Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial
The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative radiotherapy (SABR) on surv...
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| Veröffentlicht in: | The Lancet (British edition) 2019-05, Vol.393 (10185), p.2051-2058 |
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| creator | Palma, David A Olson, Robert Harrow, Stephen Gaede, Stewart Louie, Alexander V Haasbeek, Cornelis Mulroy, Liam Lock, Michael Rodrigues, George B Yaremko, Brian P Schellenberg, Devin Ahmad, Belal Griffioen, Gwendolyn Senthi, Sashendra Swaminath, Anand Kopek, Neil Liu, Mitchell Moore, Karen Currie, Suzanne Bauman, Glenn S Warner, Andrew Senan, Suresh |
| description | The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative radiotherapy (SABR) on survival, oncological outcomes, toxicity, and quality of life in patients with a controlled primary tumour and one to five oligometastatic lesions.
This randomised, open-label phase 2 study was done at 10 hospitals in Canada, the Netherlands, Scotland, and Australia. Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0–1, and a life expectancy of at least 6 months were eligible. After stratifying by the number of metastases (1–3 vs 4–5), we randomly assigned patients (1:2) to receive either palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group), using a computer-generated randomisation list with permuted blocks of nine. Neither patients nor physicians were masked to treatment allocation. The primary endpoint was overall survival. We used a randomised phase 2 screening design with a two-sided α of 0·20 (wherein p |
| doi_str_mv | 10.1016/S0140-6736(18)32487-5 |
| format | Article |
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This randomised, open-label phase 2 study was done at 10 hospitals in Canada, the Netherlands, Scotland, and Australia. Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0–1, and a life expectancy of at least 6 months were eligible. After stratifying by the number of metastases (1–3 vs 4–5), we randomly assigned patients (1:2) to receive either palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group), using a computer-generated randomisation list with permuted blocks of nine. Neither patients nor physicians were masked to treatment allocation. The primary endpoint was overall survival. We used a randomised phase 2 screening design with a two-sided α of 0·20 (wherein p<0·20 designates a positive trial). All analyses were intention to treat. This study is registered with ClinicalTrials.gov, number NCT01446744.
99 patients were randomised between Feb 10, 2012, and Aug 30, 2016. Of 99 patients, 33 (33%) were assigned to the control group and 66 (67%) to the SABR group. Two (3%) patients in the SABR group did not receive allocated treatment and withdrew from the trial; two (6%) patients in the control group also withdrew from the trial. Median follow-up was 25 months (IQR 19–54) in the control group versus 26 months (23–37) in the SABR group. Median overall survival was 28 months (95% CI 19–33) in the control group versus 41 months (26–not reached) in the SABR group (hazard ratio 0·57, 95% CI 0·30–1·10; p=0·090). Adverse events of grade 2 or worse occurred in three (9%) of 33 controls and 19 (29%) of 66 patients in the SABR group (p=0·026), an absolute increase of 20% (95% CI 5–34). Treatment-related deaths occurred in three (4·5%) of 66 patients after SABR, compared with none in the control group.
SABR was associated with an improvement in overall survival, meeting the primary endpoint of this trial, but three (4·5%) of 66 patients in the SABR group had treatment-related death. Phase 3 trials are needed to conclusively show an overall survival benefit, and to determine the maximum number of metastatic lesions wherein SABR provides a benefit.
