Matches in SemOpenAlex for { <https://semopenalex.org/work/W2133494786> ?p ?o ?g. }
- W2133494786 endingPage "102" @default.
- W2133494786 startingPage "91" @default.
- W2133494786 abstract "BackgroundAfter breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy.MethodsHaving safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2·5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00983684.Findings1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1·20% (95% CI 0·53–2·71) in the targeted intraoperative radiotherapy and 0·95% (0·39–2·31) in the external beam radiotherapy group (difference between groups 0·25%, −1·04 to 1·54; p=0·41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3·3%] of 1113 vs external beam radiotherapy, 44 [3·9%] of 1119; p=0·44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0·5%]) than in the external beam radiotherapy group (23 patients [2·1%]; p=0·002).InterpretationFor selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks.FundingUniversity College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF). After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy. Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2·5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00983684. 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1·20% (95% CI 0·53–2·71) in the targeted intraoperative radiotherapy and 0·95% (0·39–2·31) in the external beam radiotherapy group (difference between groups 0·25%, −1·04 to 1·54; p=0·41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 [3·3%] of 1113 vs external beam radiotherapy, 44 [3·9%] of 1119; p=0·44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients [0·5%]) than in the external beam radiotherapy group (23 patients [2·1%]; p=0·002). For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks." @default.
- W2133494786 created "2016-06-24" @default.
- W2133494786 creator A5002412211 @default.
- W2133494786 creator A5010375570 @default.
- W2133494786 creator A5017353601 @default.
- W2133494786 creator A5021116939 @default.
- W2133494786 creator A5021616230 @default.
- W2133494786 creator A5027557581 @default.
- W2133494786 creator A5034459193 @default.
- W2133494786 creator A5038725960 @default.
- W2133494786 creator A5040656504 @default.
- W2133494786 creator A5041699297 @default.
- W2133494786 creator A5047032886 @default.
- W2133494786 creator A5052253923 @default.
- W2133494786 creator A5060216513 @default.
- W2133494786 creator A5064150548 @default.
- W2133494786 creator A5070502173 @default.
- W2133494786 creator A5072789687 @default.
- W2133494786 creator A5075789134 @default.
- W2133494786 creator A5081258520 @default.
- W2133494786 creator A5083121185 @default.
- W2133494786 creator A5083158555 @default.
- W2133494786 creator A5085733368 @default.
- W2133494786 creator A5087397883 @default.
- W2133494786 creator A5088247085 @default.
- W2133494786 creator A5090962975 @default.
- W2133494786 date "2010-07-01" @default.
- W2133494786 modified "2023-10-15" @default.
- W2133494786 title "Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial" @default.
- W2133494786 cites W1934904577 @default.
- W2133494786 cites W1967043197 @default.
- W2133494786 cites W1968351555 @default.
- W2133494786 cites W1982853521 @default.
- W2133494786 cites W2000399996 @default.
- W2133494786 cites W2018645723 @default.
- W2133494786 cites W2019661342 @default.
- W2133494786 cites W2026900073 @default.
- W2133494786 cites W2032541700 @default.
- W2133494786 cites W2032589295 @default.
- W2133494786 cites W2033320300 @default.
- W2133494786 cites W2039079413 @default.
- W2133494786 cites W2043468165 @default.
- W2133494786 cites W2045929349 @default.
- W2133494786 cites W2046809995 @default.
- W2133494786 cites W2047548257 @default.
- W2133494786 cites W2056048989 @default.
- W2133494786 cites W2058033719 @default.
- W2133494786 cites W2068017316 @default.
- W2133494786 cites W2081233470 @default.
- W2133494786 cites W2089519948 @default.
- W2133494786 cites W2093610897 @default.
- W2133494786 cites W2094237775 @default.
- W2133494786 cites W2094650757 @default.
- W2133494786 cites W2103771621 @default.
- W2133494786 cites W2104148650 @default.
- W2133494786 cites W2114744102 @default.
- W2133494786 cites W2114971051 @default.
- W2133494786 cites W2119579281 @default.
- W2133494786 cites W2119777918 @default.
- W2133494786 cites W2123541246 @default.
- W2133494786 cites W2128772705 @default.
- W2133494786 cites W2139627902 @default.
- W2133494786 cites W2140159807 @default.
- W2133494786 cites W2142655452 @default.
- W2133494786 cites W2146232565 @default.
- W2133494786 cites W2149455283 @default.
- W2133494786 cites W2149955179 @default.
- W2133494786 cites W2154875949 @default.
- W2133494786 cites W2158615473 @default.
- W2133494786 cites W2164605844 @default.
- W2133494786 cites W2171279313 @default.
- W2133494786 cites W2316011039 @default.
- W2133494786 cites W3021410191 @default.
- W2133494786 cites W4293107555 @default.
- W2133494786 doi "https://doi.org/10.1016/s0140-6736(10)60837-9" @default.
- W2133494786 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/20570343" @default.
- W2133494786 hasPublicationYear "2010" @default.
- W2133494786 type Work @default.
- W2133494786 sameAs 2133494786 @default.
- W2133494786 citedByCount "673" @default.
- W2133494786 countsByYear W21334947862012 @default.
- W2133494786 countsByYear W21334947862013 @default.
- W2133494786 countsByYear W21334947862014 @default.
- W2133494786 countsByYear W21334947862015 @default.
- W2133494786 countsByYear W21334947862016 @default.
- W2133494786 countsByYear W21334947862017 @default.
- W2133494786 countsByYear W21334947862018 @default.
- W2133494786 countsByYear W21334947862019 @default.
- W2133494786 countsByYear W21334947862020 @default.
- W2133494786 countsByYear W21334947862021 @default.
- W2133494786 countsByYear W21334947862022 @default.
- W2133494786 countsByYear W21334947862023 @default.
- W2133494786 crossrefType "journal-article" @default.
- W2133494786 hasAuthorship W2133494786A5002412211 @default.
- W2133494786 hasAuthorship W2133494786A5010375570 @default.
- W2133494786 hasAuthorship W2133494786A5017353601 @default.
- W2133494786 hasAuthorship W2133494786A5021116939 @default.
- W2133494786 hasAuthorship W2133494786A5021616230 @default.