Use Of Intraoperative Radiation Therapy Research Articles

A Phase II Trial of Intraoperative Radiotherapy after Surgical Resection of Brain Metastases: Feasibility and Efficacy NCT04847284

Intraoperative radiation therapy (IORT) is an alternative to local radiation therapy for brain metastases, reducing total treatment time, and improving patient comfort, but the most effective dose is unknown. The objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy. This trial is a single-institution, open-label, prospective, non-randomized study for intraoperative radiotherapy immediately after resection of brain metastases. Registered in January 2021, currently ongoing, planned to enroll 25 patients with IK ≥70, brain damage newly diagnosed by MRI, without dural contact and at least 1 cm to the optic nerve, chiasm and brainstem. In the baseline visit, the General Cognitive State will be carried out: Minimum Mental State Exams. Specific cognitive study: 1- Processing speed (SYmbol digit modalities test), 2- Executive function (TMT, back and forward digit span test, phonological and semantic verbal fluency test, Stroop color-word test), 3- Verbal memory (FCSRT). Quality of life will be monitored by completing the EORTC QL-C30 and BN20 questionnaires. Intraoperative radiation therapy will be performed with a 50 kV low energy X-ray portable linear accelerator using spherical applicators ranging from 1.5 to 4 cm kV to deliver 20 Gy to the surface. During IORT a maximum dose (DMax) of 8 Gy will be allowed to the optic nerve/chiasm and brainstem structures. MRI will be performed 72 hours after IORT. Neurocognitive Test and MRI after 6 weeks and every 3 months. The primary endpoint will be local progression free survival (PFS). Secondary endpoints will be overall survival, time to save cancer therapy, cognitive performance and quality of life, as well as IORT-related neurotoxicity complications will be evaluated according to the scale of the CTACAE version 4. The analysis of the median local progression free survival, overall survival will be analyzed using the Kaplan-Meier curve (long range test). All results will be considered statistically significant with a p value < 0.05. The statistical analysis will be carried out with statistical software. The trial is open and ongoing to recruitment; we have included 7 patients. The 85.7% were male, mean age was 61.4 years range (43-74). The 57.1% were lung cancer metastases. For now, no tumor recurrence or neurocognitive complications have been observed and then once you have the results ready, we will publish them. The limited current literature on the use of IORT in brain metastases appears to show efficacy and safety, but the most effective dose is unknown as well as whether it is as effective as other radiotherapy alternatives. Our study is ongoing and needs to be completed and evaluated with more follow-up in order to reach definitive conclusions.

¿Se puede realizar la radioterapia intraoperatoria de forma asistencial en el tratamiento del cáncer de mama en estadios iniciales?

After conservative surgery in breast cancer adjuvant radiation therapy is indicated, such treatment can be performed as partial irradiation in well-selected cases and without risk factors for local relapse following the guidelines of international consensus. Partial irradiation is performed by several techniques such as interstitial brachytherapy, external radiation therapy, and also through intraoperative radiation therapy techniques at the same surgical act due to mobile electron accelerators or low-energy photons units. This allows local treatment to be performed in a single day, increasing the surgical time, but with advantages in terms of the tumor bed localization accuracy, immediacy of irradiation and greater patient satisfaction. There is extensive experience in the use of this technique with results comparable to other ways of partial irradiation in terms of local control, minimal side effects, good cosmetic results and even better no cancer related survival. This article reviews the evidence in the use of intraoperative radiation therapy in early-stage breast cancer derived from the main trials comparing it to whole breast irradiation, to confirm that it is already available for standard of care practice in patients who are candidates for partial irradiation.

Experience of the usage intraoperative radiation therapy in patients with early breast cancer

