Presentation Authors: Anup Patel*, London, United Kingdom
Introduction: Baseline serum testosteroneâ€™s (s-T) prognostic value in hormone naive advanced prostatic cancer (aPCa) patients receiving androgen deprivation therapy (ADT) was examined by pooled analysis.
Methods: aPCa patients who received continuous luteinizing hormone releasing hormone (LHRH) antagonist or agonist ADT with 1 year planned treatment and follow-up, were selected for post-hoc analysis from two large prospective, randomized, parallel-arm, phase 3 trials (NCT00295750 â€“ global; NCT00928434 - USA). Kaplan Maier (K-M) survival estimates and Cox proportional hazards regression models and adjusted multivariate analysis were used to evaluate time to PSA rise, progression-free survival (PFS) and overall survival (OS), comparing low ( < 250ng/dL) vs. normal (>250ng/dL) s-T level groups, and lowest vs. higher s-T quartiles.
Results: On intention to treat analysis, 138 (16.5%) of 838 eligible men had baseline s-T < 250ng/dL. Lower s-T quartile (n=206) was < 282ng/dL vs. >503ng/dL for highest quartile (n=210). Key baseline demographic characteristics between low and normal s-T groups respectively were comparable; Gleason grade 7-10 (55 vs. 58%), stage, and PSA >20ng/ml categories (38% each). All survival end-points were significantly worse (p < 0.05) for low baseline s-T level patients (time to PSA progression, PFS and OS hazard ratios 1.77, 1.88 and 2.23 respectively) as shown in Table 1.
Conclusions: Biochemically hypogonadal hormone naÃ¯ve aPCa patients had significantly worse 1-year time to PSA progression, PFS and OS, after LHRH-based medical castration. International guidelines should prompt practice change by incorporating baseline s-T measurement in hormone naÃ¯ve aPCa patients, to identify and better inform those with hypogonadal s-T levels for potential inclusion into future new treatment trials versus ADT.
Source of Funding: Ferring Provided Grant for Independent Statistical Data Aanalysis