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Clinical Trial
. 2024 Aug 1;130(15):2713-2722.
doi: 10.1002/cncr.35310. Epub 2024 Apr 6.

Dose-intensified stereotactic body radiotherapy for painful vertebral metastases: A randomized phase 3 trial

Matthias Guckenberger  1   2 , Charlotte Billiet  3 , Daniel Schnell  4 , Ciro Franzese  5 , Mateusz Spałek  6 , Susanne Rogers  7 , Jean-Jacques Stelmes  8   9 , Daniel M Aebersold  10 , Hossein Hemmatazad  10 , Frank Zimmermann  11 , Jörg Zimmer  12 , Thomas Zilli  8   13 , Alessio Bruni  14 , Brigitta G Baumert  15 , Franziska Nägler  16 , Philipp Gut  17 , Robert Förster  1   18 , Indira Madani  1
Affiliations
Free article
Clinical Trial

Dose-intensified stereotactic body radiotherapy for painful vertebral metastases: A randomized phase 3 trial

Matthias Guckenberger et al. Cancer. .
Free article

Abstract

Background: The purpose of this randomised study was to determine whether dose-intensified stereotactic body radiotherapy (SBRT) for painful vertebral metastases results in increased rates of pain improvement compared with conventional external beam radiotherapy (cEBRT) (control) 6 months after treatment.

Methods: This randomized, controlled phase 3 trial was conducted between November 2016 and January 2023, when it was stopped early. Patients were eligible if they were aged 18 years or older; had one or two painful, stable, or potentially unstable vertebral metastases; and had a life expectancy of 1 year or longer according to the investigator's estimates. Patients received 48.5 grays (Gy) in 10 fractions (with epidural involvement) or 40 Gy in five fractions (without epidural involvement) in the SBRT group and 30 Gy in 10 fractions or 20 Gy in five fractions in the cEBRT group, respectively. The primary end point was an improvement in the pain score at the treated site by at least 2 points (on a visual analog scale from 0 to 10 points) at 6-month follow-up. Data were analyzed on an intention-to-treat and per-protocol basis.

Results: Of 214 patients who were screened for eligibility, 63 were randomized 1:1 between SBRT (33 patients with 36 metastases) and cEBRT (30 patients with 31 metastases). The median age of all patients was 66 years, and 40 patients were men (63.5%). In the intention-to-treat analysis, the 6-month proportion of patients who had metastases with pain reduction by 2 or more points was significantly higher in the SBRT group versus the control group (69.4% vs. 41.9%, respectively; two-sided p = .02). Changes in opioid medication intake relative to baseline were nonsignificant between the groups. No differences were observed in vertebral compression fracture or adverse event rates between the groups.

Conclusions: Dose-intensified SBRT improved pain score more effectively than cEBRT at 6 months.

Keywords: bone metastases; conventional external beam radiotherapy; pain; stereotactic body radiotherapy (SBRT); vertebral metastases.

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References

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