Case report: IORT as an alternative treatment option for breast cancer patients with difficulty staying still.

Background: Administering radiation therapy to individuals with intellectual disabilities (ID) and psychiatric patients taking antipsychotics poses challenges, especially with whole breast irradiation (WBI) due to difficulty staying still (DSS). In such scenarios, intraoperative radiotherapy (TARGIT-IORT) provides an alternative. Although prior studies have shown its applicability in special cases where WBI may be contraindicated, there is a paucity of literature emphasizing its role in patients with ID and psychiatric conditions who have DSS. Therefore, our case series aims to highlight the applicability of administering TARGIT-IORT in such patients. Case reports: Four breast cancer patients underwent lumpectomy and TARGIT-IORT. Among them, two patients had ID, with one experiencing a decreased range of motion. The other two had psychiatric disorders, including schizophrenia and bipolar disorder, both manifesting involuntary movements and DSS. Three patients had invasive ductal carcinoma (IDC), and one had invasive lobular carcinoma (ILC). All patients undergoing TARGIT-IORT tolerated the procedure well. Notably, none of the patients exhibited evidence of disease on follow-up. Conclusion: Our study underscores the potential use of TARGIT-IORT as a viable treatment option for breast cancer patients with intellectual and psychiatric disabilities. Unlike traditional EBRT, TARGIT-IORT offers a single radiation dose, addressing challenges associated with compliance or DSS. Our findings demonstrate positive outcomes and tolerance, especially in patients where standard oncologic procedures are difficult to achieve. TARGIT-IORT could also benefit breast cancer patients with concurrent movement disorders like Parkinson's disease and other movement disorders. Nonetheless, future studies are needed to reinforce its applicability for patients with DSS.

Clinical Outcomes of Breast-Conserving Surgery with Synchronous 50-kV X-ray Intraoperative Partial Breast Irradiation in Patients Aged 64 Years or Older with Low-Risk Breast Cancer.

Background: Breast-conserving surgery with synchronous 50-kV X-ray intraoperative radiation therapy (TARGIT-IORT) is a convenient form of partial breast irradiation; however, the existing literature supports a wide range of local control rates. Objectives: We investigated the treatment effectiveness and toxic effects of TARGIT-IORT in a patient cohort aged 64 years or older with low-risk breast cancer. Design: Retrospective analysis. Methods: Patients who received breast-conserving surgery with synchronous TARGIT-IORT at a single institution from 2016 to 2019 were reviewed. Additional whole breast irradiation was recommended at the discretion of the treating radiation oncologist. Baseline patient demographics and treatment details were recorded. Acute and chronic toxicities, measured using the Common Terminology Criteria for Adverse Events version 3.0 or 4.0 and breast cosmetic outcomes, using the Harvard Cosmesis score, were recorded. Locoregional recurrence, distant metastasis, and overall survival were recorded, and 5-year rates were estimated using the Kaplan-Meier method. Results: 61 patients were included with a median follow-up of 3.5 years and median age of 72 years. Eight (13%) patients received additional whole breast irradiation, and fifty-four (89%) received adjuvant hormone therapy. There were no local, regional, or distance recurrences. One patient died of complications from COVID-19 infection. Grade 2 + acute and chronic toxicities were observed in 6 (12%) and 7 (14%) patients, respectively. One patient experienced a grade 3 acute toxicity. Cosmetic outcome was "excellent" or "good" in 45 (92%) patients. Conclusions: Breast TARGIT-IORT was well tolerated and conferred excellent disease control in this cohort of patients with low-risk breast cancer. While continued follow-up is required, TARGIT-IORT may be an appropriate treatment option for this population.

Case Report: Bilateral targeted intraoperative radiotherapy: a safe and effective alternative for synchronous bilateral breast cancer.

