Authors
Robert G Maki, David R D'Adamo, Mary L Keohan, Michael Saulle, Scott M Schuetze, Samir D Undevia, Michael B Livingston, Matthew M Cooney, Martee L Hensley, Monica M Mita, Chris H Takimoto, Andrew S Kraft, Anthony D Elias, Bruce Brockstein, Nathalie E Blachere, Mark A Edgar, Lawrence H Schwartz, Li-Xuan Qin, Cristina R Antonescu, Gary K Schwartz
Publication date
2009/7/1
Journal
Journal of Clinical Oncology
Volume
27
Issue
19
Pages
3133-3140
Publisher
American Society of Clinical Oncology
Description
Purpose
Since activity of sorafenib was observed in sarcoma patients in a phase I study, we performed a multicenter phase II study of daily oral sorafenib in patients with recurrent or metastatic sarcoma.
Patients and Methods
We employed a multiarm study design, each representing a sarcoma subtype with its own Simon optimal two-stage design. In each arm, 12 patients 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 one Response Evaluation Criteria in Solid Tumors (RECIST) was observed, 25 further patients with that sarcoma subtype were accrued.
Results
Between October 2005 and November 2007, 145 patients were treated; 144 were eligible for toxicity and 122 for response. Median age was 55 years; female-male ratio was 1.8:1. The median number of cycles was 3. Five of 37 patients with angiosarcoma had a …
Total citations
Scholar articles
RG Maki, DR D'Adamo, ML Keohan, M Saulle… - Journal of Clinical Oncology, 2009