Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial

Vicini, Frank A.; Cecchini, Reena S.; White, Julia; Arthur, Douglas W.; Julian, Thomas B.; Rabinovitch, Rachel; Kuske, Robert R.; Ganz, Patricia A.; Parda, David S.; Scheier, Michael F.; Winter, Kathryn; Paik, Soonmyung; Kuerer, Henry Mark; Vallow, Laura A.; Pierce, Lori J.; Mamounas, Eleftherios P.; McCormick, Beryl; Costantino, Joseph P.; Bear, Harry D.; Germain, Isabelle; Gustafson, G.; Grossheim, L.; Petersen, Ivy A.; Hudes, Richard; Curran, Walter J.; Bryant, John; Wolmark, Norman

doi:10.1016/s0140-6736(19)32514-0

Cited by 351 publications

(309 citation statements)

References 23 publications

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“…In the completed trials, APBI was delivered using intraoperative radiation, brachytherapy or external beam techniques [20][21][22][23][24].Local recurrence rates were overall slightly higher in the partial breast groups, especially in patients with higher risk breast cancer subtypes [20,22,25]. Results of two large randomized trials (NSABP B-39/RTOG 0413, RAPID) were recently presented at the SABCS18 and subsequently published in the Lancet in 2019 [26,27].…”

Section: Partial Breast Irradiation (Pbi)mentioning

confidence: 99%

Recent advances in radiotherapy of breast cancer

et al. 2020

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Radiation therapy is an integral part of the multidisciplinary management of breast cancer. Regional lymph node irradiation in younger trials seems to provide superior target coverage as well as a reduction in long-term toxicity resulting in a small benefit in the overall survival rate. For partial breast irradiation there are now two large trials available which support the role of partial breast irradiation in low risk breast cancer patients. Multiple randomized trials have established that a sequentially applied dose to the tumor bed improves local control with the cost of worse cosmetic results.

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Section: Partial Breast Irradiation (Pbi)mentioning

confidence: 99%

Recent advances in radiotherapy of breast cancer

et al. 2020

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“…When the TARGIT-A trial protocol was published in 1999,8 restricting radiotherapy to only the area around the tumour had been explored in small patient series9 and one randomised trial,10 which had reported inferior results. At that time whole breast radiotherapy was the standard of care, and it remains so today, despite the publication of our initial results111213 and several other approaches 1415161718192021…”

Section: Introductionmentioning

confidence: 99%

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

Vaidya

Bulsara

Baum

et al. 2020

BMJ

195

209

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ObjectiveTo 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.

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“…A randomized controlled study comparing the safety and cosmetic effects of 3D-CRT and WBI found that APBI 3D-CRT presented increased cosmetic and late radiation toxicity compared with standard WBI at 3-year follow-up ( 11 ). RTOG 0413, a phase III trial comparing different APBI technique with WBI for a diverse group of early stage patients, have shown that APBI did not meet the equivalent criteria of WBI at a median follow-up of 10.2 years, even though the absolute difference of IBTR between the two groups was only 0.7% difference ( 28 ). The 5-year recurrence rate of partial breast irradiation in the ELIOT study was slightly higher than that of the whole breast irradiation group ( 29 ).…”

Section: Discussionmentioning

confidence: 99%

Long-Term Results of Partial Breast Irradiation After Breast-Conserving Surgery for Early Stage Breast Cancer: A Prospective Phase II Trial in China

Shui

Wang

et al. 2020

Front. Oncol.

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Background Partial breast radiotherapy (PBI) has emerged as an option after breast-conserving surgery for early stage breast cancer patients. Methods A total of 55 patients with early stage breast cancer between 2009 and 2013 were enrolled in this single-institutional phase II prospective clinical trial. All patients received adjuvant PBI-IMRT after lumpectomy, with the prescription of 48 Gy in 12 fractions at 4 Gy per fraction, 5 days a week. The primary endpoint was ipsilateral breast tumor recurrence (IBTR), the other endpoints were a regional nodal failure (RNF), distant metastasis (DM) rate, disease-free survival (DFS), and overall survival (OS). These endpoints were used to evaluate clinical outcomes. The cosmetic effects and the late toxicity were assessed according to Harvard standard scale and CTCAE 3.0, respectively. Results In our cohorts, the median age was 45.60 years old (range 31–65 years) and 29.09% of these patients were post-menopause ( n = 16). Most patients were T1 stage (65.45%) or N0 stage (70.91%). 80% of patients were ER-positive, 67.27% PR positive, and 61.82% HER2 negative. At the median follow-up of 9.25 years, RNF was 0% and IBTR occurred in only one patient (1.82%) to the chest wall. Except for one patient (1.82%) had DM to lung and pleura and died from disease progression, the remaining patients were alive at the end of the 10-year follow-up. The 10-year DFS and OS were 94.55 and 98.18%. One patient (1.82%) was diagnosed with endometrial cancer after PBI. Except for 9 patients who declined the cosmetic assessment, the rest of the 46 patients (83.64%) were all rated as good and well-satisfied with the appearance of the irradiated breast. No breast retraction and fibrosis were observed in any of the patients. Additionally, only 4 patients experienced grade 1 late toxicity (7.28%). None had grade 3 or higher late toxicity. Conclusion This is the first study to report the 10-year results of PBI after breast-conserving surgery in Chinese patients. Our study suggested that PBI had durable local control and maintained good cosmetic outcomes with minimal late toxicity at long term follow up for the early stage breast cancer patients.

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Long-term primary results of accelerated partial breast irradiation after breast-conserving surgery for early-stage breast cancer: a randomised, phase 3, equivalence trial

Cited by 351 publications

References 23 publications

Recent advances in radiotherapy of breast cancer

Recent advances in radiotherapy of breast cancer

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

Long-Term Results of Partial Breast Irradiation After Breast-Conserving Surgery for Early Stage Breast Cancer: A Prospective Phase II Trial in China

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