Orthopedics Medical News about metastatic or recurrent sarcomas;Sorafenib

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Phase II study of sorafenib in patients with metastatic or recurrent sarcomas
Journal of Clinical Oncology, 05/21/09

Maki RG et al. - In a study to assess the use of daily oral sorafenib in pts with recurrent or metastatic sarcoma, it was shown that as a single agent, sorafenib has activity against angiosarcoma and minimal activity against other sarcomas.

Methods

A multiarm study design was used, each representing a sarcoma subtype with its own Simon optimal 2-stage design.
In each arm, 12 pts who received 0 to 1 prior lines of therapy were treated (0 to 3 for angiosarcoma and malignant peripheral-nerve sheath tumor).
If at least 1 RECIST was observed, 25 further pts with that sarcoma subtype were accrued.

Results

145 pts were treated; 144 were eligible for toxicity and 122 for response.
Median age was 55 yrs; female-male ratio was 1.8:1.
Median number of cycles was 3.
5 of 37 pts with angiosarcoma had a partial response (response rate, 14%); this was the only arm to meet RECIST response rate primary endpoint.
Median progression-free survival was 3.2 mos; median overall survival was 14.3 mos.
Adverse events necessitated dose reduction for 61% of pts.
Statistical modeling in this limited cohort indicated sorafenib toxicity was correlated inversely to pt height.
There was no correlation between phosphorylated extracellular signal regulated kinase expression and response in 6 pts with angiosarcoma with paired pre- and post-therapy biopsies.

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