Intermittent androgen suppression with leuprolide and flutamide for prostate cancer: a pilot study.
OBJECTIVE
To affirm the feasibility of using intermittent androgen suppression in patients with hormone-naive prostate cancer.


METHODS
Leuprolide and flutamide were administered for 9 to 12 months and then discontinued until prostate-specific antigen (PSA) levels reached a threshold value determined by the baseline PSA value. This constituted one cycle of treatment. Androgen suppression was then administered intermittently as described until there was evidence of androgen independence.


RESULTS
Twenty-two patients with PSA failure after primary therapy with surgery and/or radiation and untreated early or Stage D2 disease were treated. Twenty-one patients completed androgen suppression during cycle 1, with a median time to PSA nadir of 3.5 months (range, 2 to 12). Fifteen patients completed cycle 1 with a median time off treatment of 6 months (range, 2 to 19) or 38% (range, 17% to 64%) of a treatment cycle. Six patients continued off treatment during cycle 1 for 1+ to 31+ months. During cycle 2, 12 patients achieved a PSA nadir in a median time of 3.5 months. Two patients completed cycle 2 with a median time off treatment of 10 months (51%). Median follow-up for all patients is 26 months (range, 10 to 51). While off treatment, all patients reported a reduction of symptoms associated with androgen suppression.


CONCLUSIONS
Intermittent androgen suppression is a feasible alternative to continuous androgen suppression for treatment of prostate cancer, and quality of life is improved while off treatment.
Higano
C S
CS
Department of Medicine, University of Washington, Seattle 98195, USA.
Ellis
W
W
Russell
K
K
Lange
P H
PH
D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D005485:Flutamide / Q000008:administration & dosage; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology
D018931:Antineoplastic Agents, Hormonal; D005485:Flutamide; D016729:Leuprolide