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

Authors

Jayant S. Vaidya
Pond R. Kelemen, New York Medical College
Jeffrey S. Tobias

DOI

10.1136/bmj.m2836

Journal Title

BMJ (Clinical research ed.)

First Page

2836

Last Page

2836

Document Type

Article

Publication Date

8-19-2020

Department

Surgery

Keywords

Aged, Breast Neoplasms, Carcinoma, Ductal, Breast, Combined Modality Therapy, Female, Humans, Intraoperative Care, Mastectomy, Segmental, Middle Aged, Neoplasm Invasiveness, Neoplasm Recurrence, Local, Prospective Studies, Radiotherapy Dosage, Survival Rate

Disciplines

Medicine and Health Sciences

Abstract

OBJECTIVE: To determine whether risk adapted intraoperative radiotherapy, delivered as a single dose during lumpectomy, can effectively replace postoperative whole breast external beam radiotherapy for early breast cancer.

DESIGN: Prospective, open label, randomised controlled clinical trial.

SETTING: 32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada.

PARTICIPANTS: 2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 cm in size, cN0-N1, eligible for breast conservation and randomised before lumpectomy (1:1 ratio, blocks stratified by centre) to either risk adapted targeted intraoperative radiotherapy (TARGIT-IORT) or external beam radiotherapy (EBRT).

INTERVENTIONS: Random allocation was to the EBRT arm, which consisted of a standard daily fractionated course (three to six weeks) of whole breast radiotherapy, or the TARGIT-IORT arm. TARGIT-IORT was given immediately after lumpectomy under the same anaesthetic and was the only radiotherapy for most patients (around 80%). TARGIT-IORT was supplemented by EBRT when postoperative histopathology found unsuspected higher risk factors (around 20% of patients).

MAIN OUTCOME MEASURES: Non-inferiority with a margin of 2.5% for the absolute difference between the five year local recurrence rates of the two arms, and long term survival outcomes.

RESULTS: Between 24 March 2000 and 25 June 2012, 1140 patients were randomised to TARGIT-IORT and 1158 to EBRT. TARGIT-IORT was non-inferior to EBRT: the local recurrence risk at five year complete follow-up was 2.11% for TARGIT-IORT compared with 0.95% for EBRT (difference 1.16%, 90% confidence interval 0.32 to 1.99). In the first five years, 13 additional local recurrences were reported (24/1140

CONCLUSION: For patients with early breast cancer who met our trial selection criteria, risk adapted immediate single dose TARGIT-IORT during lumpectomy was an effective alternative to EBRT, with comparable long term efficacy for cancer control and lower non-breast cancer mortality. TARGIT-IORT should be discussed with eligible patients when breast conserving surgery is planned.

Comments

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Recommended Citation

Vaidya, J. S., Kelemen, P. R., & Tobias, J. S. (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 (Clinical research ed.), 370, 2836-2836. https://doi.org/10.1136/bmj.m2836