Background. Comprehensive treatment of breast cancer includes surgery, radiation therapy and systemic treatment. Radiation therapy plays an integral role in the treatment of early breast cancer. The appointment of a targeted dose of radiation to the bed of the primary tumor reduces the risk of local recurrence.Objective: to evaluate the effectiveness of intraoperative radiation therapy in the treatment of early breast cancer.Materials and methods. A retrospective study was conducted on the basis of the St. Petersburg City Clinical Oncology Center. Patients with organ-preserving surgery and intraoperative radiation therapy were selected. Of the 352 patients, 273 patients met the inclusion/non-inclusion criteria. Inclusion criteria were verified breast cancer, clinical stage I–IIA, tumor size no more than 3 cm, absence of visible axillary lymph nodes and monocentric nature of tumor growth. All patients underwent sectoral resection of the mammary gland with a biopsy of the sentinel lymph nodes and intraoperative radiation therapy.Results. The mean age of the patients was 59 years. For 273 patients, the median follow-up was 59.1 months. During this period, 18 (6.6 %) local recurrences of the disease were noted, of which 7 (39 %) patients with luminal A, 6 (33 %) patients with luminal B, 1 (6 %) patient with luminal B HER2/neu 3+, and 4 (22 %) patients with triple negative breast cancer. Within 3 years of follow-up, recurrence-free survival was 98.5 %, within 5 years – 96.4 %.Conclusion. The use of intraoperative radiation therapy for early breast cancer is an effective and safe treatment method.

The Use of Intraoperative Radiation Therapy (IORT) in Multimodality Management of Cancer Patients: a Single Institution Experience.

Intraoperative radiation therapy (IORT) is a highly conformal type of radiation therapy given at time of surgery aiming for better tumor local control. It increases the tumor radiation dose without exceeding normal tissues tolerance doses. To assess the feasibility of IORT and short-term toxicities in patients with different cancer sites treated with multidisciplinary protocol including IORT. Medical records of cancer patients who received IORT as a part of their multidisciplinary treatment at King Faisal Specialized Hospital and Research center (KFSH&RC), Riyadh, Saudi Arabia, from January 2013 until December 2017 were retrospectively reviewed. A total of 188 patients with 210 IORT applications were analyzed. Twenty-two patients had two applications at the same time. One hundred sixteen patients were males. Median age at time of diagnosis was 49.5years (19-77). One hundred thirty-four patients had primary, while 54 cases had recurrent disease. Gastroesophageal cancer and soft tissue sarcoma were the most frequent diagnosis in 49 patients followed by colorectal cancer in 35 patients. Major surgeries with curative intent done in 183 patients (97.3%). Hyperthermic intraperitoneal chemotherapy (HIPEC) was performed in 118 (62.8%) patients. The 30-day postoperative mortality rate was 3.2%. Fifty-four (28.7%) patients develop grades III-IV complications according to Clavien-Dindo grading system. The data presented discusses using of IORT treatment for different malignant tumors as a part of multimodality treatment. IORT seems safe and feasible; however, a longer follow-up period is needed for proper evaluation and to define the role of IORT in a tailored multimodality approach.

Intraoperative radiation therapy for early stage breast cancer

Background and objectiveWe report our experiences with Intraoperative radiation therapy (IORT) among breast cancer (BC) patients in our region.MethodsAll patients who received radical IORT from April 2014 on to March 2020 were included in the study. Patient selection criteria included: Age equal or older than 45 years old; All cases of invasive carcinomas (in cases of lobular carcinomas only with MRI and confirmation); Patients who were 45–50 years old with a tumor size of 0–2 cm, 50–55 years old with a tumor size of < 2.5 cm, and those who were ≥ 55 years old with a tumor size of < 3 cm; Invasive tumors only with a negative margin; Negative nodal status (exception in patients with micrometastasis); A positive estrogen receptor status. Primary endpoints included death and recurrence which were assessed using the Kaplan–Meier method.ResultsOverall, 252 patients entered the study. Mean (SD) age of patients was 56.43 ± 7.79 years. In total, 32.9% of patients had a family history of BC. Mean (SD) tumor size was 1.56 ± 0.55 cm. Mean (IQR) follow-up of patients was 36.3 ± 18.7 months. Overall, 8 patients (3.1%) experienced recurrence in follow-up visits (disease-free-survival of 96.1%), among which four (1.5%) were local recurrence, two (0.8%) were regional recurrence and two patients (0.8%) had metastasis. Median (IQR) time to recurrence was 46 (22, 53.7) months among the eight patient who had recurrence. Overall, one patient died due to metastasis in our series. Eleven patients (4.3%) with DCIS in our study received IORT. All these patients had free margins in histopathology examination and none experienced recurrence.ConclusionInhere we reported our experience with the use of IORT in a region where facilities for IORT are limited using our modified criteria for patient selection.

