Search Results (22)

Background: Intraoperative radiotherapy (IORT) offers single-session treatment during breast-conserving surgery (BCS). Outcomes depend heavily on patient selection and tumor characteristics. Objectives: To assess local recurrence (LR) and prognosis using the 2024 American Society for Radiation Oncology (ASTRO) risk classification in IORT-treated patients. Methods: This multicenter retrospective study analyzed 358 IORT cases (356 patients) treated between 2014 and 2018 using the Zeiss INTRABEAM system. Cases were classified per the 2024 ASTRO partial-breast irradiation guidelines. The primary endpoint was local recurrence-free survival (LRFS); secondary endpoints included overall survival (OS) and mastectomy-free survival (MFS). Findings: The median age was 66 years (range 48–80); all tumors were invasive with a median tumor size of 10 mm. At a median follow-up of 7.1 years, LR occurred in 14/358 cases (3.9%) at a median of 5.2 years post-diagnosis. Five- and 8-year LRFS were 98.3% and 94.8%, respectively; 5- and 8-year OS were 99.4% and 97.7%; MFS at 8 years was 98.2%. Cases that were classified as “conditionally recommended” or “conditionally not recommended” had significantly higher LR than the “suitable” group (8.5% vs. 2.7%; HR 3.25, 95% CI 1.05–10.08, p = 0.041). Exploratory analysis showed that cases with ≥2 conditional criteria carried a markedly higher risk than those with 0–1 (21.4% vs. 3.2%; Firth-penalized Cox HR 8.26, 95% CI 2.06–26.06, p = 0.005). Conclusions: In appropriately selected patients, IORT achieves local control consistent with contemporary series. The 2024 ASTRO risk classification effectively identifies high-risk cases, supporting its use for risk-adapted candidate selection. Full article

Intraoperative radiotherapy (IORT) is a radiation technique that allows for the delivery of a high radiation dose to the target while preserving the surrounding structures, which can be displaced during the surgical procedure. An important limitation of this technique is the lack of real-time image guidance, which is one of the main achievements of modern radiation therapy because it allows for treatment optimization. IORT can be delivered by low-energy X-rays or by accelerated electrons. The present review describes the most relevant clinical applications for IORT and discusses the potential advantages of using artificial intelligence (AI) to overcome some of the current limitations of IORT. In recent decades, IORT has proven to be an effective treatment in several cancer types. In breast cancer, IORT can be used to deliver a single dose of radiation (partial breast irradiation) or as a boost in high-risk patients. In locally advanced rectal cancer, a single dose to the tumor bed can improve local control and prevent pelvic relapse in primary and recurrent tumors. In sarcomas, IORT enables the delivery of high doses, achieving good functional outcomes with low toxicity in tumors located in the retroperitoneum and extremities. In pancreatic cancer, IORT shows promising results in borderline resectable and unresectable cases. Ongoing technological advances are addressing current challenges in imaging and radiation planning, paving the way for personalized, image-guided IORT. Recent innovations such as CT- and MRI-equipped hybrid operating theaters allow for real-time imaging, which could be used for AI-assisted segmentation and planning. Moreover, the implementation of AI in terms of machine learning, deep learning, and radiomics can improve the interpretation of imaging, predict treatment outcomes, and optimize workflow efficiency. Full article

Background/Objectives: Intraoperative radiotherapy (IORT) has been used for decades to improve local control in advanced and recurrent head and neck cancers by delivering a concentrated dose of radiation directly to the tumor bed during surgery. Despite its potential advantages, IORT remains controversial due to its high complication rates and logistical complexity. This systematic review aims to assess the current evidence on IORT in head and neck oncology, evaluating its indications, effectiveness, and limitations. Methods: A systematic literature review was conducted in accordance with Cochrane systematic review method and reported following PRISMA guidelines. Databases, including Medline, Embase, Cochrane, and Web of Science, were searched for studies evaluating IORT in head and neck cancer. Outcomes of interest included local control rates, overall survival, complications, and treatment logistics. Data were weighted based on patient numbers, and statistical analyses included weighted means and comparative tests. Results: Included in this review are 47 studies that included 2330 patients. The studies were highly heterogeneous, limiting definitive conclusions. IORT was mainly used in stage III/IV or recurrent tumors, with an average dose of 14.7 Gy (range: 1–40 Gy). The five-year local control was 47% to 82%. Complication rates included wound necrosis (22,3%), fistulas 34 (17.8%), and carotid blow-out (14.5%). Logistical constraints remain a major limitation. Conclusions: The heterogeneous data and logistic challenges of IORT in head and neck oncology have limited its use, and the benefits remain uncertain. Full article