Ontario Institute for Cancer Research and London Regional Cancer Program Catalyst Grant.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(18)32487-5</identifier><identifier>PMID: 30982687</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Ablation ; Aged ; Brain research ; Cancer ; Cancer therapies ; Clinical trials ; Disease-Free Survival ; Dose Fractionation, Radiation ; Female ; Funding ; Humans ; Information sharing ; Lesions ; Life expectancy ; Life span ; Male ; Medical research ; Metastases ; Metastasis ; Middle Aged ; Neoplasm Metastasis - radiotherapy ; Neoplasm Metastasis - therapy ; Oncology ; Palliation ; Palliative Care ; Patients ; Physicians ; Prostate ; Quality of life ; Radiation therapy ; Radio frequency ; Radiosurgery - adverse effects ; Radiosurgery - methods ; Radiosurgery - mortality ; Randomization ; Regulatory approval ; Standard of care ; Survival ; Survival Analysis ; Toxicity ; Treatment Outcome ; Tumors</subject><ispartof>The Lancet (British edition), 2019-05, Vol.393 (10185), p.2051-2058</ispartof><rights>2019 Elsevier Ltd</rights><rights>Copyright © 2019 Elsevier Ltd. All rights reserved.</rights><rights>2019. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c445t-24c9f3646be55cf729dd97cd2364a86333b974992686821c5d278d82a21ee2333</citedby><cites>FETCH-LOGICAL-c445t-24c9f3646be55cf729dd97cd2364a86333b974992686821c5d278d82a21ee2333</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673618324875$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30982687$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Palma, David A</creatorcontrib><creatorcontrib>Olson, Robert</creatorcontrib><creatorcontrib>Harrow, Stephen</creatorcontrib><creatorcontrib>Gaede, Stewart</creatorcontrib><creatorcontrib>Louie, Alexander V</creatorcontrib><creatorcontrib>Haasbeek, Cornelis</creatorcontrib><creatorcontrib>Mulroy, Liam</creatorcontrib><creatorcontrib>Lock, Michael</creatorcontrib><creatorcontrib>Rodrigues, George B</creatorcontrib><creatorcontrib>Yaremko, Brian P</creatorcontrib><creatorcontrib>Schellenberg, Devin</creatorcontrib><creatorcontrib>Ahmad, Belal</creatorcontrib><creatorcontrib>Griffioen, Gwendolyn</creatorcontrib><creatorcontrib>Senthi, Sashendra</creatorcontrib><creatorcontrib>Swaminath, Anand</creatorcontrib><creatorcontrib>Kopek, Neil</creatorcontrib><creatorcontrib>Liu, Mitchell</creatorcontrib><creatorcontrib>Moore, Karen</creatorcontrib><creatorcontrib>Currie, Suzanne</creatorcontrib><creatorcontrib>Bauman, Glenn S</creatorcontrib><creatorcontrib>Warner, Andrew</creatorcontrib><creatorcontrib>Senan, Suresh</creatorcontrib><title>Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative radiotherapy (SABR) on survival, oncological outcomes, toxicity, and quality of life in patients with a controlled primary tumour and one to five oligometastatic lesions.
This randomised, open-label phase 2 study was done at 10 hospitals in Canada, the Netherlands, Scotland, and Australia. Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0–1, and a life expectancy of at least 6 months were eligible. After stratifying by the number of metastases (1–3 vs 4–5), we randomly assigned patients (1:2) to receive either palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group), using a computer-generated randomisation list with permuted blocks of nine. Neither patients nor physicians were masked to treatment allocation. The primary endpoint was overall survival. We used a randomised phase 2 screening design with a two-sided α of 0·20 (wherein p<0·20 designates a positive trial). All analyses were intention to treat. This study is registered with ClinicalTrials.gov, number NCT01446744.
99 patients were randomised between Feb 10, 2012, and Aug 30, 2016. Of 99 patients, 33 (33%) were assigned to the control group and 66 (67%) to the SABR group. Two (3%) patients in the SABR group did not receive allocated treatment and withdrew from the trial; two (6%) patients in the control group also withdrew from the trial. Median follow-up was 25 months (IQR 19–54) in the control group versus 26 months (23–37) in the SABR group. Median overall survival was 28 months (95% CI 19–33) in the control group versus 41 months (26–not reached) in the SABR group (hazard ratio 0·57, 95% CI 0·30–1·10; p=0·090). Adverse events of grade 2 or worse occurred in three (9%) of 33 controls and 19 (29%) of 66 patients in the SABR group (p=0·026), an absolute increase of 20% (95% CI 5–34). Treatment-related deaths occurred in three (4·5%) of 66 patients after SABR, compared with none in the control group.
SABR was associated with an improvement in overall survival, meeting the primary endpoint of this trial, but three (4·5%) of 66 patients in the SABR group had treatment-related death. Phase 3 trials are needed to conclusively show an overall survival benefit, and to determine the maximum number of metastatic lesions wherein SABR provides a benefit.
