Baseline bone pain as a prognostic marker for survival for men with metastatic hormone-sensitive prostate cancer (mHSPC): Patient-level analysis of SWOG 1216 trial.

Abstract

188 Background: Pain from bone metastasis significantly predicts overall survival (OS) in men with castration-resistant prostate cancer (PMID: 18487572). However, it has not been extensively evaluated in men with mHSPC. We hypothesized that baseline bone pain in men with mHSPC will be a significant prognostic marker for OS. Therefore, SWOG 1216 trial data which randomized men with mHSPC to androgen deprivation therapy (ADT) with orteronel vs bicalutamide was evaluated (PMID: 35446628,NCT01809691). Methods: Patient level data from SWOG 1216 were analyzed for those with documentation of baseline bone pain (yes or no). Patients were categorized into 2 cohorts: those with bone pain (BP1) vs those without bone pain (BP0). Progression-free survival (PFS) and OS were summarized by median with 95% confidence intervals (CI). Multivariable analyses on PFS and OS were done using Cox proportional hazard model, and were adjusted for treatment arm, disease burden, Gleason score, PSA (log base 2–transformed) and age (Table). All the analyses were done using R version 4.2.1. Results: Of the 1279 study participants: 301 men were in BP1 (23.5%) vs 896 were in BP0 (70.51%) cohort. Bone pain status was unavailable in 82 men (6.4%) men. Compared to BP0, BP1 cohort had lower median age (66 vs 68 years, p<0.01) and higher disease burden (70.4% vs 41.6%, p<0.001). Men in BP0 cohort had significantly better median PFS (3.7 vs. 1.3 yrs; p<0.001) and OS (NR vs 3.9 vs NR, p<0.001) then men in BP1 cohort. After adjustment for other prognostic variables including treatment, disease burden, Gleason score, log2PSA and age; bone pain was significantly associated with decreased PFS and OS (Table). Conclusions: Men with mHSPC with bone pain at baseline have worse survival outcomes despite treatment intensification and may be prioritized for enrollment in clinical trials. These data may aid patient counseling and warrant the inclusion of bone pain in the prognostic models of mHSPC. Clinical trial information: NCT01809691 . [Table: see text]