Pediatric Facial Fracture Associated Craniofacial and Cervical Spine Injury.

Management of pediatric facial fractures depends on location and severity, age, and associated injuries. Accurate diagnosis of associated injuries is crucial for effective treatment. This study evaluates the incidence of associated injuries and seeks to determine the influencing factors to provide imaging guidance. A retrospective review of pediatric facial fractures from the American College of Surgeons National Trauma Data Bank from 2017 to 2021 was completed. Associated cervical spine (c-spine), skull fracture, traumatic brain injury (TBI), and intracranial bleeding were evaluated. Demographics, fracture patterns, mechanisms, protective devices, and the Glasgow Coma Scale (GCS) were reviewed. A total of 44,781 pediatric patients with 65,613 facial fractures were identified. Of the total, 5.47% had a c-spine injury, 21.86% had a skull fracture, 18.82% had TBI, and 5.76% had intracranial bleeding. Multiple fractures significantly increased the rate of all associated cranial and c-spine injuries. Single midface fractures had the highest c-spine, TBI, and intracranial bleeding rates. With increasing age, there was a significant increase in c-spine injury and TBI, while there was a decrease in skull fractures. Motor vehicle accidents and GCS <13 were associated with significantly increased rates of all injuries. Among pediatric patients with facial fractures, 5.47% had a c-spine injury, 21.86% had a skull fracture, 18.82% had TBI, and 5.76% had intracranial bleeding. The authors' findings recommend c-spine imaging in older age and cranial imaging in younger patients. Multiple facial fractures, fractures of the midface, decreased GCS, and motor vehicle accidents increase the need for both c-spine and cranial imaging.

A Phase II Trial of Once Weekly Hypofractionated Breast Irradiation for Early Stage Breast Cancer.

PURPOSE: To report an interim analysis of a phase II trial of once weekly, hypofractionated breast irradiation (WH-WBI) following breast conserving surgery (BCS). METHODS: Patients had stage 0-II breast cancer treated with breast BCS with negative margins. WH-WBI was 28.5 or 30Gy delivered to the whole breast using tangential beams with no elective coverage of lymph nodes. The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Secondary endpoints were distant disease-free survival (DDFS), recurrence free survival (RFS), overall survival (OS), adverse events and cosmesis. RESULTS: From 2011 to 2015, 158 patients received WH-WBI. Median follow up was 4.4 years (range 0.2-8.1). Stage distribution was DCIS 22%; invasive pN0 68%; invasive pN1 10%. 80 patients received 30 Gy and 78 received 28.5 Gy with median follow up times of 5.6 and 3.7 years, respectively. There were 5 IBTR events, all in the 30 Gy group. The 5- and 7- year risks of IBRT for all patients were 2.2% (95% CI 0.6-5.8) and 6.0% (95% CI 1.1-17.2), respectively. The 7-year rates of DDFS, RFS, and OS were 96.3%, 91.5% and 89.8%, respectively. Improvement in IBTR-free time was seen in DCIS, lobular histology, low grade tumors, Her2 negative tumors and 28.5 Gy dose (all p < 0.0001). CONCLUSIONS: Disease-specific outcomes after WH-WBI are favorable and parallel those seen with conventional radiation techniques for stage 0-II breast cancer.

Evaluation of ERAS protocol implementation on complex spine surgery complications and length of stay: a Single Institution Study.

BACKGROUND CONTEXT: With the goal of improving patient outcomes, the Integrated Spine Center at UT Southwestern Medical Center implemented an enhanced recovery after surgery (ERAS) protocol which includes pre- and post-surgery guidelines. Numerous studies have shown benefit of implementation of ERAS protocols to standardize perioperative care in line with best practices; however, the literature on complication rates, LOS, and readmissions shows mixed results. PURPOSE: The goal of this study was to investigate the impact of the ERAS protocol implementation on complication rates in the perioperative period, as well as hospital and ICU length of stay and hospital re-admission rates. STUDY DESIGN/SETTING: A retrospective cohort study was performed on all patients who underwent spine surgery between September 2016 and September 2021 at a single institution. Patients who met inclusion criteria were divided into non-ERAS and ERAS groups, and comparative statistics were used to evaluate ERAS protocol effectiveness. PATIENT SAMPLE: All patients who underwent spine surgery at UT Southwestern between September 2016 and September 2021 were evaluated for inclusion in the study. The patient sample was further refined to include only complex patient cases which were able to receive the full ERAS protocol (non-emergent admissions). OUTCOME MEASURES: Presence of absence of post-operative complications including surgical site infection, AKI, DVT, MI, sepsis, pneumonia, PE, stroke, shock, and other complications were compared between groups, as were hospital and ICU length of stay, and 7, 30, and 90 day readmissions. Self-reported or functional measures were not used in outcome evaluation. METHODS: A database of patient and surgery characteristics was built using an EMR query tool with spot checks performed by the authors. Control and treatment groups were matched for gender, age, BMI, ASA score, and surgery type. Total number of complication rates was compared between ERAS and non-ERAS groups, and comparative statistics were used to determine significance. RESULTS: Significant differences between ERAS versus non-ERAS groups were found in rates of UTI (6.8% vs. 3.1%, respectively; p=.031), constipation (20.6% vs. 11.4%, respectively; p=.001), and any complications (31.4% vs. 19.4%, respectively; p<.001). There was no significant difference in the rates of other complications, in length of hospital or ICU stay, or readmissions at 7, 30, and 90 days. CONCLUSIONS: Implementation of the ERAS protocol did not decrease complication rates or length of stay, and ERAS patients had significantly higher rates of UTI, constipation, and any complications. There may have been confounding factors due to the impact of COVID-19 on delivery of care, as well as misalignment between ERAS goals and outcome measures.

