Dosimetric Feasibility and Acute Toxicity in a Prospective Trial of Ultrashort-Course Accelerated Partial Breast Irradiation (APBI) Using a Multi-Lumen Balloon Brachytherapy Device
Background Shorter courses of APBI, including single-fraction intraoperative therapy, are under active investigation. We designed a prospective trial to identify and address the potential radiobiological and logistical shortcomings of single-fraction APBI. Methods We designed a single-arm, multi-ins...
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Veröffentlicht in: | Annals of surgical oncology 2013-04, Vol.20 (4), p.1295-1301 |
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creator | Khan, A. J. Vicini, F. A. Brown, S. Haffty, B. G. Kearney, Thomas Dale, R. Lyden, M. Arthur, D. |
description | Background
Shorter courses of APBI, including single-fraction intraoperative therapy, are under active investigation. We designed a prospective trial to identify and address the potential radiobiological and logistical shortcomings of single-fraction APBI.
Methods
We designed a single-arm, multi-institutional, prospective phase II trial that sequentially treats 3 cohorts of women (each
n
= 30) with 3 progressively hypofractionated schedules. Eligible women were age ≥50 years with unifocal invasive or in situ tumors ≤3.0 cm, excised with negative margins, and with negative lymph nodes and positive hormone receptors. We defined strict dosimetric criteria for appropriateness.
Results
A total of 30 patients were enrolled at the 7 Gy × 4 fractions dose-level and followed for 6 months. The median skin dose as a percent of prescription dose (PD) was 84 % (40–100), and the median rib dose was 71 % (16–119). Also, 95 % of the PTV_eval received a median of 95 % of PD (range 85–103). The V150 (range 14–48 cc) and V200 (range 0–29 cc) criteria were met in all cases. One breast infection occurred and was treated; 2 cases of symptomatic fat necrosis and 2 cases of symptomatic seromas occurred.
Conclusion
Short-course APBI is dosimetrically feasible using the Contura MLB and appears to be tolerable in terms of acute toxicities. Our approach is based on well-defined radiobiological parameters and allows for an abbreviated course of treatment that is guided by full pathological review and the ability to objectively achieve and validate acceptable dosimetric criteria in each case. We have opened enrollment to the next schedule of 8.25 Gy for 3 fractions. |
doi_str_mv | 10.1245/s10434-012-2671-1 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1512330654</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1512330654</sourcerecordid><originalsourceid>FETCH-LOGICAL-c405t-3411c809cd40a218d04f389b8dd347f5c892f1e96b08eeb97d60c98d93042c063</originalsourceid><addsrcrecordid>eNp1kc9uEzEQhy0EoiXwAFyQJS7lsOCxvbveY5JSiBREDs155bVnG1f7J9jeqnkvHhCvUhBC4mTL881ne36EvAX2EbjMPwVgUsiMAc94UUIGz8gl5OlEFgqepz0rVFbxIr8gr0K4ZwxKwfKX5IILkJXKxSX5eT0G12P0ztAb1ME1rnPxRPVg6dJMEent-OjMfOQGqunOj-GIJrqHVPFOd3Rs6b6LXofD6GO2HicfMLUa7NDriJbutI8zuPLJH-nGe22djm4c6NVyt9p8oPvghrsk_zZ10WXbqceBrnTXjQlZeW0Op3hIsuOJXuODM_iavGh1F_DN07og-5vPt-uv2fb7l816uc2MZHnMhAQwilXGSqY5KMtkK1TVKGuFLNvcqIq3gFXRMIXYVKUtmKmUrQST3LBCLMjV2Xv0448JQ6x7F9LHOj3gOIUacuBCsCKXCX3_D3qfJjGk19UgoASuFJ-FcKZMGmPw2NZH73rtTzWweo60Pkdap0jrOdLUvCDvnsxT06P90_E7wwTwMxBSabhD_9fV_7X-ApYkrOA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1317128826</pqid></control><display><type>article</type><title>Dosimetric Feasibility and Acute Toxicity in a Prospective Trial of Ultrashort-Course Accelerated Partial Breast Irradiation (APBI) Using a Multi-Lumen Balloon Brachytherapy Device</title><source>MEDLINE</source><source>SpringerLink Journals (MCLS)</source><creator>Khan, A. J. ; Vicini, F. A. ; Brown, S. ; Haffty, B. G. ; Kearney, Thomas ; Dale, R. ; Lyden, M. ; Arthur, D.</creator><creatorcontrib>Khan, A. J. ; Vicini, F. A. ; Brown, S. ; Haffty, B. G. ; Kearney, Thomas ; Dale, R. ; Lyden, M. ; Arthur, D.</creatorcontrib><description>Background
Shorter courses of APBI, including single-fraction intraoperative therapy, are under active investigation. We designed a prospective trial to identify and address the potential radiobiological and logistical shortcomings of single-fraction APBI.
