UNASSIGNED: 301 Background: PFS6 was identified to be a robust intermediate endpoint in the setting of second-line therapy for advanced @entity189 (Sonpavde, ESMO Congress, 2012) We studied the impact of second-line prognostic factors (Sonpavde, ESMO Congress 2012) (liver metastasis [LM], @entity417 [Hb<10 g/dl], ECOG-performance status [PS] >= 1, @entity1054 [ @entity1054 ]) on PFS6 and response rate (RR) to enable comparison of outcomes across phase II trials. METHODS: Twelve phase II trials evaluating second-line chemotherapy and/or biologics (n=748) in @entity1 with progressive disease were pooled. PFS was defined as @entity5 progression or @entity204 from any cause. PFS6 was defined from the date of registration and calculated using the Kaplan-Meier method. RESULTS: Data regarding progression, Hb, LM, PS and @entity1054 were available in 570 @entity1 , who were considered evaluable. The mean age was 65.1 years, 45.3% had ECOG-PS >= 1, 30.2% had LM, 14.6% had @entity417 and @entity1054 was <6 months (mo) in 60.2%. The overall median PFS was 2.7 mo, PFS6 was 22.2% (95% CI: 18.8-25.9) and RR was 17.5% (95% CI: 14.5%-20.9%). PFS6 and RR varied significantly according to risk group (Table). For every unit increase in risk group, the hazard of progression in 6 mo increased by 41% and the odds of response decreased by 48%. CONCLUSIONS: PFS6 and RR vary as a function of prognostic factors in @entity1 receiving second-line therapy for advanced @entity189 . These data facilitate comparison of outcomes across phase II trials enrolling heterogeneous populations. [Table: see text].

Impact of baseline prognostic factors on progression-free survival at 6 months (PFS6) and response in @entity1 receiving second-line therapy for advanced @entity189 ( XXXX ).

@entity1 :: ('9606', 'Species') :: ['patients'] @entity417 :: ('MESH:D000740', 'Disease') :: ['anemia'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity189 :: ('MESH:D002277', 'Disease') :: ['UC'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity1054 :: ('MESH:D000377', 'Disease') :: ['TFPC', 'time from prior chemotherapy']
@entity189 :: (MESH:D002277,Disease) :: ['UC']
