Back to Search
Start Over
Activity of second-line chemotherapy in docetaxel-refractory hormone-refractory prostate cancer patients : randomized phase 2 study of ixabepilone or mitoxantrone and prednisone.
- Source :
-
Cancer [Cancer] 2007 Aug 01; Vol. 110 (3), pp. 556-63. - Publication Year :
- 2007
-
Abstract
- Background: This randomized, noncomparative, multicenter, clinical trial evaluated ixabepilone or mitoxantrone/prednisone (MP) as second-line chemotherapy for taxane-refractory, hormone-refractory, prostate cancer (HRPC).<br />Methods: Patients with HRPC that progressed during or within 60 days of cessation of taxane chemotherapy were randomly selected with equal probability to ixabepilone 35 mg/m(2) intravenously every 3 weeks, or mitoxantrone 14 mg/m(2) intravenously every 3 weeks and prednisone 5 mg orally twice daily. Treatment continued until progression or toxicity; crossover was allowed.<br />Results: Forty-one patients were accrued to each arm of the study. The median number of cycles administered for each arm was 3. Median survival from protocol entry was 10.4 months with ixabepilone and 9.8 months with MP. Prostate-specific antigen (PSA) declines of >or=50% were observed in 17% of ixabepilone (95% CI, 7-32) and 20% of second-line MP patients (95% CI, 9-35). Partial responses were observed in 1 of 24 ixabepilone and in 2 of 21 MP patients with evaluable measurable disease. Median duration of second-line ixabepilone and MP treatment was 2.2 months and 2.3 months, respectively. For third-line crossover treatment, PSA declines of >or=50% were observed in 3 of 27 ixabepilone-treated and 4 of 15 MP-treated patients. Prior taxane response was associated with an increased likelihood of second-line ixabepilone or MP response. Low baseline lactate dehydrogenase and absence of visceral metastases independently predicted improved survival. The most common grade 3/4 toxicity associated with second-line treatment was neutropenia (54% of ixabepilone patients and 63% of MP patients).<br />Conclusions: Ixabepilone and MP had modest activity as second-line chemotherapy for docetaxel-refractory HRPC. The median survival for the entire cohort treated in this study was 9.8 months.<br /> ((c) 2007 American Cancer Society.)
- Subjects :
- Adenocarcinoma drug therapy
Adenocarcinoma secondary
Aged
Aged, 80 and over
Cross-Over Studies
Docetaxel
Epothilones administration & dosage
Humans
Male
Middle Aged
Mitoxantrone administration & dosage
Neoplasms, Hormone-Dependent pathology
Prednisone administration & dosage
Prostate-Specific Antigen blood
Prostatic Neoplasms pathology
Salvage Therapy
Survival Rate
Taxoids therapeutic use
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Drug Resistance, Neoplasm
Neoplasms, Hormone-Dependent drug therapy
Prostatic Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0008-543X
- Volume :
- 110
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 17577218
- Full Text :
- https://doi.org/10.1002/cncr.22811