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Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor
Author(s) -
Schuetze Scott M.,
Bolejack Vanessa,
Choy Edwin,
Ganjoo Kristen N.,
Staddon Arthur P.,
Chow Warren A.,
Tawbi Hussein A.,
Samuels Brian L.,
Patel Shreyaskumar R.,
Mehren Margaret,
D'Amato Gina,
Leu Kirsten M.,
Loeb David M.,
Forscher Charles A.,
Milhem Mohammed M.,
Rushing Daniel A.,
Lucas David R.,
Chugh Rashmi,
Reinke Denise K.,
Baker Laurence H.
Publication year - 2017
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.30379
Subject(s) - medicine , chordoma , dasatinib , chondrosarcoma , sarcoma , alveolar soft part sarcoma , epithelioid sarcoma , oncology , soft tissue sarcoma , radiology , surgery , imatinib , pathology , myeloid leukemia
BACKGROUND Alveolar soft part sarcoma (ASPS), chondrosarcoma (CS), chordoma, epithelioid sarcoma, and solitary fibrous tumor (SFT) are malignant tumors that are relatively resistant to chemotherapy and for which more effective drug therapy is needed. METHODS The 5 listed subtypes were enrolled into a single indolent sarcoma cohort in a phase 2 study of dasatinib using a Bayesian continuous monitoring rule for enrollment. The primary objective was to estimate the 6‐month progression‐free survival (PFS) rate according to the Choi criteria with a target of ≥50%. Cross‐sectional imaging was performed before the start of treatment, every 2 months for 6 months, and then every 3 months during treatment. The 2‐ and 5‐year survival rates were determined. RESULTS One hundred sixteen patients were enrolled within 45 months, and 109 began treatment with dasatinib. The 6‐month PFS rate and the median PFS were 48% and 5.8 months, respectively. The PFS rate at 6 months was highest with ASPS (62%) and lowest with SFT (30%). More than 10% of the patients with ASPS, CS, or chordoma had stable disease for more than 1 year. Collectively, for all 5 subtypes, the 2‐ and 5‐year overall survival rates were 44% and 13%, respectively. An objective response was observed in 18% of the patients with CS or chordoma. CONCLUSIONS Dasatinib failed to achieve control of sarcoma growth for at least 6 months in more than 50% of the patients in this trial according to the Choi tumor response criteria. An objective tumor response and prolonged stable disease was observed in >10% of patients with CS or chordoma. Cancer 2017;90–97. © 2016 American Cancer Society.