Methods
We designed a single-arm, multi-institutional, prospective phase II trial that sequentially treats 3 cohorts of women (each
n
= 30) with 3 progressively hypofractionated schedules. Eligible women were age ≥50 years with unifocal invasive or in situ tumors ≤3.0 cm, excised with negative margins, and with negative lymph nodes and positive hormone receptors. We defined strict dosimetric criteria for appropriateness.
Results
A total of 30 patients were enrolled at the 7 Gy × 4 fractions dose-level and followed for 6 months. The median skin dose as a percent of prescription dose (PD) was 84 % (40–100), and the median rib dose was 71 % (16–119). Also, 95 % of the PTV_eval received a median of 95 % of PD (range 85–103). The V150 (range 14–48 cc) and V200 (range 0–29 cc) criteria were met in all cases. One breast infection occurred and was treated; 2 cases of symptomatic fat necrosis and 2 cases of symptomatic seromas occurred.
Conclusion
Short-course APBI is dosimetrically feasible using the Contura MLB and appears to be tolerable in terms of acute toxicities. Our approach is based on well-defined radiobiological parameters and allows for an abbreviated course of treatment that is guided by full pathological review and the ability to objectively achieve and validate acceptable dosimetric criteria in each case. We have opened enrollment to the next schedule of 8.25 Gy for 3 fractions.</description><identifier>ISSN: 1068-9265</identifier><identifier>EISSN: 1534-4681</identifier><identifier>DOI: 10.1245/s10434-012-2671-1</identifier><identifier>PMID: 23149853</identifier><language>eng</language><publisher>New York: Springer-Verlag</publisher><subject>Aged ; Brachytherapy - adverse effects ; Brachytherapy - instrumentation ; Breast Neoplasms - pathology ; Breast Neoplasms - radiotherapy ; Breast Neoplasms - surgery ; Breast Oncology ; Carcinoma, Ductal - pathology ; Carcinoma, Ductal - radiotherapy ; Carcinoma, Ductal - surgery ; Carcinoma, Lobular - pathology ; Carcinoma, Lobular - radiotherapy ; Carcinoma, Lobular - surgery ; Catheterization ; Feasibility Studies ; Female ; Follow-Up Studies ; Humans ; Mastectomy ; Medicine ; Medicine & Public Health ; Middle Aged ; Neoplasm Grading ; Neoplasm Invasiveness ; Neoplasm Staging ; Oncology ; Prognosis ; Prospective Studies ; Radiation Injuries - etiology ; Radiation Injuries - prevention & control ; Radiometry ; Surgery ; Surgical Oncology ; Survival Rate</subject><ispartof>Annals of surgical oncology, 2013-04, Vol.20 (4), p.1295-1301</ispartof><rights>Society of Surgical Oncology 2012</rights><rights>Society of Surgical Oncology 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c405t-3411c809cd40a218d04f389b8dd347f5c892f1e96b08eeb97d60c98d93042c063</citedby><cites>FETCH-LOGICAL-c405t-3411c809cd40a218d04f389b8dd347f5c892f1e96b08eeb97d60c98d93042c063</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1245/s10434-012-2671-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1245/s10434-012-2671-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23149853$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Khan, A. J.</creatorcontrib><creatorcontrib>Vicini, F. A.</creatorcontrib><creatorcontrib>Brown, S.</creatorcontrib><creatorcontrib>Haffty, B. G.</creatorcontrib><creatorcontrib>Kearney, Thomas</creatorcontrib><creatorcontrib>Dale, R.</creatorcontrib><creatorcontrib>Lyden, M.</creatorcontrib><creatorcontrib>Arthur, D.</creatorcontrib><title>Dosimetric Feasibility and Acute Toxicity in a Prospective Trial of Ultrashort-Course Accelerated Partial Breast Irradiation (APBI) Using a Multi-Lumen Balloon Brachytherapy Device</title><title>Annals of surgical oncology</title><addtitle>Ann Surg Oncol</addtitle><addtitle>Ann Surg Oncol</addtitle><description>Background
Shorter courses of APBI, including single-fraction intraoperative therapy, are under active investigation. We designed a prospective trial to identify and address the potential radiobiological and logistical shortcomings of single-fraction APBI.
Methods
We designed a single-arm, multi-institutional, prospective phase II trial that sequentially treats 3 cohorts of women (each
n
= 30) with 3 progressively hypofractionated schedules. Eligible women were age ≥50 years with unifocal invasive or in situ tumors ≤3.0 cm, excised with negative margins, and with negative lymph nodes and positive hormone receptors. We defined strict dosimetric criteria for appropriateness.