Background: The incidence of bilateral breast cancer (BBC) ranges from 1.4% to 11.8%. BBC irradiation is a challenge in current clinical practice due to the large target volume that must be irradiated while minimizing the dose to critical organs. Supine or prone breast techniques can be used, with the latter providing better organ sparing; both, however, result in lengthy treatment times. The use of Intra-operative radiotherapy (IORT) in breast cancer patients who choose breast conservation has been highlighted in previous studies, but there is a scarcity of literature analyzing the utility and applicability of IORT in BBC. This case series aims to highlight the applicability of administering bilateral IORT in patients with BBC. Case reports: Five patients with bilateral early-stage breast cancer (or DCIS) were treated with breast-conserving surgery followed by bilateral IORT. Of the 10 breast cancers, 8 were diagnosed as either DCIS or IDC, while the other 2 were diagnosed as invasive lobular carcinoma and invasive carcinoma, respectively. During surgery, all patients received bilateral IORT. Furthermore, 1 patient received external beam radiation therapy after her final pathology revealed grade 3 DCIS. The IORT procedure was well tolerated by all five patients, and all patients received aromatase inhibitors as adjuvant therapy. Additionally, none of these patients showed evidence of disease after a 36-month median follow-up. Conclusion: Our findings demonstrate the successful use of IORT for BCS in patients with BBC. Furthermore, none of the patients in our study experienced any complications, suggesting the feasibility of the use of IORT in BBC. Considering the benefits of improved patient compliance and a reduced number of multiple visits, IORT may serve as an excellent patient-centered alternative for BBC. Future studies are recommended to reinforce the applicability of IORT in patients with BBC.

Case Report: Intraoperative radiotherapy as the new standard of care for breast cancer patients with disabling health conditions or impairments.

In selected patients, intraoperative radiotherapy (IORT) offers an alternative to standard external beam radiotherapy (EBRT) while providing equivalent breast cancer control outcomes. After IORT, most patients do not require external beam radiotherapy and thus avoid the need to travel to and from a radiotherapy centre in the weeks after surgery. EBRT is associated with an increased risk of non-breast cancer mortality and poorer cosmetic outcomes while increasing patient travel time, emissions associated with travel and time spent in the hospital. Consequently, EBRT is associated with an overall reduction in quality of life compared to IORT. Patients with other on-going health conditions or clinical impairments are likely to be affected by the daily radiotherapy requirement. Should these patients be consulted during their pre-operative assessment as to options to undergo IORT? This paper describes a case of IORT and follow up in a functionally blind patient. Quality of life effects are elucidated and further support the use of IORT in selected breast cancer patients with health conditions or impairments.

Radioterapia intraoperatoria de la mama con intrabeam, experiencia de la Unidad de Mastología del Hospital Italiano de Buenos Aires / Intraoperative radiotherapy of the breast with intrabeam, experience of the Mastology Unit of the Italian Hospital of Buenos Aires

Objetivo: La radioterapia intraoperatoria (IORT) es la radioterapia que se administra directamente al lecho tumoral. Existen varias modalidades de IORT. La empleada en nuestro centro es la que utiliza el dispositivo Intrabeam, el cual a través de rayos X de baja energía y un aplicador esférico que se adapta al lecho tumoral, permite la administración de la radiación a los tejidos con mayor riesgo de recidiva. Presentamos nuestra experiencia inicial de IORT con el dispositivo Intrabeam. Material y método: Se seleccionaron 51 pacientes con cáncer de mama para IORT con Intrabeam ® según protocolo TARGIT-A, desde febrero 2021 hasta mayo 2022. Los indicaciones fueron: pacientes mayores a 45 años, con tumores unifocales, < 3 cm de diámetro, luminales A o B, con axila clínica e imagenológicamente negativa. También se incluyen pacientes con carcinoma intraductal, de bajo grado o de grado intermedio. Resultados: La edad media fue de 66 años. Según el examen histológico definitivo, el tamaño tumoral promedio fue de 11.9 mm, con 95% de las pacientes con tumores menores a 2 cm. El 82.3% de nuestras pacientes completaron su tratamiento radiante sólo con la radioterapia intraoperatoria, pero en 9 casos (17.6%) fue necesario agregar radioterapia externa del volumen mamario. 10 pacientes (25.6%) tuvieron complicaciones, 2 casos fueron seromas que precisaron varias aspiraciones para su resolución. El resultado estético es muy bueno. Conclusiones: La IORT con Intrabeam es una alternativa segura y bien tolerada frente a la radioterapia externa en pacientes seleccionadas, con un buen resultado estético a corto plazo(AU)

