Randomised clinical trial - prophylactic radiation therapy to asymptomatic bone metastases improved survival

[Graham49]

Prophylactic Radiation Therapy Versus Standard of Care for Patients With High-Risk Asymptomatic Bone Metastases: A Multicenter, Randomized Phase II Clinical Trial

Authors: Erin F. Gillespie, MD, MPH orcid.org/0000-0002-1386-1542 [e-mail], Joanna C. Yang, MD, MPH, Noah J. Mathis, BA orcid.org/0000-0003-1125-6282, Catherine B. Marine, BA orcid.org/0009-0009-1736-2255, Charlie White, MS orcid.org/0000-0003-1671-3155, Zhigang Zhang, PhD, Christopher A. Barker, MD, … SHOW ALL … , and Jonathan T. Yang, MD, PhDAUTHORS INFO & AFFILIATIONS

Publication: Journal of Clinical Oncology

Volume 42, Number 1

doi.org/10.1200/JCO.23.00753

Journal of Clinical Oncology

Volume 42, Number 1

January 2024

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Abstract

Purpose

External-beam radiation therapy (RT) is standard of care (SOC) for pain relief of symptomatic bone metastases. We aimed to evaluate the efficacy of radiation to asymptomatic bone metastases in preventing skeletal-related events (SRE).

Methods

In a multicenter randomized controlled trial, adult patients with widely metastatic solid tumor malignancies were stratified by histology and planned SOC (systemic therapy or observation) and randomly assigned in a 1:1 ratio to receive RT to asymptomatic high-risk bone metastases or SOC alone. The primary outcome of the trial was SRE. Secondary outcomes included hospitalizations for SRE and overall survival (OS).

Results

A total of 78 patients with 122 high-risk bone metastases were enrolled between May 8, 2018, and August 9, 2021, at three institutions across an affiliated cancer network in the United States. Seventy-three patients were evaluable for the primary end point. The most common primary cancer types were lung (27%), breast (24%), and prostate (22%). At 1 year, SRE occurred in one of 62 bone metastases (1.6%) in the RT arm and 14 of 49 bone metastases (29%) in the SOC arm (P < .001). There were significantly fewer patients hospitalized for SRE in the RT arm compared with the SOC arm (0 v 4, P = .045). At a median follow-up of 2.5 years, OS was significantly longer in the RT arm (hazard ratio [HR], 0.49; 95% CI, 0.27 to 0.89; P = .018), which persisted on multivariable Cox regression analysis (HR, 0.46; 95% CI, 0.23 to 0.85; P = .01).

Conclusion

Radiation delivered prophylactically to asymptomatic, high-risk bone metastases reduced SRE and hospitalizations. We also observed an improvement in OS with prophylactic radiation, although a confirmatory phase III trial is warranted.

[Maxone73]

very good catch!

[Ramp7]

I've basically had it performed twice on bone metastases. As it has been explained to me, the scar tissue helps prevent new blood vessels from forming keeping the cancer at bay. Not sure how accurate that is

[Purple-Bike]

Great post. The evidence for SBRT is getting even stronger.

[V10fanatic]

I've had it done twice as well. So far, so good.