Purpose: The aim of the present study is to analyze, for the first time, the results of a large prospective academic multicenter trial of partial breast irradiation (PBI) with exclusive photon intraoperative radiation therapy (ph-IORT) in early breast cancer patients, focusing on ipsilateral breast tumor recurrence. The secondary endpoints were (a) incidence of regional/distant recurrence, (b) survival, and (c) toxicity. Methods: From January 2013 to December 2022, patients with low-risk TARGIT-A criteria invasive breast cancer were included in a prospective academic multicenter study of exclusive PBI with ph-IORT during breast-conserving surgery, conducted in three university hospitals in Las Palmas (Hospital Universitario Insular, Hospital Universitario Materno-Infantil, and Hospital Universitario de Gran Canaria Dr. Negrín). Results: Three hundred and twelve patients were included in the study. The mean age at diagnosis was 62 years (46–88). All tumors were classified as luminal molecular profile. No patient received supplementary external beam radiotherapy. Four patients developed ipsilateral breast tumor recurrence (IBTR) at 19, 29, 43, and 62 months of follow-up. Seventeen patients died of intercurrent diseases, and there were only 2 breast cancer-related deaths at 68 and 95 months, respectively. With a median follow-up of 78 months (7–140), actuarial 5-year freedom from local relapse and cancer survival rates were 98.9% and 100%, respectively. No patient developed early or late grade-3 toxicity. Conclusions: Partial breast irradiation with ph-IORT is a feasible, safe, and useful treatment in early breast cancer patients after BCS. A longer follow-up is needed to confirm the present results. Full article

Objective: We aimed to analyze the current literature for IORT in gynecological cancers and summarized clinical outcomes regarding patient selection. Methods: A systematic search was conducted utilizing PUBMED, Embase, and CINAHL to identify studies following PRISMA-ScR guidelines. A PICOS structure was utilized: population: patients with epithelial gynecological cancers; intervention: IORT; C: a comparator was not required, as we aimed to analyze patient selection; outcome: clinical outcomes and overall survival; and S: experimental and quasi-experimental analytical observational studies and descriptive observational studies, excluding case series published in English and limited to the last 10 years. Data extraction was conducted for patient selection, IORT, oncological outcomes, and morbidity. Results: A total of 707 results were identified, and 509 studies were uploaded to Covidence for screening after removing duplications. Of the 21 eligible studies, 9 were included in the final review. The total number of patients included was 348. The studies were retrospective single-institution studies, except for one. There was significant heterogeneity in their design and protocols. IORT was exclusively used for recurrent and advanced stage gynecological cancers adjunct to pelvic exenteration or laterally extended endopelvic resections with variable indications across institutions. The mean number of IORT patients per study was 2.8 per year. Survival rates were variable and dependent on the surgical margin. Endometrial cancer had a favorable outcome compared to vulvar and cervical cancers. Conclusions: Current clinical practice, as demonstrated by the research, is consistent with NCCN guidelines that endorse the application of IORT in instances of recurrent cervical, vaginal, and vulvar malignancies; however, there are no established recommendations for primary tumors. The analysis shows that there are gaps in our knowledge, mainly regarding the status of the margins, the criteria used to choose patients, and the outcomes that are specific to each histology. The standardization of protocols and prospectively powered studies are needed to refine patient selection criteria. Full article

