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Multicenter phase II study of trabectedin in patients with metastatic castration-resistant prostate cancer
- Publication Year :
- 2011
- Publisher :
- Oxford University Press, 2011.
-
Abstract
- 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.
- Subjects :
- Oncology
Adult
Male
medicine.medical_specialty
Urology
Phases of clinical research
Dioxoles
Cohort Studies
Internal medicine
Tetrahydroisoquinolines
medicine
Humans
Treatment Failure
Neoplasm Metastasis
Antineoplastic Agents, Alkylating
Trabectedin
Aged
Aged, 80 and over
Taxane
business.industry
Prostatic Neoplasms
Sarcoma
Hematology
Middle Aged
Prostate-specific antigen
Treatment Outcome
Docetaxel
Tolerability
Cohort
business
Orchiectomy
medicine.drug
Cohort study
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....9b1ff4aedf629945aec186ec95bcd457