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Background We require high-quality information on the current burden, the types of therapy and resources available, methods of delivery, care pathways and long-term outcomes for people with aphasia. Aim To document and inform international delivery of post-stroke aphasia treatment, to optimise recovery and reintegration of people with aphasia. Methods & Procedures Multi-centre, prospective, non-randomised, open study, employing blinded outcome assessment, where appropriate, including people with post-stroke aphasia, able to attend for 30 minutes during the initial language assessment, at first contact with a speech and language therapist for assessment of aphasia at participating sites. There is no study-mandated intervention. Assessments will occur at baseline (first contact with a speech and language therapist for aphasia assessment), discharge from Speech and Language Therapy (SLT), 6 and 12-months post-stroke. Our primary outcome is changed from baseline in the Amsterdam Nijmegen Everyday Language Test (ANELT/Scenario Test for participants with severe verbal impairments) at 12-months post-stroke. Secondary outcomes at 6 and 12 months include the Therapy Outcome Measure (TOMS), Subjective Index of Physical and Social Outcome (SIPSO), Aphasia Severity Rating Scale (ASRS), Western Aphasia Battery Aphasia Quotient (WAB-AQ), stroke and aphasia quality of life scale (SAQoL-39), European Quality of Life Scale (EQ-5D), lesion description, General Health Questionnaire (GHQ-12), resource use, and satisfaction with therapy provision and success. We will collect demography, clinical data, and therapy content. Routine neuroimaging and medication administration records will be accessed where possible; imaging will be pseudonymised and transferred to a central reading centre. Data will be collected in a central registry. We will describe demography, stroke and aphasia profiles and therapies available. International individual participant data (IPD) meta-analyses will examine treatment responder rates based on minimal detectable change & clinically important changes from baseline for primary and secondary outcomes at 6 and 12 months. Multivariable meta-analyses will examine associations between demography, therapy, medication use and outcomes, considering service characteristics. Where feasible, costs associated with treatment will be reported. Where available, we will detail brain lesion size and site, and examine correlations with SLT and language outcome at 12 months. Conclusion International differences in care, resource utilisation and outcomes will highlight avenues for further aphasia research, promote knowledge sharing and optimise aphasia rehabilitation delivery. IPD meta-analyses will enhance and expand understanding, identifying cost-effective and promising approaches to optimise rehabilitation to benefit people with aphasia.

External beam radiotherapy is an effective curative treatment option for localized prostate cancer, the most common cancer in men worldwide. However, conventionally fractionated courses of curative external beam radiotherapy are usually 8–9 weeks long, resulting in a substantial burden to patients and the health-care system. This problem is exacerbated in low-income and middle-income countries where health-care resources might be scarce and patient funds limited. Trials have shown a clinical equipoise between hypofractionated schedules of radiotherapy and conventionally fractionated treatments, with the advantage of drastically shortening treatment durations with the use of hypofractionation. The hypofractionated schedules are supported by modern consensus guidelines for implementation in clinical practice. Furthermore, several economic evaluations have shown improved cost effectiveness of hypofractionated therapy compared with conventional schedules. However, these techniques demand complex infrastructure and advanced personnel training. Thus, a number of practical considerations must be borne in mind when implementing hypofractionation in low-income and middle-income countries, but the potential gain in the treatment of this patient population is substantial., Conventionally fractionated external beam radiotherapy is an effective treatment for localized prostate cancer, but long treatment programmes result in a substantial burden to patients and the health-care system, which is particularly problematic in low-income and middle-income countries (LMICs) where health-care resources might be scarce and patient funds limited. Here, the authors discuss the outcomes and benefits of hypofractionation — in terms of both oncology and economics — and how it could be used to improve prostate cancer care in LMICs., Key points The global burden of prostate cancer is increasing and prostate cancer is becoming a major source of health-care burden in low-income and middle-income countries (LMICs).Radiotherapy is an essential treatment modality in the management of prostate cancer. However, radiotherapy resources are lacking in LMICs, resulting in excess morbidity and mortality.Hypofractionated radiotherapy schedules offer an opportunity to maintain excellent treatment outcomes while shortening curative radiotherapy courses. This approach expands the treatment capacity and could improve crucial access in communities with limited radiotherapy resources.Initial investments are required for technological upgrades, such as intensity-modulated radiotherapy and image-guided radiotherapy, as well as in specialized training in order to optimally provide hypofractionated treatment. Discussion amongst government agencies and device manufacturers is essential to lower these costs.Personnel training and access to external consultation are critical resources for developing radiotherapy centres. Information and communication technologies enable remote guidance between developing and developed radiotherapy centres.In the long term, hypofractionation programmes result in long-term cost savings and simultaneously expand patient access to a curative modality in the management of prostate cancer.

