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二溴卫矛醇(DBD)用于IV期黑色素瘤的II期研究。

A phase II study of dibromodulcitol (DBD) in stage IV melanoma.

作者信息

Hopkins J, Richards F, Case D, Pope E, Jackson D V, Stuart J J, Muss H B, White D R, Cooper M R, Spurr C L

出版信息

Am J Clin Oncol. 1984 Oct;7(5):555-6. doi: 10.1097/00000421-198410000-00033.

DOI:10.1097/00000421-198410000-00033
PMID:6507378
Abstract

Twenty-four patients were evaluated in a non-randomized study to assess the effectiveness of dibromodulcitol (DBD) in Stage IV melanoma. Patients received 100 mg/m2 of DBD orally for 35 days. The dose was escalated to 130 mg/m2 and then to 160 mg/m2 if no significant hematologic toxicity occurred. There were no objective responses, including six patients who had had no prior chemotherapy. Five patients (21%) remained stable. Median survival was 151 days. Survival favored females, nonvisceral involvement pretherapy, and patients with a disease-free interval (DFI) of greater than 1 year. None of these advantages was statistically significant. Toxicity was predominantly hematologic, but nausea, vomiting, shortness of breath, and diarrhea were also seen. Oral DBD, using this dose and schedule, does not appear efficacious in advanced disseminated melanoma.

摘要

在一项非随机研究中对24例患者进行了评估,以评估二溴卫矛醇(DBD)对IV期黑色素瘤的疗效。患者口服100mg/m²的DBD,持续35天。如果未出现明显的血液学毒性,剂量可增至130mg/m²,然后增至160mg/m²。没有出现客观缓解,包括6例未曾接受过化疗的患者。5例患者(21%)病情稳定。中位生存期为151天。生存期在女性、治疗前无内脏受累以及无病间期(DFI)大于1年的患者中更有利。这些优势均无统计学意义。毒性主要为血液学毒性,但也可见恶心、呕吐、呼吸急促和腹泻。按照此剂量和方案使用口服DBD,在晚期播散性黑色素瘤中似乎无效。

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