TARGIT-A Trial

Clinical studies are first required before targeted intraoperative radiotherapy can become established as a new treatment option, allowing a large number of patients to benefit from this type of treatment.

The aim of the TARGIT-A study (TARGeted Intraoperative radioTherapy) is to show that minimally invasive radiotherapy during breast surgery (intraoperative radiotherapy, IORT) can be just as effective as traditional radiotherapy, which takes approximately 3-6 weeks and is often experienced as very stressful by patients. Targeted intraoperative radiotherapy minimizes the time required for the treatment and therefore also the possible side-effects. 

Patients who are 45 years of age or older with a breast carcinoma verified by biopsy and suitable for breast conserving surgery can be included in the study. Within the TARGIT-A randomised trial, they are offered on a random basis, to either received their radiotherapy immediately after the removal of the tumor, the usual course of external radiotherapy. If the detailed examination of the tissue sample by the pathologist after the surgery reveals further risk factors, the patients additionally receive traditional external radiotherapy; this is expected in about 15% of cases.

3451 patients were studied and the results of this trial which started in March 2000 have been published in the Lancet in 2010 and 2013.

 

5-year results of the TARGIT-A trial were published in the Lancet on 11 November 2013  

  • The TARGIT-A trial was a randomised trial testing an individualised approach of radiation after lumpectomy for breast cancer.
  • The TARGIT technique uses the Intrabeam device for delivering precise and timely dose of intraoperative radiotherapy accurately to the tumour bed.
  • An academic insight led to the development of this device through a collaborative effort between University College London and the Photoelectron Corporation in 1990s.
  • It was first used on 2 July 1998 in the Middlesex Hospital, UCL, London. Intrabeam is currently manufactured by Carl Zeiss
  • The comparison in the TARGIT-A trial was between standard radiation therapy that is given over several weeks after a lumpectomy vs. a risk-adapted approach using single dose of TARGeted Intraoperative radioTherapy (TARGIT) given at the time of lumpectomy.
  • The risk-adapted protocol recommended that if the patients who had received TARGIT were found to have high risk factors postoperatively, they also received whole breast radiation - which occurred in 15-20% of cases as expected in the protocol; otherwise, about 80% of such patients completed their treatment (surgery and radiation) during their lumpectomy.
  • The pre-specified non-inferiority margin was an absolute difference in local recurrence of breast cancer between TARGIT and EBRT of 2.5% -- in simple terms, if the absolute difference in local recurrence between the two treatments being compared was less than 2.5%, they would be considered non-inferior to each other in terms of local control of breast cancer.
  • 3451 patients from 33 centres in 11 countries participated in the TARGIT-A trial (UK, USA, Germany, Italy, France Poland , Switzerland, Norway, Denmark, Canada and Australia) from 24 March 2000 to 25 June 2012. (map).

Results:

  • When TARGIT is given with lumpectomy, the 5-year local recurrence of breast cancer is similar to EBRT
  • When TARGIT is given as a second procedure, the difference in local recurrence between TARGIT and EBRT was more than 2.5%
  • Breast cancer mortality with TARGIT were similar to EBRT
  • Mortality from other causes  was significantly lower with TARGIT due to fewer deaths from  cardiovascular causes and other cancers.
  • The results remain stable with longer follow up.

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The TARGIT trial office has received its main funding from the Health Technology Assessment programme of the National Institutes of Health Research, UK.

 

TARGIT ISCTARGIT investigators at the  -  10-year International Steering Committee meeting in 2010

First publication of the main results:

 

Vaidya JS, Joseph DJ, Tobias JS, Bulsara M, Wenz F, Saunders C, Alvarado M, Flyger HL, Massarut S, Eiermann W, Keshtgar M, Dewar J, Kraus-Tiefenbacher U, Sutterlin M, Esserman L, Holtveg HM, Roncadin M, Pigorsch S, Metaxas M, Falzon M, Matthews A, Corica T, Williams NR, Baum M. Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomised, non-inferiority phase 3 trial. The Lancet.  2010 ;376(9735):91-102.

 

5-year results and first analysis of survival

 

Vaidya JS, Wenz F, Bulsara M, Tobias JS, Joseph DJ, Keshtgar M, Flyger HL, Massarut S, Alvarado M, Saunders C, Eiermann W, Metaxas M, Sperk E, Sütterlin M, Brown D, Esserman L, Roncadin M, Thompson A, Dewar JA, Holtveg HMR, Pigorsch S, Falzon M, Harris E, Matthews A, Brew-Graves C, Potyka I, Corica T, Williams NR, Baum M. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. The Lancet. 11 November 2013. doi:10.1016/s0140-6736(13)61950-9 

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