Background Historically, IBD has been thought to increase the underlying risk of radiation related toxicity in the treatment of prostate cancer. In the modern era, contemporary radiation planning and delivery may mitigate radiation-related toxicity in this theoretically high-risk cohort. This is the first manuscript to report clinical outcomes for men diagnosed with prostate cancer and underlying IBD curatively treated with stereotactic body radiation therapy (SBRT). Methods A large institutional database of patients (n = 4245) treated with SBRT for adenocarcinoma of the prostate was interrogated to identify patients who were diagnosed with underlying IBD prior to treatment. All patients were treated with SBRT over five treatment fractions using a robotic radiosurgical platform and fiducial tracking. Baseline IBD characteristics including IBD subtype, pre-SBRT IBD medications, and EPIC bowel questionnaires were reviewed for the IBD cohort. Acute and late toxicity was evaluated using the CTCAE version 5.0. Results A total of 31 patients were identified who had underlying IBD prior to SBRT for the curative treatment of prostate cancer. The majority (n = 18) were diagnosed with ulcerative colitis and were being treated with local steroid suppositories for IBD. No biochemical relapses were observed in the IBD cohort with early follow up. High-grade acute and late toxicities were rare (n = 1, grade 3 proctitis) with a median time to any GI toxicity of 22 months. Hemorrhoidal flare was the most common low-grade toxicity observed (n = 3). Conclusion To date, this is one of the largest groups of patients with IBD treated safely and effectively with radiation for prostate cancer and the only review of patients treated with SBRT. Caution is warranted when delivering therapeutic radiation to patients with IBD, however modern radiation techniques appear to have mitigated the risk of GI side effects.

This exploratory study evaluates immunological changes in high-risk Gleason 9 prostate cancer patients treated with EBRT+BT compared to EBRT alone. Notably, BT demonstrates the potential to elicit a T cell response which may support further investigation using circulating immune cells as predictive and prognostic biomarkers for radiotherapy response.

Purpose/objectives High dose rate (HDR) interstitial brachytherapy (ISBT) boost is integral for definitive radiation treatment of primary vaginal cancer. Technological advances with CT or MRI guidance provide improved precision and ability to treat more extensively invasive tumors over historical techniques, but reported experience is limited. We sought to provide updated outcome and toxicity data for women with primary vaginal cancer undergoing treatment with a modern ISBT technique. Material/methods Databases of primary vaginal carcinoma patients treated at two Canadian academic cancer institutions were combined including patient, tumor and treatment characteristics, and survival outcomes and toxicity data. Descriptive statistics, survival estimates based on the Kaplan-Meier method, and univariable/multivariable Cox proportional hazards regression analyses are reported. Results Between 2002 and 2017, 67 women with primary vaginal cancer were treated with 3D HDR ISBT. FIGO stage distribution was I (22.4%), II (50.8%), III (17.9%), IVa (9.0%). All patients received external beam radiotherapy and HDR ISBT of 500–750 cGy per fraction over 2–4 fractions. Median follow-up was 2.68 years (95% confidence interval: 2.04–6.04). Cumulative rate of grade 3–4 genitourinary/gastrointestinal toxicity was 10.4%. Four patients developed vaginal fistula. Progression-free survival at 2 and 3 years was 73.5% and 66.4% for all patients, 78.3% and 75.0% for stage I-II and 61.6% and 46.2% for stage III-IVa, respectively (log-rank p = 0.252). Conclusions Use of 3D image-guided HDR ISBT boost was safe and resulted in improved survival outcomes compared to historical rates in this series of primary vaginal cancer patients. Prospective study is warranted to better define clinical and dosimetric predictors of local control.

