XXXX Maintenance Therapy After @entity1205 Induction in Castration-Resistant @entity263 .

@entity1 @entity13850 @entity263 @entity5 @entity3470 @entity158 @entity1205 @entity1486
LESSONS LEARNED: @entity13850 maintenance therapy after @entity1205 induction chemotherapyis safe in @entity1 with @entity263 , although biochemical or @entity5 responses are rare;does not diminish quality of life; anddelays radiological and/or symptomatic progression by approximately 6 months. BACKGROUND: No standard therapy is available for @entity1 with @entity263 ( @entity263 ) who have responded to @entity1205 and do not yet have disease progression. Hence, we designed a single-arm phase II trial to explore whether the @entity3470 inhibitor @entity13850 can maintain the response to @entity1205 without compromising quality of life. METHODS: After successful @entity1205 induction (75 mg/m(2) every 3 weeks; 6-10 cycles), 21 @entity263 @entity1 underwent @entity13850 maintenance treatment (25 mg weekly; 4 weeks per cycle). The primary endpoint was the time to treatment failure (TTTF) (i.e., radiological and/or symptomatic progression). The secondary endpoints included the @entity5 response rate (RECIST 1.0), safety (National @entity5 Institute Common Terminology Criteria for Adverse Events, version 3.0), quality of life (Functional Assessment of @entity5 Therapy-Prostate [FACT-P]), @entity158 (Present @entity158 Intensity [PPI] scale), @entity1486 (PSA) parameters, including time to PSA progression (TTPP) according to @entity263 Clinical Trials Working Group criteria, and serial enumeration of circulating endothelial cells (CECs) and endothelial progenitor cells (CEPs). RESULTS: @entity1 received a median of 7 cycles of @entity13850 (range, 1-28), resulting in a median TTTF of 24.3 weeks (95% confidence interval [CI], 16.1-33.0), 1 partial @entity5 response (4.8%), 1 PSA response (4.8%), and a median TTPP of 12.2 weeks (95% CI, 7.8-23.9). Grade 3-4 adverse events were infrequent, and FACT-P and PPI scores remained stable during treatment. CECs did not predict clinical benefit, and CEPs were not consistently detectable. CONCLUSION: @entity13850 maintenance therapy after successful @entity1205 induction is feasible, does not adversely affect quality of life, and, in this exploratory single-arm phase II study, resulted in a median TTTF of 24.3 weeks.
