Bleomycin, vincristine, lomustine and dacarbazine (BOLD) in combination with recombinant interferon alpha-2b for metastatic uveal melanoma
Bleomycin, vincristine, lomustine and dacarbazine (BOLD) in combination with recombinant interferon alpha-2b for metastatic uveal melanoma
复制标题
DOI：
10.1016/s0959-8049(03)00132-1
复制
发表时间：
2003-05-01
影响因子：
8.4
通讯作者：
Pyrhönen, S
中科院分区：
文献类型：
--
作者：
Kivelä, T;Suciu, S;Pyrhönen, S
这项EORTC多中心研究分析了BOLD化疗联合重组干扰素α-2b对转移性葡萄膜黑色素瘤患者的疗效和耐受性。博莱霉素15 mg，第1、4天；长春新碱1 mg/m(2)，第1天；洛莫司汀80 mg，第1天；达卡巴津200 mg/m(2)，第1~5天。每4周给药一次，至少两个周期。皮下(S.C.)干扰素α-2b 3x10(6)Iu于第1周期第8天开始，6周后每周3次。24例患者接受了两个周期的中位治疗(中位年龄60.5岁)。无一例客观有效(0%；95%可信区间0-14)，2例(8.3%)保持稳定，20例进展，2例(8.3%)无法评估。中位无进展生存期为1.9个月(95%CI：1.8~3.4)，总生存期为10.6个月(95%CI：6.9~16.4)。随着治疗特征的日益有利，总体生存率得到改善(赫尔辛基大学中心医院(HUH)工作制定阶段IVBA、IVBb和IVBc的中位数分别为14.7月和6.9月；P=0.018)。13%的患者出现3级脱发和神经毒性。这项多中心研究没有证实早先的报告，即BOLD与人白细胞或重组干扰素将在转移性葡萄膜黑色素瘤中诱导至少15%的客观反应。(C)2003爱思唯尔科学有限公司。保留所有权利。
This EORTC multicentre study analysed the efficacy and tolerability in patients with metastatic uveal melanoma of BOLD chemotherapy in combination with recombinant interferon alpha-2b. The dose of bleomycin was 15 mg on days 2 and 5, of vincristine 1 mg/m(2) on days 1 and 4, of lomustine 80 mg on day 1, and of dacarbazine (DTIC) 200 mg/m(2) on days 1-5. given every 4 weeks for a minimum of two cycles. Subcutaneous (s.c.) interferon alpha-2b at a dose of 3x10(6) IU was initiated on day 8 of the first cycle, and continued at a dose of 6x10(6) IU three times per week after 6 weeks. A median of two cycles were administered to 24 patients (median age 60.5 years). None achieved an objective response (0%; 95% Confidence Interval (CI): 0-14), 2 (8.3%) remained stable, 20 showed progression, and 2 (8.3%) were inevaluable. The median progression-free survival was 1.9 months (95% CI: 1.8-3.4) and overall survival 10.6 months (95% CI: 6.9-16.4). Overall survival improved with increasingly favourable pretreatment characteristics (median, 14.7 versus 6.9 versus 6.0 months for Helsinki University Central Hospital (HUCH) Working Formulation stages IVBa, IVBb and IVBc, respectively; P=0.018). Grade 3 alopecia and neurotoxicity occurred in 13% of the patients. This multicentre study did not confirm earlier reports that BOLD with human leucocyte or recombinant interferon would induce at least 15% objective responses in metastatic uveal melanoma. (C) 2003 Elsevier Science Ltd. All rights reserved.