Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial
After brain metastasis resection, whole brain radiotherapy decreases local recurrence, but might cause cognitive decline. We did this study to determine if stereotactic radiosurgery (SRS) to the surgical cavity improved time to local recurrence compared with that for surgical resection alone. In thi...
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| Veröffentlicht in: | The lancet oncology 2017-08, Vol.18 (8), p.1040-1048 |
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| creator | Mahajan, Anita Ahmed, Salmaan McAleer, Mary Frances Weinberg, Jeffrey S Li, Jing Brown, Paul Settle, Stephen Prabhu, Sujit S Lang, Frederick F Levine, Nicholas McGovern, Susan Sulman, Erik McCutcheon, Ian E Azeem, Syed Cahill, Daniel Tatsui, Claudio Heimberger, Amy B Ferguson, Sherise Ghia, Amol Demonte, Franco Raza, Shaan Guha-Thakurta, Nandita Yang, James Sawaya, Raymond Hess, Kenneth R Rao, Ganesh |
| description | After brain metastasis resection, whole brain radiotherapy decreases local recurrence, but might cause cognitive decline. We did this study to determine if stereotactic radiosurgery (SRS) to the surgical cavity improved time to local recurrence compared with that for surgical resection alone.
In this randomised, controlled, phase 3 trial, we recruited patients at a single tertiary cancer centre in the USA. Eligible patients were older than 3 years, had a Karnofsky Performance Score of 70 or higher, were able to have an MRI scan, and had a complete resection of one to three brain metastases (with a maximum diameter of the resection cavity ≤4 cm). Patients were randomly assigned (1:1) with a block size of four to either SRS of the resection cavity (within 30 days of surgery) or observation. Patients were stratified by histology of the primary tumour, metastatic tumour size, and number of metastases. The primary endpoint was time to local recurrence in the resection cavity, assessed by blinded central review of brain MRI scans by the study neuroradiologist in the modified intention-to-treat population that analysed patients by randomised allocation but excluded patients found ineligible after randomisation. Participants and other members of the treatment team (excluding the neuroradiologist) were not masked to treatment allocation. The trial is registered with ClinicalTrials.gov, number NCT00950001, and is closed to new participants.
Between Aug 13, 2009, and Feb 16, 2016, 132 patients were randomly assigned to the observation group (n=68) or SRS group (n=64), with 128 patients available for analysis; four patients were ineligible (three from the SRS group and one from the observation group). Median follow-up was 11·1 months (IQR 4·8–20·4). 12-month freedom from local recurrence was 43% (95% CI 31–59) in the observation group and 72% (60–87) in the SRS group (hazard ratio 0·46 [95% CI 0·24–0·88]; p=0·015). There were no adverse events or treatment-related deaths in either group.
SRS of the surgical cavity in patients who have had complete resection of one, two, or three brain metastases significantly lowers local recurrence compared with that noted for observation alone. Thus, the use of SRS after brain metastasis resection could be an alternative to whole-brain radiotherapy.
National Institutes of Health. |
| doi_str_mv | 10.1016/S1470-2045(17)30414-X |
| format | Article |
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In this randomised, controlled, phase 3 trial, we recruited patients at a single tertiary cancer centre in the USA. Eligible patients were older than 3 years, had a Karnofsky Performance Score of 70 or higher, were able to have an MRI scan, and had a complete resection of one to three brain metastases (with a maximum diameter of the resection cavity ≤4 cm). Patients were randomly assigned (1:1) with a block size of four to either SRS of the resection cavity (within 30 days of surgery) or observation. Patients were stratified by histology of the primary tumour, metastatic tumour size, and number of metastases. The primary endpoint was time to local recurrence in the resection cavity, assessed by blinded central review of brain MRI scans by the study neuroradiologist in the modified intention-to-treat population that analysed patients by randomised allocation but excluded patients found ineligible after randomisation. Participants and other members of the treatment team (excluding the neuroradiologist) were not masked to treatment allocation. The trial is registered with ClinicalTrials.gov, number NCT00950001, and is closed to new participants.
