TY - JOUR
T1 - Stereotactic Radiation for the Comprehensive Treatment of Oligometastases (SABR-COMET)
T2 - Extended Long-Term Outcomes
AU - Harrow, Stephen
AU - Palma, David A.
AU - Olson, Robert
AU - Gaede, Stewart
AU - Louie, Alexander V.
AU - Haasbeek, Cornelis
AU - Mulroy, Liam
AU - Lock, Michael
AU - Rodrigues, George B.
AU - Yaremko, Brian P.
AU - Schellenberg, Devin
AU - Ahmad, Belal
AU - Senthi, Sashendra
AU - Swaminath, Anand
AU - Kopek, Neil
AU - Liu, Mitchell
AU - Schlijper, Roel
AU - Bauman, Glenn S.
AU - Laba, Joanna
AU - Qu, X. Melody
AU - Warner, Andrew
AU - Senan, Suresh
N1 - Funding Information: This study was funded by the Ontario Institute for Cancer Research and London Regional Cancer Program Catalyst Grant. Disclosures: S.H. has received honoraria from AstraZeneca, Pfizer, and Takeda Pharmaceuticals, has consulted for AstraZeneca, and has received travel, accommodations, and expense reimbursements from AstraZeneca and Takeda Pharmaceuticals, unrelated to the current study. D.P. receives research funding from the Ontario Institute for Cancer Research and is a consultant with Equity for Need Inc, unrelated to the current study. R.O. has received grant funding from Varian Medical Systems and is a consultant with Equity for Need Inc, unrelated to the current study. A.L. has received honoraria for advisory board and speaking engagements from AstraZeneca, Varian Medical Systems, and Reflexion Medical, unrelated to the current study. M.L. has consulted for Sanofi Canada and has participated in a speaker's bureau for Ferring and AbbVie, unrelated to the current study. D.S. has received honoraria from AstraZeneca, Merck, and Pfizer and has received research funding from Varian Medical Systems, unrelated to the current study. B.A. has consulted for Ferring, AbbVie, and Genentech, unrelated to the current study. A.S. has received honoraria from Bristol Meyers Squibb and has consulted for AstraZeneca, unrelated to the current study. G.B. has received honoraria from Bayer AG, unrelated to the current study. S.S. has received honoraria from AstraZeneca, BeiGene, Varian Medical Systems, and MSD Oncology, has consulted for AstraZeneca, Celgene, Varian Medical Systems, and MSD Oncology, has participated in a speaker's bureau for AstraZeneca, and has received research funding from ViewRay, AstraZeneca, and Varian Medical Systems, unrelated to the current study. Publisher Copyright: © 2022 Elsevier Inc.
PY - 2022/11/15
Y1 - 2022/11/15
N2 - Purpose: Long-term randomized data assessing the effect of ablative therapies in patients with oligometastases are lacking. The Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastases (SABR-COMET) randomized phase 2 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 and Materials: Patients were eligible if they had a controlled primary tumor and 1 to 5 metastases, with all metastases amenable to SABR. Patients were randomized in a 1:2 ratio between palliative standard-of-care treatment (control arm) versus SABR to all metastases plus standard of care (SABR arm). The primary endpoint was overall survival (OS) and secondary endpoints included progression-free survival (PFS), toxicity, quality of life (using the Functional Assessment of Cancer Therapy: General [FACT-G]), and time to new metastases. Results: Ninety-nine patients were randomized between 2012 and 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 versus 13.6% in the control arm (hazard ratio, 0.50; 95% confidence interval, 0.30-0.84; P = .008). Eight-year PFS estimates were 21.3% versus 0.0%, respectively (hazard ratio, 0.45; 95% confidence interval, 0.28-0.72; P < .001). Rates of grade ≥ 2 acute or late toxic effects were 30.3% versus 9.1% (P = .019), with no new grade 3 to 5 toxic effects. FACT-G quality of life scores declined over time in both arms, but there were no differences in quality of life scores between arms. The use of systemic therapy overall was similar between arms, but patients in the SABR arm were less likely to require cytotoxic chemotherapy (33.3% vs 54.6%, respectively, P = .043). Conclusions: SABR achieved durable improvements in OS and PFS, with no new major toxicity signals with extended follow-up. A minority of patients randomized to the SABR arm (21.3%) achieved > 5 years of survival without recurrence.
AB - Purpose: Long-term randomized data assessing the effect of ablative therapies in patients with oligometastases are lacking. The Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastases (SABR-COMET) randomized phase 2 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 and Materials: Patients were eligible if they had a controlled primary tumor and 1 to 5 metastases, with all metastases amenable to SABR. Patients were randomized in a 1:2 ratio between palliative standard-of-care treatment (control arm) versus SABR to all metastases plus standard of care (SABR arm). The primary endpoint was overall survival (OS) and secondary endpoints included progression-free survival (PFS), toxicity, quality of life (using the Functional Assessment of Cancer Therapy: General [FACT-G]), and time to new metastases. Results: Ninety-nine patients were randomized between 2012 and 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 versus 13.6% in the control arm (hazard ratio, 0.50; 95% confidence interval, 0.30-0.84; P = .008). Eight-year PFS estimates were 21.3% versus 0.0%, respectively (hazard ratio, 0.45; 95% confidence interval, 0.28-0.72; P < .001). Rates of grade ≥ 2 acute or late toxic effects were 30.3% versus 9.1% (P = .019), with no new grade 3 to 5 toxic effects. FACT-G quality of life scores declined over time in both arms, but there were no differences in quality of life scores between arms. The use of systemic therapy overall was similar between arms, but patients in the SABR arm were less likely to require cytotoxic chemotherapy (33.3% vs 54.6%, respectively, P = .043). Conclusions: SABR achieved durable improvements in OS and PFS, with no new major toxicity signals with extended follow-up. A minority of patients randomized to the SABR arm (21.3%) achieved > 5 years of survival without recurrence.
UR - http://www.scopus.com/inward/record.url?scp=85134355653&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.ijrobp.2022.05.004
DO - https://doi.org/10.1016/j.ijrobp.2022.05.004
M3 - Article
C2 - 35643253
SN - 0360-3016
VL - 114
SP - 611
EP - 616
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 4
ER -