Single institute experience of intraoperative radiation therapy in early-stage breast cancer
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SUBMITTER: Chi M
PROVIDER: S-EPMC8601266 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Adjuvant whole breast radiation therapy has developed into the standard of care for patients following a lumpectomy for early-stage breast cancer. However, there is recent interest in intraoperative radiation therapy (IORT) to minimize toxicity while still improving local control beyond surgical resection and anti-estrogen therapy alone.All patients were evaluated pre-operatively in a multidisciplinary clinic setting at a community hospital for suitability for breast conservation therapy. A total of 109 patients were reviewed receiving 110 IORT treatments. Patients were followed with clinical breast examinations and mammography as clinically indicated.At a median follow-up of 29.9 months, 2/110 (1.8%) patients experienced a local failure. One patient (0.9%) experienced a regional failure. Local control, disease-free survival and overall survival at 3 years were 98.9% (95%CI 92.2-99.8), 97.2% (95%CI 88.9-99.3), and 96.0% (95%CI 84.9-99.0), respectively. Five-year local control, disease-free survival, and overall survival rates were 96.3% (95%CI 84.7-99.2), 94.6% (95%CI 83.2-98.3), and 92.5% (95%CI 80.4-97.3), respectively. Patient self-reported cosmetic outcome was available for 51 patients, with all patients reporting being either very pleased, pleased, or satisfied with their cosmetic outcome, and no patients reported being dissatisfied or worse.The results of our series suggest the feasibility of utilizing IORT in a community-based cancer center with a high degree of local control, and patient satisfaction with regard to cosmesis. While the results of this series suggest that IORT may be a promising modality, longer follow-up is warranted to better understand exactly which clinicopathological features can predict long-term locoregional disease control.
| S-EPMC5978806 | biostudies-other
Project description:BackgroundTo date no one has examined the quality of life and direct costs of care in treating early stage breast cancer with adjunct intraoperative radiation therapy (IORT) versus external beam radiation therapy (EBRT) over the life of the patient. As well no one has examined the effects of radiation exposure with both therapies on the longer term sequelae. The purpose of this analysis was to examine the cost-effectiveness of IORT vs. EBRT over the life of the patient.MethodsA Markov decision-analytic model evaluated these treatment strategies in terms of the direct costs in treating patients over their lifetime (including the downstream costs associated with radiation exposure) and the resultant quality of life of these patients. Medicare reimbursement amounts in treating patients were used for acute, steady state, recurrent cancer(s), and complications associated with radiation exposure. Quality adjusted life years (QALYs) derived from the medical literature were assessed with each of these states. Life expectancies as well were derived from the medical literature. Cost-effectiveness was evaluated for dominance and net monetary benefit [at a willingness to pay (WTP)] of $50,000/QALY. Sensitivity analysis was also performed.ResultsIORT was the dominant (least costly with greater QALYs) versus EBRT: total costs over the life of the patient = $53,179 (IORT) vs. $63,828 (EBRT) and total QALYs: 17.86 (IORT) vs. 17.06 (EBRT). At a willingness to pay of $50,000 for each additional QALY, the net monetary benefit demonstrated that IORT was the most cost effective option: $839,815 vs. $789,092. The model was most sensitive to the probabilities of recurrent cancer and death for both IORT and EBRT.ConclusionIORT is the more valuable (lower cost with improved QALYs) strategy for use in patients presenting with early stage ER+ breast cancer. It should be used preferentially in these patients.
