Bone pain at diagnosis linked to poorer outcomes in advanced prostate cancer
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Key takeaways:
- Men without bone pain at diagnosis achieved longer PFS and OS.
- Bone pain at diagnosis should be a factor for trial enrollment and patient counseling.
Men with bone pain at diagnosis of metastatic, hormone-resistant prostate cancer had shorter survival than men without bone pain, according to study results.
Those with initial baseline exhibited a 66% higher risk for death, a secondary analysis of the randomized SWOG-1216 trial showed.
“The focus should now be on developing trials or novel management strategies for this subset of patients who are experiencing poorer outcomes,” Georges Gebrael, MD, genitourinary research fellow at Huntsman Cancer Institute at University of Utah, told Healio.
Background and methods
Bone pain is associated with worse OS among men with castration-resistant prostate cancer. However, data on the impact of baseline bone pain in newly diagnosed metastatic, hormone-sensitive disease is limited, Gebrael told Healio.
The prospective, randomized SWOG-1216 trial enrolled patients with newly diagnosed metastatic, hormone-resistant prostate cancer.
Researchers randomly assigned men to receive either 300 mg oral orteronel twice daily or 50 mg oral bicalutamide daily. Treatment continued until disease progression, unacceptable toxicity or patient withdrawal.
Gebrael and colleagues conducted a post hoc secondary analysis to compare survival among men based on presence or absence of bone pain at time of diagnosis.
The analysis included data from 1,197 men (median age, 67.6 years; interquartile range, 61.8-73.6), 301 of whom reported bone pain at diagnosis and 896 of whom reported no bone pain. Men with baseline bone pain were younger (median age, 66 years vs. 68.2 years) and had higher incidence of high-volume disease (70.4% vs. 41.6%).
OS served as the primary endpoint. PFS and PSA response served as secondary endpoints.
Results, next steps
Median follow-up was 4 years.
Baseline bone pain appeared associated with shorter PFS (median, 1.3 years vs. 3.7; adjusted HR = 1.46; 95% CI, 1.22-1.74) and OS (median, 3.9 years vs. not reached; adjusted HR = 1.66; 95% CI, 1.34-2.05).
Researchers acknowledged study limitations, including the post hoc secondary analysis design and the fact the study did not account for synchronous vs. metachronous disease status, as that had not been established as a prognostic factor when the SWOG-1216 trial was designed in 2011.
“Patients presenting with initial baseline bone pain should now be counseled on the importance of initiating systemic therapy immediately or enrolling in clinical trials, given the shorter overall survival associated with the presence of baseline bone pain,” Gebrael told Healio.
There are “few baseline prognostic or predictive biomarkers” to guide treatment for newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC), Gebrael added.
He cited the “urgent need” to personalize treatment approaches in this setting.
“Identifying a robust and valid prognostic model in mHSPC based on easily assessable and accessible baseline disease characteristics, such as bone pain status, could be crucial for treatment selection,” Gebrael said. “Additionally, identifying a subset of patients with poor prognosis at the time of metastatic prostate cancer diagnosis helps determine which patients should be prioritized for enrollment in clinical trials that could ultimately improve outcomes compared to the current standard of care.”
For more information:
Georges Gebrael, MD, can be reached at georges.gebrael@hsc.utah.edu.
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Gebrael G, et al. JAMA Netw Open. 2024;doi:10.1001/jamanetworkopen.2024.19966.
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