Results
A total of 30 patients were enrolled at the 7 Gy × 4 fractions dose-level and followed for 6 months. The median skin dose as a percent of prescription dose (PD) was 84 % (40–100), and the median rib dose was 71 % (16–119). Also, 95 % of the PTV_eval received a median of 95 % of PD (range 85–103). The V150 (range 14–48 cc) and V200 (range 0–29 cc) criteria were met in all cases. One breast infection occurred and was treated; 2 cases of symptomatic fat necrosis and 2 cases of symptomatic seromas occurred.
Conclusion
Short-course APBI is dosimetrically feasible using the Contura MLB and appears to be tolerable in terms of acute toxicities. Our approach is based on well-defined radiobiological parameters and allows for an abbreviated course of treatment that is guided by full pathological review and the ability to objectively achieve and validate acceptable dosimetric criteria in each case. We have opened enrollment to the next schedule of 8.25 Gy for 3 fractions.</description><subject>Aged</subject><subject>Brachytherapy - adverse effects</subject><subject>Brachytherapy - instrumentation</subject><subject>Breast Neoplasms - pathology</subject><subject>Breast Neoplasms - radiotherapy</subject><subject>Breast Neoplasms - surgery</subject><subject>Breast Oncology</subject><subject>Carcinoma, Ductal - pathology</subject><subject>Carcinoma, Ductal - radiotherapy</subject><subject>Carcinoma, Ductal - surgery</subject><subject>Carcinoma, Lobular - pathology</subject><subject>Carcinoma, Lobular - radiotherapy</subject><subject>Carcinoma, Lobular - surgery</subject><subject>Catheterization</subject><subject>Feasibility Studies</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Mastectomy</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neoplasm Grading</subject><subject>Neoplasm Invasiveness</subject><subject>Neoplasm Staging</subject><subject>Oncology</subject><subject>Prognosis</subject><subject>Prospective Studies</subject><subject>Radiation Injuries - etiology</subject><subject>Radiation Injuries - prevention & control</subject><subject>Radiometry</subject><subject>Surgery</subject><subject>Surgical Oncology</subject><subject>Survival Rate</subject><issn>1068-9265</issn><issn>1534-4681</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kc9uEzEQhy0EoiXwAFyQJS7lsOCxvbveY5JSiBREDs155bVnG1f7J9jeqnkvHhCvUhBC4mTL881ne36EvAX2EbjMPwVgUsiMAc94UUIGz8gl5OlEFgqepz0rVFbxIr8gr0K4ZwxKwfKX5IILkJXKxSX5eT0G12P0ztAb1ME1rnPxRPVg6dJMEent-OjMfOQGqunOj-GIJrqHVPFOd3Rs6b6LXofD6GO2HicfMLUa7NDriJbutI8zuPLJH-nGe22djm4c6NVyt9p8oPvghrsk_zZ10WXbqceBrnTXjQlZeW0Op3hIsuOJXuODM_iavGh1F_DN07og-5vPt-uv2fb7l816uc2MZHnMhAQwilXGSqY5KMtkK1TVKGuFLNvcqIq3gFXRMIXYVKUtmKmUrQST3LBCLMjV2Xv0448JQ6x7F9LHOj3gOIUacuBCsCKXCX3_D3qfJjGk19UgoASuFJ-FcKZMGmPw2NZH73rtTzWweo60Pkdap0jrOdLUvCDvnsxT06P90_E7wwTwMxBSabhD_9fV_7X-ApYkrOA</recordid><startdate>20130401</startdate><enddate>20130401</enddate><creator>Khan, A. J.</creator><creator>Vicini, F. A.</creator><creator>Brown, S.</creator><creator>Haffty, B. G.</creator><creator>Kearney, Thomas</creator><creator>Dale, R.</creator><creator>Lyden, M.</creator><creator>Arthur, D.</creator><general>Springer-Verlag</general><general>Springer Nature B.V</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>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</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>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>20130401</creationdate><title>Dosimetric Feasibility and Acute Toxicity in a Prospective Trial of Ultrashort-Course Accelerated Partial Breast Irradiation (APBI) Using a Multi-Lumen Balloon Brachytherapy Device</title><author>Khan, A. J. ; Vicini, F. A. ; Brown, S. ; Haffty, B. G. ; Kearney, Thomas ; Dale, R. ; Lyden, M. ; Arthur, D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c405t-3411c809cd40a218d04f389b8dd347f5c892f1e96b08eeb97d60c98d93042c063</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Aged</topic><topic>Brachytherapy - adverse effects</topic><topic>Brachytherapy - instrumentation</topic><topic>Breast Neoplasms - pathology</topic><topic>Breast Neoplasms - radiotherapy</topic><topic>Breast Neoplasms - surgery</topic><topic>Breast Oncology</topic><topic>Carcinoma, Ductal - pathology</topic><topic>Carcinoma, Ductal - radiotherapy</topic><topic>Carcinoma, Ductal - surgery</topic><topic>Carcinoma, Lobular - pathology</topic><topic>Carcinoma, Lobular - radiotherapy</topic><topic>Carcinoma, Lobular - surgery</topic><topic>Catheterization</topic><topic>Feasibility Studies</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Mastectomy</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Neoplasm Grading</topic><topic>Neoplasm Invasiveness</topic><topic>Neoplasm Staging</topic><topic>Oncology</topic><topic>Prognosis</topic><topic>Prospective Studies</topic><topic>Radiation Injuries - etiology</topic><topic>Radiation Injuries - prevention & control</topic><topic>Radiometry</topic><topic>Surgery</topic><topic>Surgical Oncology</topic><topic>Survival Rate</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Khan, A. J.