Wound Complications Following Wide Resection and Intraoperative Radiation Therapy for Management of Soft Tissue Sarcoma of the Extremities

In cases where wide margins are not readily achievable during limb-sparing surgery (LSS) for soft tissue sarcoma (STS) of the extremity, intraoperative radiation therapy (IORT) may be used either alone or in conjunction with post-operative radiation (PORT) to improve local control with potentially decreased toxicities. The aim of this study is to describe wound healing issues following IORT for extremity STS.Retrospective analysis was performed for 92 patients treated with LSS and IORT for definitive management of extremity STS between 2012 and 2020 at a single institution. No patients received pre-operative RT. Major wound complications were classified as follows: secondary operation for wound repair requiring general/regional anesthesia, other invasive procedure for wound management, readmission for wound care, or persistent deep packing over 120 days. Univariate and multivariate binary logistic regression analyses were performed to identify factors associated with development of major wound complications.Median age at IORT was 58 years (IQR 35-71). Tumor distribution was 25% upper extremity and 75% lower extremity. The most common histologies were undifferentiated pleomorphic sarcoma (27%), synovial sarcoma (24%), and liposarcoma (18%). Tumors were grade 1 (14%), grade 2 (34%), and grade 3 (52%). 37% had received pre-operative chemotherapy. Median tumor size at resection was 7 cm (IQR 5-11), and 28% of patients had tumors over 10 cm in maximum dimension. The majority of patients received a prescribed IORT dose of 12 Gy (27%) or 15 Gy (66%). 30% of patients underwent complex surgical closure, as defined by use of a muscle flap (11%, n = 10), fasciocutaneous flap (5%, n = 5), and/or skin graft (16%, n = 15). 90% of patients were discharged in less than 1 week from LSS with IORT. 72% subsequently received PORT at a median time of 7 weeks from LSS (IQR 5-11). Overall, the rate of major wound complications was 18% (n = 17), of which 4 events occurred prior to PORT and 9 events occurred within 4 months from IORT. In total, 10% (n = 9) required a secondary operation for wound repair, 5% (n = 5) required an invasive procedure (commonly drainage of a seroma/hematoma), and 3% (n = 3) required readmission for wound care. None required persistent deep packing. On univariate analysis, factors predicting for development of a major wound complication included current smoking status (HR 15.86, P = 0.02) and complex wound closure (HR 3.32, P = 0.03), both of which remained significant on multivariate analysis. Factors that were not associated with wound complications included age, tumor size, IORT dose, pre-operative chemotherapy, and PORT.Despite the bias of selective use of IORT for more challenging surgical cases, IORT was not associated with increased rates of wound complications as compared to historical reports, and patients were able to transition to the next phase of therapy in a timely manner as part of optimal interdisciplinary management of STS.

Breast conservative surgery and whole breast radiotherapy versus breast conservative surgery and IORT: surgical opinion.

To define the possibility of intraoperative radiation therapy (IORT)'s application on clinical practice and point out the problems observed by Verona Breast Unit. Among the patients of the Breast Unit at Azienda Ospedaliera Universitaria Integrata of Verona, treated between July 2015 and June 2017, were identified 459 patients undergoing breast conserving surgery for a carcinoma, followed by IORT in 77 cases or by Whole Breast Radiotherapy (WBRT) in 382 cases. The data of WBRT group were analyzed considering IORT eligibility criteria to identify a sub-group of eligible patients, for whom we evaluated the diagnostic process that had led to exclusion from IORT. In WBRT group 184 patients (48%) had a ductal NOS infiltrating carcinoma, of which 64 cases (16.8%) were eligible for IORT. Other 79 patients of WBRT group (21%) presented DCIS, of which only 27 were in the American Society for Radiation Oncology "suitable" group for IORT. Considering the results of the preoperative exams, or rather needle biopsy and MRI scan, 55 patients of 64 (85.9%) resulted unsuitable for IORT, while nine patients (14.1%) could be eligible. IORT's major limits are: the restricted eligibility criteria, especially on histology; the need of a complete execution of preoperative exams and the technical limits of these exams. ASTRO suitable group, including small diameter, low-grade DCIS, might be used to extend the eligibility criteria. A multidisciplinary approach might improve the preoperative study, so the use of IORT in clinical practice.

