Breast Cancer IORT validated to be effective and efficient
TARGIT-A study long-term outcomes published
Instead of 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.
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. 1140 patients were randomized to the TARGIT-IORT arm and treated with INTRABEAM® while 1158 patients were randomized to the EBRT arm.
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.
Local recurrence rate
The local recurrence rate shows a non-inferior outcome for immediate TARGIT-IORT compared with EBRT.
The total number of deaths and deaths from other causes shows fewer deaths for immediate TARGIT-IORT than for EBRT.
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.
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.2
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.3
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.4
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.5
*per patient treatment course
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.
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.
Completeness of follow-up
>95% for TARGIT-A compared to APBI trials (80%), @ 5-years1,6,7
TARGIT-A @ 102 months, in an APBI trial (86.05 months) comparison1,6,7
of N=2298 for TARGIT-A, in an APBI trial comparison1,6,7
Oversight by independent steering committee selected by governmental funded National Institute for Health Research (NIHR) Health Technology Assessment Programme ensures high transparency of results.1
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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
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
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
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
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