Use of MRI in patients with severe diffuse traumatic brain injury: A matched National Trauma Data Bank analysis.

OBJECTIVE: Magnetic resonance imaging (MRI) is increasingly used to evaluate patients with diffuse traumatic brain injury (dTBI). However, the utility of early MRI is understudied. We hypothesize that early MRI patients will have increased length of stay but no changes in intracranial pressure (ICP) management or disposition. METHODS: The 2019 National Trauma Data Bank was queried for patients with dTBI and Glasgow Coma Scale score ≤8. Extra-axial and focal intra-axial hemorrhages were excluded. Clinical characteristics were controlled for. Patients with and without MRI were compared for ICP management, outcome, mortality, and disposition. A propensity score matching algorithm was used to create a 1:1 match cohort. RESULTS: In 2568 patients, MRI was less common in severe dTBI patients with clear reasons for poor examination, including bilaterally unreactive pupils or midline shift. After matching, 501 patients who underwent MRI within 1 week were compared with 501 patients without MRI. Magnetic resonance imaging patients had longer intensive care unit stays (11.6 ± 9.6 vs. 13.4 ± 9.5, p < 0.01; 95% confidence interval [95% CI], -3.03 to -0.66). There was no difference between groups in ICP monitor (23.6% vs. 27.3%; p = 0.17; 95% CI, -0.09 to 0.02) or ventriculostomy placement (13.6% vs. 13.2%, p = 0.85; 95% CI, -0.04 to 0.05) or in withdrawal of care (15.0% vs. 18.6%, p = 0.12; 95% CI, -0.08 to 0.01). MRI patients were more likely to be discharged to inpatient rehabilitation (42.9% vs. 33.5%; p < 0.01; 95% CI, 0.03-0.15) but not to home (9.4% vs. 9.0%; p = 0.83; 95% CI, -0.03 to 0.04). CONCLUSION: The decision to pursue early brain MRI may be driven by lack of obvious reasons for a patient's poor neurologic status. MRI patients had longer intensive care unit stays but no difference in rates of placement of ICP monitors or ventriculostomies or withdrawal of care. Further study is required to define the role of early MRI in dTBI patients. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level IV.

Trends of the Oswestry Disability Index in Adult Spinal Deformity Patients: A 3-Year Study.

BACKGROUND: Patients with adult spinal deformity (ASD) undergoing operative treatment may have varying degrees of improvement in patient-reported outcomes. The Oswestry Disability Index (ODI) assesses improvement in quality of life. We aim to measure longitudinal outcomes of ODI scores over 3 years to determine if early ODI scores predict late ODI scores and to analyze longitudinal changes in ODI scores. METHODS: Two hundred thirty-five patients above the age of 18 who underwent surgical correction of ASD at a single institution from 2016 to 2021 and completed ODI questionnaires at follow-up appointments met inclusion criteria. ODI scores were included from follow-up visits at 0 months (immediately postoperative) and within ±1 month of 3, 6, 12, 18, 24, 30, and 36 months. Percent change in ODI from 0 months was calculated, and unpaired t tests were conducted. RESULTS: ODI scores increased by 8.8% immediately postoperatively, and the percent change from preoperative ODI scores at each subsequent visit were as follows: -11.1% at 3 months, -21.4% at 6 months, -25.4% at 12 months, -28% at 18 months, -31.3% at 24 months, -25.7% at 30 months, and -36.5% at 36 months. ODI scores at each follow-up visit showed significant improvement from baseline (P < 0.001). There was an improvement in scores from 3 to 6 months (P = 0.04), but no significant difference in 6-month interval visits following 6 months. CONCLUSIONS: Our results demonstrate a significant and sustained improvement in ODI scores over 3 years following surgical correction of ASD. ODI scores were stable after 6 months, indicating that ODI scores at 6 months may be predictive of scores out to 3 years postoperatively. Examining individual components of ODI sub-scores and comparing ODI results to other PROMs are critical to better assess long-term outcomes in ASD.

