Phase 2 study of dasatinib in patients with alveolar soft part sarcoma, chondrosarcoma, chordoma, epithelioid sarcoma, or solitary fibrous tumor

Cancer - Tập 123 Số 1 - Trang 90-97 - 2017
Scott M. Schuetze1, Vanessa Bolejack2, Edwin Choy3, Kristen N. Ganjoo4, Arthur P. Staddon5, Warren Chow6, Hussein A. Tawbi7, Brian L. Samuels8, Shreyaskumar Patel7, Margaret von Mehren9, Gina Z. D’Amato10, Kirsten Leu11, David M. Loeb12, Charles Forscher13, Mohammed Milhem14, Daniel A. Rushing15, David R. Lucas1, Rashmi Chugh1, Denise K. Reinke16, Laurence H. Baker1
1University of Michigan, Ann Arbor, Michigan
2Cancer Research and Biostatistics, Seattle, Washington
3Massachussetts General Hospital Boston Massachusetts
4Stanford University, Palo Alto, California
5University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
6City of Hope Medical Center, Duarte, California
7The University of Texas MD Anderson Cancer Center, Houston, Texas
8Northwest Oncology Post Falls Idaho
9Fox Chase Cancer Center, Philadelphia, Pennsylvania
10Georgia Cancer Specialists Sandy Springs Georgia
11Nebraska Cancer Specialists Omaha Nebraska
12Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland
13Cedars Sinai Medical Center, Los Angeles, California
14University of Iowa, Iowa City, Iowa
15Indiana University, Indianapolis, Indiana
16Sarcoma Alliance Through Research and Collaboration Ann Arbor Michigan

Tóm tắt

BACKGROUNDAlveolar 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.METHODSThe 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.RESULTSOne 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.CONCLUSIONSDasatinib 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.

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Cancer

Tập 123 Số 1

90-97

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