Combination of LHRH analog with @entity1943 analog and @entity619 versus chemotherapy in XXXX : a randomized phase II study.

@entity1 @entity12749 @entity137 @entity263 @entity6 @entity2879 @entity1503 @entity619 @entity342 @entity18245 @entity158 @entity1943 @entity1486
OBJECTIVES: To evaluate prospectively the combination of a luteinizing hormone-releasing hormone analog with a @entity1943 analog and @entity619 in @entity1 with @entity263 ( @entity263 ) in a randomized Phase II study. @entity263 presents a challenging therapeutic problem. Salvage chemotherapy is the usual approach at this stage of the disease. The combination of a luteinizing hormone-releasing hormone analog with a @entity1943 analog and @entity619 has produced objective clinical responses in @entity263 . METHODS: Forty @entity1 with @entity263 were randomized to receive one of two treatments. Group 1 underwent chemotherapy ( @entity12749 140 mg three times daily and @entity2879 100 mg orally for 21 days) and group 2 the combination of a @entity1943 analog ( @entity18245 30 mg intramuscularly every 14 days) and @entity619 (4 mg tapered to 1 mg), in addition to @entity342 ablation by orchiectomy or a luteinizing hormone-releasing hormone analog (triptorelin 3.75 mg intramuscularly every 28 days). The clinical and @entity1486 response, overall survival, time to progression, and @entity137 were compared between the two groups. RESULTS: The data of 20 @entity1 in group 1 and 18 in group 2 were analyzed. The demographic and clinical data were similar in the two groups at study entry. A @entity1486 response (decrease of greater than 50%) was observed in 45% of group 1 and 44% of group 2. The difference was not statistically significant. A partial clinical response was observed in 29% and 30% of groups 1 and 2, respectively. Again, the difference was not statistically significant. Changes in performance status and @entity158 score during treatment were not significantly different in the two groups. @entity1503 was more frequent in group 1 (80% of @entity1 ), and mild @entity6 was more frequent in group 2 (22% of @entity1 ). The overall survival was 18.8 months in group 1 and 18 months in group 2 (not statistically significant). The time to progression was 6 versus 4 months and, in the @entity1486 responder subgroup, it was 8 versus 7.7 months in groups 1 and 2, respectively (neither difference was statistically significant). CONCLUSIONS: The results of our randomized Phase II study indicated that the new combination treatment (luteinizing hormone-releasing hormone analog, @entity1943 analog, and @entity619 ) may be equally effective as salvage chemotherapy in @entity1 with @entity263 in terms of the clinical and @entity1486 response, overall survival, and time to progression. A larger prospective Phase III trial is required to confirm our observations.