Identifying Correlation Among Patient-Reported Outcome Measures: A Study of PROMIS-29, ODI, and VAS in Adult Spinal Deformity Patients.

BACKGROUND: Adult spinal deformity (ASD) is becoming increasingly common in aging populations. Patient-reported outcome measures (PROMs) are self-reported patient surveys administered pre- and postoperatively that provide insight into patient improvement. We aim to compare 3 of the most utilized PROMs: PROMIS-29, Oswestry Disability Index (ODI), and Visual Analogue Scale (VAS), to investigate whether they provide unique and independent assessments of patient outcomes when assessed longitudinally. METHODS: We retrospectively reviewed a database of ASD at UT Southwestern Medical Center between 2016 and 2021. Adult patients (>18 years old) were included if they underwent long-segment (>4 levels) thoracolumbar fusion. PROMIS-29, ODI, and VAS scores were collected preoperatively and at 3-, 6-, 12-, 18-, 24-, 30-, and 36-month follow-ups. Scores were recorded ±1 month of the time points. Pearson correlation coefficients for each PROM were then calculated in a pairwise fashion. RESULTS: A total of 163 patients were included in our analysis. ODI and VAS showed significant covariance, with VAS Neck and VAS Back having Pearson coefficients of 0.95 and 0.94, respectively. ODI and PROMIS-29 also showed significant covariance, with Physical Function and ODI showing a Pearson coefficient of 0.95. PROMIS-29 and VAS demonstrated less correlation regarding Pain and Physical Function; however, they showed a significantly high Pearson coefficient when comparing VAS Back with PROMIS-29 Sleep and Pain Intensity (r = 0.97 and r = 0.96, respectively). CONCLUSIONS: All 3 PROMs demonstrated significant correlation over 36 months, indicating that simultaneous administration of each during follow-up is redundant. The measure that provided the least unique information was ODI, as both VAS and PROMIS-29 demonstrated similar progression and assessed additional metrics. PROMIS-29 provided the same information as VAS and ODI, with extra facets of patient-reported outcomes, indicating that it may be a more comprehensive measure of longitudinal patient improvement.

Consensus Quality Measures and Dose Constraints for Breast Cancer From the Veterans Affairs Radiation Oncology Quality Surveillance Program and American Society for Radiation Oncology Expert Panel.

PURPOSE: Using evidence-based radiation therapy to direct care for patients with breast cancer is critical to standardize practice, improve safety, and optimize outcomes. To address this need, the Veterans Affairs (VA) National Radiation Oncology Program (NROP) established the VA Radiation Oncology Quality Surveillance Program to develop clinical quality measures (QMs). The VA NROP contracted with the American Society for Radiation Oncology to commission 5 Blue Ribbon Panels for breast, lung, prostate, rectal, and head and neck cancers. METHODS AND MATERIALS: The Breast Cancer Blue Ribbon Panel experts worked collaboratively with the NROP to develop consensus QMs for use throughout the VA system, establishing a set of QMs for patients in several areas, including consultation and work-up; simulation, treatment planning, and treatment; and follow-up care. As part of this initiative, consensus dose-volume histogram (DVH) constraints were outlined. RESULTS: In total, 36 QMs were established. Herein, we review the process used to develop QMs and final consensus QMs pertaining to all aspects of radiation patient care, as well as DVH constraints. CONCLUSIONS: The QMs and expert consensus DVH constraints are intended for ongoing quality surveillance within the VA system and centers providing community care for Veterans. They are also available for use by greater non-VA community measures of quality care for patients with breast cancer receiving radiation.

Increasing mastectomy rates among all age groups for early stage breast cancer: a 10-year study of surgical choice.

First-line surgical options for early stage breast cancer and ductal carcinoma in situ include breast conserving surgery or mastectomy. We analyzed factors that influence the receipt of mastectomy and resultant trends over time. Registry analysis was carried out for 21,869 women who underwent up-front surgical treatment for stage 0, I or II breast cancer between 1998 and 2007 using data from the Kentucky Cancer Registry. We examined the trend of treatment over time and assessed the probability of receiving mastectomy using multivariate logistic regression. Overall, 54.5% of women received breast conservation and 45.5% received mastectomy over a 10-year period (annual BCS rate range: 46.9-61.2%). The overall mastectomy rate substantially decreased from 53.1% in 1998 to 38.8% in 2005 (p < 0.0001), but then increased to 45% in 2007 (p < 0.001). Between 2005 and 2007, the increase in mastectomies in the age groups of <50 years, 50-69 years, and ≥ 70 years was 7.5% (p = 0.0351), 4.9% (p = 0.0132) and, 8.0% (p = 0.0283), respectively. On multivariate analysis, the rate of receiving mastectomy was drastically higher for women with stage I or II (versus in situ) disease and moderate or poorly differentiated (versus well differentiated) histology. The rate was modestly higher for uninsured and government-insured (versus privately insured) patients, patients older than 70 years (versus younger), rural (versus urban) location, receptor negative (versus receptor positive) disease, and unusual histologies (versus ductal and lobular histology). There was no statistically significant difference in surgical choice with regard to race. Determinants of mastectomy for in situ and early stage breast cancer include stage, histology, age, insurance status, county of residence, receptor status. The rate of mastectomy declined until 2005 and is now increasing across all age groups, especially for women < 50 years and ≥ 70 years.