Between Aug 13, 2009, and Feb 16, 2016, 132 patients were randomly assigned to the observation group (n=68) or SRS group (n=64), with 128 patients available for analysis; four patients were ineligible (three from the SRS group and one from the observation group). Median follow-up was 11·1 months (IQR 4·8–20·4). 12-month freedom from local recurrence was 43% (95% CI 31–59) in the observation group and 72% (60–87) in the SRS group (hazard ratio 0·46 [95% CI 0·24–0·88]; p=0·015). There were no adverse events or treatment-related deaths in either group.
SRS of the surgical cavity in patients who have had complete resection of one, two, or three brain metastases significantly lowers local recurrence compared with that noted for observation alone. Thus, the use of SRS after brain metastasis resection could be an alternative to whole-brain radiotherapy.
National Institutes of Health.</description><identifier>ISSN: 1470-2045</identifier><identifier>EISSN: 1474-5488</identifier><identifier>DOI: 10.1016/S1470-2045(17)30414-X</identifier><identifier>PMID: 28687375</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Brain cancer ; Brain Neoplasms - pathology ; Brain Neoplasms - radiotherapy ; Brain Neoplasms - secondary ; Brain Neoplasms - surgery ; Cancer ; Cancer therapies ; Cognitive ability ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Magnetic Resonance Imaging ; Male ; Melanoma ; Metastasectomy ; Metastases ; Metastasis ; Middle Aged ; Motivation ; Neoplasm Recurrence, Local - diagnostic imaging ; Neoplasm Recurrence, Local - radiotherapy ; Patients ; Platinum ; Radiation therapy ; Radiosurgery ; Radiotherapy, Adjuvant ; Single-Blind Method ; Studies ; Surgery ; Surgical techniques ; Survival Rate ; Time Factors ; Toxicity ; Tumor Burden ; Tumors ; Watchful Waiting ; Young Adult</subject><ispartof>The lancet oncology, 2017-08, Vol.18 (8), p.1040-1048</ispartof><rights>2017 Elsevier Ltd</rights><rights>Copyright © 2017 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Aug 1, 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c492t-cbf6ec325d2eb22a400113d70c261b7e5a98b28fbe2de29b1f966bc597ecfc313</citedby><cites>FETCH-LOGICAL-c492t-cbf6ec325d2eb22a400113d70c261b7e5a98b28fbe2de29b1f966bc597ecfc313</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S147020451730414X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28687375$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mahajan, Anita</creatorcontrib><creatorcontrib>Ahmed, Salmaan</creatorcontrib><creatorcontrib>McAleer, Mary Frances</creatorcontrib><creatorcontrib>Weinberg, Jeffrey S</creatorcontrib><creatorcontrib>Li, Jing</creatorcontrib><creatorcontrib>Brown, Paul</creatorcontrib><creatorcontrib>Settle, Stephen</creatorcontrib><creatorcontrib>Prabhu, Sujit S</creatorcontrib><creatorcontrib>Lang, Frederick F</creatorcontrib><creatorcontrib>Levine, Nicholas</creatorcontrib><creatorcontrib>McGovern, Susan</creatorcontrib><creatorcontrib>Sulman, Erik</creatorcontrib><creatorcontrib>McCutcheon, Ian E</creatorcontrib><creatorcontrib>Azeem, Syed</creatorcontrib><creatorcontrib>Cahill, Daniel</creatorcontrib><creatorcontrib>Tatsui, Claudio</creatorcontrib><creatorcontrib>Heimberger, Amy B</creatorcontrib><creatorcontrib>Ferguson, Sherise</creatorcontrib><creatorcontrib>Ghia, Amol</creatorcontrib><creatorcontrib>Demonte, Franco</creatorcontrib><creatorcontrib>Raza, Shaan</creatorcontrib><creatorcontrib>Guha-Thakurta, Nandita</creatorcontrib><creatorcontrib>Yang, James</creatorcontrib><creatorcontrib>Sawaya, Raymond</creatorcontrib><creatorcontrib>Hess, Kenneth R</creatorcontrib><creatorcontrib>Rao, Ganesh</creatorcontrib><title>Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial</title><title>The lancet oncology</title><addtitle>Lancet Oncol</addtitle><description>After brain metastasis resection, whole brain radiotherapy decreases local recurrence, but might cause cognitive decline. We did this study to determine if stereotactic radiosurgery (SRS) to the surgical cavity improved time to local recurrence compared with that for surgical resection alone.