Objetive: Intraoperative radiation therapy (IORT) is a radiation therapy delivered directly to the tumor bed. There are several modalities of IORT. The one used in our center is the one that uses the Intrabeam device, which through low-energy X-rays and a spherical applicator that adapts to the tumor bed, allows the administration of radiation to the tissues with the highest risk of recurrence. We present our initial experience with the Intrabeam device at our center. Material and method: From February 2021 to May 2022, 51 patients with breast cáncer were selected for IORT with Intrabeam® according to the TARGIT-A protocol. The indications were: patients older than 45 years, with unifocal tumors, < 3 cm in diameter, luminal A or B, with negative clinical and imaging axilla. Patients with intraductal, low-grade or intermediate-grade carcinoma were also included. Results: The mean age was 66 years. According to the definitive histological examination, the average tumor size was 11.9 mm, 95% of the patients with tumors smaller than 2 cm. 82.3% of our patients completed their radiant treatment with intraoperative radiotherapy alone, but in 9 cases (17.6%) it was necessary to add external radiotherapy of the breast volume. 10 patients (25.6%) had complications, 2 cases were seromas that required several aspirations for their resolution. The aesthetic result is very good. Conclusions: IORT with Intrabeam is a safe and well tolerated alternative versus external radiotherapy in selected patients and provides a good shortterm aesthetic result(AU)

Breast Conserving Surgery in Combination With Targeted Intraoperative Radiotherapy Compared to Mastectomy for In-breast-tumor-recurrence.

BACKGROUND/AIM: Mastectomy is the standard treatment of in-breast-recurrence of breast cancer after breast conserving surgery (BCS) and external beam radiation therapy (EBRT). In selected cases, it is possible to preserve the breast if targeted intraoperative radiotherapy (TARGIT-IORT) can be given during the second lumpectomy. This is a comparative analysis of overall survival and quality of life (QoL). PATIENTS AND METHODS: Patients in our database with in-breast-recurrence and either mastectomy or BCS and TARGIT-IORT were included. Identified patients were offered participation in a prospective QoL-analysis using the BREAST-Q questionnaire. The cohorts were compared for confounding parameters, overall survival, and QoL. RESULTS: Thirty-six patients treated for in-breast-recurrence were included, 21 had received a mastectomy and 16 patients had received BCS with TARGIT-IORT. Mean follow-up was 12.8 years since primary diagnosis and 4.2 years since recurrence. Both groups were balanced regarding prognostic parameters. Overall survival was numerically longer for BCS and TARGIT-IORT, but the numbers were too small for formal statistical analysis. No patient had further in-breast-recurrence. Psychosocial and sexual wellbeing did not differ between both groups. Physical wellbeing was significantly superior for those whose breast could be preserved (p-value=0.021). Patient-reported incidence and severity of lymphedema of the arm was significantly worse in the mastectomy group (p=0.007). CONCLUSION: Preserving the breast by use of TARGIT-IORT was safe with no re-recurrence and no detriment to overall survival in our analysis and led to a statistically significant improvement in physical wellbeing and incidence of lymphedema. These data should increase the confidence in offering breast preservation after in-breast-recurrence of breast cancer.

Global adoption of single-shot targeted intraoperative radiotherapy (TARGIT-IORT) for breast cancer-better for patients, better for healthcare systems.