| S-EPMC5679386 | biostudies-literature
Project description:Purpose/objectiveWe present our single-institution experience in the management of invasive breast cancer with targeted intraoperative radiotherapy (TARGIT-IORT), focusing on patient suitability for IORT determined by the American Society for Radiation Oncology (ASTRO) Accelerated Partial Breast Irradiation (APBI) consensus guidelines.Materials/methodsWe identified 237 patients treated for biopsy-proven early-stage invasive breast cancer using low energy x-ray TARGIT-IORT at the time of lumpectomy between September 2013 and April 2020 who were prospectively enrolled in an institutional review board (IRB) approved database. We retrospectively reviewed preoperative and postoperative clinicopathologic factors to determine each patient's ASTRO APBI suitability (suitable, cautionary or unsuitable) according to the 2017 consensus guidelines (CG). Change in suitability group was determined based on final pathology. Kaplan-Meier methods were used to estimate the survival probability and recurrence probability across time.Results237 patients were included in this analysis, based on preoperative clinicopathologic characteristics, 191 (80.6%) patients were suitable, 46 (19.4%) were cautionary and none were deemed unsuitable. Suitability classification changed in 95 (40%) patients based on final pathology from lumpectomy. Increasing preoperative lesion size or a body mass index (BMI) ≥ 30 kg/m2 were significant predictors for suitability group change. Forty-one (17.3%) patients received additional adjuvant whole breast radiotherapy after TARGIT-IORT. At a median follow up of 38.2 months (range 0.4 - 74.5), five (2.1%) patients had ipsilateral breast tumor recurrences (IBTR), including two (0.8%) true local recurrences defined as a recurrence in the same quadrant as the initial lumpectomy bed with the same histology as the initial tumor. IBTR occurred in 1/103 (0.09%) patient in the post-op suitable group, 4/98 (4.08%) patients in the post-op cautionary group, and no patients in the post-op unsuitable group. At 3-years, the overall survival rate was 98.4% and the local recurrence free survival rate was 97.1%.ConclusionThere is a low rate of IBTR after TARGIT-IORT when used in appropriately selected patients. Change in suitability classification pre to postoperatively is common, highlighting a need for further investigation to optimize preoperative patient risk stratification in this setting. Patients who become cautionary or unsuitable based on final pathology should be considered for additional adjuvant therapy.
| S-EPMC9277011 | biostudies-literature
Project description:IntroductionIntraoperative radiation therapy is an emerging option for adjuvant therapy for early stage breast cancer, although it is not currently considered standard of care in the United States. We applied time-driven activity-based costing to compare two alternative methods of breast intraoperative radiation therapy, including treatment similar to the techniques employed in the TARGIT-A clinical trial and a novel version with CT-guidance and high-dose-rate (HRD) brachytherapy.Methods and materialsProcess maps were created to describe the steps required to deliver intraoperative radiation therapy for early stage breast cancer at each institution. The components of intraoperative radiation therapy included personnel, equipment, and consumable supplies. The capacity cost rate was determined for each resource. Based on this, the delivery costs were calculated for each regimen. For comparison across centers, we did not account for indirect facilities costs and interinstitutional differences in personnel salaries.ResultsThe CT-guided, HRD form of intraoperative radiation therapy costs more to deliver ($4,126.21) than the conventional method studied in the TARGIT-A trial ($1,070.45). The cost of the brachytherapy balloon applicator ($2,750) was the primary driver of the estimated differences in costs. Consumable supplies were the largest contributor to the brachytherapy-based approach, whereas personnel costs were the largest contributor to costs of the standard form of intraoperative radiation therapy.ConclusionsWhen compared with the more established method of intraoperative radiation therapy using a portable superficial photon unit, the delivery of treatment with CT guidance and HDR brachytherapy is associated with substantially higher costs. The excess costs are driven primarily by the cost of the disposable brachytherapy balloon applicator and, to a lesser extent, additional personnel costs. Future work should include evaluation of a less expensive brachytherapy applicator to increase the anticipated value of brachytherapy-based intraoperative radiation therapy.
