Multicenter phase II trial of sunitinib in the treatment of nongastrointestinal stromal tumor sarcomas.
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. [(18)F]-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.
George
Suzanne
S
Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, 44 Binney St, D1210, Boston, MA 02115, USA. suzanne_george@dfci.harvard.edu
Merriam
Priscilla
P
Maki
Robert G
RG
Van den Abbeele
Annick D
AD
Yap
Jeffrey T
JT
Akhurst
Timothy
T
Harmon
David C
DC
Bhuchar
Gauri
G
O'Mara
Margaret M
MM
D'Adamo
David R
DR
Morgan
Jeffrey
J
Schwartz
Gary K
GK
Wagner
Andrew J
AJ
Butrynski
James E
JE
Demetri
George D
GD
Keohan
Mary L
ML
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D049268:Positron-Emission Tomography; D011758:Pyrroles / Q000627:therapeutic use*; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D012983:Soft Tissue Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000077210:Sunitinib; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib