Breast Cancer IORT validated to be effective and efficient

TARGIT-A study long-term outcomes published


10 Countries

32 Centers

2298 Patients

Treatment Workflow

Additionally to the standard treatment workflow of giving only EBRT for breast-conserving treatments the TARGIT-A trial investigates two additional treatment approaches, IORT Boost + EBRT and single IORT without EBRT.
 

Patient Characteristics

Compared to other APBI studies, the patients selected for the TARGIT-A trial were mainly good prognosis but not elderly, and there were a substantial number of adverse prognosis patients.

Study protocol in overview

Between 2000 and 2012, 2298 patients aged 45 and older with invasive ductal carcinoma were randomized in 32 centers from 10 countries and treated with INTRABEAM®. 1140 patients were randomized to the TARGIT-IORT arm and 1158 patients to the EBRT arm.

#1 Positive clinical results confirmed
  • Local recurrence-free survival (LRFS) and overall survival (OS) for IORT similar compared to EBRT
  • Lower side-effects of IORT treatments compared to EBRT prove more gentle treatment option for patients
  • Pre-pathology results proved immediate irradiation to be better than delayed irradiation

Vaidya, J. S. et al. (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

 

"Single dose intra-operative radiotherapy for early stage breast cancer can be a better alternative to conventional whole breast radiotherapy for most patients during primary tumor management."

Professor Jayant Vaidya (08/2020)
Professor of Surgery and Oncology and Consultant
Surgeon at the University College London (UK) and
Chief Principal Investigator of the TARGIT-A study

Local recurrence rate

The local recurrence rate shows a non-inferior outcome for immediate TARGIT-IORT compared with EBRT.

#2 Efficiency-driven treatment approach upheld
  • Clinical results prove one-shot IORT treatment courses can replace up to 15-30 fractions of EBRT treatments for 80% of patients
  • Significantly lower treatment burden for patients due to less fractions and related effects

Vaidya, J. S. et al. (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

 

"These excellent results provide real clinical justification for single intraoperative radiation in suitable patients with early breast cancer. It is now essential to develop the corresponding treatment guidelines as soon as possible."

Professor Jeffrey Tobias (08/2020)
Professor of Oncology at the University College
London (UK) and joint initiator of the TARGIT-A study

 

“This study reflects two decades of interdisciplinary clinical research by leading radiation oncologists, surgeons, physicists and health economists. The TARGIT-A trial has offered many breast cancer patients a treatment that is well tolerated, effective, convenient and highly cost efficient.”

Professor William Small (08/2020)
Professor and Chairman of Radio-oncology at the Loyola University,
Senior Editor of ASTRO Advances in Radiation Oncology,
Chair of ACR Commission on Radiation Oncology,
Chicago (USA) and renown radiation oncologist

Cosmesis

Objective assessment of cosmetic outcome after targeted intraoperative radiotherapy compared with EBRT over the years show a very good IORT cosmesis over time while EBRT decreases.

Pain

Radiation-related pain symptoms in patients with breast cancer show a significantly lower risk of developing moderate to severe pain for IORT patients compared to EBRT patients.

Time Matters

Due to immediate IORT during tumor resection biological wound healing response is downregulated which hinders epidermal growth factors (EGF) to help residual tumor cells to re-grow.

Cost-effectiveness

IORT costs are substantially lower compared to EBRT. Comparing the overall costs and real-costs of IORT and EBRT shows that in both cases the treatment costs can be reduced by more than 50% using IORT.

Keshtgar MR, Williams NR, Bulsara M., et al. (2013) Objective assessment of cosmetic outcome after targeted intraoperative radiotherapy in breast cancer: results from a randomised controlled trial. Breast Cancer Research and Treatment 140, pages 519–525, doi.org/10.1007/s10549-013-2641-8

Welzel G, Boch A, Sperk E, et al. (2013) Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. Radiation Oncology Journal 8, 9. doi.org/10.1186/1748-717X-8-9

Fabris L., Berton S., Citron F. et al. (2016). Radiotherapy-induced miR-223 prevents relapse of breast cancer by targeting the EGF pathway. Oncogene 35, 4914–4926 doi:10.1038/onc.2016.23

*per patient treatment course
Monten C, Lievens Y. (2017). Adjuvant breast radiotherapy: How to trade-off cost and effectiveness?. Radiother Oncol, https://doi.org/10.1016/j.radonc.2017.11.005

#3 Validation method fulfills highest scientific standards
  • Oversight by independent steering committee ensures high transparency of results
  • Follow-up time is with 8.6 years very long compared to other studies in IORT and completeness of patient follow-up is with over 95% at five years very high

Vaidya, J. S. et al. (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 TARGIT-A long-term outcomes are published in a highly respected peer reviewed medical journal and are based on a very high patient follow-up completeness, follow-up time, and sample size."

Professor Max Bulsara (08/2020)
Chair of Biostatistics at the University of Notre Dame
(Australia) and Statistician of the TARGIT-A study

Completeness of follow-up

Follow-up Time

Sample Size

Transparency

>95% for TARGIT-A compared to APBI trials (80%), @ 5-years1,2,3

TARGIT-A @ 102 months, in an APBI trial (86.05 months) comparison1,2,3

of N=2298 for TARGIT-A, in an APBI trial comparison1,2,3

Oversight by independent steering committee selected from governmental funded National Institute for Health Research (NIHR) Health Technology Assessment Programme ensures high transparency of results.1

1 Vaidya, J. S. et al. (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
2 Strnad, V. et al. (2020). DEGRO practical guideline for partial-breast irradiation. Strahlenther Onkol 196, 749–763. https://doi.org/10.1007/s00066-020-01613-z
3 Korzets, Y. et al. (2019). Toxicity and clinical outcomes of partial breast irradiation compared to whole breast irradiation for early-stage breast cancer: a systematic review and meta-analysis. Breast cancer research and treatment, 175(3), 531–545. https://doi.org/10.1007/s10549-019-05209-9

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