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See Latest ArticlesPhase II study of sorafenib in patients with metastatic or recurrent sarcomas
Journal of Clinical Oncology, 07/09/09
Maki RG et al. - In a study to assess the use of daily oral sorafenib in pts with recurrent or metastatic sarcoma, it was determined 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 Response Evaluation Criteria in Solid Tumors (RECIST) was observed, 25 more pts with that sarcoma subtype were accrued.
- 145 pts were treated; 144 were eligible for toxicity and 122 for response.
- Median age was 55 years; 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 the RECIST response rate primary end point.
- Median progression-free survival was 3.2 mos; median overall survival was 14.3 mos.
- Adverse events (typically dermatological) necessitated dose reduction for 61% of pts.
- Statistical modeling in this limited patient 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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