Back to Search
Start Over
Multicenter phase II study of trabectedin in patients with metastatic castration-resistant prostate cancer.
- Source :
-
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2012 May; Vol. 23 (5), pp. 1234-1240. Date of Electronic Publication: 2011 Sep 19. - Publication Year :
- 2012
-
Abstract
- Background: This multicenter phase II trial evaluated the efficacy and safety of trabectedin in metastatic castration-resistant prostate cancer (CRPC).<br />Patients and Methods: 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).<br />Results: 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.<br />Conclusions: Two different trabectedin schedules showed modest activity in metastatic CRPC. Further studies may require identification of predictive factors of response in prostate cancer.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Alkylating adverse effects
Antineoplastic Agents, Alkylating therapeutic use
Cohort Studies
Dioxoles adverse effects
Humans
Male
Middle Aged
Neoplasm Metastasis
Orchiectomy
Prostatic Neoplasms pathology
Prostatic Neoplasms surgery
Sarcoma pathology
Sarcoma surgery
Tetrahydroisoquinolines adverse effects
Trabectedin
Treatment Failure
Treatment Outcome
Dioxoles therapeutic use
Prostatic Neoplasms drug therapy
Sarcoma drug therapy
Tetrahydroisoquinolines therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1569-8041
- Volume :
- 23
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 21930687
- Full Text :
- https://doi.org/10.1093/annonc/mdr399