Ontario Institute for Cancer Research and London Regional Cancer Program Catalyst Grant.</description><subject>Ablation</subject><subject>Aged</subject><subject>Brain research</subject><subject>Cancer</subject><subject>Cancer therapies</subject><subject>Clinical trials</subject><subject>Disease-Free Survival</subject><subject>Dose Fractionation, Radiation</subject><subject>Female</subject><subject>Funding</subject><subject>Humans</subject><subject>Information sharing</subject><subject>Lesions</subject><subject>Life expectancy</subject><subject>Life span</subject><subject>Male</subject><subject>Medical research</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis - radiotherapy</subject><subject>Neoplasm Metastasis - therapy</subject><subject>Oncology</subject><subject>Palliation</subject><subject>Palliative 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S</au><au>Warner, Andrew</au><au>Senan, Suresh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial</atitle><jtitle>The Lancet (British edition)</jtitle><addtitle>Lancet</addtitle><date>2019-05-18</date><risdate>2019</risdate><volume>393</volume><issue>10185</issue><spage>2051</spage><epage>2058</epage><pages>2051-2058</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><abstract>The oligometastatic paradigm suggests that some patients with a limited number of metastases might be cured if all lesions are eradicated. Evidence from randomised controlled trials to support this paradigm is scarce. We aimed to assess the effect of stereotactic ablative radiotherapy (SABR) on survival, oncological outcomes, toxicity, and quality of life in patients with a controlled primary tumour and one to five oligometastatic lesions.
This randomised, open-label phase 2 study was done at 10 hospitals in Canada, the Netherlands, Scotland, and Australia. Patients aged 18 or older with a controlled primary tumour and one to five metastatic lesions, Eastern Cooperative Oncology Group score of 0–1, and a life expectancy of at least 6 months were eligible. After stratifying by the number of metastases (1–3 vs 4–5), we randomly assigned patients (1:2) to receive either palliative standard of care treatments alone (control group), or standard of care plus SABR to all metastatic lesions (SABR group), using a computer-generated randomisation list with permuted blocks of nine. Neither patients nor physicians were masked to treatment allocation. The primary endpoint was overall survival. We used a randomised phase 2 screening design with a two-sided α of 0·20 (wherein p<0·20 designates a positive trial). All analyses were intention to treat. This study is registered with ClinicalTrials.gov, number NCT01446744.
99 patients were randomised between Feb 10, 2012, and Aug 30, 2016. Of 99 patients, 33 (33%) were assigned to the control group and 66 (67%) to the SABR group. Two (3%) patients in the SABR group did not receive allocated treatment and withdrew from the trial; two (6%) patients in the control group also withdrew from the trial. Median follow-up was 25 months (IQR 19–54) in the control group versus 26 months (23–37) in the SABR group. Median overall survival was 28 months (95% CI 19–33) in the control group versus 41 months (26–not reached) in the SABR group (hazard ratio 0·57, 95% CI 0·30–1·10; p=0·090). Adverse events of grade 2 or worse occurred in three (9%) of 33 controls and 19 (29%) of 66 patients in the SABR group (p=0·026), an absolute increase of 20% (95% CI 5–34). Treatment-related deaths occurred in three (4·5%) of 66 patients after SABR, compared with none in the control group.
SABR was associated with an improvement in overall survival, meeting the primary endpoint of this trial, but three (4·5%) of 66 patients in the SABR group had treatment-related death. Phase 3 trials are needed to conclusively show an overall survival benefit, and to determine the maximum number of metastatic lesions wherein SABR provides a benefit.
Ontario Institute for Cancer Research and London Regional Cancer Program Catalyst Grant.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>30982687</pmid><doi>10.1016/S0140-6736(18)32487-5</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2019-05, Vol.393 (10185), p.2051-2058 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_journals_2226394922 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Ablation Aged Brain research Cancer Cancer therapies Clinical trials Disease-Free Survival Dose Fractionation, Radiation Female Funding Humans Information sharing Lesions Life expectancy Life span Male Medical research Metastases Metastasis Middle Aged Neoplasm Metastasis - radiotherapy Neoplasm Metastasis - therapy Oncology Palliation Palliative Care Patients Physicians Prostate Quality of life Radiation therapy Radio frequency Radiosurgery - adverse effects Radiosurgery - methods Radiosurgery - mortality Randomization Regulatory approval Standard of care Survival Survival Analysis Toxicity Treatment Outcome Tumors |
| title | Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial |
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