In the context of breast cancer treatment optimization, this study prospectively examines the feasibility and outcomes of utilizing intraoperative radiotherapy (IORT) as a boost in combination with standard external beam radiotherapy (EBRT) for high-risk patients. Different guidelines recommend such a tumor bed boost in addition to whole breast irradiation with EBRT for patients with risk factors for local breast cancer recurrence. The TARGIT BQR (NCT01440010) is a prospective, multicenter registry study aimed at ensuring the quality of clinical outcomes. It provides, for the first time, data from a large cohort with a detailed assessment of acute and long-term toxicity following an IORT boost using low-energy X-rays. Inclusion criteria encompassed tumors up to 3.5 cm in size and preoperative indications for a boost. The IORT boost, administered immediately after tumor resection, delivered a single dose of 20 Gy. EBRT and systemic therapy adhered to local tumor board recommendations. Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs). Between 2011 and 2020, 1133 patients from 10 centers were preoperatively enrolled. The planned IORT boost was conducted in 90%, and EBRT in 97% of cases. Median follow-up was 32 months (range 1–120, 20.4% dropped out), with a median age of 61 years (range 30–90). No acute grade 3 or 4 toxicities were observed. Acute side effects included erythema grade 1 or 2 in 4.4%, palpable seroma in 9.1%, punctured seroma in 0.3%, and wound healing disorders in 2.1%. Overall, chronic teleangiectasia of any grade occurred in 16.2%, fibrosis grade ≥ 2 in 14.3%, pain grade ≥ 2 in 3.4%, and hyperpigmentation in 1.1%. In conclusion, a tumor bed boost through IORT using low-energy X-rays is a swift and feasible method that demonstrates low rates in terms of acute or long-term toxicity profiles in combination with whole breast irradiation. Full article

Background: The current standard of local treatment for patients with localized breast cancer (BC) includes whole breast irradiation (WBI) after breast-conserving surgery (BCS). Ultrahypofractionated WBI schemes (1-week treatment) were shown not to be inferior to the standard WBI. Tumor bed boost using photon intraoperative radiotherapy (IORT) is safe and feasible in combination with standard WBI. The aim of the present study is to assess, for the first time, the feasibility and safety of combining photon IORT with ultrahypofractionated WBI. Methods: Patients diagnosed with low-risk early BC candidates for BCS were included in this prospective study. IORT was administered at a dose of 20 Gy to the surface’s applicator, and WBI was administered 3–5 weeks after surgery at a total dose of 26 Gy in five consecutive days. Results: From July 2020 to December 2022, seventy-two patients diagnosed with low-risk early BC and treated in our institution were included in this prospective study. All patients completed the proposed treatment, and no severe acute or late grade 3 toxicity was observed 3 and 12 months after WBI, respectively. Conclusions: Our results confirm for the first time that the combination of ultrafractionation WBI and photon-IORT after BCS is a feasible and safe option in patients with early BC. Full article

Postsurgical radiotherapy (RT) has been early proven to prevent local tumor recurrence, initially performed with whole brain RT (WBRT). Subsequent to disadvantageous cognitive sequalae for the patient and the broad distribution of modern linear accelerators, focal irradiation of the tumor has omitted WBRT in most cases. In many studies, the effectiveness of local RT of the resection cavity, either as single-fraction stereotactic radiosurgery (SRS) or hypo-fractionated stereotactic RT (hFSRT), has been demonstrated to be effective and safe. However, whereas prospective high-level incidence is still lacking on which dose and fractionation scheme is the best choice for the patient, further ablative techniques have come into play. Neoadjuvant SRS (N-SRS) prior to resection combines straightforward target delineation with an accelerated post-surgical phase, allowing an earlier start of systemic treatment or rehabilitation as indicated. In addition, low-energy intraoperative RT (IORT) on the surgical bed has been introduced as another alternative to external beam RT, offering sterilization of the cavity surface with steep dose gradients towards the healthy brain. This consensus paper summarizes current local treatment strategies for resectable brain metastases regarding available data and patient-centered decision-making. Full article