Intraoperative radiation therapy (IORT) for soft tissue sarcoma – ESTRO IORT Task Force/ACROP recommendations

PurposeTo describe guidelines for the use of intraoperative radiation therapy (IORT) in the treatment of soft-tissue sarcomas (STS). MethodsA panel of experts in the field performed a systematic literature review, supplemented their clinical experience and developed recommendations for the use of IORT in the treatment of STS. ResultsBased on the evidence from the systematic literature review and the clinical experience of the panel members, recommendations regarding patient selection, incorporation into multimodal treatment concepts and the IORT procedure itself are made. The rationale for IORT in extremity and retroperitoneal STS is summarized and results of the major series in terms of patient and treatment characteristics, oncological outcome and toxicity are presented. We define surgical factors, volumes for irradiation, technical requirements, dose prescription, recording and reporting, treatment delivery and care during the course of IORT covering the main IORT techniques used for the treatment of STS.In extremity STS, evidence originates from a few small prospective and mainly from retrospective single centre studies. Based on those reports, IORT containing-approaches result in very high local control rates with low rates of acute and late toxicity.In retroperitoneal sarcomas, evidence is derived from one prospective randomized trial, a few prospective and a large number of retrospective studies. The randomized trial compared IORT combined with moderate doses of postoperative external-beam radiation therapy (EBRT) to high-dose postoperative EBRT alone after gross total resection, clearly favouring the IORT-containing approach. These results have been confirmed by the prospective and retrospective studies, which similarly showed high local control rates with acceptable toxicity, mainly favouring combinations of preoperative EBRT and IORT. ConclusionsIORT-containing approaches result in high rates of local control with low to acceptable toxicity rates. Based on the available evidence, we made recommendations for the use of IORT in STS. Clinicians and researchers are encouraged to use these guidelines in clinical routine as well as in the design of future trials.

The use of intraoperative radiation therapy in the management of locally recurrent rectal cancer

Locally recurrent rectal cancer (LRRC) is associated with substantial tumor- and treatment-related morbidity. Curative-intent surgical resection is challenging, and when used as a single modality, the results have been poor. Durable local control (LC) and long-term overall survival (OS) may be achieved with combined modality therapy including radiotherapy (RT), chemotherapy, and surgical resection. RT dose escalation utilizing intra-operative RT (IORT), when combined with external beam RT (EBRT), may offer improved LC particularly for those who have undergone sub-total resection. Curative treatment options are still feasible in patients who experience LR following previous pelvic RT, with data supporting the safety and efficacy of EBRT, surgery, and IORT as long as clinicians are cognizant of repeat RT exposure to small bowel. Advancement in patient selection, RT treatment techniques, and systemic therapies offer an interesting opportunity to improve outcomes for patients with LRRC and should be evaluated further in prospective studies.

The American Brachytherapy Society consensus statement on intraoperative radiation therapy

PurposeAlthough radiation therapy has traditionally been delivered with external beam or brachytherapy, intraoperative radiation therapy (IORT) represents an alternative that may shorten the course of therapy, reduce toxicities, and improve patient satisfaction while potentially lowering the cost of care. At this time, there are limited evidence-based guidelines to assist clinicians with patient selection for IORT. As such, the American Brachytherapy Society presents a consensus statement on the use of IORT. MethodsPhysicians and physicists with expertise in intraoperative radiation created a site-directed guideline for appropriate patient selection and utilization of IORT. ResultsSeveral IORT techniques exist including radionuclide-based high-dose-rate, low-dose-rate, electron, and low-energy electronic. In breast cancer, IORT as monotherapy should only be used on prospective studies. IORT can be considered in the treatment of sarcomas with close/positive margins or recurrent sarcomas. IORT can be considered in conjunction with external beam radiotherapy for retroperitoneal sarcomas. IORT can be considered for colorectal malignancies with concern for positive margins and in the setting of recurrent gynecologic cancers. For thoracic, head and neck, and central nervous system malignancies, utilization of IORT should be evaluated on a case-by-case basis. ConclusionsThe present guidelines provide clinicians with a summary of current data regarding IORT by treatment site and guidelines for the appropriate patient selection and safe utilization of the technique. High-dose-rate, low-dose-rate brachytherapy methods are appropriate when IORT is to be delivered as are electron and low-energy based on the clinical scenario.

