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Michaelson MD , Bellmunt J , Hudes GR , Goel S , Lee RJ , Kantoff PW , Stein CA , Lardelli P , Pardos I , Kahatt C , Nieto A , Cullell-Young M , Lewis NL , Smith MR
Multicenter phase II study of trabectedin in patients with metastatic castration-resistant prostate cancer
Annals of Oncology. 2012 May;23(5) :1234-1240
PMID: WOS:000303336400022   
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This multicenter phase II trial evaluated the efficacy and safety of trabectedin in metastatic castration-resistant prostate cancer (CRPC). Two schedules were evaluated in three cohorts: weekly as 3-h i.v. infusion at 0.58 mg/m(2) for 3 out of 4 weeks (Cohort A, n = 33), and every 3 weeks (q3wk) as 24-h infusion at 1.5 mg/m(2) (Cohort B1, n = 5) and 1.2 mg/m(2) (Cohort B2, n = 20). The primary end point was prostate-specific antigen (PSA) response; secondary end points included safety, tolerability and time to progression (TTP). Trabectedin resulted in PSA declines >= 50% in 12.5% (Cohort A) and 10.5% (Cohort B2) of patients. Among men pretreated with taxane-based chemotherapy, PSA response was 13.6% (Cohort A) and 15.4% (Cohort B2). PSA responses lasted 4.1-8.6 months, and median TTP was 1.5 months (Cohort A) and 1.9 months (Cohort B2). The dose of 1.5 mg/m(2) (approved for soft tissue sarcoma) given as 24-h infusion q3wk was not tolerable in these patients. At 1.2 mg/m(2) q3wk and 0.58 mg/m(2) weekly, the most common adverse events were nausea, fatigue and transient neutropenia and transaminase increase. Two different trabectedin schedules showed modest activity in metastatic CRPC. Further studies may require identification of predictive factors of response in prostate cancer.
Michaelson, M. D. Bellmunt, J. Hudes, G. R. Goel, S. Lee, R. J. Kantoff, P. W. Stein, C. A. Lardelli, P. Pardos, I. Kahatt, C. Nieto, A. Cullell-Young, M. Lewis, N. L. Smith, M. R. PharmaMar; JJ M. D. Michaelson's institution received research funding from PharmaMar and J & J; SG received research funding from PharmaMar; JB received honoraria for a PharmaMar advisory board; RJL served on an advisory board for Amgen (with compensation). 21 Oxford univ press Oxford 933ch Mon r, 1989, controlled clinical trials, v10, p1