| S-EPMC7198347 | biostudies-literature
Project description:PurposeTo investigate patient-perceived quality of life (QOL) among patients treated with a novel form of breast intraoperative radiation therapy (PB-IORT).Methods and materialsPatients treated with PB-IORT as part of a phase II clinical trial from 2013 to 2020 were identified. Patients were given the European Organization for Research and Treatment of Cancer (EORTC) core 30-item Quality of Life Questionnaire (QLQ-C30) encompassing global health, functionality, and symptomatology at baseline, 1-month, 6-months, 12-months, and 24-months after PB-IORT. Scores were on a 100-point scale with change greater than 10 considered clinically significant. Scores at interval follow-up were compared to baseline using repeated measure modeling with an unstructured covariance matrix.ResultsThe cohort consisted of 303 patients, a majority of which were White (84.2%) with a median age of 64 years (IQR: 52, 76). One month after PB-IORT, a decline from baseline in physical (-2.5, 95% CI: -4.4 - -0.55, p = 0.01), role (-7.6, 95% CI: -11.7 - -3.5, p < 0.001), and social functioning (-3.0, 95% CI: -5.5 - -0.42, p = 0.02) were observed, which correlated with increased fatigue (8.4, 95% CI: 5.5-11.3, p < 0.001). At 6 months, nearly all QOL measures returned to baseline or improved. There were no statistically or clinically significant differences from baseline in overall global health. All functional and symptom scale differences were less than 10, indicating minimal clinical significance.ConclusionsPB-IORT has minimal negative impact on QOL, further supporting this patient-centered treatment approach for early-stage breast cancer.
| S-EPMC9149037 | biostudies-literature
Project description:Background/objectiveIntra-operative radiation therapy (IORT) is a newer partial breast irradiation technique that has been well studied in 2 large randomized trials, the TARGIT-A and ELIOT trials. We initiated our IORT program in 2018 in the context of a registry trial, and aim to report our early results thus far.MethodsWe instituted an IORT practice using Intrabeam® low energy 50kVp x-rays for selected breast cancer cases in 2018. Patients were enrolled on our institutional registry protocol which allowed for IORT in ER + patients with grade 1-2 DCIS ≤ 2.5 cm or invasive disease ≤ 3.5 cm in patients of at least 45 years of age.ResultsBetween January 2018 and December 2021, 181 patients with clinical stage 0-IIA ER + breast cancer were evaluated. One hundred sixty-seven patients ultimately received IORT to 172 sites. The majority of patients received IORT at the time of initial diagnosis and surgery (160/167; 95.8%). Re-excision post IORT occurred in 16/167 patients (9.6%) due to positive margins. Adjuvant RT to the whole breast +/- LN was ultimately given to 23/167 (13.8%) patients mainly due to positive sentinel LN found on final pathology (12/23; 52%); other reasons were close margins for DCIS (3/23; 13%), tumor size (3/23; 4.3%), and multifactorial (5/23; 17.4%). Five patients (3%) had post-operative complications of wound dehiscence. There were 3 local recurrences (1.6%) at a median follow-up of 27.9 months (range: 0.7- 54.8 months).ConclusionsIORT has been proven to be a safe and patient-centered form of local adjuvant RT for our population, in whom compliance with a longer course of external beam radiation can be an issue. Long term efficacy remains to be evaluated through continued follow up. In the era of COVID-19 and beyond, IORT has been an increasingly attractive option, as it greatly minimizes toxicities and patient visits to the clinic.Trial registrationAll patients were prospectively enrolled on an institutional review board-approved registry trial (IRB number: 2018-9409).
| S-EPMC10367245 | biostudies-literature
Project description:Objectives: To evaluate efficacy and safety of intensity-modulated radiotherapy (IMRT) in the management of esthesioneuroblastoma (ENB). Methods and Materials: A retrospectively analysis of 52 ENB patients treated with IMRT between 8/2008 and 8/2018 was performed. Thirteen of the 44 patients (29.5%) with newly diagnosed and 2 of the 8 patients with recurrent disease presented regional lymph node metastasis. The median dose of IMRT was 66 (range 52.5-75) Gy for all patients. Elective nodal irradiation (ENI) was provided to all excluding 6 patients in this cohort. Results: With a median follow-up time of 32.5 (6~121) months, the 3-year overall survival (OS), progression-free survival (PFS), local progression-free survival (LPFS), regional progression-free survival (RPFS), and distant metastasis-free survival (DMFS) rates for the entire cohort were 89.7, 69.5, 89.7, 95.1, and 85.4%, respectively. Multivariate analysis revealed that N-classification (N- vs. N+) at presentation was the only significant prognosticators for PFS. No significant prognosticator was identified for other survival outcome. No severe (i.e., grade 3 or 4) IMRT-induced acute toxicity was observed. Severe late toxicities were infrequent (11.5%), which included dysosmia (3.8%), hearing loss (3.8%), radiation brain injury (1.9%), and temporal lobe necrosis (1.9%). Moreover, late ocular toxicity secondary to IMRT was not observed. Conclusion: IMRT produced acceptable 3-year outcomes in terms of OS (89.7%), LPFS (89.7%), and RPFS (95.1%) rates without substantial late adverse effects. Further investigations for a more effective systemic strategy for distant disease control as well as a precision radiation technique for further improvement in local control are needed.