Micro abstract: Targeted intraoperative radiotherapy (TARGIT-IORT) is delivered immediately after lumpectomy for breast cancer. We estimated its impact. At least 44,752 patients with breast cancer were treated with TARGIT-IORT in 260 centres in 35 countries, saving >20 million miles of travel and preventing ~2,000 non-breast cancer deaths. The TARGIT-IORT website (https://targit.org.uk/travel) provides maps and tools to find the nearest centre offering TARGIT-IORT and travel savings. Background: Targeted intraoperative radiotherapy (TARGIT-IORT) delivers radiotherapy targeted to the fresh tumour bed exposed immediately after lumpectomy for breast cancer. TARGIT-A trial found TARGIT-IORT to be as effective as whole-breast radiotherapy, with significantly fewer deaths from non-breast cancer causes. This paper documents its worldwide impact and provides interactive tools for clinicians and patients. Method: Centres using TARGIT-IORT provided the date of the first case and the total number of patients. We plotted these data on a customised Google Map. An interactive web-based tool provided directions to the closest centre. Using the data from the TARGIT-A trial, we estimated the total savings in travel miles, carbon footprint, and the number of non-breast cancer deaths that might be prevented. Results: Data from 242 (93%) of the 260 centres treating patients from 35 countries were available. From the first patient treated in 1998 to early 2020, at least 44,752 women with breast cancer have been treated with TARGIT-IORT. The TARGIT-IORT website (https://targit.org.uk/travel) displays the Google Map of centres with number of cases and an interactive tool for patients to find the nearest centre offering TARGIT-IORT and their travel savings. Scaling up to the already treated patients, >20 million miles of travel would have been saved and about 2,000 deaths prevented. Conclusion: One can ascertain the number of patients treated with a novel treatment. These data show how widely TARGIT-IORT has now been adopted and gives an indication of its beneficial worldwide impact on a large number of women with breast cancer.

Case Report: Can Targeted Intraoperative Radiotherapy in Patients With Breast Cancer and Pacemakers be the New Standard of Care?

Background: Partial breast irradiation with Intra-operative radiotherapy (IORT) has become a popular management option as opposed to whole breast radiation using external beam radiotherapy for breast cancer patients. While previous studies have highlighted the use of IORT in breast cancer patients, there is a scarcity of literature on the use of IORT in those who also have ipsilateral pacemakers. Thus, the aim of our case report is to highlight the applicability of IORT in breast cancer patients who also have a pacemaker. Case Reports: Two female patients with an implanted dual-chamber pacemaker presented with a diagnosis of left-sided invasive ductal carcinoma on mammogram. Mammography of the left breast revealed a 10 mm and 7 mm spiculated mass, respectively, further confirmed with an ultrasound-guided core biopsy that was conclusive of clinical Stage I T1 N0 grade 2, ER +, PR + Her2 - invasive ductal carcinoma. They met our eligibility criteria for IORT, which is being performed as a registry trial. These patients underwent a wide excision lumpectomy along with IORT. Conclusion: Our findings underscore the successful use of targeted IORT for breast-conserving surgery in a patient with invasive ductal carcinoma and pacemaker, hence eliminating the necessity for relocating pacemaker surgeries in these patients. Furthermore, no device failure or malfunction for the pacemaker was recorded before, during, or after the surgery, demonstrating the safety of using IORT in patients with preinstalled pacemaker despite a lack of evidence on safe radiation dosage or manufacturer guidelines. Nonetheless, the effects of IORT on pacemaker < 10 cm were not studied in our patients and further clinical studies are recommended to reinforce the applicability and safe distance of IORT in breast cancer patients with pacemaker.

Effectiveness and safety of intraoperative radiotherapy (IORT) with low-energy X-rays (INTRABEAM®) for accelerated partial breast irradiation (APBI).

