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西南肿瘤协作组指导的索拉非尼治疗晚期软组织肉瘤的 2 期临床试验(S0505)。

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

机构信息

Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania 19111, USA.

出版信息

Cancer. 2012 Feb 1;118(3):770-6. doi: 10.1002/cncr.26334. Epub 2011 Jul 12.

DOI:10.1002/cncr.26334
PMID:21751200
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3576704/
Abstract

BACKGROUND

Patients with advanced soft tissue sarcomas (STS) have limited therapeutic options. Sorafenib (BAY 43-9006) is a multitargeted tyrosine kinase inhibitor of raf, vascular endothelial growth factor receptors 1 (VEGFR1) through 3, platelet-derived growth factor B, fms-like tyrosine kinase 3, and c-kit, and some of these may be relevant in STS.

METHODS

The authors tested sorafenib at a dose of 400 mg twice daily in patients with advanced vascular sarcoma (VS), high-grade liposarcomas, and leiomyosarcomas who had received 0 or 1 previous regimens for advanced disease.

RESULTS

Fifty-one patients were accrued to the study, and 37 were evaluable for toxicity and response. There were no unexpected side effects and no confirmed responses. The median progression-free survival was 3 months, and the median overall survival was 17 months. 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 to 3 months for the patients who had liposarcoma and leiomyosarcomas.

CONCLUSIONS

Sorafenib at the dose and schedule studied did not result in any responses in the VS, liposarcoma, or leiomyosarcoma cohort according to Response Evaluation Criteria in Solid Tumors.

摘要

背景

晚期软组织肉瘤(STS)患者的治疗选择有限。索拉非尼(BAY 43-9006)是一种多靶点酪氨酸激酶抑制剂,可抑制 Raf、血管内皮生长因子受体 1(VEGFR1)至 3、血小板衍生生长因子 B、fms 样酪氨酸激酶 3 和 c-kit,其中一些可能与 STS 相关。

方法

作者在接受过 0 或 1 种晚期疾病治疗方案的晚期血管肉瘤(VS)、高级别脂肪肉瘤和平滑肌肉瘤患者中,以每天两次、每次 400mg 的剂量测试了索拉非尼。

结果

共有 51 例患者入组该研究,37 例可评估毒性和反应。未出现意外的副作用,也没有确认的缓解。中位无进展生存期为 3 个月,中位总生存期为 17 个月。VS 组 8 例患者中有 6 例获得了延长的临床获益(稳定疾病或更好),中位无进展生存期为 5 个月,而脂肪肉瘤和平滑肌肉瘤患者的中位无进展生存期为 2 至 3 个月。

结论

根据实体瘤反应评估标准,在研究剂量和方案下,索拉非尼未在 VS、脂肪肉瘤或平滑肌肉瘤队列中产生任何缓解。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413d/3576704/a79af7fa9d36/nihms301510f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413d/3576704/77503bcae6db/nihms301510f1a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413d/3576704/bde09586de18/nihms301510f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413d/3576704/a79af7fa9d36/nihms301510f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413d/3576704/77503bcae6db/nihms301510f1a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413d/3576704/bde09586de18/nihms301510f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/413d/3576704/a79af7fa9d36/nihms301510f3.jpg

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