scholarly journals 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 ◽  
2020 ◽  
pp. m2836 ◽  
Author(s):  
Jayant S Vaidya ◽  
Max Bulsara ◽  
Michael Baum ◽  
Frederik Wenz ◽  
Samuele Massarut ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Single Dose ◽  
Local Recurrence ◽  
Early Breast Cancer ◽  
External Beam Radiotherapy ◽  
Breast Cancer Mortality ◽  
Intraoperative Radiotherapy ◽  
Term Survival ◽  
Free Survival

AbstractObjectiveTo 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.DesignProspective, open label, randomised controlled clinical trial.Setting32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada.Participants2298 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).InterventionsRandom 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 measuresNon-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.ResultsBetween 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 v 11/1158) but 14 fewer deaths (42/1140 v 56/1158) for TARGIT-IORT compared with EBRT. With long term follow-up (median 8.6 years, maximum 18.90 years, interquartile range 7.0-10.6) no statistically significant difference was found for local recurrence-free survival (hazard ratio 1.13, 95% confidence interval 0.91 to 1.41, P=0.28), mastectomy-free survival (0.96, 0.78 to 1.19, P=0.74), distant disease-free survival (0.88, 0.69 to 1.12, P=0.30), overall survival (0.82, 0.63 to 1.05, P=0.13), and breast cancer mortality (1.12, 0.78 to 1.60, P=0.54). Mortality from other causes was significantly lower (0.59, 0.40 to 0.86, P=0.005).ConclusionFor 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.Trial registrationISRCTN34086741, NCT00983684.

scholarly journals Single-dose intraoperative radiotherapy during lumpectomy for breast cancer: an innovative patient-centred treatment

2021 ◽  
Author(s):  
Jayant S. Vaidya ◽  
◽  
Max Bulsara ◽  
Michael Baum ◽  
Jeffrey S. Tobias
Keyword(s):  
Breast Cancer ◽  
Single Dose ◽  
Local Recurrence ◽  
External Beam Radiotherapy ◽  
Intraoperative Radiotherapy ◽  
External Beam ◽  
Breast Cancer Outcome ◽  
Cancer Outcome

SummaryIn the randomised TARGIT-A trial, risk-adapted targeted intraoperative radiotherapy (TARGIT-IORT) during lumpectomy was non-inferior to whole-breast external beam radiotherapy, for local recurrence. In the long-term, no difference was found in any breast cancer outcome, whereas there were fewer deaths from non-breast-cancer causes. TARGIT-IORT should be included in pre-operative consultations with eligible patients.

scholarly journals New clinical and biological insights from the international TARGIT-A randomised trial of targeted intraoperative radiotherapy during lumpectomy for breast cancer

2021 ◽  
Author(s):  
Jayant S. Vaidya ◽  
Max Bulsara ◽  
Michael Baum ◽  
Frederik Wenz ◽  
Samuele Massarut ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Local Recurrence ◽  
Cancer Mortality ◽  
Breast Cancer Mortality ◽  
Intraoperative Radiotherapy ◽  
Lymph Node Status ◽  
Recurrence Free Survival ◽  
Free Survival ◽  
Distant Relapse ◽  
Local Recurrence Free Survival

Abstract Background The TARGIT-A trial reported risk-adapted targeted intraoperative radiotherapy (TARGIT-IORT) during lumpectomy for breast cancer to be as effective as whole-breast external beam radiotherapy (EBRT). Here, we present further detailed analyses. Methods In total, 2298 women (≥45 years, invasive ductal carcinoma ≤3.5 cm, cN0–N1) were randomised. We investigated the impact of tumour size, grade, ER, PgR, HER2 and lymph node status on local recurrence-free survival, and of local recurrence on distant relapse and mortality. We analysed the predictive factors for recommending supplemental EBRT after TARGIT-IORT as part of the risk-adapted approach, using regression modelling. Non-breast cancer mortality was compared between TARGIT-IORT plus EBRT vs. EBRT. Results Local recurrence-free survival was no different between TARGIT-IORT and EBRT, in every tumour subgroup. Unlike in the EBRT arm, local recurrence in the TARGIT-IORT arm was not a predictor of a higher risk of distant relapse or death. Our new predictive tool for recommending supplemental EBRT after TARGIT-IORT is at https://targit.org.uk/addrt. Non-breast cancer mortality was significantly lower in the TARGIT-IORT arm, even when patients received supplemental EBRT, HR 0.38 (95% CI 0.17–0.88) P = 0.0091. Conclusion TARGIT-IORT is as effective as EBRT in all subgroups. Local recurrence after TARGIT-IORT, unlike after EBRT, has a good prognosis. TARGIT-IORT might have a beneficial abscopal effect. Trial registration ISRCTN34086741 (21/7/2004), NCT00983684 (24/9/2009).

scholarly journals Long-term prognosis of patients with local recurrence after conservative surgery and radiotherapy for early breast cancer

2005 ◽  
Vol 41 (17) ◽  
pp. 2637-2644 ◽  
Author(s):  
A.C. Voogd ◽  
F.J. van Oost ◽  
E.J.T. Rutgers ◽  
P.H.M. Elkhuizen ◽  
A.N. van Geel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Local Recurrence ◽  
Early Breast Cancer ◽  
Conservative Surgery ◽  
Long Term Prognosis

scholarly journals Intraoperative radiotherapy to treat newly diagnosed solitary brain metastasis: initial experience and long-term outcomes

