TOPLINE:
METHODOLOGY:
- Prostate cancer often metastasizes to the bones, leading to pain and a reduced quality of life. While the relationship between bone pain and overall survival in metastatic, castration-resistant prostate cancer is well-documented, its impact in metastatic hormone-sensitive prostate cancer is less clear.
- Researchers conducted a post hoc secondary analysis using data from the SWOG-1216 phase 3 randomized clinical trial, which included 1279 men diagnosed with metastatic hormone-sensitive prostate cancer from 248 centers across the United States. Patients had received androgen deprivation therapy either with orteronel or bicalutamide.
- Among the 1197 patients (median age, 67.6 years) with data on bone pain included in the secondary analysis, 301 (23.5%) reported bone pain at baseline.
- The primary outcome was overall survival; secondary outcomes included progression-free survival and prostate-specific antigen response.
TAKEAWAY:
- The median overall survival for patients with baseline bone pain was 3.9 years compared with not reached (95% CI, 6.6 years to not reached) for those without bone pain at a median follow-up of 4 years (adjusted hazard ratio [aHR], 1.66; P < .001).
- Similarly, patients with bone pain had a shorter progression-free survival vs those without bone pain (median, 1.3 years vs 3.7 years; aHR, 1.46; P < .001).
- The complete prostate-specific antigen response rate at 7 months was also lower for patients with baseline bone pain (46.3% vs 66.3%; P < .001).
IN PRACTICE:
Patients with metastatic hormone-sensitive prostate cancer “with baseline bone pain had worse survival outcomes than those without baseline bone pain,” the authors wrote. “These results highlight the need to consider bone pain in prognostic modeling, treatment selection, patient monitoring, and follow-up and suggest prioritizing these patients for clinical trials and immediate systemic treatment initiation.”
SOURCE:
The study, led by Georges Gebrael, MD, Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, was published online in JAMA Network Open.
LIMITATIONS:
The post hoc design may introduce bias. Orteronel failed to receive regulatory approval, which may affect the generalizability of the findings. In addition, the study did not account for synchronous vs metachronous disease status, a known established prognostic factor.
DISCLOSURES:
The study was funded by the National Institutes of Health/National Cancer Institute and Millennium Pharmaceuticals (Takeda Oncology Company). Several authors declared ties with various sources.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.