PURPOSE: To evaluate treatment outcomes in patients with early-stage breast cancer (ESBC) treated with targeted intraoperative radiation therapy (IORT) administered as accelerated partial breast irradiation (APBI). METHODS: Between December 2014 and May 2019, 50 patients diagnosed with ESBC were treated with a 50 kilovoltage (kV) X-ray source with a single dose of 20 Gy using the Intrabeam® radiotherapy delivery system. All patients were followed prospectively to assess local control (LC), disease-free survival (DFS), cancer-specific survival (CSS), overall survival (OS), radiation-induced toxicity, and cosmetic outcomes. We also evaluated the prognostic implications of the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). RESULTS: Median follow-up was 53 months. Mean patient age was 70 years. The mean duration of radiation delivery was 22.25 min. Two patients developed a recurrence. One death was recorded. Elevated pretreatment NLR levels were a significant risk factor for mortality (p = 0.0026). The most common treatment-related toxicities were breast induration (30%) and seroma (18%). Five-year LC, DFS, CSS, and OS rates were 97.1%, 93.9%, 100%, and 94.4%, respectively. Cosmesis was excellent or good in most cases (94%). CONCLUSION: These findings confirm the effectiveness of a single dose of 20 Gy of IORT with the Intrabeam device as APBI. The toxicity profile was good with excellent cosmesis. These results provide further support for the clinical use of APBI in well-selected patients.

Dosimetric evaluation of incorporating the revised V4.0 calibration protocol for breast intraoperative radiotherapy with the INTRABEAM system.

In breast-targeted intraoperative radiotherapy (TARGIT) clinical trials (TARGIT-B, TARGIT-E, TARGIT-US), a single fraction of radiation is delivered to the tumor bed during surgery with 1.5- to 5.0-cm diameter spherical applicators and an INTRABEAM x-ray source (XRS). This factory-calibrated XRS is characterized by two depth-dose curves (DDCs) named "TARGIT" and "V4.0." Presently, the TARGIT DDC is used to treat patients enrolled in clinical trials; however, the V4.0 DDC is shown to better represent the delivered dose. Therefore, we reevaluate the delivered prescriptions under the TARGIT protocols using the V4.0 DDC. A 20-Gy dose was prescribed to the surface of the spherical applicator, and the TARGIT DDC was used to calculate the treatment time. For a constant treatment time, the V4.0 DDC was used to recalculate the dosimetry to evaluate differences in dose rate, dose, and equivalent dose in 2-Gy fractions (EQD2) for an α/ß = 3.5 Gy (endpoint of locoregional relapse). At the surface of the tumor bed (i.e., spherical applicator surface), the calculations using the V4.0 DDC predicted increased values for dose rate (43-16%), dose (28.6-23.2 Gy), and EQD2 (95-31%) for the 1.5- to 5.0-cm diameter spherical applicator sizes, respectively. In general, dosimetric differences are greatest for the 1.5-cm diameter spherical applicator. The results from this study can be interpreted as a reevaluation of dosimetry or the dangers of underdosage, which can occur if the V4.0 DDC is inadvertently used for TARGIT clinical trial patients. Because the INTRABEAM system is used in TARGIT clinical trials, accurate knowledge about absorbed dose is essential for making meaningful comparisons between radiation treatment modalities, and reproducible treatment delivery is imperative. The results of this study shed light on these concerns.

Targeted Intraoperative Radiotherapy During Breast-conserving Surgery for Breast Cancer in Patients After Implant Augmentation.

BACKGROUND/AIM: Targeted intraoperative radiotherapy (TARGIT IORT) is an option during breast-conserving surgery (BCS). No data have yet been published regarding the safety of TARGIT IORT with implants in situ. TARGIT IORT is an attractive option in this context because of the risk of capsular fibrosis following external beam radiotherapy (EBRT) in such patients. PATIENTS AND METHODS: We are reporting a retrospective analysis of 16 patients who received TARGIT IORT during BCS for early breast cancer after previous implant-based breast augmentation. TARGIT IORT was performed using the Intrabeam™method. RESULTS: Follow-up varied from 98 to 5 months. There were no procedure-related complications. One patient developed local recurrence after 36 months of follow-up. Among the remaining patients (15/16), no breast-cancer-related events occurred. CONCLUSION: This series of patients with TARGIT IORT during BCS after implant-based breast augmentation revealed no safety concerns and gives some confidence in discussing this option with selected patients.