In this randomised, controlled, phase 3 trial, we recruited patients at a single tertiary cancer centre in the USA. Eligible patients were older than 3 years, had a Karnofsky Performance Score of 70 or higher, were able to have an MRI scan, and had a complete resection of one to three brain metastases (with a maximum diameter of the resection cavity ≤4 cm). Patients were randomly assigned (1:1) with a block size of four to either SRS of the resection cavity (within 30 days of surgery) or observation. Patients were stratified by histology of the primary tumour, metastatic tumour size, and number of metastases. The primary endpoint was time to local recurrence in the resection cavity, assessed by blinded central review of brain MRI scans by the study neuroradiologist in the modified intention-to-treat population that analysed patients by randomised allocation but excluded patients found ineligible after randomisation. Participants and other members of the treatment team (excluding the neuroradiologist) were not masked to treatment allocation. The trial is registered with ClinicalTrials.gov, number NCT00950001, and is closed to new participants.
Between Aug 13, 2009, and Feb 16, 2016, 132 patients were randomly assigned to the observation group (n=68) or SRS group (n=64), with 128 patients available for analysis; four patients were ineligible (three from the SRS group and one from the observation group). Median follow-up was 11·1 months (IQR 4·8–20·4). 12-month freedom from local recurrence was 43% (95% CI 31–59) in the observation group and 72% (60–87) in the SRS group (hazard ratio 0·46 [95% CI 0·24–0·88]; p=0·015). There were no adverse events or treatment-related deaths in either group.
SRS of the surgical cavity in patients who have had complete resection of one, two, or three brain metastases significantly lowers local recurrence compared with that noted for observation alone. Thus, the use of SRS after brain metastasis resection could be an alternative to whole-brain radiotherapy.
National Institutes of Health.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Brain cancer</subject><subject>Brain Neoplasms - pathology</subject><subject>Brain Neoplasms - radiotherapy</subject><subject>Brain Neoplasms - secondary</subject><subject>Brain Neoplasms - surgery</subject><subject>Cancer</subject><subject>Cancer therapies</subject><subject>Cognitive ability</subject><subject>Disease-Free Survival</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Melanoma</subject><subject>Metastasectomy</subject><subject>Metastases</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Motivation</subject><subject>Neoplasm Recurrence, Local - diagnostic imaging</subject><subject>Neoplasm Recurrence, Local - radiotherapy</subject><subject>Patients</subject><subject>Platinum</subject><subject>Radiation therapy</subject><subject>Radiosurgery</subject><subject>Radiotherapy, Adjuvant</subject><subject>Single-Blind Method</subject><subject>Studies</subject><subject>Surgery</subject><subject>Surgical techniques</subject><subject>Survival Rate</subject><subject>Time Factors</subject><subject>Toxicity</subject><subject>Tumor Burden</subject><subject>Tumors</subject><subject>Watchful Waiting</subject><subject>Young