group was 31% and for the melphalan-platinum group was 37.8%. The overall response rate was 34.6%. Residual tumor diameter (less than or greater than 2 cm) exerted a statistically significant effect on response—47.8 vs 24.4%. Of the 47 complete responders, 7, or 14.9%, have relapsed, with the median duration of remission of 44+ months. Of the 158 patients evaluable for survival, 90 patients have died, with a median survival time of 27.9 months (HAC = 26.4 months, melphalan-platinum = 29.6 months). Age, FIGO stage, histologic grade, and residual disease all exerted a significant effect on survival time. Second-line therapy in the treatment failures was of no benefit. Hematologic toxicity was greater in the melphalan-platinum group. Gastrointestinal toxicity was severe in both groups. Other toxicities were minor and infrequent.