盐酸Bendamustine耐火软组织肉瘤患者:noncomparative多中心2期研究的德国肉瘤组(aio - 001)。

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哈特曼JT,梅耶尔F, Schleicher J, Horger M, Huober J, Meisinger我Pintoffl J, Kafer G, Kanz L,格伦沃尔德V

盐酸Bendamustine耐火软组织肉瘤患者:noncomparative多中心2期研究的德国肉瘤组(aio - 001)。

癌症。2007年8月15日,110 (4):861 - 6。

PubMed ID

17599772 (在PubMed

]

文摘

背景:对晚期软组织肉瘤患者(STS),没有标准的治疗与蒽环霉素和异环磷酰胺建立了以往化疗后。Bendamustine盐酸盐是一个双官能团的烷化剂,不是其他cross-resistant DNA-interacting物质包括蒽环霉素和oxazaphosphorines。它显示的单在难治性淋巴瘤、骨髓瘤,一些实体肿瘤。第二阶段的研究开始评估bendamustine在以前治疗的病人的疗效。方法:36 44筛选病人包括和收到101周期(中位数2周期;范围,1 - 8周期),21日作为二线治疗15三线治疗。中位数年龄为55岁(范围、18 - 79年)。Bendamustine被作为一个剂量的静脉输液超过30分钟100毫克/米(2)连续2天,重复每28天。百分之八十八的周期可以给没有剂量或安排修改。结果:毒性轻微,国家癌症研究所共同组成的毒性标准(CTC)三年级嗜中性白血球减少症在11%和9%的三年级贫血患者。 Nonhematologic toxicities were noticed with CTC grade 3 fever in 3% of patients. No other grade 3 toxicity and no treatment-related toxic deaths were observed. The best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria was 1 partial remission (3%) and disease stabilizations in 31% of patients. Six of 15 patients (40%) with leiomyosarcoma histology achieved stable disease. The estimated 3-month and 6-month progression-free survival rates were 35.3% and 23.5%, respectively, for all histologic subtypes included. CONCLUSIONS: In patients with refractory STS, bendamustine is well tolerated and appears moderately effective, particularly in patients with leiomyosarcoma histology.

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药物

Bendamustine