2015 ◽  
Vol 122 (4) ◽  
pp. 825-832 ◽  
Author(s):  
Robert J. Weil ◽  
Gaurav G. Mavinkurve ◽  
Samuel T. Chao ◽  
Michael A. Vogelbaum ◽  
John H. Suh ◽  
...  
Keyword(s):  
Brain Metastasis ◽  
Intraoperative Radiotherapy ◽  
Progression Free Survival ◽  
Patient Treatment ◽  
Karnofsky Performance Scale ◽  
Newly Diagnosed ◽  
Term Survival ◽  
Solitary Brain Metastasis ◽  
Free Survival

OBJECT The authors assessed the feasibility of intraoperative radiotherapy (IORT) using a portable radiation source to treat newly diagnosed, surgically resected, solitary brain metastasis (BrM). METHODS In a nonrandomized prospective study, 23 patients with histologically confirmed BrM were treated with an Intrabeam device that delivered 14 Gy to a 2-mm depth to the resection cavity during surgery. RESULTS In a 5-year minimum follow-up period, progression-free survival from the time of surgery with simultaneous IORT averaged (± SD) 22 ± 33 months (range 1–96 months), with survival from the time of BrM treatment with surgery+IORT of 30 ± 32 months (range 1–96 months) and overall survival from the time of first cancer diagnosis of 71 ± 64 months (range 4–197 months). For the Graded Prognostic Assessment (GPA), patients with a score of 1.5–2.0 (n = 12) had an average posttreatment survival of 21 ± 26 months (range 1–96 months), those with a score of 2.5–3.0 (n = 7) had an average posttreatment survival of 52 ± 40 months (range 5–94 months), and those with a score of 3.5–4.0 (n = 4) had an average posttreatment survival of 17 ± 12 months (range 4–28 months). A BrM at the treatment site recurred in 7 patients 9 ± 6 months posttreatment, and 5 patients had new but distant BrM 17 ± 3 months after surgery+IORT. Six patients later received whole-brain radiation therapy, 7 patients received radiosurgery, and 2 patients received both treatments. The median Karnofsky Performance Scale scores before and 1 and 3 months after surgery were 80, 90, and 90, respectively; at the time of this writing, 3 patients remain alive with a CNS progression-free survival of > 90 months without additional BrM treatment. CONCLUSIONS The results of this study demonstrate the feasibility of resection combined with IORT at a dose of 14 Gy to a 2-mm peripheral margin to treat a solitary BrM. Local control, distant control, and long-term survival were comparable to those of other commonly used modalities. Surgery combined with IORT seems to be a potential adjunct to patient treatment for CNS involvement by systemic cancer.

scholarly journals Detection of local recurrence following breast-conserving treatment in young women with early breast cancer: Optimization of long-term follow-up strategies

The Breast ◽  
2013 ◽  
Vol 22 (3) ◽  
pp. 351-356 ◽  
Author(s):  
Maurice J.C. van der Sangen ◽  
Sanne W.M. Scheepers ◽  
Philip M.P. Poortmans ◽  
Ernest J.T. Luiten ◽  
Grard A.P. Nieuwenhuijzen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Local Recurrence ◽  
Early Breast Cancer ◽  
Young Women ◽  
Breast Conserving Treatment ◽  
Long Term Follow Up

Long-Term Benefits of 5 Years of Tamoxifen: 10-Year Follow-Up of a Large Randomized Trial in Women at Least 50 Years of Age With Early Breast Cancer

2011 ◽  
Vol 29 (13) ◽  
pp. 1657-1663 ◽  
Author(s):  
Allan Hackshaw ◽  
Michael Roughton ◽  
Sharon Forsyth ◽  
Kathryn Monson ◽  
Krystyna Reczko ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Contralateral Breast Cancer ◽  
Disease Free Survival ◽  
Contralateral Breast ◽  
Free Survival ◽  
Free Data ◽  
Cv Disease

Purpose The Cancer Research UK “Over 50s” trial compared 5 and 2 years of tamoxifen in women with early breast cancer. Results are reported after median follow-up of 10 years. Patients and Methods Between 1987 and 1997, 3,449 patients age 50 to 81 years with operable breast cancer who had been taking 20 mg of tamoxifen for 2 years were randomly assigned to either stop or continue for an additional 3 years, if they were alive and recurrence free. Data on recurrences, new tumors, deaths, and cardiovascular events were obtained (April 2010). Results There were 1,103 recurrences, 755 deaths as a result of breast cancer, 621 cardiovascular (CV) events, and 236 deaths as a result of CV events. Fifteen years after starting treatment, for every 100 women who received tamoxifen for 5 years, 5.8 fewer experienced recurrence, compared with those who received tamoxifen for 2 years. The risk of contralateral breast cancer was significantly reduced (hazard ratio, 0.70; 95% CI, 0.48 to 1.00). Among women age 50 to 59 years, there was a 35% reduction in CV events (P = .005) and 59% reduction in death as a result of a CV event (P = .02); in older women, the effect was much smaller and not statistically significant. Conclusion Taking tamoxifen for the recommended 5 years reduces the risk of recurrence or contralateral breast cancer 15 years after starting treatment. It also lowers the risk of CV disease and death as a result of a CV event, particularly among those age 50 to 59 years. Women should therefore be encouraged to complete the full course. Although aromatase inhibitors improve disease-free survival, tamoxifen remains a cheap and highly effective alternative, particularly in developing countries.

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