Title |
SARC009: Phase 2 study of dasatinib in patients with previously treated, high‐grade, advanced sarcoma
|
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Published in |
Cancer (0008543X), December 2015
|
DOI | 10.1002/cncr.29858 |
Pubmed ID | |
Authors |
Scott M Schuetze, J Kyle Wathen, David R Lucas, Edwin Choy, Brian L Samuels, Arthur P Staddon, Kristen N Ganjoo, Margaret von Mehren, Warren A Chow, David M Loeb, Hussein A Tawbi, Daniel A Rushing, Shreyaskumar R Patel, Dafydd G Thomas, Rashmi Chugh, Denise K Reinke, Laurence H Baker |
Abstract |
Dasatinib exhibited activity in preclinical models of sarcoma. The Sarcoma Alliance for Research through Collaboration (SARC) conducted a multicenter, phase 2 trial of dasatinib in patients with advanced sarcoma. Patients received dasatinib twice daily. The primary objective was to estimate the clinical benefit rate (CBR) (complete response or partial response within 6 months or stable disease duration of ≥6 months) with a target of ≥25%. Patients were enrolled into 1 of 7 different cohorts and assessed by imaging every 8 weeks using Choi criteria tumor response and a Bayesian hierarchical design. For each subtype, enrollment was stopped after a minimum of 9 patients were treated if there was a <1% chance the CBR was ≥25%. A total of 200 patients were enrolled. Accrual was stopped early in 5 cohorts because of low CBR. The leiomyosarcoma (LMS) and undifferentiated pleomorphic sarcoma (UPS) cohorts fully accrued and 6 of 47 and 8 of 42 evaluable patients, respectively, exhibited clinical benefit. The probability that the CBR was ≥25% in the LMS and UPS cohorts was 0.008 and 0.10, respectively. The median progression-free survival ranged from 0.9 months in patients with rhabdomyosarcoma to 2.2 months in patients with LMS. The median overall survival was 8.6 months. The most frequent adverse events were constitutional, gastrointestinal, and respiratory, and 36% of patients required dose reduction for toxicity. Serious adverse events attributed to therapy occurred in 11% of patients. Dasatinib may have activity in patients with UPS but is inactive as a single agent in the other sarcoma subtypes included herein. The Bayesian design allowed for the early termination of accrual in 5 subtypes because of lack of drug activity. Cancer 2015. © 2015 American Cancer Society. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United States | 1 | 50% |
Unknown | 1 | 50% |
Demographic breakdown
Type | Count | As % |
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Scientists | 1 | 50% |
Science communicators (journalists, bloggers, editors) | 1 | 50% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 57 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Ph. D. Student | 10 | 18% |
Other | 8 | 14% |
Student > Master | 6 | 11% |
Student > Bachelor | 3 | 5% |
Student > Doctoral Student | 3 | 5% |
Other | 9 | 16% |
Unknown | 18 | 32% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 13 | 23% |
Biochemistry, Genetics and Molecular Biology | 7 | 12% |
Agricultural and Biological Sciences | 5 | 9% |
Engineering | 2 | 4% |
Veterinary Science and Veterinary Medicine | 1 | 2% |
Other | 7 | 12% |
Unknown | 22 | 39% |