Adult</subject><issn>1470-2045</issn><issn>1474-5488</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkd2KFDEQhRtR3HX1EZSANytsa5JOd7q9EVn8gwUFFfYu5Kd6zdLdGavSA_MuPqyZmdULb4RAiuI7J5U6VfVU8JeCi-7VV6E0ryVX7bnQLxquhKqv71Wnpa3qVvX9_UN9RE6qR0S3nAstePuwOpF91-tGt6fVry-Jcp02gDbHLTDKgJCy9Tl6hjbERCveAO7YFpBWYskR4LbAaWFjQubTvJkgw7RjCAQ-Q2AObVzYDNlSOUCvmWUUl5sJag9LRrgo1ktIcyQIF8Wi9NI07evNjyJgDcsY7fS4ejDaieDJ3X1WfX__7tvlx_rq84dPl2-vaq8GmWvvxg58I9sgwUlpVfmoaILmXnbCaWjt0DvZjw5kADk4MQ5d53w7aPCjb0RzVp0ffTeYfq5A2ZTJPEyTXSCtZMQgdNMpLZqCPv8HvU0rLmW6QknVCt13vFDtkfKYiBBGs8E4W9wZwc0-PnOIz-yzMUKbQ3zmuuie3bmvbobwV_UnrwK8OQJQ1rGNgIZ8hMVDiFh2b0KK_3niN96uriY</recordid><startdate>201708</startdate><enddate>201708</enddate><creator>Mahajan, Anita</creator><creator>Ahmed, Salmaan</creator><creator>McAleer, Mary Frances</creator><creator>Weinberg, Jeffrey S</creator><creator>Li, Jing</creator><creator>Brown, Paul</creator><creator>Settle, Stephen</creator><creator>Prabhu, Sujit S</creator><creator>Lang, Frederick F</creator><creator>Levine, Nicholas</creator><creator>McGovern, Susan</creator><creator>Sulman, Erik</creator><creator>McCutcheon, Ian E</creator><creator>Azeem, Syed</creator><creator>Cahill, Daniel</creator><creator>Tatsui, Claudio</creator><creator>Heimberger, Amy B</creator><creator>Ferguson, Sherise</creator><creator>Ghia, Amol</creator><creator>Demonte, Franco</creator><creator>Raza, Shaan</creator><creator>Guha-Thakurta, Nandita</creator><creator>Yang, James</creator><creator>Sawaya, Raymond</creator><creator>Hess, Kenneth R</creator><creator>Rao, Ganesh</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8C2</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>201708</creationdate><title>Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial</title><author>Mahajan, Anita ; Ahmed, Salmaan ; McAleer, Mary Frances ; Weinberg, Jeffrey S ; Li, Jing ; Brown, Paul ; Settle, Stephen ; Prabhu, Sujit S ; Lang, Frederick F ; Levine, Nicholas ; McGovern, Susan ; Sulman, Erik ; McCutcheon, Ian E ; Azeem, Syed ; Cahill, Daniel ; Tatsui, Claudio ; Heimberger, Amy B ; Ferguson, Sherise ; Ghia, Amol ; Demonte, Franco ; Raza, Shaan ; Guha-Thakurta, Nandita ; Yang, James ; Sawaya, Raymond ; Hess, Kenneth R ; Rao, Ganesh</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c492t-cbf6ec325d2eb22a400113d70c261b7e5a98b28fbe2de29b1f966bc597ecfc313</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Brain cancer</topic><topic>Brain Neoplasms - 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Academic</collection><jtitle>The lancet oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mahajan, Anita</au><au>Ahmed, Salmaan</au><au>McAleer, Mary Frances</au><au>Weinberg, Jeffrey S</au><au>Li, Jing</au><au>Brown, Paul</au><au>Settle, Stephen</au><au>Prabhu, Sujit S</au><au>Lang, Frederick F</au><au>Levine, Nicholas</au><au>McGovern, Susan</au><au>Sulman, Erik</au><au>McCutcheon, Ian E</au><au>Azeem, Syed</au><au>Cahill, Daniel</au><au>Tatsui, Claudio</au><au>Heimberger, Amy B</au><au>Ferguson, Sherise</au><au>Ghia, Amol</au><au>Demonte, Franco</au><au>Raza, Shaan</au><au>Guha-Thakurta, Nandita</au><au>Yang, James</au><au>Sawaya, Raymond</au><au>Hess, Kenneth R</au><au>Rao, Ganesh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial</atitle><jtitle>The lancet oncology</jtitle><addtitle>Lancet Oncol</addtitle><date>2017-08</date><risdate>2017</risdate><volume>18</volume><issue>8</issue><spage>1040</spage><epage>1048</epage><pages>1040-1048</pages><issn>1470-2045</issn><eissn>1474-5488</eissn><abstract>After brain metastasis resection, whole brain radiotherapy decreases local recurrence, but might cause cognitive decline. We did this study to determine if stereotactic radiosurgery (SRS) to the surgical cavity improved time to local recurrence compared with that for surgical resection alone.