A phase II study investigating the acute toxicity of targeted intraoperative radiotherapy as tumor-bed boost plus whole breast irradiation after breast-conserving surgery in Korean patients.

BACKGROUND: There are concerns regarding local toxicity when IORT is applied in Asian women with a smaller breast volume than that of Western women. Trials are required to develop safety profiles for this technique. The aim of this trial was to evaluate acute toxicity after intra-operative radiotherapy (IORT) with low-energy X-ray plus whole breast irradiation (WBI) in Asian patients with breast cancer. METHODS: This single-arm, single-institute, phase II trial investigated acute toxicity after completion of radiotherapy (targeted IORT followed by WBI) in Korean patients treated with breast-conserving surgery (BCS). In the conventional WBI arm from the TARGIT-A trial, the incidence of acute toxicity within 6 months was 15%. To prove the non-inferiority of the acute toxicity rate, 215 patients were required. This trial is registered with ClinicalTrials.gov (NCT02213991). RESULTS: Two-hundred and fifteen women were enrolled, and 198 underwent IORT. In 33 patients, clinically significant complications during the acute period were noted. The incidence of acute toxicity was 16.7% (95% CI 11.5-21.9%). There were 29 patients with seroma needing more than 3 aspirations, 4 with wound infection, and 2 with skin breakdown. There was no difference in the rate of complications according to the tumor volume or the tumor-breast volume ratio. Advanced age and high BMI were risk factors for acute complications. CONCLUSIONS: Targeted intra-operative radiotherapy using Intrabeam® is a safe procedure for Korean patients with breast cancer with an acceptable toxicity profile in the acute period.

Cosmetic outcome as rated by patients, doctors, nurses and BCCT.core software assessed over 5 years in a subset of patients in the TARGIT-A Trial.

BACKGROUND: The purpose of this research was to assess agreement between four rating systems of cosmetic outcome measured in a subset of patients with early breast cancer participating in the randomised TARGIT-A trial. TARGIT-A compared risk-adapted single-dose intra-operative radiotherapy (TARGIT-IORT) to whole breast external beam radiotherapy (EBRT). METHODS: Patients, their Radiation Oncologist and Research Nurse completed a subjective cosmetic assessment questionnaire before radiotherapy and annually thereafter for five years. Objective data previously calculated by the validated BCCT.core software which utilizes digital photographs to score symmetry, colour and scar was also used. Agreement was assessed by the Kappa statistic and longitudinal changes were assessed by generalized estimating equations. RESULTS: Overall, an Excellent-Good (EG) cosmetic result was scored more often than a Fair-Poor (FP) result for both treatment groups across all time points, with patients who received TARGIT-IORT scoring EG more often than those who received EBRT however this was statistically significant at Year 5 only. There was modest agreement between the four rating systems with the highest Kappa score being moderate agreement which was between nurse and doctor scores at Year 1 with Kappa = 0.46 (p < 0.001), 95% CI (0.24, 0.68). CONCLUSION: Despite similar overall findings between treatment groups and rating systems, the inter-rater agreement was only modest. This suggests that the four rating systems utilized may not necessarily be used interchangeably and it is arguable that for an outcome such as cosmetic appearance, the patient's point of view is the most important. TRIAL REGISTRATION: TARGIT-A ISRCTN34086741 , Registered 21 July 2004, retrospectively registered.

Targeted Intraoperative Radiotherapy Tumour Bed Boost during Breast-Conserving Surgery after Neoadjuvant Chemotherapy - a Subgroup Analysis of Hormone Receptor-Positive HER2-Negative Breast Cancer.