</creatorcontrib><creatorcontrib>Vicini, F. A.</creatorcontrib><creatorcontrib>Brown, S.</creatorcontrib><creatorcontrib>Haffty, B. G.</creatorcontrib><creatorcontrib>Kearney, Thomas</creatorcontrib><creatorcontrib>Dale, R.</creatorcontrib><creatorcontrib>Lyden, M.</creatorcontrib><creatorcontrib>Arthur, D.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Annals of surgical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Khan, A. J.</au><au>Vicini, F. A.</au><au>Brown, S.</au><au>Haffty, B. G.</au><au>Kearney, Thomas</au><au>Dale, R.</au><au>Lyden, M.</au><au>Arthur, D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Dosimetric Feasibility and Acute Toxicity in a Prospective Trial of Ultrashort-Course Accelerated Partial Breast Irradiation (APBI) Using a Multi-Lumen Balloon Brachytherapy Device</atitle><jtitle>Annals of surgical oncology</jtitle><stitle>Ann Surg Oncol</stitle><addtitle>Ann Surg Oncol</addtitle><date>2013-04-01</date><risdate>2013</risdate><volume>20</volume><issue>4</issue><spage>1295</spage><epage>1301</epage><pages>1295-1301</pages><issn>1068-9265</issn><eissn>1534-4681</eissn><abstract>Background
Shorter courses of APBI, including single-fraction intraoperative therapy, are under active investigation. We designed a prospective trial to identify and address the potential radiobiological and logistical shortcomings of single-fraction APBI.
Methods
We designed a single-arm, multi-institutional, prospective phase II trial that sequentially treats 3 cohorts of women (each
n
= 30) with 3 progressively hypofractionated schedules. Eligible women were age ≥50 years with unifocal invasive or in situ tumors ≤3.0 cm, excised with negative margins, and with negative lymph nodes and positive hormone receptors. We defined strict dosimetric criteria for appropriateness.
Results
A total of 30 patients were enrolled at the 7 Gy × 4 fractions dose-level and followed for 6 months. The median skin dose as a percent of prescription dose (PD) was 84 % (40–100), and the median rib dose was 71 % (16–119). Also, 95 % of the PTV_eval received a median of 95 % of PD (range 85–103). The V150 (range 14–48 cc) and V200 (range 0–29 cc) criteria were met in all cases. One breast infection occurred and was treated; 2 cases of symptomatic fat necrosis and 2 cases of symptomatic seromas occurred.
Conclusion
Short-course APBI is dosimetrically feasible using the Contura MLB and appears to be tolerable in terms of acute toxicities. Our approach is based on well-defined radiobiological parameters and allows for an abbreviated course of treatment that is guided by full pathological review and the ability to objectively achieve and validate acceptable dosimetric criteria in each case. We have opened enrollment to the next schedule of 8.25 Gy for 3 fractions.</abstract><cop>New York</cop><pub>Springer-Verlag</pub><pmid>23149853</pmid><doi>10.1245/s10434-012-2671-1</doi><tpages>7</tpages></addata></record> |
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subjects | Aged Brachytherapy - adverse effects Brachytherapy - instrumentation Breast Neoplasms - pathology Breast Neoplasms - radiotherapy Breast Neoplasms - surgery Breast Oncology Carcinoma, Ductal - pathology Carcinoma, Ductal - radiotherapy Carcinoma, Ductal - surgery Carcinoma, Lobular - pathology Carcinoma, Lobular - radiotherapy Carcinoma, Lobular - surgery Catheterization Feasibility Studies Female Follow-Up Studies Humans Mastectomy Medicine Medicine & Public Health Middle Aged Neoplasm Grading Neoplasm Invasiveness Neoplasm Staging Oncology Prognosis Prospective Studies Radiation Injuries - etiology Radiation Injuries - prevention & control Radiometry Surgery Surgical Oncology Survival Rate |
title | Dosimetric Feasibility and Acute Toxicity in a Prospective Trial of Ultrashort-Course Accelerated Partial Breast Irradiation (APBI) Using a Multi-Lumen Balloon Brachytherapy Device |
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