TY - JOUR
T1 - Stereotactic ablative body radiotherapy in patients with oligometastatic cancers
T2 - a prospective, registry-based, single-arm, observational, evaluation study
AU - Chalkidou, Anastasia
AU - Macmillan, Thomas
AU - Grzeda, Mariusz T.
AU - Peacock, Janet
AU - Summers, Jennifer
AU - Eddy, Saskia
AU - Coker, Bola
AU - Patrick, Hannah
AU - Powell, Helen
AU - Berry, Lee
AU - Webster, Gareth
AU - Ostler, Peter
AU - Dickinson, Peter D.
AU - Hatton, Matthew Q.
AU - Henry, Ann
AU - Keevil, Stephen
AU - Hawkins, Maria A.
AU - Slevin, Nick
AU - van As, Nicholas
N1 - Funding Information:
NHS England funded this study via the CtE scheme. We thank the patients who took part in the study and the clinical teams across the 17 NHS Trusts involved in the scheme for their work in recruiting and treating patients and collecting patient data. We also thank the team running the PROPEL database, and especially Xiaoxu Zou and Sandy Sahdra for providing database management support for this project. We would also like to thank Antony Carver for his insights on biologically effective dose calculation and α/β ratio selection. This work was supported by the Wellcome/Engineering and Physical Sciences Research Council Centre for Medical Engineering (WT 203148/Z/16/Z).
Funding Information:
AH and PO report working during the conduct of the study for a NHS Trust (AH for St James's University Hospital Leeds; PO for Mount Vernon Cancer Centre) commissioned to deliver stereotactic ablative body radiotherapy as part of the Commissioning through Evaluation (CtE) scheme. HPa, HPo, and LB report working during the conduct of the study for the UK National Institute for Health and Care Excellence (NICE), which was commissioned by NHS England to manage the CtE project. MAH declares funding from the UK National Institute for Health Research Biomedical Research Centre at University College London Hospitals NHS Foundation Trust, outside the submitted work. NvA reports receiving consultancy honorarium from Accuray, outside the submitted work. JP, JS, SE, BC, TM, MTG, AC, and SK report that their place of employment at the time of the study, King's Technology Evaluation Centre, was contracted by NICE during the conduct of the study. All other authors declare no competing interests.
Publisher Copyright:
© 2021 Elsevier Ltd
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2021/1
Y1 - 2021/1
N2 - Background: Stereotactic ablative body radiotherapy (SABR) is increasingly being used to treat oligometastatic cancers, but high-level evidence to provide a basis for policy making is scarce. Additional evidence from a real-world setting is required. We present the results of a national study of patients with extracranial oligometastases undergoing SABR, representing the largest dataset, to our knowledge, on outcomes in this population so far. Methods: In 2015, National Health Service (NHS) England launched a Commissioning through Evaluation scheme that funded a prospective, registry-based, single-arm, observational, evaluation study of patients with solid cancer and extracranial oligometastases treated with SABR. Prescribed doses ranged from 24–60 Gy administered in three to eight fractions. The study was done at 17 NHS radiotherapy centres in England. Patients were eligible for the scheme if aged 18 years or older with confirmed primary carcinoma (excluding haematological malignancies), one to three extracranial metastatic lesions, a disease-free interval from primary tumour development to metastases of longer than 6 months (with the exception of synchronous colorectal liver metastases), a WHO performance status of 2 or lower, and a life expectancy of at least 6 months. The primary outcome was overall survival at 1 year and 2 years from the start of SABR treatment. The study is now completed. Findings: Between June 15, 2015, and Jan 30, 2019, 1422 patients were recruited from 17 hospitals in England. The median age of the patients was 69 years (IQR 62–76), and the most common primary tumour was prostate cancer (406 [28·6%] patients). Median follow-up was 13 months (IQR 6–23). Overall survival was 92·3% (95% CI 90·5–93·9) at 1 year and 79·2% (76·0–82·1) at 2 years. The most common grade 3 adverse event was fatigue (28 [2·0%] of 1422 patients) and the most common serious (grade 4) event was increased liver enzymes (nine [0·6%]). Notreatment-related deaths were reported. Interpretation: In patients with extracranial oligometastatic cancer, use of SABR was associated with high overall survival and low toxicity. ’The study findings complement existing evidence from a randomised, phase 2 trial, and represent high-level, real-world evidence supporting the use of SABR in this patient cohort, with a phase 3 randomised, controlled trial to confirm these findings underway. Based on the selection criteria in this study, SABR was commissioned by NHS England in March, 2020, as a treatment option for patients with oligometastatic disease. Funding: NHS England Commissioning through Evaluation scheme.
AB - Background: Stereotactic ablative body radiotherapy (SABR) is increasingly being used to treat oligometastatic cancers, but high-level evidence to provide a basis for policy making is scarce. Additional evidence from a real-world setting is required. We present the results of a national study of patients with extracranial oligometastases undergoing SABR, representing the largest dataset, to our knowledge, on outcomes in this population so far. Methods: In 2015, National Health Service (NHS) England launched a Commissioning through Evaluation scheme that funded a prospective, registry-based, single-arm, observational, evaluation study of patients with solid cancer and extracranial oligometastases treated with SABR. Prescribed doses ranged from 24–60 Gy administered in three to eight fractions. The study was done at 17 NHS radiotherapy centres in England. Patients were eligible for the scheme if aged 18 years or older with confirmed primary carcinoma (excluding haematological malignancies), one to three extracranial metastatic lesions, a disease-free interval from primary tumour development to metastases of longer than 6 months (with the exception of synchronous colorectal liver metastases), a WHO performance status of 2 or lower, and a life expectancy of at least 6 months. The primary outcome was overall survival at 1 year and 2 years from the start of SABR treatment. The study is now completed. Findings: Between June 15, 2015, and Jan 30, 2019, 1422 patients were recruited from 17 hospitals in England. The median age of the patients was 69 years (IQR 62–76), and the most common primary tumour was prostate cancer (406 [28·6%] patients). Median follow-up was 13 months (IQR 6–23). Overall survival was 92·3% (95% CI 90·5–93·9) at 1 year and 79·2% (76·0–82·1) at 2 years. The most common grade 3 adverse event was fatigue (28 [2·0%] of 1422 patients) and the most common serious (grade 4) event was increased liver enzymes (nine [0·6%]). Notreatment-related deaths were reported. Interpretation: In patients with extracranial oligometastatic cancer, use of SABR was associated with high overall survival and low toxicity. ’The study findings complement existing evidence from a randomised, phase 2 trial, and represent high-level, real-world evidence supporting the use of SABR in this patient cohort, with a phase 3 randomised, controlled trial to confirm these findings underway. Based on the selection criteria in this study, SABR was commissioned by NHS England in March, 2020, as a treatment option for patients with oligometastatic disease. Funding: NHS England Commissioning through Evaluation scheme.
UR - http://www.scopus.com/inward/record.url?scp=85098482654&partnerID=8YFLogxK
U2 - 10.1016/S1470-2045(20)30537-4
DO - 10.1016/S1470-2045(20)30537-4
M3 - Article
AN - SCOPUS:85098482654
SN - 1470-2045
VL - 22
SP - 98
EP - 106
JO - The Lancet Oncology
JF - The Lancet Oncology
IS - 1
ER -