INTRODUCTION: In a previous study our group showed a beneficial effect of targeted intraoperative radiotherapy (TARGIT-IORT) as an intraoperative boost on overall survival after neoadjuvant chemotherapy (NACT) compared to an external boost (EBRT). In this study we present the results of a detailed subgroup analysis of the hormone receptor (HR)-positive HER2-negative patients. METHODS: In this cohort study involving 46 patients with HR-positive HER2-negative breast cancer after NACT, we compared the outcomes of 21 patients who received an IORT boost to those of 25 patients treated with an EBRT boost. All patients received whole breast radiotherapy. RESULTS: Median follow-up was 49 months. Whereas disease-free-survival and breast cancer-specific mortality were not significantly different between the groups, the 5-year Kaplan-Meier estimate of overall mortality was significantly lower by 21% with IORT, p = 0.028. Non-breast cancer-specific mortality was significantly lower by 16% with IORT, p = 0.047. CONCLUSION: Although our results have to be interpreted with caution, we have shown that the improved overall survival demonstrated previously could be reproduced in the HR-positive HER2-negative subgroup. These data give further support to the inclusion of such patients in the TARGIT-B (Boost) randomised trial that is testing whether IORT boost is superior to EBRT boost.

Targeted Intraoperative Radiotherapy Tumour Bed Boost During Breast Conserving Surgery after Neoadjuvant Chemotherapy in HER2 Positive and Triple Negative Breast Cancer.

INTRODUCTION: Targeted intraoperative radiotherapy (TARGIT - IORT) as a tumour bed boost after breast conserving surgery is well established for women with early breast cancer. A previous study from our group shows a beneficial effect of TARGIT-IORT on overall survival (OS) but not disease-free survival (DFS) after neoadjuvant chemotherapy compared to an external boost suggesting a potential non-inferiority of TARGIT-IORT. In this study, we present results regarding the high-risk subset of patients (i.e. with triple negative (TN) and HER2 positive tumours) from this cohort. METHOD: In this non-randomized cohort study involving patients with HER2 positive (n= 28) and triple negative (n=42) tumours after NACT we compared outcomes of 40 patients with tumour bed boost applied with TARGIT IORT during lumpectomy versus 30 patients treated in the previous 13 months with external (EBRT) boost. All patients received whole breast radiotherapy. Rates of DFS and OS were compared. RESULTS: Median follow up was 49 months. In comparison of TARGIT-IORT vs. EBRT 5-year Kaplan- Meier estimates of OS showed no significant difference among patients with HER2 positive tumours (100% vs. 91.7%, log rank p = 0.22). The same was seen for DFS (83.3% vs. 77.0%, log rank p=0.38). The results for TN cases were similar (OS : 87.5% vs. 74.1%, log rank p=0.488; DFS 87.5% vs. 60%, log rank p=0.22). CONCLUSION: Although survival estimates trended towards favouring TARGIT-IORT, no significant differences could be observed and the significantly positive result for OS favoring TARGIT-IORT in the whole cohort of 116 patients could not be reproduced in this subset analysis of patients with TN and HER2 positive tumours. This may be contributable to the limited number of patients but may also indicate that effects seen in the whole cohort were mainly driven by ER and/or PR positive and HER2 negative tumours. Most importantly, non-inferiority of TARGIT-IORT as an intraoperative boost could be reproduced in these high-risk patients.

Environmental and social benefits of the targeted intraoperative radiotherapy for breast cancer: data from UK TARGIT-A trial centres and two UK NHS hospitals offering TARGIT IORT.