Introduction: According to the literature only sparse data are available on the use of high-dose-rate intraoperative brachytherapy (IOHDR-BT) as a boost to external-beam irradiation (EBRT) in combination with a wide resection in patients with high-grade soft tissue sarcomas (STS). Materials and Methods: Applying a retrospective study design, we investigated all patients who between 2010 and 2016 underwent marginal resection of a high-grade STS and intraoperative radiotherapy, followed by EBRT. We included only patients with a traceable follow-up time of at least two years. Of 89 patients, 35 met our inclusion criteria and showed an average follow-up of four years. Results: We found an overall 2-year local control rate of 94.3%. The local recurrence rate for R0 resections was 6%, whereas recurrences occurred in 13% of R1 resections and in 100% of R2 resections. One affected patient received only intraoperative radiotherapy. The recurrence rate by tumour entity was 36% for LPS, 11% for myxofibrosarcoma and 17% for undifferentiated pleomorphic sarcoma. Conclusion: The treatment regimen consisting of limb-preserving surgery, IORT and pre- or postoperative radiotherapy consistently shows excellent local control rates. Full article

Background: To report the final results of a prospective, one-armed, single-center phase I/II trial (NCT01566123). Methods: Between 2007 and 2017, 37 patients with primary or recurrent (N = 6) retroperitoneal sarcomas were enrolled. Treatment included preoperative IMRT of 45–50 Gy with a simultaneous integrated boost of 50–56 Gy, surgery and IORT. The primary endpoint was local control (LC) at 5 years. The most common histology was dedifferentiated liposarcoma (51%), followed by leiomyosarcoma (24%) and well-differentiated liposarcoma (14%). The majority of lesions were high-grade (FNCLCC G1: 30%, G2: 38%, G3: 27%, two missing). Five patients were excluded from LC analysis per protocol. Results: The minimum follow-up of the survivors was 62 months (median: 109; maximum 162). IORT was performed for 27 patients. Thirty-five patients underwent gross total resection; the pathological resection margin was mostly R+ (80%) and, less often, R0 (20%). We observed 10 local recurrences. The 5-year LC of the whole cohort was 59.6%. Eleven patients received a dose > 50 Gy plus IORT boost; LC was 64.8%; the difference, however, was not significant (p = 0.588). Of 37 patients, 15 were alive and 22 deceased at the time of final analysis. The 5-year OS was 59.5% (68.8% per protocol). Conclusions: The primary endpoint of a 5-year LC of 70% was not met. This might be explained by the inclusion of recurrent disease and the high rate of G3 lesions and leiomyosarcoma, which have been shown to profit less from radiotherapy. Stratification by grading and histology should be considered for future studies. Full article

Background: Intraoperative radiotherapy (IORT) is a therapeutic de-escalation option in older women with low-risk early breast cancer (EBC). A qualitative study was implemented to describe EBC physicians’ points of view on IORT as a de-escalation option. Methods: Recorded face-to-face and telephone semi-structured interviews were conducted among diverse physicians from seven French comprehensive cancer centers. Interview transcripts were grouped as corpus to construct a typology. Thematic analysis was performed. Results: Positions toward IORT were contrasted between the 16 participating physicians. Five fully supported IORT as a de-escalation option, four were not in favor, and seven had a more reserved or neutral opinion. Points of divergence concerned treatment efficacy, treatment duration, side effects and sequelae, psychological impact, compliance with adjuvant endocrine therapy, logistical constraints, financial cost, and availability of other techniques of partial breast irradiation. Physicians in favor of IORT emphasized direct benefits for the patient, and those against pointed the lack of specific guidelines, risk of lost opportunity in older women with long life expectancy, and challenges of shared decision making. Conclusions: Despite national policies to preserve cancer patients’ quality of life and increase their participation in medical decision making, therapeutic de-escalation using IORT is not consensual among physicians. Further efforts are needed to promote patient-centered care. Full article

