Phase III clinical trial of the combination of cisplatin, dacarbazine, and carmustine with or without tamoxifen in patients with advanced malignant melanoma
Phase III clinical trial of the combination of cisplatin, dacarbazine, and carmustine with or without tamoxifen in patients with advanced malignant melanoma
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DOI：
10.1200/jco.1999.17.6.1884
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发表时间：
1999-06-01
影响因子：
45.3
通讯作者：
Michalak, JC
中科院分区：
文献类型：
--
作者：
Creagan, ET;Suman, VJ;Michalak, JC
目的：进行一项前瞻性随机III期临床试验，以评估在顺铂（CDDP）、达卡巴嗪（DTIC）和卡莫司汀（BCNU）三药方案中加入他莫昔芬（TAM）是否能显著提高晚期恶性黑色素瘤患者的无进展生存期和总生存期。患者和方法：晚期恶性黑色素瘤患者采用CDDP + DTIC + BCNU （CDB）治疗，伴或不伴TAM。剂量计划为CDDP 25mg /m(2)，在3周周期的第1至3天，在500 mt葡萄糖和1/2生理盐水（NS）中静脉注射30至45分钟；DTIC 220 mg/m(2) IV，在500 mt葡萄糖和1/2 NaCl中1小时，在3周周期的第1至3天；BCNU 150 mg/m(2) IV，在750至1,000 mt葡萄糖和5%水中，每奇数3周周期的第1天，2至3小时；TAM每天早晨口服20毫克。结果：184例患者入组。这些患者被观察到死亡或至少1.3年。最后一次联系时，12人还活着。CDB组的中位进展时间为3.4个月，CDB + BAM组为3.1个月。CDB组和CDB + TAM组的中位生存时间分别为6.8个月和6.9个月。无进展生存期（P = .429）和总体。生存率（P = .545）没有发现治疗差异。结论：在CDB三药方案中加入TAM治疗晚期恶性黑色素瘤并没有发现有意义的临床优势。(C) 1999年由美国临床肿瘤学会出版。
Purpose: A prospective randomized phase III clinical trial was conducted to assess whether the addition of tamoxifen (TAM) to the three-agent regimen of cisplatin (CDDP), dacarbazine (DTIC), and carmustine (BCNU) significantly increased the progression-free survival and overall survival of patients with advanced malignant melanoma.Patients and Methods: Patients with advanced malignant melanoma were treated with CDDP + DTIC + BCNU (CDB) with or without TAM. The dose schedule was CDDP 25 mg/m(2) given intravenously (IV) for 30 to 45 minutes in 500 mt of dextrose and 1/2 normal saline (NS) on days 1 to 3 of a 3-week cycle; DTIC 220 mg/m(2) IV for 1 hour in 500 mt of dextrose and 1/2 NaCl on days 1 to 3 of a 3-week cycle; BCNU 150 mg/m(2) IV for 2 to 3 hours in 750 to 1,000 mt of dextrose and 5% water on day 1 of every odd 3-week cycle; and TAM 20 mg taken orally every morning.Results: There were 184 eligible patients enrolled. These patients were observed until death or for a minimum of 1.3 years. At last contact 12 were still alive. The median rime ta progression was 3.4 months on the CDB arm and 3.1 months on the CDB + BAM arm. The median survival time wets 6.8 months with CDB and 6.9 months with CDB + TAM. Progression-free survival (P = .429) and overall. survival (P = .545) were not found to differ by treatment.Conclusion: The addition of TAM to this three-agent regimen of CDB was not found to provide a meaningful clinical advantage in the treatment of patients with advanced malignant melanoma.(C) 1999 by American Society of Clinical Oncology.