Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery: Recommendations of the Groupe Européen de Curiethérapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009)

Polgár, Csaba; Limbergen, Erik; Pötter, Richard; Kovács, György; Polo, Alfredo; Łyczek, Jarosław; Hildebrandt, Guido; Niehoff, Peter; Guinot, José Luis; Guedea, Ferrán; Johansson, Bengt; Ott, Oliver J.; Major, Tibor; Strnad, Vratislav

doi:10.1016/j.radonc.2010.01.014

Cited by 563 publications

(265 citation statements)

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“…The suitability criteria for PBI that have been suggested by ASTRO 142 and the European SocieTy for Radiotherapy & Oncology (ESTRO) 143 might be refined based on the TARGIT-A trial results. The ASTRO and ESTRO guidelines would normally exclude many of the patients with 'adverse' factors who were in fact eligible for the TARGIT-A trial's risk-adapted approach, and in the TARGIT-A trial it was found that these 'adverse' factors do not predict a worse outcome with TARGIT compared with EBRT.…”

Section: Suggested Modification To American Society For Radiation Oncmentioning

confidence: 99%

An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial)

Vaidya

Wenz

Bulsara

et al. 2016

Health Technol Assess

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BackgroundBased on our laboratory work and clinical trials we hypothesised that radiotherapy after lumpectomy for breast cancer could be restricted to the tumour bed. In collaboration with the industry we developed a new radiotherapy device and a new surgical operation for delivering single-dose radiation to the tumour bed – the tissues at highest risk of local recurrence. We named it TARGeted Intraoperative radioTherapy (TARGIT). From 1998 we confirmed its feasibility and safety in pilot studies.ObjectiveTo compare TARGIT within a risk-adapted approach with whole-breast external beam radiotherapy (EBRT) over several weeks.DesignThe TARGeted Intraoperative radioTherapy Alone (TARGIT-A) trial was a pragmatic, prospective, international, multicentre, non-inferiority, non-blinded, randomised (1 : 1 ratio) clinical trial. Originally, randomisation occurredbeforeinitial lumpectomy (prepathology) and, if allocated TARGIT, the patient received it during the lumpectomy. Subsequently, the postpathology stratum was added in which randomisation occurredafterinitial lumpectomy, allowing potentially easier logistics and a more stringent case selection, but which needed a reoperation to reopen the wound to give TARGIT as a delayed procedure. The risk-adapted approach meant that, in the experimental arm, if pre-specified unsuspected adverse factors were found postoperatively after receiving TARGIT, EBRT was recommended. Pragmatically, this reflected how TARGIT would be practised in the real world.SettingThirty-three centres in 11 countries.ParticipantsWomen who were aged ≥ 45 years with unifocal invasive ductal carcinoma preferably ≤ 3.5 cm in size.InterventionsTARGIT within a risk-adapted approach and whole-breast EBRT.Main outcome measuresThe primary outcome measure was absolute difference in local recurrence, with a non-inferiority margin of 2.5%. Secondary outcome measures included toxicity and breast cancer-specific and non-breast-cancer mortality.ResultsIn total, 3451 patients were recruited between March 2000 and June 2012. The following values are 5-year Kaplan–Meier rates for TARGIT compared with EBRT. There was no statistically significant difference in local recurrence between TARGIT and EBRT. TARGIT was non-inferior to EBRT overall [TARGIT 3.3%, 95% confidence interval (CI) 2.1% to 5.1% vs. EBRT 1.3%, 95% CI 0.7% to 2.5%;p = 0.04; Pnon-inferiority = 0.00000012] and in the prepathology stratum (n = 2298) when TARGIT was given concurrently with lumpectomy (TARGIT 2.1%, 95% CI 1.1% to 4.2% vs. EBRT 1.1%, 95% CI 0.5% to 2.5%;p = 0.31; Pnon-inferiority = 0.0000000013). With delayed TARGIT postpathology (n = 1153), the between-group difference was larger than 2.5% and non-inferiority was not established for this stratum (TARGIT 5.4%, 95% CI 3.0% to 9.7% vs. EBRT 1.7%, 95% CI 0.6% to 4.9%;p = 0.069; Pnon-inferiority = 0.06640]. The local recurrence-free survival was 93.9% (95% CI 90.9% to 95.9%) when TARGIT was given with lumpectomy compared with 92.5% (95% CI 89.7% to 94.6%) for EBRT (p = 0.35). In a planned subgroup analysis, progesterone receptor (PgR) status was found to be the only predictor of outcome: hormone-responsive patients (PgR positive) had similar 5-year local recurrence with TARGIT during lumpectomy (1.4%, 95% CI 0.5% to 3.9%) as with EBRT (1.2%, 95% CI 0.5% to 2.9%;p = 0.77). Grade 3 or 4 radiotherapy toxicity was significantly reduced with TARGIT. Overall, breast cancer mortality was much the same between groups (TARGIT 2.6%, 95% CI 1.5% to 4.3% vs. EBRT 1.9%, 95% CI 1.1% to 3.2%;p = 0.56) but there were significantly fewer non-breast-cancer deaths with TARGIT (1.4%, 95% CI 0.8% to 2.5% vs. 3.5%, 95% CI 2.3% to 5.2%;p = 0.0086), attributable to fewer deaths from cardiovascular causes and other cancers, leading to a trend in reduced overall mortality in the TARGIT arm (3.9%, 95% CI 2.7% to 5.8% vs. 5.3%, 95% CI 3.9% to 7.3%;p = 0.099]. Health economic analyses suggest that TARGIT was statistically significantly less costly than EBRT, produced similar quality-adjusted life-years, had a positive incremental net monetary benefit that was borderline statistically significantly different from zero and had a probability of > 90% of being cost-effective. There appears to be little uncertainty in the point estimates, based on deterministic and probabilistic sensitivity analyses. If TARGIT were given instead of EBRT in suitable patients, it might potentially reduce costs to the health-care providers in the UK by £8–9.1 million each year. This does not include environmental, patient and societal costs.LimitationsThe number of local recurrences is small but the number of events for local recurrence-free survival is not as small (TARGIT 57 vs. EBRT 59); occurrence of so few events (< 3.5%) also implies that both treatments are effective and any difference is unlikely to be large. Not all 3451 patients were followed up for 5 years; however, more than the number of patients required to answer the main trial question (n = 585) were followed up for > 5 years.ConclusionsFor patients with breast cancer (women who are aged ≥ 45 years with hormone-sensitive invasive ductal carcinoma that is up to 3.5 cm in size), TARGIT concurrent with lumpectomy within a risk-adapted approach is as effective as, safer than and less expensive than postoperative EBRT.Future workThe analyses will be repeated with longer follow-up. Although this may not change the primary result, the larger number of events may confirm the effect on overall mortality and allow more detailed subgroup analyses. The TARGeted Intraoperative radioTherapy Boost (TARGIT-B) trial is testing whether or not a tumour bed boost given intraoperatively (TARGIT) boost is superior to a tumour bed boost given as part of postoperative EBRT.Trial registrationCurrent Controlled Trials ISRCTN34086741 and ClinicalTrials.gov NCT00983684.FundingUniversity College London Hospitals (UCLH)/University College London (UCL) Comprehensive Biomedical Research Centre, UCLH Charities, Ninewells Cancer Campaign, National Health and Medical Research Council and German Federal Ministry of Education and Research (BMBF). From September 2009 this project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 73. See the NIHR Journals Library website for further project information.