OBJECTIVE: To quantify the journeys and CO2 emissions if women with breast cancer are treated with risk-adapted single-dose targeted intraoperative radiotherapy (TARGIT) rather than several weeks' course of external beam whole breast radiotherapy (EBRT) treatment. SETTING: (1) TARGIT-A randomised clinical trial (ISRCTN34086741) which compared TARGIT with traditional EBRT and found similar breast cancer control, particularly when TARGIT was given simultaneously with lumpectomy, (2) 2 additional UK centres offering TARGIT. PARTICIPANTS: 485 UK patients (249 TARGIT, 236 EBRT) in the prepathology stratum of TARGIT-A trial (where randomisation occurred before lumpectomy and TARGIT was delivered simultaneously with lumpectomy) for whom geographical data were available and 22 patients treated with TARGIT after completion of the TARGIT-A trial in 2 additional UK breast centres. OUTCOME MEASURES: The shortest total journey distance, time and CO2 emissions from home to hospital to receive all the fractions of radiotherapy. METHODS: Distances, time and CO2 emissions were calculated using Google Maps and assuming a fuel efficiency of 40 mpg. The groups were compared using the Student t test with unequal variance and the non-parametric Wilcoxon rank-sum (Mann-Whitney) test. RESULTS: TARGIT patients travelled significantly fewer miles: TARGIT 21 681, mean 87.1 (SE 19.1) versus EBRT 92 591, mean 392.3 (SE 30.2); had lower CO2 emissions 24.7 kg (SE 5.4) vs 111 kg (SE 8.6) and spent less time travelling: 3 h (SE 0.53) vs 14 h (SE 0.76), all p<0.0001. Patients treated with TARGIT in 2 hospitals in semirural locations were spared much longer journeys (753 miles, 30 h, 215 kg CO2 per patient). CONCLUSIONS: The use of TARGIT intraoperative radiotherapy for eligible patients with breast cancer significantly reduces their journeys for treatment and has environmental benefits. If widely available, 5 million miles (8 000 000 km) of travel, 170 000 woman-hours and 1200 tonnes of CO2 (a forest of 100 hectares) will be saved annually in the UK. TRIAL REGISTRATION NUMBER: ISRCTN34086741; Post-results.

Intraoperative radiotherapy of the breast for early-stage breast cancer: ready for primetime.

The findings of the TARGIT A and ELIOT prospective, randomized controlled trials provide compelling data regarding the efficacy and safety of single fraction intraoperative radiotherapy as an alternative to standard postoperative radiotherapy in the management of early-stage breast cancer. This editorial summarizes the findings of both studies and discusses the importance of patient selection in identifying potential candidates for intraoperative radiotherapy.

Intraoperative radiotherapy for breast cancer.

Intra-operative radiotherapy (IORT) as a treatment for breast cancer is a relatively new technique that is designed to be a replacement for whole breast external beam radiotherapy (EBRT) in selected women suitable for breast-conserving therapy. This article reviews twelve reasons for the use of the technique, with a particular emphasis on targeted intra-operative radiotherapy (TARGIT) which uses X-rays generated from a portable device within the operating theatre immediately after the breast tumour (and surrounding margin of healthy tissue) has been removed. The delivery of a single fraction of radiotherapy directly to the tumour bed at the time of surgery, with the capability of adding EBRT at a later date if required (risk-adaptive technique) is discussed in light of recent results from a large multinational randomised controlled trial comparing TARGIT with EBRT. The technique avoids irradiation of normal tissues such as skin, heart, lungs, ribs and spine, and has been shown to improve cosmetic outcome when compared with EBRT. Beneficial aspects to both institutional and societal economics are discussed, together with evidence demonstrating excellent patient satisfaction and quality of life. There is a discussion of the published evidence regarding the use of IORT twice in the same breast (for new primary cancers) and in patients who would never be considered for EBRT because of their special circumstances (such as the frail, the elderly, or those with collagen vascular disease). Finally, there is a discussion of the role of the TARGIT Academy in developing and sustaining high standards in the use of the technique.

Intraoperative radiotherapy in breast conserving surgery.

Intraoperative radiotherapy (IORT) of the breast is the administration of a single fraction of radiation to the tumor bed while shielding low risk and uninvolved tissues from the effects of radiation. The TARGIT A and ELIOT trials demonstrate efficacy of IORT when administered at the time of lumpectomy to post-menopausal women with low to intermediate grade, lymph node negative, invasive ductal carcinoma, consistent with international guidelines defining suitable candidates for accelerated partial breast radiotherapy.