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Volume 376, Issue 9735, Pages (July 2010)

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Presentation on theme: "Volume 376, Issue 9735, Pages (July 2010)"— Presentation transcript:

1 Volume 376, Issue 9735, Pages 91-102 (July 2010)
Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial  Dr Jayant S Vaidya, PhD, David J Joseph, MD, Jeffrey S Tobias, FRCR, Max Bulsara, PhD, Frederik Wenz, MD, Christobel Saunders, FRCS, Michael Alvarado, MD, Henrik L Flyger, MD, Samuele Massarut, MD, Wolfgang Eiermann, MD, Mohammed Keshtgar, PhD, John Dewar, FRCR, Uta Kraus-Tiefenbacher, MD, Marc Sütterlin, MD, Laura Esserman, MD, Helle MR Holtveg, MD, Mario Roncadin, MD, Steffi Pigorsch, MD, Marinos Metaxas, PhD, Mary Falzon, FRCPath, April Matthews, BSc, Tammy Corica, PGDPH, Norman R Williams, PhD, Michael Baum, FRCS  The Lancet  Volume 376, Issue 9735, Pages (July 2010) DOI: /S (10) Copyright © 2010 Elsevier Ltd Terms and Conditions

2 Figure 1 Targeted intraoperative radiotherapy technique with the Intrabeam system (A) The applicator being placed in the tumour bed. (B) The x-ray source is delivered to the tumour bed by use of a surgical support stand. The sterile applicator is joined with a sterile drape that is used to cover the stand during treatment delivery. The Lancet  , DOI: ( /S (10) ) Copyright © 2010 Elsevier Ltd Terms and Conditions

3 Figure 2 Randomisation strata
TARGIT=targeted intraoperative radiotherapy. EBRT=external beam radiotherapy. (A) Prepathology entry. Randomisation was done before the definitive surgical removal of the tumour. Characteristics that would prompt addition of EBRT were predefined (eg, unexpected lobular carcinoma, extensive intraductal component, positive margins at first excision, in addition to others by individual centre). (B) Postpathology entry/TARGIT as a second procedure. Postpathology entry allowed for patients randomised for entry to the trial only once the pathological characteristics of the tumour had been reported. If allocated to TARGIT the wound was opened, the applicator inserted, and TARGIT given as a second surgical procedure. *Decided by each centre at the outset—eg, grade 3, node involvement, lymphovascular invasion. The Lancet  , DOI: ( /S (10) ) Copyright © 2010 Elsevier Ltd Terms and Conditions

4 Figure 3 Trial profile TARGIT=targeted intraoperative radiotherapy. EBRT=external beam radiotherapy. Data for number of patients screened for eligibility are not available from all centres. The Lancet  , DOI: ( /S (10) ) Copyright © 2010 Elsevier Ltd Terms and Conditions

5 Figure 4 Local recurrence in the conserved breast
(A) Survival free of local recurrence in the conserved breast in entire cohort. Shaded area represents 95% CIs. (B) Survival free of local recurrence in the conserved breast; all patients in the two randomised groups. (C) Annual hazards of local recurrence. Error bars represent 95% CIs. There were no recurrences in years 1 or 4. These graphs (A, B, and C) are restricted to 4 years because less than 420 (<20%) patients have a follow-up beyond this point; however, all patients (with a maximum follow-up of 10 years) are included in the analysis, as recommended by Pocock and colleagues.28 The Lancet  , DOI: ( /S (10) ) Copyright © 2010 Elsevier Ltd Terms and Conditions


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