The Effect of Race in the Palliative Treatment of Bone Metastases.

PURPOSE: Prior studies demonstrated that single and multiple-fraction radiation therapy (RT) provide comparable pain relief in palliative-care patients. In addition, unconscious racial biases may affect practice patterns in oncology. In this study, we examined the effect of race on the duration of RT for palliative treatment of bone metastases. METHODS AND MATERIALS: This is a retrospective study of 707 patients treated for bone metastases between 2013 and 2020 (1348 treatments). Patient race, demographics, RT dose, number of fractions, use of stereotactic radiosurgery (SRS), and performance score were collected. A short-course was defined as a single fraction, whereas a long-course was defined as more than one fraction. SRS cases were analyzed separately. RESULTS: Of all nonradiosurgery RT treatments delivered, 28.9% were single fraction and 71.1% were multiple fraction. In total, 76% of the patients were White and 24% were non-White. With regard to race, the number of White patients receiving short- and long-course RT was 256 (27.9%) and 663 (72.1%), respectively. The number of non-White patients receiving short- and long-course RT was 97 (31.9%) and 207 (68.1%), respectively. There was no difference in treatment duration based on patient race (P = .20). The use of SRS did not vary based on race (P = .79). There was no statistically significant difference in Karnofsky Performance Status Scale score between White and non-White patients (P = .44). CONCLUSIONS: Analysis of patient and physician characteristics revealed that race did not influence treatment decisions such as duration of palliative RT regimen or use of SRS. Although palliative-care regimens must be individualized for each patient, such investigations can identify potential biases in treatment decisions.

Final Analysis of a Phase 2 Trial of Once Weekly Hypofractionated Whole Breast Irradiation for Early-Stage Breast Cancer.

PURPOSE: We hypothesize that 5-fraction once weekly hypofractionated (WH) whole breast irradiation (WBI) would be safe and effective after breast-conserving surgery for medically underserved patients with breast cancer. We report the protocol-specified primary endpoint of in-breast tumor recurrence (IBTR) at 5 years. METHODS AND MATERIALS: After provided informed consent, patients were treated with WH-WBI after breast-conserving surgery were followed prospectively on an institutional review board-approved protocol. Women included in this study had stage 0-II breast cancer treated with negative surgical margins and met prespecified criteria for being underserved. WH-WBI was 28.5 or 30 Gy delivered to the whole breast with no elective coverage of lymph nodes. The primary endpoint was IBTR at 5 years. Secondary endpoints were distant disease-free survival, recurrence-free survival, overall survival, adverse events, and cosmesis. RESULTS: One hundred fifty-eight patients received WH-WBI on protocol from 2010 to 2015. Median follow-up was 5.5 years (range, 0.2-10.0 years). Stage distribution was 22% ductal carcinoma in situ, 68% invasive pN0, and 10% invasive pN1. Twenty-eight percent of patients had grade 3 tumors, 10% were estrogen receptor negative, and 24% required adjuvant chemotherapy. There were 6 IBTR events. The 5-, 7-, and 10-year risks of IBTR for all patients were 2.7% (95% confidence interval [CI], 0.89-6.34), 4.7% (95% CI, 1.4-11.0) and 7.2% (95% CI, 2.4-15.8), respectively. The 5-, 7-, and 10-year rates of distant disease-free survival were 96.4%, 96.4%, and 86.4%; the recurrence-free survival rates were 95.8%, 93.6%, and 80.7%; and the overall survival rates were 96.7%, 88.6%, and 76.7%, respectively. Improvement in IBTR-free time was seen in ductal carcinoma in situ, lobular histology, low-grade tumors, T1 stage, Her2-negative tumors, and receipt of a radiation boost to the lumpectomy bed. CONCLUSIONS: Postoperative WH-WBI has favorable disease-specific outcomes that are comparable to those seen with conventional and moderately hypofractionated radiation techniques. WH-WBI could improve access to care for underserved patients with stage 0-II breast cancer.

Disparities in the application of adjuvant radiotherapy after breast-conserving surgery for early stage breast cancer: impact on overall survival.

