NEW YORK (Reuters Health) Jan 12 - Finasteride and flutamide in combination produce significant declines in prostate specific antigen (PSA) in men with biochemical failure after local therapy, researchers report.
Dr. Paul J. Monk of Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus, Ohio and colleagues note that about a third of men treated for localized prostate cancer will have serological progression.
As an alternative to androgen deprivation therapy - which has a high response rate but a myriad of side effects - the researchers propose peripheral androgen blockade with a 5-alpha reductase inhibitor (finasteride) and an antiandrogen (flutamide).
"Because patients with PSA-only recurrences after definitive local therapy are not necessarily destined to die of their disease, they are excellent candidates for therapy that may have lower toxicity, while retaining the potential to control their disease," the investigators said in their report, published online December 16 in Cancer.
They tested the effect of daily therapy with finasteride 5 mg and flutamide 750 mg in 99 men who'd each had a PSA increase of at least 1 ng/mL.
The PSA level fell by at least 80% in 96% of subjects, and it became undetectable (<0.2 ng/mL) in 73%. The median time to a nadir value was 3.2 months.
The median time to PSA progression was 85 months. The five-year overall survival rate was 87%. And with a median follow-up of 10 years, the median survival time has not been reached.
Currently 22 patients remain on therapy. Of the 77 patients off protocol treatment, 43 have died, including 13 who died of progressive prostate cancer.
Eighteen men stopped therapy for side effects, mainly diarrhea, liver enzyme elevations, and gynecomastia. Another 21 came off the protocol because of disease progression. Nine withdrew their consent.
The researchers say their five-year metastasis-free rate of 97% compares favorably with the 67% rate reported in a recently updated retrospective study of 450 men who did not receive any additional therapies after surgery.
Summing up, Dr. Monk pointed out, "The combination of finasteride and flutamide was well tolerated, durable and active making it a good option to incorporate in a controlled study in this important population of men."
SOURCE: http://bit.ly/y8AWYQ
Cancer 2011.
Dr. Paul J. Monk of Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus, Ohio and colleagues note that about a third of men treated for localized prostate cancer will have serological progression.
As an alternative to androgen deprivation therapy - which has a high response rate but a myriad of side effects - the researchers propose peripheral androgen blockade with a 5-alpha reductase inhibitor (finasteride) and an antiandrogen (flutamide).
"Because patients with PSA-only recurrences after definitive local therapy are not necessarily destined to die of their disease, they are excellent candidates for therapy that may have lower toxicity, while retaining the potential to control their disease," the investigators said in their report, published online December 16 in Cancer.
They tested the effect of daily therapy with finasteride 5 mg and flutamide 750 mg in 99 men who'd each had a PSA increase of at least 1 ng/mL.
The PSA level fell by at least 80% in 96% of subjects, and it became undetectable (<0.2 ng/mL) in 73%. The median time to a nadir value was 3.2 months.
The median time to PSA progression was 85 months. The five-year overall survival rate was 87%. And with a median follow-up of 10 years, the median survival time has not been reached.
Currently 22 patients remain on therapy. Of the 77 patients off protocol treatment, 43 have died, including 13 who died of progressive prostate cancer.
Eighteen men stopped therapy for side effects, mainly diarrhea, liver enzyme elevations, and gynecomastia. Another 21 came off the protocol because of disease progression. Nine withdrew their consent.
The researchers say their five-year metastasis-free rate of 97% compares favorably with the 67% rate reported in a recently updated retrospective study of 450 men who did not receive any additional therapies after surgery.
Summing up, Dr. Monk pointed out, "The combination of finasteride and flutamide was well tolerated, durable and active making it a good option to incorporate in a controlled study in this important population of men."
SOURCE: http://bit.ly/y8AWYQ
Cancer 2011.
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