[Tolerance and clinical and biological responses during the first 6 months of treatment with 1-month sustained release LHRH agonists leuprolerin and triptolerin in patients with metastatic prostate cancer].
OBJECTIVE
Comparative efficacy and safety of 2 LHRH analogues in metastatic prostatic carcinoma.


METHODS
68 patients received monthly injections for 6 months (randomization): either subcutaneous leuprolide 3.75 mg LP (n = 36), or intramuscular triptorelin 3.75 mg LP (n = 32). (Flare-up prevention: nilutamide). Parameters re-evaluated at 1.3 and 6 months: centralized assays of plasma testosterone (T), LH and serum PSA; clinical symptoms. Main criterion: proportion of patients with T < or = 0.5 ng/mL.


RESULTS
The percentages of patients with T < or = 0.50 ng/mL was not significantly different between the two groups and were equal to 100 and 90%, 97 and 100%, and 100 and 96% at the 3 study times, for leuprolide or triptorelin, respectively. The difference was significant at 1 month on complementary analysis at the limit of T < 0.30 ng/mL: 86% with leuprolide versus 60% with triptorelin (p = 0.02) and for mean plasma testosterone: 0.16 +/- 0.10 ng/mL versus 0.33 +/- 0.44 ng/mL, respectively (p = 0.02). The clinical subjective efficacy was not significantly different.


CONCLUSIONS
Both treatments were effective, although plasma testosterone fell more rapidly with leuprolide. No conclusion about the possible clinical or survival benefits can be formulated. Overall safety was satisfactory.
Abbou
C C
CC
Service d'Urologie, Hôpital Henri Mondor, Créteil, France.
Lucas
C
C
Leblanc
V
V
D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy*; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D004361:Drug Tolerance; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use; D048289:Imidazolidines; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D016729:Leuprolide / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D013739:Testosterone / Q000097:blood; D013997:Time Factors; D017329:Triptorelin Pamoate / Q000008:administration & dosage / Q000627:therapeutic use*
D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D007093:Imidazoles; D048289:Imidazolidines; D017329:Triptorelin Pamoate; D013739:Testosterone; C021277:nilutamide; D017430:Prostate-Specific Antigen; D016729:Leuprolide
Tolérance et réponses clinique et biologique au cours des 6 premiers mois de traitement par la leuproréline ou la triptoréline, agonistes de la LHRH à libération prolongée sur 1 mois chez des patients présentant un cancer de la prostate métastasé.