长春地辛与达卡巴嗪联合或不联合非特异性免疫系统刺激用于转移性黑色素瘤患者的II期研究。

Phase II study of vindesine and dacarbazine with or without non-specific stimulation of the immune system in patients with metastatic melanoma.

作者信息

Verschraegen C F, Legha S S, Hersh E M, Plager C, Papadopoulos N, Burgess M A

机构信息

University of Texas Health Sciences Center, Department of Internal Medicine, Houston 77030.

出版信息

Eur J Cancer. 1993;29A(5):708-11. doi: 10.1016/s0959-8049(05)80351-x.

DOI:10.1016/s0959-8049(05)80351-x

PMID:8471328

Abstract

A single dose of dacarbazine (DTIC), followed by a 5-day intravenous infusion of vindesine (VDS) was administered every 3 weeks to 103 patients with metastatic melanoma. One half of the patients were randomised to receive intravenous methanol extraction residue (MER) of bacillus Calmette-Guerin (BCG) in addition to chemotherapy, on days 7 and 14 of each course. 98 patients were evaluable. The response rates in treatment groups were 16 and 17%, respectively (confidence interval 9-24%). Neither the response rate nor the survival improved when MER was added to chemotherapy. Toxicity was moderate except for a significant granulocytopenia. The combination of DTIC and VDS is not more effective than DTIC alone and has added neurotoxicity.

摘要

对103例转移性黑色素瘤患者每3周给予一次达卡巴嗪（DTIC）单剂量，随后进行5天长春地辛（VDS）静脉输注。其中一半患者在每个疗程的第7天和第14天除接受化疗外，还随机接受卡介苗（BCG）的静脉甲醇提取物（MER）。98例患者可进行评估。治疗组的缓解率分别为16%和17%（置信区间9 - 24%）。化疗中加入MER后，缓解率和生存率均未提高。除显著的粒细胞减少外，毒性为中度。DTIC与VDS联合使用并不比单独使用DTIC更有效，且增加了神经毒性。