Purpose: To assess the safety and long-term outcome of a multimodality treatment consisting of radical surgery, intra-operative radiotherapy (IORT), and cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) for patients with locally advanced rectal cancer (LARC) or locally recurrent rectal carcinoma (LRRC) and peritoneal metastases (PM). Methods: The present study was a single-center cohort study, including all consecutive patients undergoing this treatment in a tertiary referral center for LARC, LRRC, and PM. Postoperative complications, intensive care stay (ICU stay), and re-admission rates were assessed as well as disease-free survival (DFS) and overall survival (OS). Results: A total of 14 LARC and 16 LRRC patients with PM were included in the study. The median ICU stay was 1 day, and 57% of patients developed a severe postoperative complication. No 90-day mortality was observed. Median DFS was 10.0 months (Interquartile Range 7.1–38.7), and median OS was 31.0 months (Interquartile Range 15.9–144.3). Conclusions: As postoperative complications and survival were in line with treatments that are accepted for LARC or LRRC and PM as separate procedures, we conclude that combined treatment with IORT and CRS-HIPEC should be considered as a treatment option for selected patients with LARC or LRRC and peritoneal metastases in tertiary referral centers. Full article

Locoregional recurrence (LRR) is the predominant pattern of relapse and often the cause of death in patients with retroperitoneal sarcomas (RPS). As a result, reducing LRR is a critical objective for RPS patients. However, unlike soft tissue sarcomas (STS) of the superficial trunk and extremity where the benefits of radiation therapy (RT) are well-established, the role of RT in the retroperitoneum remains controversial. Historically, preoperative or postoperative RT, either alone or in combination with intraoperative radiation (IORT), was commonly justified for RPS based on extrapolation from the superficial trunk and extremity STS literature. However, long-awaited results were recently published from the European Organization for Research and Treatment of Cancer (EORTC) STRASS study of preoperative radiotherapy plus surgery versus surgery alone for patients with RPS; there was no statistical difference in the primary endpoint of abdominal recurrence-free survival. However, several subset analyses and study limitations complicate the interpretation of the results. This review explores and contextualizes the body of evidence regarding RT’s role in managing RPS. Full article

The aim of this retrospective study is to compare the two boost subgroups, IORT or IMRT, in terms of overall survival (OS), progression-free survival (PFS), cosmesis, and acute and late toxicity. It shall be shown whether and which of the boost techniques offers better results with respect to the facial points, since there are already many studies on applying boost to the tumor bed after/during breast conserving surgery, and there are few which compare the different techniques. For this comparison, two subgroups of 76 patients each (n = 152), treated between 2002 and 2015, were enrolled in the study. In one subgroup, the 9 Gy boost was intraoperatively administered after complete removal of the primary tumor, while the other subgroup received the boost of 8.4 Gy percutaneously and simultaneously integrated into the tumor bed after breast conserving surgery. Both subgroups have subsequently undergone whole breast irradiation (WBI) of 50.4/50 Gy in 1.8–2 Gy per fraction. OS and the incidence of late toxicity did not differ between the two subgroups and no risk factor was found regarding PFS. Acute toxicities initially occurred significantly less (p < 0.001) in the IORT subgroup; however, after WBI took place, this difference vanished. Therefore, boost application by means of IORT or IMRT can be considered equivalent. Full article

Introduction: The clinical practice and outcome results of intraoperative electron radiation therapy (IOeRT) in cancer patients have been extensively reported over 4 decades. Electron beams can be delivered in the promising FLASH dose rate. Methods and Materials: Several cancer models were approached by two alternative radiobiological strategies to optimize local cancer control: boost versus exclusive IOeRT. Clinical outcomes are revisited via a bibliometric search performed for the elaboration of ESTRO/ACROP IORT guidelines. Results: In the period 1982 to 2020, a total of 19,148 patients were registered in 116 publications concerning soft tissue sarcomas (9% of patients), unresected and borderline-resected pancreatic cancer (22%), locally recurrent and locally advanced rectal cancer (22%), and breast cancer (45%). Clinical outcomes following IOeRT doses in the range of 10 to 25 Gy (with or without external beam fractionated radiation therapy) show a wide range of local control from 40 to 100% depending upon cancer site, histology, stage, and treatment intensity. Constraints for normal tissue tolerance are important to maintain tumor control combined with acceptable levels of side effects. Conclusions: IOeRT represents an evidence-based approach for several tumor types. A specific risk analysis for local recurrences supports the identification of cancer models that are candidates for FLASH studies. Full article