PHASE-II TRIAL OF DOCETAXEL IN PATIENTS WITH ADVANCED CUTANEOUS MALIGNANT-MELANOMA PREVIOUSLY UNTREATED WITH CHEMOTHERAPY
PHASE-II TRIAL OF DOCETAXEL IN PATIENTS WITH ADVANCED CUTANEOUS MALIGNANT-MELANOMA PREVIOUSLY UNTREATED WITH CHEMOTHERAPY
复制标题
DOI：
10.1200/jco.1995.13.12.2895
复制
发表时间：
1995-12-01
影响因子：
45.3
通讯作者：
BENJAMIN, RS
中科院分区：
文献类型：
--
作者：
BEDIKIAN, AY;WEISS, GR;BENJAMIN, RS
目的：进行了一项II期研究，以确定多西他赛对转移性恶性黑色素瘤患者的疗效。患者和方法：1992年6月至1994年3月期间，40名患有转移性恶性黑色素瘤且既往未接受化疗的患者接受了多西他赛100 mg/m（2）治疗每21天静脉注射1小时以上，无患者发生脑转移。毒性和随访数据provided.Results：1例患者有组织学证实的完全反应，持续了14个月以上。4例患者部分缓解，使总缓解率达到12.5%（95%置信区间[CI]，6%-30%）。1例部分缓解患者有1处胸壁转移，在多西他赛最大缓解后手术治愈，18+个月后仍无肿瘤复发。22例患者肿瘤稳定。总的中位生存期为13个月，主要的血液学毒性为中性粒细胞减少，严重但短暂。周围神经病变是3例患者的限制性非血液学毒性。其他重要的毒性包括皮肤毒性、体液潴留、口腔粘膜炎和过敏反应。地塞米松和苯海拉明预给药可降低过敏反应、皮肤毒性和体液潴留的发生率。应在多药联合方案中对该药物进行进一步研究。(C)1995年，美国临床肿瘤学会。
Purpose: A phase II study was undertaken to determine the efficacy of docetaxel in patients with metastatic malignant melanoma.Patients and Methods: Between June 1992 and March 1994, 40 patients with metastatic malignant melanoma and no prior chemotherapy were treated with docetaxel 100 mg/m(2) administered intravenously over 1 hour every 21 days, None of the patients had brain metastasis. Toxicity and follow-up data are provided.Results: One patient had a histologically confirmed complete response that lasted for 14+ months. Four patients held partial responses, bringing the overall response rate to 12.5% (95% confidence interval [CI], 6% to 30%). A patient with a partial response had a single chest-wall metastasis and was rendered free of disease surgically after a maximal response to docetaxel and remained free of tumor recurrence after 18+ months. Tumor was stabilized in 22 patients. The overall median survival time was 13 months, The main hematologic toxicity was neutropenia, which was severe but transient. Peripheral neuropathy was the limiting nonhematologic toxicity in three patients. Other important toxicities included cutaneous toxicity, fluid retention, oral mucositis, and hypersensitivity reactions, Preadministration of dexamethasone and diphenhydramine reduced the incidence of hypersensitivity reactions, cutaneous toxicities, and fluid retention.Conclusion: Docetaxel has definite but low-level activity against malignant melanoma. Further investigation of this drug should be conducted in multidrug combination programs. (C) 1995 by American Society of Clinical Oncology.