Authors: | Monk, J. P.; Halabi, S.; Picus, J.; Hussain, A.; Philips, G.; Kaplan, E.; Ahles, T.; Gu, L.; Vogelzang, N.; Kelly, W. K.; Small, E. J. |
Article Title: | Efficacy of peripheral androgen blockade in prostate cancer patients with biochemical failure after definitive local therapy |
Abstract: | Background: The treatment for prostate cancer patients with biochemical failure after local therapy remains controversial. Peripheral androgen blockade using a combination of a 5-alpha reductase inhibitor and an antiandrogen may allow control of the prostate-specific antigen (PSA). Because testosterone levels are not suppressed, this approach may be associated with less morbidity than conventional gonadal androgen suppression. Methods: All patients had undergone previous definitive local therapy and had evidence of a rising PSA >1ng/mL, with no evidence of recurrent disease. Patients received both finasteride, 5 mg orally per day, and flutamide, 250 mg orally 3Ã - a day. Patients were followed for a PSA response and quality of life assessment. Results: Ninety-nine of 101 accrued patients were eligible. A a≤yen;80% PSA decline was seen in 96 (96%) patients. The median time to PSA progression was 85 months. With a median follow-up of 10 years, the median survival time had not been reached, and the 5-year overall survival rate was 87%. Toxicity was mild, with 18 patients stopping for toxicity; 15 had diarrhea, 4 had gynecomastia, and 3 had transaminase elevation. Baseline Functional Assessment of Cancer Therapy Prostate Module and Treatment Outcome Index scores decreased by 5 points each at 6 months after enrollment. Conclusions: The use of the finasteride/flutamide combination is feasible, and results in PSA declines of a≤yen;80% in 96% of patients with serologic progression after definitive local therapy. There were no unexpected toxicities, and the change in quality of life was mild. Further evaluation of this or a similar regimen in a controlled clinical trial is warranted. © 2011 American Cancer Society. |
Keywords: | adult; controlled study; treatment response; aged; survival rate; major clinical study; overall survival; fatigue; salvage therapy; diarrhea; drug efficacy; hypertension; side effect; cancer patient; follow up; prostate specific antigen; edema; progression free survival; quality of life; drug eruption; thrombocyte; anemia; weight reduction; hemoglobin; creatinine blood level; deep vein thrombosis; urea nitrogen blood level; hematuria; dyspnea; hyperglycemia; prostate cancer; alkaline phosphatase; hyperkalemia; hypoalbuminemia; malaise; prothrombin time; survival time; feasibility study; prostatectomy; cancer specific survival; heart infarction; finasteride; recurrent disease; skin disease; hot flush; external beam radiotherapy; flutamide; heart arrhythmia; lymphocyte; neurologic disease; gynecomastia; proteinuria; impotence; heart muscle ischemia; mood disorder; phlebitis; partial thromboplastin time; weight gain; psa failure; biochemical failure free survival; breast tenderness; functional assessment of cancer therapy prostate module score; treatment outcome index score |
Journal Title: | Cancer |
Volume: | 118 |
Issue: | 17 |
ISSN: | 0008-543X |
Publisher: | Wiley Blackwell |
Date Published: | 2012-09-01 |
Start Page: | 4139 |
End Page: | 4147 |
Language: | English |
DOI: | 10.1002/cncr.26732 |
PROVIDER: | scopus |
PUBMED: | 22180287 |
PMCID: | PMC5558439 |
DOI/URL: | |
Notes: | --- - "Export Date: 1 October 2012" - "CODEN: CANCA" - "Source: Scopus" |