Phase II randomized study of dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine alone in advanced melanoma patients
Phase II randomized study of dacarbazine, carmustine, cisplatin and tamoxifen versus dacarbazine alone in advanced melanoma patients
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DOI：
10.1097/00008390-200104000-00015
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发表时间：
2001-04-01
影响因子：
2.2
通讯作者：
Monfardini, S
中科院分区：
文献类型：
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作者：
Sileni, VC;Nortilli, R;Monfardini, S
这项随机II期试验旨在确定达卡巴嗪（DTIC）、卡莫司汀（BCNU）、顺铂（DDP）和他莫昔芬（DBDT方案）联合治疗与单用DTIC治疗转移性黑色素瘤患者的活性和毒性。60例转移性黑色素瘤患者随机接受BCNU 150 mg/m2静脉注射（i. v.）第1天，顺铂25 mg/m2，第1 - 3天每日静脉注射，DTIC 220 mg/m2，第1 - 3天每日静脉注射，他莫昔芬160 mg，每日口服，化疗前7天（DBDT组; A组）。每28天重复一个治疗周期，而BCNU每两个周期给药一次。DTIC组（B组）患者在第1天单独接受DTIC 1200 mg/m2静脉注射，每21天重复一次。每两个周期对患者进行一次评估;有反应的患者最多继续治疗12个周期。DBDT组的总缓解率为26%，DTIC组为5%，完全缓解率为2.5%，DTIC组为0%。DBDT的中位无进展生存期和中位生存期分别为4个月和9个月，DTIC为2个月和7个月，DBDT与显著的血液学毒性相关：33%的患者发生III或IV级中性粒细胞减少症，28%的患者发生III或IV级血小板减少症。总之，使用DBDT获得的总体缓解率大于DTIC单独使用获得的总体缓解率;然而，这种组合增加了毒性，对总生存期的影响有限。2001年利平科特威廉姆斯&威尔金斯。
This randomized phase II trial was performed to define the activity and toxicity of the combination of dacarbazine (DTIC), carmustine (BCNU), cisplatin (DDP) and tamoxifen (DBDT regimen) versus DTIC alone in patients with metastatic melanoma. Sixty patients with metastatic melanoma were randomly assigned to receive BCNU 150 mg/m(2) intravenously (i.v.) on day 1, cisplatin 25 mg/m(2) i.v. daily on days 1 to 3, DTIC 220 mg/m(2) i.v. daily on days 1 to 3 and tamoxifen 160 mg orally daily for 7 days prior to chemotherapy (DBDT arm; arm A). Treatment cycles were repeated every 28 days, while BCNU was given every two cycles. The DTIC arm (arm B) patients received DTIC alone 1200 mg/m(2) i.v. on day 1, repeated every 21 days. Patients were evaluated every two cycles; responding patients continued the treatment for a maximum of 12 cycles. The overall response rate was 26% in the DBDT arm and 5% in the DTIC arm. Complete responses were 2.5% for DBDT and 0% for DTIC. The median progression-free survival and the median survival were 4 and 9 months, respectively for DBDT, and 2 and 7 months for DTIC, DBDT was associated with significant haematological toxicity: 33% of the patients experienced a grade III or IV neutropenia and 28% a grade III or IV thrombocytopenia. In conclusion, the overall response rate obtained with DBDT was greater than that obtained with DTIC alone; however, this combination increases toxicity with limited impact on overall survival. 2001 Lippincott Williams & Wilkins.