BACKGROUND: Definitive local therapy of early stage breast cancer includes adjuvant radiotherapy after breast-conserving surgery (BCS). The authors analyzed factors that influence the receipt of radiotherapy therapy and their resultant impact on outcome. METHODS: Using data from the Kentucky Cancer Registry, the authors analyzed the rate of adjuvant radiotherapy for 11,914 women who underwent BCS as a primary surgical treatment for stage 0, I, or II breast cancer between 1998 and 2007. The authors assessed the probability of receiving radiotherapy by using multivariate logistic regression and measured impact on outcome by using Cox survival analysis. RESULTS: Overall, 66.2% of women received adjuvant radiotherapy for BCS over a 10-year period (annual rate range, 60.9%-70.1%). On multivariate analysis, the rate of receiving radiotherapy was drastically lower for women aged older than 70 years (vs younger) and rural Appalachian (vs non-Appalachian) populations. The rate was modestly lower for African American (vs white) women, those with in situ (vs invasive) disease, and uninsured (vs insured) patients. Lack of radiotherapy was associated with an increased hazard ratio for death of 1.67 (95% CI, 1.508-1.851) on Cox survival analysis when age, stage, tumor size, grade, hormone receptors, smoking, and insurance were factored into the analysis. The 10-year overall survival for patients who received adjuvant radiotherapy versus BCS alone was 79.7% versus 67.6% (P < .0001). CONCLUSIONS: Despite widespread knowledge of the benefit of RT after BCS, the rate of undertreatment remains high, with significant disparities for elderly, rural, minority, and uninsured women. Multidisciplinary management strategies, including accelerated and hypofractionated radiation regimens, are needed to eliminate disparities and improve outcomes.

A Statewide Multi-Institutional Study of Asymptomatic Pretreatment Testing of Radiation Therapy Patients for SARS-CoV-2 in a High-Incidence Region of the United States.

PURPOSE: Our purpose was to establish the prevalence of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in asymptomatic patients scheduled to receive radiation therapy and its effect on management decisions. METHODS AND MATERIALS: Between April 2020 and July 2020, patients without influenza-like illness symptoms at four radiation oncology departments (two academic university hospitals and two community hospitals) underwent polymerase chain reaction testing for SARS-CoV-2 before the initiation of treatment. Patients were tested either before radiation therapy simulation or after simulation but before treatment initiation. Patients tested for indications of influenza-like illness symptoms were excluded from this analysis. Management of SARS-CoV-2-positive patients was individualized based on disease site and acuity. RESULTS: Over a 3-month period, a total of 385 tests were performed in 336 asymptomatic patients either before simulation (n = 75), post-simulation, before treatment (n = 230), or on-treatment (n = 49). A total of five patients tested positive for SARS-CoV-2, for a pretreatment prevalence of 1.3% (2.6% in north/central New Jersey and 0.4% in southern New Jersey/southeast Pennsylvania). The median age of positive patients was 58 years (range, 38-78 years). All positive patients were white and were relatively equally distributed with regard to sex (2 male, 3 female) and ethnicity (2 Hispanic and 3 non-Hispanic). The median Charlson comorbidity score among positive patients was five. All five patients were treated for different primary tumor sites, the large majority had advanced disease (80%), and all were treated for curative intent. The majority of positive patients were being treated with either sequential or concurrent immunosuppressive systemic therapy (80%). Initiation of treatment was delayed for 14 days with the addition of retesting for four patients, and one patient was treated without delay but with additional infectious-disease precautions. CONCLUSIONS: Broad-based pretreatment asymptomatic testing of radiation oncology patients for SARS-CoV-2 is of limited value, even in a high-incidence region. Future strategies may include focused risk-stratified asymptomatic testing.

ASTRO Radiation Therapy Summary of the ASCO-ASTRO-SSO Guideline on Management of Hereditary Breast Cancer.

PURPOSE: To develop a summary of recommendations regarding locoregional management of patients with breast cancer and germline mutations in breast cancer susceptibility genes based on the American Society of Clinical Oncology/American Society for Radiation Oncology/Society of Surgical Oncology Guideline on Management of Hereditary Breast Cancer. METHODS: The American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology convened an expert panel to develop recommendations based on a systematic review of the literature and a formal consensus process. A total of 58 articles met the eligibility criteria and formed the evidentiary basis for the locoregional therapy recommendations. Additionally, 6 randomized controlled trials of systemic therapy also met eligibility criteria. RESULTS: A joint evidence-based guideline was developed by a multidisciplinary panel, which has been separately published. From this guideline, the radiation-oncologist authors of the panel extracted pertinent surgical and radiation-specific recommendations of findings that are hereby presented. CONCLUSIONS: Patients with newly diagnosed breast cancer and BRCA1/2 mutations may be considered for breast conserving therapy (BCT), expecting similar rates of local control of the index cancer as noncarriers. The significant risk of contralateral breast cancer in these women (especially younger women), coupled with the higher risk of new cancers in the ipsilateral breast, warrant discussion of bilateral mastectomy. For women with mutations in BRCA1/2 or moderate-penetrance genes who are eligible for mastectomy, nipple-sparing mastectomy is a reasonable approach. There is no evidence of increased toxicity or contralateral breast cancer events from radiation exposure in BRCA1/2 carriers. Patients with mutations in moderate-risk genes should be offered BCT as one choice after appropriate counseling. Radiation therapy should not be withheld in ATM carriers if BCT is planned. For patients with germline TP53 mutations, mastectomy is advised and radiation therapy is contraindicated except for those with a significant risk of locoregional recurrence.

