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Dasatinib plus docetaxel active in castration-resistant prostate cancer

Araujo JC. Cancer. 2012;118:63-71.

Issue: January 10, 2012

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A combination treatment of dasatinib and docetaxel showed a high response rate and a favorable toxicity profile in men with castration-resistant prostate cancer, according to researchers from The University of Texas MD Anderson Cancer Center.

“[In preclinical studies], dasatinib (Sprycel, Bristol-Myers Squibb) significantly lowered serum PSA concentrations and increased bone mineral density, and treatment with dasatinib plus docetaxel (Taxotere, Sanofi-Aventis) had greater activity than either agent alone,” the researchers wrote. “These studies led to our hypothesis that combining dasatinib with docetaxel would improve treatment of patients with metastatic castration-resistant prostate cancer by targeting both the tumor and bone microenvironment.”

The researchers conducted a phase 1/2 study to evaluate the toxicity, pharmacokinetics and maximum-tolerated dose of dasatinib combined with docetaxel. Secondary objectives included tumor response, PSA response, PFS, bone scan changes and bone turnover markers.

The study included 46 patients. The phase 1 study included 16 patients and five different dose cohorts: 50 mg dasatinib with 60 mg/m² docetaxel; 50 mg dasatinib with 75 mg/m² docetaxel; 70 mg dasatinib with 75 mg/m² docetaxel; 100 mg dasatinib with 75 mg/m² docetaxel; and 120 mg dasatinib with 75 mg/m² docetaxel. There were no dose-limiting toxicities and the maximum-tolerated dose was not reached. Thirteen patients experienced at least one grade-3 or higher adverse event.

For the phase 2 study, dasatinib 100 mg daily and docetaxel 75 mg/m2 was chosen as the dose. Among the 46 patients, 37 had a decrease of PSA, which included 26 who had a confirmed PSA response. Among Response Evaluation Criteria in Solid Tumors (RECIST)-evaluable patients, 60% had a partial response and 17% remained on therapy without response or progression for 18 or more weeks. Bone scan response was improved in 30% of patients and stable in 41% of patients, and 7% showed bone scan progression.

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