In an analysis from the SWOG-1216 trial reported in JAMA Network Open, Gebrael et al found that the presence of bone pain at diagnosis was associated with poorer progression-free and overall survival in patients with newly diagnosed metastatic hormone-sensitive prostate cancer.
Study Details
In the U.S. multicenter phase III trial, patients were randomly assigned between March 2013 and July 2017 to receive androgen-deprivation therapy with orteronel at 300 mg twice daily or bicalutamide at 50 mg daily until disease progression or unacceptable toxicity. The primary endpoint was overall survival. Among the total population of 1,279 patients, the current analysis included 1,197 with known baseline pain status: 301 (23.5%) who had bone pain at diagnosis and 896 (70.1%) who did not.
Key Findings
Among the 1,197 patients included in the analysis, the median age was 67.6 years, including 66.0 years among those with bone pain vs 68.2 years among those without bone pain (P = .02). Those with bone pain had a higher incidence of high-volume disease (70.4% vs 41.6%, P < .001).
In analysis adjusting for age, treatment type, Gleason score, disease volume, Zubrod performance status, and prostate-specific antigen level, at a median follow-up of 4.0 years (interquartile range = 2.5–5.4 years), patients with bone pain had a median progression-free survival of 1.3 years (95% confidence interval [CI] = 1.1–1.7 years) compared with 3.7 years (95% CI = 3.3–4.2 years) in patients without initial bone pain (adjusted hazard ratio [HR] = 1.46, 95% CI = 1.22–1.74, P < .001). Median overall survival was 3.9 years (95% CI = 3.3–4.8 years) among those with baseline bone pain vs not reached (95% CI = 6.6 years to not reached) among those without baseline bone pain (adjusted HR = 1.66, 95% CI = 1.34–2.05, P < .001).
The investigators concluded, “In this post hoc secondary analysis of the SWOG-1216 randomized clinical trial, patients with baseline bone pain at metastatic hormone-sensitive prostate cancer diagnosis had worse survival outcomes than those without bone pain. These data suggest prioritizing these patients for enrollment in clinical trials, may aid patient counseling, and indicate that the inclusion of bone pain in prognostic models of metastatic hormone-sensitive prostate cancer may be warranted.”
Neeraj Agarwal, MD, of Huntsman Cancer Institute at the University of Utah, Salt Lake City, is the corresponding author for the JAMA Network Open article.
Disclosure: The study was funded by grants from the National Cancer Institute and in part by Millennium Pharmaceuticals (Takeda Oncology Company). For full disclosures of the study authors, visit jamanetwork.com.
