Leuprorelin three-month depot in the treatment of advanced and metastatic prostate cancer: long-term follow-up results.
OBJECTIVE
To determine median survival time, median time to tumor progression and maintenance of testosterone suppression (i.e. < or = 50 ng/dl) during long-term treatment with subcutaneous injections of leuprorelin acetate 3-month depot (LAD-3M). In Germany 62 patients with advanced prostate cancer participated in a prospective, randomized, multicenter phase II trial as part of a European study. Of these, 37 patients entered the follow-up study.


METHODS
Standard clinical investigations and methods were employed in the study.


RESULTS
Twenty-five of the 62 (40.3%) patients died during the course of the study. No death had a causal relationship with the study drug. Median survival time, median time to tumor progression and median period of progression-free survival were 1,149 (3.1 years), 1,015 (2.8 years) and 680 days (1.9 years), respectively. Adequate suppression of testosterone serum levels to the castration range was confirmed. Objective and subjective response as well as the safety profile were comparable to previously published results with LAD-3M, LAD-1 M and other LHRH analogues.


CONCLUSIONS
The results of this follow-up study confirm long-term efficacy and safety of LAD-3M for treatment in advanced prostate cancer. LAD-3M is a suitable alternative to the established shorter-acting LHRH-a depot formulations.
Jocham
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Department of Urology, Medical University of Lübeck, Germany.
D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D001859:Bone Neoplasms / Q000556:secondary; D002277:Carcinoma / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D003692:Delayed-Action Preparations; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005060:Europe; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D016729:Leuprolide / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D013739:Testosterone / Q000097:blood; D013997:Time Factors
D018931:Antineoplastic Agents, Hormonal; D003692:Delayed-Action Preparations; D013739:Testosterone; D017430:Prostate-Specific Antigen; D016729:Leuprolide