Review of current perspectives on low-energy X-ray intraoperative radiotherapy in early stage breast cancer

In early stage breast cancer, intraoperative radiation therapy (IORT) is a form of accelerated partial breast irradiation (APBI) that provides attractive therapeutic effects while shortening the overall treatment time and sparing the normal tissue radiation exposure. This technique has been used in Taiwan for several years in selected patients with breast cancer. However, some randomized trials pointed out that IORT is associated with higher rate of recurrence, therefore impeding its wider use as one of the standard managements in breast cancer. Also, despite its theoretical benefits for smaller tumor after surgery, the problem of recurrence warrants the necessity of strict and careful patient selection. The purpose of this article is to comprehensively review the updated consensus and current opinions on the use of IORT for early stage breast cancer.

Abstract ES1-1: Accelerated partial breast irradiation: Update of an ASTRO consensus guideline

Abstract Authors Correa CRa, Harris EEb, Leonardi MCc, Smith BDd, Taghian AGe, Thompson AMf, White Jg, Harris JRh; aDept. of Radiation Oncology, Faxton St. Luke's Healthcare, Utica, NY, bDept. of Radiation Oncology, E. Carolina Univ., Greenville, NC, cDept. of Radiation Oncology, European Inst. of Oncology, Milan, Italy, dDept. of Radiation Oncology and fDept. of Breast Surgical Oncology, The Univ. of Texas MD Anderson Cancer Center, Houston, TX, eDept. of Radiation Oncology, Massachusetts General Hosp., Boston, MA, gDept. of Radiation Oncology, Ohio State Univ. Cancer Center, Columbus, OH, hDept. of Radiation Oncology, Brigham and Women's Hosp. and Dana-Farber Cancer Inst., Boston, MA Purpose To update the accelerated partial breast irradiation Consensus Statement published in 2009 and provide guidance on use of intraoperative radiation therapy (IORT) for partial breast irradiation in early-stage breast cancer, based on published evidence complemented by expert opinion. Methods A systematic PubMed search using the same terms as the original Consensus Statement yielded 419 articles; 44 articles were selected. The authors synthesized the published evidence and, through a series of conference calls and e-mails, reached consensus regarding the recommendations. Results The new recommendations include lowering the age in the “suitability group” from 60 to 50 years and in the “cautionary group” to 40 years for patients who meet all other elements of suitability (Table 1). Patients with low-risk ductal carcinoma in situ, as per RTOG 9804 criteria, were categorized in the “suitable” group. The task force agreed to maintain the current criteria based on margin status. Recommendations for the use of IORT for breast cancer patients include: counseling patients regarding the higher risk of ipsilateral breast tumor recurrence with IORT compared with whole breast irradiation; the need for prospective monitoring of long-term local control and toxicity with low-energy radiograph IORT given limited follow-up; and restriction of IORT to women with invasive cancer considered “suitable.” Conclusion These recommendations will provide updated clinical guidance regarding use of accelerated partial breast irradiation for radiation oncologists and other specialists participating in the care of breast cancer patients. Table 1 Comparison of patient groups in original and updated consensus statementsPatient groupRisk factorOriginalUpdateSUITABLEAge≥60 y≥50 y MarginsNegative by at least 2 mmNo change T stageT1Tis or T1 DCISNot allowedIf all: screen detected, low to intermediate nuclear grade, size ≤2.5 cm, and resected with margins negative at ≥3 mmCAUTIONARYAge50-59 y40-49 y if all other criteria for "suitable" are met; ≥50 y if patient has at least 1 of the pathologic factors[lowast] and no "unsuitable" factors MarginsClose (&amp;lt;2 mm)No change DCIS≤3 cm≤3 cm and does not meet "suitable" criteriaUNSUITABLEAge&amp;lt;50 y&amp;lt;40 y; 40-49 y and does not meet "cautionary" criteria MarginsPositiveNo change DCIS&amp;gt;3 cmNo change[lowast]Pathologic factors: size 2.1-3 cm, T2, close margins (&amp;lt;2 mm), limited/focal lymphovascular space invasion, ER(-), clinically unifocal with total size 2.1-3 cm, invasive lobular histology, pure DCIS ≤3 cm if "suitable" criteria not fully met, extensive intraductal component ≤3 cm Citation Format: Correa CR. Accelerated partial breast irradiation: Update of an ASTRO consensus guideline [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr ES1-1.

Future Directions of Intraoperative Radiation Therapy: A Brief Review.

