Originally published as JCO Early Release 10.1200/JCO.2008.20.9890 on May 18 2009

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Multicenter Phase II Trial of Sunitinib in the Treatment of Nongastrointestinal Stromal Tumor Sarcomas

From the Dana-Farber Cancer Institute; Massachusetts General Hospital; Ludwig Center at Dana-Farber/Harvard Cancer Center, Boston, MA; and the Memorial Sloan-Kettering Cancer Center, New York, NY.

Corresponding author: Suzanne George, MD, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, 44 Binney St, D1210, Boston, MA 02115; e-mail: suzanne_george{at}dfci.harvard.edu.

Purpose To evaluate the potential benefit of continuous daily dosing sunitinib in patients with advanced nongastrointestinal stromal tumor (GIST) sarcomas.

Patients and Methods A total of 53 patients with advanced non-GIST soft tissue sarcomas received sunitinib 37.5 mg daily. Primary end point was Response Evaluation Criteria in Solid Tumors defined response. Secondary end points were stable disease at 16 and 24 weeks. [¹⁸F]-fluorodeoxyglucose positron emission tomography was performed on a subset of 24 patients at baseline and after 10 to 14 days of therapy.

Results Forty-eight patients were eligible for response. One patient (desmoplastic round cell tumor [DSRCT]) achieved a confirmed partial response (PR) and remained on study for 56 weeks. Ten patients (20%) achieved stable disease for at least 16 weeks. Metabolic PR was seen in 10 (47%) of 21 of patients. Metabolic stable disease was seen in 11 (52%) of 21. There were no unexpected toxicities observed.

Conclusion Sunitinib demonstrated notable evidence of metabolic response in several patients with non-GIST sarcoma. The relevance of disease control observed in subtypes with an indolent natural history is unknown, however, the durable disease control observed in DSRCT, solitary fibrous tumor, and giant cell tumor of bone suggests that future evaluation of sunitinib in these subtypes may be warranted.

Supported in part by Pfizer Inc; the Virginia and Daniel K. Ludwig Trust for Cancer Research; Cycle for Survival and NCI program project CA47179 (R.G.M., G.K.S.) and correlative studies supported by National Comprehensive Cancer Network, protocol No. NCCN-S109.

Presented in part at the 13th Annual Connective Tissue Oncology Society Conference, Seattle, WA, October 31 to November 3, 2007; and the 44th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 30 to June 3, 2008.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available JCO.org.

Clinical trial information can be found for the following: NCT00474994 [ClinicalTrials.gov] .

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