Patient-Reported Outcomes and Cosmesis After Once-Weekly Hypofractionated Breast Irradiation in Medically Underserved Patients.

PURPOSE: To evaluate patient-reported outcomes (PROs) and cosmesis from a phase 2 trial of once-weekly hypofractionated breast irradiation (WH-WBI) after breast-conserving surgery (BCS). METHODS AND MATERIALS: Patients had stage 0-II breast cancer treated with BCS and negative margins. WH-WBI was 28.5 to 30 Gy in 5 weekly fractions of 5.7 to 6 Gy delivered with or without a boost. PROs were collected for 3 years after treatment using the Breast Cancer Treatment Outcome Scale (BCTOS) and European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). Physicians rated cosmetic outcome with the Global Cosmesis Score. Longitudinal growth models were used to assess changes in BCTOS across time, and baseline values and changes between time points were correlated with patient and treatment factors. RESULTS: From 2011 to 2015, 158 women received WH-WBI, and 148 were eligible for analysis after a median follow-up of 39.3 months. Adverse changes (P < .001) in global BCTOS score and breast pain and arm function subscores were observed 6 months after radiation therapy, followed by improvement to near-baseline values at years 1 and 3. Adverse changes in BCTOS cosmetic subscore were also detected at 6 months (P < .001), with no significant improvement at 1 (P = .385) and 3 (P = .644) years. No effect was detected for longitudinal changes in BCTOS scoring for age, body mass index, diabetes, smoking, breast volume, tumor size, seroma volume, dosimetric factors, dose, boost, or systemic therapy. Physician-rated cosmesis at 3 years was excellent/good in 89% and fair/poor in 11%. CONCLUSIONS: WH-WBI was associated with transient worsening in arm function and breast pain but persistent adverse changes in cosmetic PROs that were typically mild or moderate in severity. Physician-rated cosmetic outcomes were acceptable.

Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline.

PURPOSE: To develop recommendations for management of patients with breast cancer (BC) with germline mutations in BC susceptibility genes. METHODS: The American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology convened an Expert Panel to develop recommendations based on a systematic review of the literature and a formal consensus process. RESULTS: Fifty-eight articles met eligibility criteria and formed the evidentiary basis for the local therapy recommendations; six randomized controlled trials of systemic therapy met eligibility criteria. RECOMMENDATIONS: Patients with newly diagnosed BC and BRCA1/2 mutations may be considered for breast-conserving therapy (BCT), with local control of the index cancer similar to that of noncarriers. The significant risk of a contralateral BC (CBC), especially in young women, and the higher risk of new cancers in the ipsilateral breast warrant discussion of bilateral mastectomy. Patients with mutations in moderate-risk genes should be offered BCT. For women with mutations in BRCA1/2 or moderate-penetrance genes who are eligible for mastectomy, nipple-sparing mastectomy is a reasonable approach. There is no evidence of increased toxicity or CBC events from radiation exposure in BRCA1/2 carriers. Radiation therapy should not be withheld in ATM carriers. For patients with germline TP53 mutations, mastectomy is advised; radiation therapy is contraindicated except in those with significant risk of locoregional recurrence. Platinum agents are recommended versus taxanes to treat advanced BC in BRCA carriers. In the adjuvant/neoadjuvant setting, data do not support the routine addition of platinum to anthracycline- and taxane-based chemotherapy. Poly (ADP-ribose) polymerase (PARP) inhibitors (olaparib and talazoparib) are preferable to nonplatinum single-agent chemotherapy for treatment of advanced BC in BRCA1/2 carriers. Data are insufficient to recommend PARP inhibitor use in the early setting or in moderate-penetrance carriers. Additional information available at www.asco.org/breast-cancer-guidelines.

Late chest wall toxicity after MammoSite breast brachytherapy.

