Abstract
4557 Background: A recent phase III trial of intermittent vs. continuous AD supports IAD as standard of care for men treated with AD for BR. To identify potential prognostic factors during 1OFF, times to T and PSA rises from our prospective trial of IAD in men with BR were analyzed in relation to times to CRPC and PCM. Methods: 72 men with BR after definitive local therapy were treated with IAD, each cycle consisting of 9 months of leuprolide and flutamide followed by a variable “off treatment” interval. T and PSA were followed monthly; AD was resumed when PSA reached a pre-specified value. Cycles repeated until CRPC, defined as ≥2 PSA rises with T≤50 ng/dL. Markers of interest from 1OFF-2ON were time to first T>50, time from first T>50 to first PSA rise ≥0.1 ng/mL, time to first PSA rise ≥0.1, and PSA doubling time (PSAdt), calculated using the first 3 PSA measurements starting from first PSA ≥0.1. The associations of these markers with CRPC and PCM were evaluated using Cox proportional hazards models (or logistic regression if the Cox proportional hazards assumption was not met), controlling for age at study entry and Gleason score categorized to ≤7 or >7. Results: A 30-day increase in time to first T>50 was significantly associated with a 75% increase in the risk of PCM. A 30-day increase in time to PSA rise from 1OFF or after T>50 was significantly associated with a 23% or 72% reduction in the risk of CRPC, respectively. While neither of the associations of PSAdt with CRPC or PCM were significant, they were of moderate size: PSAdt displayed a moderate reduction in risk of CRPC by 35% and PCM by 38%. Conclusions: During the first “off treatment” interval of IAD, the time to first T>50 is prognostic for PCM. Time to first PSA rise after 1OFF and after first T>50 are both prognostic for CRPC. [Table: see text]
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