The use of intraoperative radiation therapy (IORT) is increasing with the development of new devices for patient treatment that allow irradiation without the need to move the patient from the surgical table. At the moment, ionizing radiation in the course of IORT is supported most often by the use of mobile devices that produce electrons, kilo voltage X-rays, and electronic brachytherapy and the development of applicators suitable for delivery of radionuclides for short-term brachytherapy. The establishment of new treatment devices and protocols that can be foreseen in the future, e.g., the development of proton or heavy ion sources suitable for IORT or the establishment of new treatment protocols such as the use of IORT in combination with immune system modulators or radiosensitizing nanoparticles, could lead to a significant increase in the use of IORT in the future. This review discusses the still limited use of IORT at this point in time and hypothesizes about possible future approaches to radiotherapy.

Use of Intraoperative Radiation Therapy in Skull Base Oncology

Use of Intraoperative Radiation Therapy in Skull Base Oncology

Intraoperative Radiation Therapy: A Promising Treatment Modality in Head and Neck Cancer.

Every year, almost 62,000 are diagnosed with a head and neck cancer (HNC) and 13,000 will succumb to their disease. In the primary setting, intraoperative radiation therapy (IORT) can be used as a boost in select patients in order to optimize local control. Addition of external beam radiation to limited volumes results in improved disease control over surgery and IORT alone. In the recurrent setting, IORT can improve outcomes from salvage surgery especially in patients previously treated with external beam radiation. The use of IORT remains limited to select institutions with various modalities being currently employed including orthovoltage, electrons, and high-dose rate brachytherapy. Practically, execution of IORT requires a coordinated effort and careful planning by a multidisciplinary team involving the head and neck surgeon, radiation oncologist, and physicist. The current review summarizes common uses, outcomes, toxicities, and technical aspects of IORT in HNC patients.

Intraoperative radiation therapy (IORT) in head and neck cancer: A systematic review.

Background:Multimodality therapy constitutes the standard treatment of advanced and recurrent head and neck cancer. Since locoregional recurrence comprises a major obstacle in attaining cure, the role of intraoperative radiation therapy (IORT) as an add-on in improving survival and local control of the disease has been investigated. IORT allows delivery of a single tumoricidal dose of radiation to areas of potential residual microscopic disease while minimizing doses to normal tissues. Advantages of IORT include the conformal delivery of a large dose of radiation in an exposed and precisely defined tumor bed, minimizing the risk of a geographic miss creating the potential for subsequent dose reduction of external beam radiation therapy (EBRT). This strategy allows for shortening overall treatment time and dose escalation. The aim of this review is to summarize recent published work on the use of IORT as an adjuvant modality to treat common head and neck cancer in the primary or recurrent setting.Methods:We searched the Medline, Scopus, Ovid, Cochrane, Embase, and ISI Web of Science databases for articles published from 1980 up to March 2016.Results:Based on relevant publications it appears that including IORT in the multimodal treatment may contribute to improved local control. However, the benefit in overall survival is not so clear.Conclusion:IORT seems to be a safe, promising adjunct in the management of head and neck cancer and yet further well organized clinical trials are required to determine its role more precisely.

Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement

PurposeTo update the accelerated partial breast irradiation Consensus Statement published in 2009 and provide guidance on use of intraoperative radiation therapy (IORT) for partial breast irradiation in early-stage breast cancer, based on published evidence complemented by expert opinion. Methods and materialsA systematic PubMed search using the same terms as the original Consensus Statement yielded 419 articles; 44 articles were selected. The authors synthesized the published evidence and, through a series of conference calls and e-mails, reached consensus regarding the recommendations. ResultsThe new recommendations include lowering the age in the “suitability group” from 60 to 50 years and in the “cautionary group” to 40 years for patients who meet all other elements of suitability (Table 1). Patients with low-risk ductal carcinoma in situ, as per Radiation Therapy Oncology Group 9804 criteria, were categorized in the “suitable” group. The task force agreed to maintain the current criteria based on margin status. Recommendations for the use of IORT for breast cancer patients include: counseling patients regarding the higher risk of ipsilateral breast tumor recurrence with IORT compared with whole breast irradiation; the need for prospective monitoring of long-term local control and toxicity with low-energy radiograph IORT given limited follow-up; and restriction of IORT to women with invasive cancer considered “suitable.” ConclusionThese recommendations will provide updated clinical guidance regarding use of accelerated partial breast irradiation for radiation oncologists and other specialists participating in the care of breast cancer patients.

