Phase 2 Southwest Oncology Group-directed intergroup trial (S0505) of sorafenib in advanced soft tissue sarcomas.

Phase 2 Southwest Oncology Group-directed intergroup trial (S0505) of sorafenib in advanced soft tissue sarcomas.
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DOI:
10.1002/cncr.26334
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发表时间:
2012-02-01
期刊:
影响因子:
6.2
通讯作者:
Borden E
Borden E
中科院分区:
医学1区
文献类型:
--
作者:
von Mehren M;Rankin C;Goldblum JR;Demetri GD;Bramwell V;Ryan CW;Borden E

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晚期软组织肉瘤(STS)的治疗选择有限。索拉非尼(BAY 43-9006)是raf、VEGFR 1 -3、PDGFRB、flt-3和c-kit的多靶点酪氨酸激酶抑制剂。我们测试了索拉非尼400 mg BID在晚期血管源性肉瘤(VS)、高级别脂肪肉瘤和平滑肌肉瘤患者中的应用,这些患者既往接受过0-1种治疗晚期疾病的方案。51例患者入选,其中37例可评价毒性和反应。没有意外的副作用,也没有确认的反应。中位无进展生存期和总生存期分别为3个月和17个月。VS队列中8例患者中有6例具有长期临床获益(病情稳定或更好),中位无进展生存期为5个月,而脂肪肉瘤和平滑肌瘤分别为2-3个月。索拉非尼在此剂量和给药方案下未导致VS、脂肪肉瘤或平滑肌肉瘤的RECIST应答。
Advanced soft tissues sarcomas (STS) have limited therapeutic options. Sorafenib (BAY 43–9006) is a multi-targeted tyrosine kinase inhibitor of raf, VEGFR1-3, PDGFRB, flt-3, and c-kit. We tested sorafenib at a dose of 400 mg BID in patients with advanced sarcomas of vascular derivation (VS), high grade liposarcomas and leiomyosarcomas who had received 0–1 prior regimens for advanced disease. Fifty one patients were accrued, with thirty-seven evaluable for toxicity and response. There were no unexpected side effects and no confirmed responses. Median progression free survival and overall survival were 3 months and 17 months, respectively. Six of 8 patients in the VS cohort had prolonged clinical benefit (stable disease or better), resulting in a median progression free survival of 5 months, compared with 2–3 months for liposarcoma and leiomyosarcomas respectively. Sorafenib, at this dose and schedule, did not result in RECIST responses in VS, liposarcoma or leiomyosarcoma.
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发表时间: 2001-06-01
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