Stereotactic Radiation for the Comprehensive Treatment of Oligometastases (SABR-COMET) - Extended Long-Term Outcomes
Abstract
BACKGROUND
Long-term randomized data assessing the impact of ablative therapies in patients with oligometastases is lacking. The BLINDED-FOR-REVIEW randomized phase II trial was originally designed with 5 years of follow-up, but the trial was amended in 2016 to extend follow-up to 10 years. Herein we report oncologic outcomes beyond 5 years.
METHODS
Patients were eligible if they had a controlled primary tumor and 1-5 metastases, with all metastases amenable to stereotactic ablative radiotherapy (SABR). Patients were randomized in a 1:2 ratio between palliative standard of care (SOC) treatment (control arm) vs. SABR to all metastases plus SOC (SABR arm). The primary endpoint was overall survival (OS) and secondary endpoints included progression-free survival (PFS), toxicity, quality of life (QOL, using the FACT-G), and time to new metastases.
RESULTS
Ninety-nine patients were randomized between 2012-2016 (n=33 in Arm 1 vs. n=66 in Arm 2). Primary tumor sites included lung (n=18), breast (n=18), colon (n=18), prostate (n=16), and other (n=29). Eight-year OS was 27.2% in the SABR arm vs. 13.6% in the control arm (hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.30-0.84; p=0.008). Eight-year PFS estimates were 21.3% vs. 0.0%, respectively (HR: 0.45; 95% CI: 0.28-0.72; p<0.001). Rates of grade ≥2 acute or late toxicities were 30.3% vs. 9.1% (p=0.019), with no new grade 3-5 toxicities. FACT-G QOL scores declined over time in both arms, but there were no differences in QOL…
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