| S-EPMC7379860 | biostudies-literature
Project description:BackgroundThere is increasing evidence that radiation therapy (RT) can be omitted for select older patients who are compliant with hormonal blockade, but there is no recent claim-based analysis for determining patterns of care and guiding possible treatment recommendations.MethodsMedicare beneficiaries who were 65 years old or older and were diagnosed with breast cancer at 1 of 12 cancer centers affiliated with an academic center in the southeastern United States were analyzed. Stage 0 or I patients treated with lumpectomy from 2012 to 2014 were identified. Patient, treatment, and center characteristics were analyzed for the utilization of RT.ResultsAmong 800 women treated with lumpectomy, 64% received adjuvant radiation. The median age was 74 years. The omission of RT was more likely in older patients, stage 0 patients, and patients with more comorbidities (P < .01). Hormonal blockade was used in 41% of the patients who did not receive RT. The utilization of hormonal blockade with the omission of RT was more likely in patients with fewer comorbidities (P < .01).ConclusionsIn an older cohort of patients who otherwise would have qualified for the omission of radiation, two-thirds were treated with radiation. Future guideline recommendations should address omission in the context of hormonal blockade compliance because only 41% of the patients used hormonal blockade when radiation was not delivered. Cancer 2018;124:475-81. © 2017 American Cancer Society.
| S-EPMC9678242 | biostudies-literature
Project description:BackgroundAdjuvant radiotherapy represents a key component in curative-intent treatment for early-stage breast cancer patients. In recent years, two accelerated partial breast irradiation (APBI) techniques are preferred for this population in our organization: electron-based Intraoperative radiation therapy (IORT) and Linac-based External Beam Radiotherapy, particularly Intensity-modulated radiation therapy (IMRT). Recently published long-term follow-up data evaluating these technologies have motivated a health technology reassessment of IORT compared to IMRT.MethodsWe developed a Markov model to simulate health-state transitions from a cohort of women with early-stage breast cancer, after lumpectomy and adjuvant APBI using either IORT or IMRT techniques. The cost-effectiveness from a private health provider perspective was assessed from a disinvestment point of view, using life-years (LYs) and recurrence-free life-years (RFLYs) as measure of benefits, along with their respective quality adjustments. Expected costs and benefits, and the incremental cost-effectiveness ratio (ICER) were reported. Finally, a sensitivity and scenario analyses were performed to evaluate the cost-effectiveness using lower IORT local recurrence and metastasis rates in IORT patients, and if equipment maintenance costs are removed.ResultsIORT technology was dominated by IMRT in all cases (i.e., fewer benefits with greater costs). Despite small differences were found regarding benefits, especially for LYs, costs were considerably higher for IORT. For sensitivity analyses with lower recurrence and metastasis rates for IORT, and scenario analyses without equipment maintenance costs, IORT was still dominated by IMRT.ConclusionsFor this cohort of patients, IMRT was, at least, non-inferior to IORT in terms of expected benefits, with considerably lower costs. As a result, IORT disinvestment should be considered, favoring the use of IMRT in these patients.
| S-EPMC10988977 | biostudies-literature
Project description:Early stage invasive breast cancer is a disease that is prevalent in the elderly population. Data regarding radiation omission for elderly population is based on patients’ age. Given the increased life expectancy, data on individualizing treatment decisions based on multiple tumor and patient related factors other than age only is emerging. This review aims to analyze published data to provide clinicians with a general oversight on approaching this question.
| S-EPMC8798144 | biostudies-literature