Reading this brief overview does not substitute the reading of the original study, but is just giving an abridged insight and is not necessarily reflecting the opinion of notified bodies and/or regulatory authorities, such as the DQS or FDA.
A brief overview - created by Elena Sperk, MD, Senior Physician, Head of the Study Administration Office, Third-Party Funding & Personnel Affairs, Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg on behalf of ZEISS, December 2020.
Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial.
Jayant S. Vaidya, Max Bulsara, Michael Baum, Frederik Wenz, Samuele Massarut, Steffi Pigorsch, Michael Alvarado, Michael Douek, Christobel Saunders, Hentrik L. Flyger, Wolfgang Eiermann, Chris Brew-Graves, Norman R. Williams, Ingrid Potyka, Nicholas Roberts, Marcelle Bernstein, Douglas Brown, Elena Sperk, Siobhan Laws, Marc Sütterlin, Tammy Corica, Steinar Lundgren, Dennis Holmes, Lorenzo Vinante, Fernando Bozza, Montserrat Pazos, Magali Le Blanc-Onfroy, Günther Gruber, Wojciech Polkowski, Konstantin J. Dedes, Marcus Niewald, Jens Blohmer, David McCready, Richard Hoefer, Pond Kelemen, Gloria Petralia, Mary Falzon, David J. Joseph, Jeffrey S. Tobias
Vaidya, J. S. et all. (2020). Long-term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial. BMJ, 370, m2836. https://doi.org/10.1136/bmj.m2836
- The scope of the prospective, randomised, controlled clinical trial TARGIT-A was to determine whether risk-adapted intraoperative radiotherapy (IORT) in form of a single-dose during lumpectomy, can effectively replace post-operative external breast cancer.
- In 32 centres from 10 countries on four continents 2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 mm in size, cN0-N1, eligible for breast conservation have been randomly randomised before lumpectomy, 1140 to TARGIT-IORT and 1158 to EBRT. In the TARGIT-IORT arm 80% of patients only received IORT while 20% also received EBRT when post-operative risk factors appeared. As primary investigation criteria (primary endpoint) of the study, the local recurrence at five years was chosen and compared for both study arms.
- TARGIT-IORT showed fewer deaths compared with EBRT. With long term follow-up no statistically significant difference was found for local recurrence-free survival, mastectomy-free survival, distant disease-free survival, overall survival and breast cancer mortality. Non-breast cancer mortality was significantly lower for TARGIT-IORT compared to EBRT.