دورية أكاديمية

Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial

التفاصيل البيبلوغرافية
العنوان: Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial
المؤلفون: Vaidya, Jayant S, Joseph, David J, Tobias, Jeffrey S, Bulsara, Max, Wenz, Frederik, Saunders, Christobel, Alvarado, Michael, Flyger, Henrik L, Massarut, Samuele, Eiermann, Wolfgang, Keshtgar, Mohammed, Dewar, John, Kraus-Tiefenbacher, Uta, Sütterlin, Marc, Esserman, Laura, Holtveg, Helle MR, Roncadin, Mario, Pigorsch, Steffi, Metaxas, Marinos, Falzon, Mary, Matthews, April, Corica, Tammy, Williams, Norman R, Baum, Michael
المصدر: The Lancet , 376 (9735) pp. 91-102. (2010)
بيانات النشر: ELSEVIER SCIENCE INC
سنة النشر: 2010
المجموعة: University College London: UCL Discovery
الوصف: Background: 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./ Methods: 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./ Findings: 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 ...
نوع الوثيقة: article in journal/newspaper
وصف الملف: text
اللغة: English
العلاقة: https://discovery.ucl.ac.uk/id/eprint/10168240/1/TARGIT-A%20paper%20front%20page%20-%20comment%20-%20summary.pdfTest; https://discovery.ucl.ac.uk/id/eprint/10168240Test/
الإتاحة: https://discovery.ucl.ac.uk/id/eprint/10168240/1/TARGIT-A%20paper%20front%20page%20-%20comment%20-%20summary.pdfTest
https://discovery.ucl.ac.uk/id/eprint/10168240Test/
حقوق: open
رقم الانضمام: edsbas.B89DA82B
قاعدة البيانات: BASE