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Background <p>Alkaline phosphatase (ALP) declines and pain responses can occur during radium-223 (<sup>223</sup>Ra) treatment, but their association with treatment outcomes is unclear.</p> Methods <p>For patients with metastatic castration-resistant prostate cancer treated with <sup>223</sup>Ra in the REASSURE study, we investigated whether ALP decline (Week 12) and/or pain response (during treatment) are associated with improved overall survival (OS). The Brief Pain Inventory-Short Form (BPI-SF) was used to assess pain at baseline and pain response (in patients with baseline BPI-SF score ≥2).</p> Results <p>Of 785 patients with baseline and Week 12 ALP measurements, 779 were eligible for the OS analyses. Overall, 80% of patients had an ALP decline. Median OS was longer in patients with than without an ALP decline (18.1 versus 14.2 months; HR 0.74; 95% CI 0.60–0.92). In patients with an ALP decline, there was no clear OS difference between those with versus without a pain response. For patients without ALP decline, median OS was longer in those with versus without a pain response (16.2 versus 10.9 months; HR 0.50; 95% CI 0.32–0.77).</p> Conclusions <p>Decreases in ALP and/or pain during <sup>223</sup>Ra treatment are associated with improved OS. This may help support clinical decisions.</p> Clinical trial registration <p>ClinicalTrials.gov identifier NCT02141438.</p> <p></p>

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Alkaline phosphatase decline and pain response as predictors of overall survival benefit in patients treated with radium-223: a post hoc analysis of the REASSURE study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年1月9日

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  • Joe M. O’Sullivan,
  • Daniel Heinrich,
  • Elena Castro,
  • Saby George,
  • Sabina Dizdarevic,
  • Sergio Baldari,
  • Markus Essler,
  • Igle Jan de Jong,
  • Secondo Lastoria,
  • Peter G. Hammerer,
  • Bertrand Tombal,
  • Nicholas D. James,
  • Jeff Meltzer,
  • Per Sandström,
  • Oliver Sartor

摘要

Background

Alkaline phosphatase (ALP) declines and pain responses can occur during radium-223 (223Ra) treatment, but their association with treatment outcomes is unclear.

Methods

For patients with metastatic castration-resistant prostate cancer treated with 223Ra in the REASSURE study, we investigated whether ALP decline (Week 12) and/or pain response (during treatment) are associated with improved overall survival (OS). The Brief Pain Inventory-Short Form (BPI-SF) was used to assess pain at baseline and pain response (in patients with baseline BPI-SF score ≥2).

Results

Of 785 patients with baseline and Week 12 ALP measurements, 779 were eligible for the OS analyses. Overall, 80% of patients had an ALP decline. Median OS was longer in patients with than without an ALP decline (18.1 versus 14.2 months; HR 0.74; 95% CI 0.60–0.92). In patients with an ALP decline, there was no clear OS difference between those with versus without a pain response. For patients without ALP decline, median OS was longer in those with versus without a pain response (16.2 versus 10.9 months; HR 0.50; 95% CI 0.32–0.77).

Conclusions

Decreases in ALP and/or pain during 223Ra treatment are associated with improved OS. This may help support clinical decisions.

Clinical trial registration

ClinicalTrials.gov identifier NCT02141438.