Intraoperative radiation therapy for high risk soft tissue sarcoma resection margins

Background and objectives: External beam radiation (EBRT) can reduce local recurrence (LR) of soft tissue sarcomas (STS). The addition of intraoperative radiation therapy (IORT) can deliver high dose radiation boost to anticipated “high risk” margins while sparing adjacent structures. Methods: A retrospective review (2004-2012) was performed of STS treated with surgical resection and IORT using HDR brachytherapy for anticipated close/positive margins. Results: Twenty-four patients underwent 25 resections with IORT (1 patient had 2 separate recurrences). Tumors were primary in 72%, deep in 96% and intermediate/high grade in 84%. Tumor locations were extremity (44%), retroperitoneal (40%), truncal (12%) and neck (4%). Common histologies included pleomorphic (32%), liposarcoma (12%) and myxofibrosarcoma (12%). Neoadjuvantly, 3 received chemotherapy and 13 received EBRT (median 50Gy; range 45-54). Median IORT dose was 12Gy (range 10-17.5). Margins were microscopically positive in 20%; none were grossly positive. Adjuvantly, 5 received EBRT (median 46Gy, range 45-50) and 2 received chemotherapy. Median follow-up was 20.1 months (range 2.7-96.4). No recurrences occurred at the IORT sites. Two-year LR free survival was 60.8% and disease specific survival was 84%. Conclusion: Use of IORT at time of STS resection was effective at preventing LR at the treated site despite “high risk” features.

Prospective Study of Local Control and Late Radiation Toxicity After Intraoperative Radiation Therapy Boost for Early Breast Cancer

To report the local recurrence rate and late toxicity of intraoperative radiation therapy (IORT) boost to the tumor bed using the Intrabeam System followed by external-beam whole-breast irradiation (WBI) in women with early-stage breast cancer in a prospective single-institution study. Women with breast cancer≤3 cm were recruited between February 2003 and May 2005. After breast-conserving surgery, a single dose of 5 Gy IORT boost was delivered using 50-kV x-rays to a depth of 10 mm from the applicator surface. This was followed by WBI to a total dose of 50 Gy in 25 fractions. Patients were reviewed at regular, predefined intervals. Late toxicities were recorded using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer Late Radiation Morbidity Scoring systems. Fifty-five patients completed both IORT boost and external-beam WBI. Median follow-up was 3.3 years (range, 1.4-4.1 years). There was no reported locoregional recurrence or death. One patient developed distant metastases. Grade 2 and 3 subcutaneous fibrosis was detected in 29 (53%) and 8 patients (15%), respectively. The use of IORT as a tumor bed boost using kV x-rays in breast-conserving therapy was associated with good local control but a clinically significant rate of grade 2 and 3 subcutaneous fibrosis.

Cost-Effectiveness Analysis of Intraoperative Radiation Therapy for Early-Stage Breast Cancer

Shortened courses of radiation therapy have been shown to be similarly effective to whole-breast external-beam radiation therapy (WB-EBRT) in terms of local control. We sought to analyze, from a societal perspective, the cost-effectiveness of two radiation strategies for early-stage invasive breast cancer: single-dose intraoperative radiation therapy (IORT) and the standard 6-week course of WB-EBRT. We developed a Markov decision-analytic model to evaluate these treatment strategies in terms of life expectancy, quality-adjusted life years (QALYs), costs, and the incremental cost-effectiveness ratio over 10years. IORT single-dose intraoperative radiation therapy was the dominant, more cost-effective strategy, providing greater quality-adjusted life years at a decreased cost compared with 6-week WB-EBRT. The model was sensitive to health state utilities and recurrence rates, but not costs. IORT was either the preferred or dominant strategy across all sensitivity analyses. The two-way sensitivity analyses demonstrate the need to accurately determine utility values for the two forms of radiation treatment and to avoid indiscriminate use of IORT. With less cost and greater QALYs than WB-EBRT, IORT is the more valuable strategy. IORT offers a unique example of new technology that is less costly than the current standard of care option but offers similar efficacy. Even when considering the capital investment for the equipment ($425K, low when compared with the investments required for robotic surgery or high-dose-rate brachytherapy), which could be recouped after 3-4years conservatively, these results support IORT as a change in practice for treating early-stage invasive breast cancer.