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Section: Suggested Modification To American Society For Radiation Oncmentioning

confidence: 99%

An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial)

Vaidya

Wenz

Bulsara

et al. 2016

Health Technol Assess

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“…Up to now, this technique is recommended by the European (GEC-ESTRO) and the American (ASTRO) societies for radiation oncology as a standard of care only for a limited range of certain breast cancer cases [1,2]. However, there is a growing…”

Section: Introductionmentioning

confidence: 99%

The IOERT IntraLine accelerator – the development, current state, and future plans

et al. 2016

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Abstract. Intraoperative electron radiation therapy (IOERT) is a cancer treatment method that combines oncologic surgery with electron beam radiotherapy. This method can reduce the duration of entire tumor treatment and increase its effectiveness. Moreover, shortening the treatment time signifi cantly reduces the cost and accessibility of the therapy. As a result of interdisciplinary research, an innovative accelerator for IOERT, the IntraLine, was developed. In the course of this work, four patent applications were fi led. Today, the work is half way through. In the near future, the device will be optimized. New mechanical design solutions will be developed. Mechanical optimization will signifi cantly reduce the weight of the device. Accelerators control system, which today is in the demo phase, will also be signifi cantly upgraded. This paper describes the stages of the IntraLine accelerator development, its current state and plans for the future R&D work, within the scope of our new Intra-Dose project.

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“…Для ее проведения применяются аппараты с использованием пучка электронов с энергией излучения 3, 5, 7 и 9 МэВ (мобиль-ный линейный ускоритель NOVAC 7 (NRT, Италия) с роботизированной рукой и аппли-каторами 4-10 см в диаметре), потока фотонов с энергией 50 кВ (система INTRABEAM); • брахитерапия (низкодозная и высокодозная), успешно применяемая во многих клиниках, внутриполостная брахитерапия с использова-нием баллонного катетера MammoSite (с источником Ir 192 ); • дистанционная ЛТ с использованием совре-менных технологий (3D-конформная ЛТ, ЛТ с модулированной интенсивностью) [16][17][18]. Критерии тщательного отбора больных ранним РМЖ для проведения ЛТ после органосохраняющих операций по методике APBI были разработаны евро-пейскими исследователями и окончательно доработа-ны американскими экспертами после тщательного анализа данных 645 статей, 4 рандомизированных и 38 проспективных исследований.…”

Section: опухоли женской репродуктивной системы Tumors Of Female Reprunclassified

Results of Early-Stage Breast Cancer Patients’ Treatment Using Accelerated Partial Breast Irradiation Technique After Breast-Conserving Surgery. Experience of N.N. Blokhin National Medical Research Center of Oncology

Трофимова¹,

Волкова²,

Nazarenko³

et al. 2017

Tumors of female reproductive system

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Patient selection for accelerated partial-breast irradiation (APBI) after breast-conserving surgery: Recommendations of the Groupe Européen de Curiethérapie-European Society for Therapeutic Radiology and Oncology (GEC-ESTRO) breast cancer working group based on clinical evidence (2009)

Cited by 563 publications

References 93 publications

An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial)

An international randomised controlled trial to compare TARGeted Intraoperative radioTherapy (TARGIT) with conventional postoperative radiotherapy after breast-conserving surgery for women with early-stage breast cancer (the TARGIT-A trial)

The IOERT IntraLine accelerator – the development, current state, and future plans

Results of Early-Stage Breast Cancer Patients’ Treatment Using Accelerated Partial Breast Irradiation Technique After Breast-Conserving Surgery. Experience of N.N. Blokhin National Medical Research Center of Oncology

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