PURPOSE: Accelerated partial breast irradiation (APBI) with the MammoSite breast brachytherapy (MBB) system is being investigated as an alternative to whole breast radiation in breast conservation therapy (BCT) at multiple centers worldwide. The newness of MBB means a complete understanding of long-term toxicity, particularly involving the chest wall, has yet to be completely articulated. We report the first pathologic rib fractures associated with MBB and dosimetric analysis of the original treatment plans. METHODS AND MATERIALS: As part of ongoing quality assurance, we reviewed the records of 129 sequential patients who underwent MBB for breast cancer and identified those who subsequently had clinically significant and radiographically documented rib fracture(s) involving the ipsilateral chest wall. Equivalent tolerance doses yielding a 5% and 50% risk of rib toxicity within 5 years from treatment with 10 fractions (as with MBB) were previously calculated using the linear quadratic equation based on 2Gy per fraction treatments delivered to one-third of the rib volume (TD5/5=37Gy; TD50/5=44Gy). The original radiation therapy plans were evaluated vis-à-vis the plane films or PET/CT images documenting the osseous abnormalities and presenting complaints to find the specific fractured ribs. The specific effected ribs were contoured on the planning CT in "bone windows" using the Nucletron MicroSelectron-classic V2 (Nucletron B.V., Veenendaal, The Netherlands) for this analysis and the original patient treatments. With these datasets, we determined the dose-volume characteristics of the effected ribs including maximal dose encompassing the entire rib on one CT slice, V(20Gy), V(30Gy), V(37Gy), V(44Gy), D(50), D(25), and D(5) (the mean dose to 50%, 25%, and 5% of the rib). RESULTS: Between May 2002 and August 2007, three of 105 patients with a minimum of 6-months follow-up who underwent adjuvant APBI by MBB were found to have a total of five treatment-related rib fractures. The average dose-volume characteristics from the original plans were as follows: D(50)=22.1Gy, D(25)=32.2Gy, D(5)=41.6Gy, max dose to 1cc=34.8, D(max) (to 0.1cc)=45.6Gy, V(20)Gy=57.4%, V(30)Gy=30.8%, V(37)Gy=15.9%, V(44)Gy=6.6%, and max dose through rib=35.8Gy. Two patients sustained two rib fractures and 1 patient had a single rib fracture. Four of five fractures occurred in postmenopausal patients and two of five fractures occurred in a patient with a history of osteoporosis and exposure to adjuvant chemotherapy. CONCLUSIONS: Fractures occurred in ribs with V(37)Gy and V(44)Gy each well below 33%. As long-term toxicity data accrue from APBI series, the traditional models for estimating the biologic equivalent dose may benefit from refinements that specifically address the unique radiobiologic and physical properties intrinsic to high-dose-rate brachytherapy for breast conservation therapy.

Multi-institutional experience using the MammoSite radiation therapy system in the treatment of early-stage breast cancer: 2-year results.

PURPOSE: To present a retrospective multi-institutional experience of patients treated with the MammoSite radiation therapy system (RTS). METHODS AND MATERIALS: Nine institutions participated in a pooled analysis of data evaluating the clinical experience of the MammoSite RTS for delivering accelerated partial breast irradiation. Between 2000 and 2004, 483 patients were treated with the MammoSite RTS to 34 Gy delivered in 10 fractions. Treatment parameters were analyzed to identify factors affecting outcome. RESULTS: Median follow-up was 24 months (minimum of 1 year). Overall, infection was documented in 9% of patients, but the rate was only 4.8% if the catheter was placed after lumpectomy. Six patients (1.2%) experienced an in-breast failure; four failures occurred remote from the lumpectomy site (elsewhere failure). Cosmetic results were good/excellent in 91% of patients. Treatment parameters identified as significant on univariate analysis were tested in multivariate regression analysis. The closed-cavity placement technique significantly reduced the risk of infection (p = 0.0267). A skin spacing of <6 mm increased the risk of severe acute skin reaction (p = 0.0178) and telangiectasia (p = 0.0280). The use of prophylactic antibiotics reduced the risk of severe acute skin reaction (p < 0.0001). The use of multiple dwell positions reduced the risk of severe hyperpigmentation (p = 0.0278). Infection was associated with an increased risk of fair or poor overall cosmesis (p = 0.0009). CONCLUSIONS: In this series of patients, the MammoSite RTS seems to have acceptable toxicity rates and cosmetic outcomes, comparable to those with whole-breast radiotherapy. On the basis of these data, the closed-cavity placement technique, use of prophylactic antibiotics, use of multiple dwell positions, and a minimum skin spacing of 6 mm seem to improve patient outcome.

Incidence and prognostic factors for seroma development after MammoSite breast brachytherapy.

