Luikart S D, Kennealey G T, Kirkwood J M
J Clin Oncol. 1984 Mar;2(3):164-8. doi: 10.1200/JCO.1984.2.3.164.
A randomized phase III study was carried out in 57 patients with metastatic melanoma treated with either dacarbazine (DTIC) given intravenously (IV) daily for 10 days using light protection, or a combination of vinblastine IV on days 1 and 2, bleomycin by continuous IV infusion during days 1-5, and cisplatin by IV infusion on day 5 (VBD). Objective response rates were similar: 14% for dacarbazine and 10% for VBD. However, dacarbazine responses were associated with a trend toward longer progression-free intervals and longer survival. Toxicity was significantly greater in the VBD arm, and fatal in two patients. Dacarbazine was also associated with severe toxicity by the 10-day light-protected schedule used here. VBD is not as effective as previously reported, and dacarbazine remains a standard of therapy for metastatic melanoma.
一项随机III期研究纳入了57例转移性黑色素瘤患者，这些患者被随机分为两组，一组接受达卡巴嗪（DTIC）治疗，采用避光措施，每天静脉注射（IV），持续10天；另一组接受长春花碱（第1天和第2天静脉注射）、博来霉素（第1 - 5天持续静脉输注）和顺铂（第5天静脉输注）联合治疗（VBD）。客观缓解率相似：达卡巴嗪组为14%，VBD组为10%。然而，达卡巴嗪治疗的缓解与无进展生存期延长和总生存期延长的趋势相关。VBD组的毒性明显更大，有两名患者死亡。按照此处采用的10天避光方案，达卡巴嗪也会导致严重毒性。VBD不如先前报道的有效，达卡巴嗪仍然是转移性黑色素瘤的治疗标准。
