January 16, 2013
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Sorafenib shows promise for patients with advanced soft tissue sarcomas

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Sorafenib appears to be a promising treatment for patients with leiomyosarcoma, according to results from a phase 2 study.

Researchers conducted the investigation to evaluate the efficacy of sorafenib (Nexavar, Bayer-Onyx), a multi-targeted tyrosine kinase inhibitor, in patients with advanced soft tissue sarcomas.

The investigators conducted an open-label, nonrandomized, multicenter study between November 2006 and January 2010. The study included 101 patients who were pre-treated with anthracycline-based chemotherapy. Of them, 36 had leiomyosarcoma, 19 had angiovascular sarcoma and 46 had other disease types.

All patients received 400 mg sorafenib twice daily for 28 days.

PFS at 6 months served as the primary endpoint. Researchers examined toxicities and clinical outcomes in all histologies, as well as leiomyosarcoma and angiovascular sarcoma.

In the per-protocol analysis, 14.5% of patients achieved partial response and 32.9% reached stable disease. For all histologies, the PFS rate reached 34.5%. PFS reached 38.4% for leiomyosarcoma and 56.3% for angiovascular sarcoma.

In the intention-to-treat analysis, PFS was 27.1% for all histologies, 35% for leiomyosarcoma and 35.5% for angiovascular sarcoma.

After stratifying by histology, PFS outcomes favored leiomyosarcoma over other histologies (P=.033).

The treatment was well tolerated, researchers added.

The findings suggest further evaluation in histology-driven trials is warranted, the researchers said.

Disclosure: The researchers report no relevant financial disclosures.