In this randomised, controlled, phase 3 trial, we recruited patients at a single tertiary cancer centre in the USA. Eligible patients were older than 3 years, had a Karnofsky Performance Score of 70 or higher, were able to have an MRI scan, and had a complete resection of one to three brain metastases (with a maximum diameter of the resection cavity ≤4 cm). Patients were randomly assigned (1:1) with a block size of four to either SRS of the resection cavity (within 30 days of surgery) or observation. Patients were stratified by histology of the primary tumour, metastatic tumour size, and number of metastases. The primary endpoint was time to local recurrence in the resection cavity, assessed by blinded central review of brain MRI scans by the study neuroradiologist in the modified intention-to-treat population that analysed patients by randomised allocation but excluded patients found ineligible after randomisation. Participants and other members of the treatment team (excluding the neuroradiologist) were not masked to treatment allocation. The trial is registered with ClinicalTrials.gov, number NCT00950001, and is closed to new participants.
Between Aug 13, 2009, and Feb 16, 2016, 132 patients were randomly assigned to the observation group (n=68) or SRS group (n=64), with 128 patients available for analysis; four patients were ineligible (three from the SRS group and one from the observation group). Median follow-up was 11·1 months (IQR 4·8–20·4). 12-month freedom from local recurrence was 43% (95% CI 31–59) in the observation group and 72% (60–87) in the SRS group (hazard ratio 0·46 [95% CI 0·24–0·88]; p=0·015). There were no adverse events or treatment-related deaths in either group.
SRS of the surgical cavity in patients who have had complete resection of one, two, or three brain metastases significantly lowers local recurrence compared with that noted for observation alone. Thus, the use of SRS after brain metastasis resection could be an alternative to whole-brain radiotherapy.
National Institutes of Health.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>28687375</pmid><doi>10.1016/S1470-2045(17)30414-X</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1470-2045 |
| ispartof | The lancet oncology, 2017-08, Vol.18 (8), p.1040-1048 |
| issn | 1470-2045 1474-5488 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1917364713 |
| source | MEDLINE; Elsevier ScienceDirect Journals Complete |
| subjects | Adult Aged Aged, 80 and over Brain cancer Brain Neoplasms - pathology Brain Neoplasms - radiotherapy Brain Neoplasms - secondary Brain Neoplasms - surgery Cancer Cancer therapies Cognitive ability Disease-Free Survival Female Follow-Up Studies Humans Magnetic Resonance Imaging Male Melanoma Metastasectomy Metastases Metastasis Middle Aged Motivation Neoplasm Recurrence, Local - diagnostic imaging Neoplasm Recurrence, Local - radiotherapy Patients Platinum Radiation therapy Radiosurgery Radiotherapy, Adjuvant Single-Blind Method Studies Surgery Surgical techniques Survival Rate Time Factors Toxicity Tumor Burden Tumors Watchful Waiting Young Adult |
| title | Post-operative stereotactic radiosurgery versus observation for completely resected brain metastases: a single-centre, randomised, controlled, phase 3 trial |
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