KEY TAKEAWAYS
- The SWOG 1216 phase III trial aimed to assess if baseline bone pain in men with mHSPC predicts OS using SWOG 1216 trial data.
- The results demonstrated that men with mHSPC and baseline bone pain exhibit poorer survival outcomes, underscoring their prioritization for clinical trials.
While bone metastasis pain is an important predictor parameter of overall survival (OS) in castration-resistant prostate cancer, its assessment in men with metastatic hormone-sensitive prostate cancer (mHSPC) is limited.
Georges Gebrael and the team conducted a study by hypothesizing that baseline bone pain would be a significant prognostic indicator for overall survival in men with mHSPC. Hence, they analyzed SWOG 1216 trial data, which randomized men with mHSPC to ADT with orteronel versus bicalutamide.
Patient-level data from SWOG 1216 were analyzed, considering documentation of baseline bone pain (yes or no). The study categorized patients into two cohorts which were those with bone pain (BP1) versus those without (BP0).
The median progression-free survival (PFS) and OS with 95% CI were summarized. Multivariable analyses on PFS and OS were conducted with the Cox proportional hazard model, adjusting for treatment arm, disease burden, Gleason score, log base 2-transformed PSA, and age. Analyses were performed using R version 4.2.1.
Of 1279 patients, 301 men were in the BP1 group (23.5%), while 896 were in the BP0 group(70.51%). Bone pain status was unavailable for 82 men (6.4%). While comparing BP1 to BP0, BP1 had a lower median age (66 vs. 68 years, P<0.01) and higher disease burden (70.4% vs. 41.6%, P<0.001).
The BP0 group exhibited significantly longer median PFS (3.7 vs. 1.3 years; P<0.001) and OS (not reached vs. 3.9 years; P<0.001) than those in the BP1 cohort. The prognostic variables (treatment, disease burden, Gleason score, log2PSA, and age) were adjusted, and bone pain remained significantly associated with decreased PFS and OS.
The study concluded that men with mHSPC experiencing baseline bone pain exhibit inferior survival outcomes despite treatment intensification, highlighting their potential prioritization for clinical trial enrollment. These findings hold significance for patient counseling and underscore the importance of incorporating bone pain into prognostic models for mHSPC.
Research was funded by SWOG Cancer Research Network.
Source: https://meetings.asco.org/abstracts-presentations/230106
Clinical Trial: https://clinicaltrials.gov/study/NCT01809691
Gebrael G, Jo Y, Swami U, et al. (2024) 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.’’ Presented at ASCO GU 2024. J Clin Oncol 42, 2024 (suppl 4; abstr 188). DOI: 10.1200/JCO.2024.42.4_suppl.188.