PURPOSE: Describe the incidence and identify risk factors for seroma development after MammoSite breast brachytherapy (MBT). METHODS AND MATERIALS: MBT patient data were prospectively recorded into a quality assurance database. Departmental and electronic records were reviewed to extract patient-, treatment-, and outcome-specific data. Stepwise logistic regression analysis was performed to identify factors associated with development of any seroma including the subset of clinically significant seroma (CSS). CSS was defined as a symptomatic seroma requiring multiple aspirations, biopsy, and/or excision. Variables analyzed included age, weight, number of excisions, time from resection to catheter placement, placement technique, balloon volume, dosimetric factors, and postbrachytherapy infection. RESULTS: MBT was performed in 109 patients, of whom 97 had minimum 6 months (median, 36) post-MBT follow-up or earlier development of seroma. All patients received 34 Gy to 1cm depth from balloon surface, delivered twice daily in 10 fractions. Seroma developed in 41% of patients at a median of 3 months (range, 0.1-25) post-MBT. One-third of seromas (13% of all patients) were CSS. The only factor identified as statistically significant for development of any seroma was catheter placement on day of resection vs. > or =1 day later (59% vs. 33%; p = 0.0066). Post-MBT infection was highly statistically significant for development of CSS (64% vs. 7%; p<0.0001). Prophylactic antibiotics reduced the risk of post-MBT infection from 37.5% to 6% (p = 0.011). CONCLUSIONS: The incidence of CSS after MBT is low. Post-MBT infection is statistically significantly associated with CSS development, the incidence of which is reduced with prophylactic antibiotics.

Predictors of cosmetic outcome following MammoSite breast brachytherapy: a single-institution experience of 100 patients with two years of follow-up.

PURPOSE: To identify the factors that predict for excellent cosmesis in patients who receive MammoSite breast brachytherapy (MBT). METHODS AND MATERIALS: One hundred patients with Stage 0, I, or II adenocarcinoma of the breast underwent adjuvant therapy using MBT. A dose of 34 Gy, delivered in 10 fractions twice daily, was prescribed to 1-cm depth using (192)Ir high-dose-rate brachytherapy. Patients were assessed for acute toxicity on the day of therapy completion, 4 weeks after therapy, and at least every 3 months by radiation, surgical, and/or medical oncologists. All available data were reviewed for documentation of cosmesis and rated using the Harvard Scale. All patients had a minimum follow-up of 6 months (median = 24 months). RESULTS: Of 100 patients treated, 90 had adequate data and follow-up. Cosmesis was excellent in 62 (68.9%), good in 19 (21.1%), fair in 8 (8.9%), and poor in 1 (1.1%) patient. Using stepwise logistic regression, the factors that predicted for excellent cosmesis were as follows: the absence vs. presence of infection (p = 0.017), and the absence vs. presence of acute skin toxicity (p = 0.026). There was a statistically significant association between acute skin toxicity (present vs. absent) and balloon-to-skin distance (<8 vs. >8 mm, p = 0.001). Factors that did not predict for cosmesis were age, balloon placement technique, balloon volume, catheter days in situ, subcutaneous toxicity, and chemotherapy or hormonal therapy. CONCLUSIONS: The acute and late-term toxicity profiles of MBT have been acceptable. Cosmetic outcome is improved by proper patient selection and infection prevention.

A Dose-Volume Response Model for Brain Metastases Treated With Frameless Single-Fraction Robotic Radiosurgery: Seeking to Better Predict Response to Treatment.

Purpose/Objective(s): To establish a dose-volume response relationship for brain metastases treated with single-fraction robotic stereotactic radiosurgery and identify predictors of local control. MATERIALS/METHODS: We reviewed a prospective institutional database of all patients treated for intact brain metastases with stereotactic radiosurgery alone using the CyberKnife robotic radiosurgery system from 2012 to 2015. Tumor response was determined based on Response Evaluation Criteria In Solid Tumors version 1.1. Survival was estimated using the Kaplan-Meier method. Logistic regression modeling was used to identify predictors of outcome and establish a dose-volume response relationship. Receiver operating characteristic curves were constructed to evaluate the predictive capability of the relationship. RESULTS: There were 357 metastases evaluated in 111 patients with a median diameter of 8.14 mm (2.00-40.77 mm). At 6 and 12 months, local control was 86.9% and 82.2%, respectively. For lesions of similar volumes, higher maximum dose, mean dose, and minimum dose (all P values <.05) predicted for better local control. Tumor volume and diameter were strongly correlated, and a dose-volume response relationship was constructed using mean dose per lesion diameter (Gy/mm) that was predictive of local control (odds ratio: 1.34, 95% confidence interval: 1.06-1.70). Area under the receiver operating characteristic curve for local control and mean dose by volume was 0.6199 with a threshold of 2.05 Gy/mm (local failure 7.6% above and 17.3% below 2.05 Gy/mm). CONCLUSION: A dose-volume response relationship exists for brain metastases treated with robotic stereotactic radiosurgery. Mean dose per volume is strongly predictive of local control and can be potentially useful during stereotactic radiosurgery plan evaluation while respecting previously established dose constraints.