Purpose To investigate the role of androgen deprivation therapy (ADT) in unfavorable intermediate risk (UIR) prostate cancer patients treated with high-dose rate (HDR) brachytherapy (BT) boost. Material and methods Data from 326 consecutive NCCN UIR prostate cancer patients treated in a single institution from 2009 to 2016 with 15 Gy HDR-BT boost plus 37.5 Gy external beam radiotherapy (EBRT) in 15 fractions to prostate and proximal seminal vesicles were retrospectively collected. Baseline information was collected and patients receiving vs. not receiving ADT were matched using a propensity-score model. Primary endpoint was biochemical-failure-free survival (BFFS). Kaplan–Meier estimates and stratified log-rank tests (adjusting for matched design) were used to compare BFFS, castration-resistance (CRFS) and metastasis free survival (MFS) outcomes between both groups. Results A total of 326 patients were included in the analysis of which 52 ADT patients were matched to 104 non-ADT patients in a 1:2 ratio. Median follow-up was 3.4 years and 5.5 years for ADT and non-ADT respectively. No significant baseline differences were observed. ADT was used for a median total time of 6 months (interquartile range [IQR]: 4–6) and delivered a median time of 2.7 months (IQR: 1.7–4.3) prior to HDR-BT. BFFS was significantly improved in the ADT group (stratified log-rank: p = 0.043) with 3-year and 6-year BFFS of 98% and 90% for the ADT group and 92% and 82% for the non-ADT group, respectively. No significant differences were detected for CRFS or MFS. Conclusion Short-term ADT increased BFFS in UIR prostate cancer patients treated with HDR-BT boost plus EBRT.

Purpose Reirradiation (re-RT) using external beam radiation therapy (EBRT) is a novel salvage strategy for local failure in prostate cancer. We performed a systematic review describing oncologic and toxicity outcomes for salvage EBRT/stereotactic radiation therapy (SBRT) re-RT. Methods and Materials A International Prospective Register of Systematic Reviews registered (#141466) systematic review, meta-analysis, and meta-regression was conducted using preferred reporting items for systematic reviews and meta-analyses guidelines. PubMed and EMBASE were searched from inception through September 2019. Outcome measures included local control (LC), biochemical relapse free survival (BRFS), and ≥grade 3 genitourinary (GU)/gastrointestinal (GI) toxicity. EBRT and SBRT data were collected separately. Meta-regression explored disease and toxicity outcomes as a function of equivalent dose in 2 Gy fractions (EQD2), length of follow-up, and partial versus whole prostate reirradiation. Results Nineteen studies representing 13 cohorts were included (428 patients). Weighted mean follow-up was 26.1 months. Median re-RT EQD2 was 77.1 Gy (α/β = 1.5), with 92% of patients receiving SBRT, 52.1% of patients receiving partial prostate re-RT, and 30.1% of patients receiving androgen deprivation therapy with re-RT. LC was 83.2% (95% confidence interval [CI], 75.5%-90.9%) and BRFS was 59.3% (47.9%-70.7%). Reported late toxicity ≥grade 3 was 3.4% (95% CI, 1.0%-5.8%) for GU and 2.0% (95% CI, 0.1%-4.0%) for GI. Meta-regression found higher LC, BRFS, and reported GU/GI toxicity with increasing EQD2, with partial prostate re-RT associated with less reported GU/GI toxicity and no detriment to LC and BRFS. Conclusions Salvage re-RT using EBRT, particularly with SBRT, is an emerging technique to treat isolated local failure of prostate cancer. With short-term follow-up, LC, BRFS, and reported toxicities appear reasonable, although further follow-up is required before definitive statements on late toxicities can be made. Our review is limited by incomplete reporting of androgen deprivation therapy use in the primary literature. Further prospective studies and longer follow-up are needed before considering re-RT as standard practice.

Cervical cancer is a deadly disease and the COVID-19 pandemic has the potential to further impact its lethality. Hypofractionated radiotherapy could mitigate this impact, however robust data in cervical cancer setting still is lacking. Information provided here could help institutions in reducing radiotherapy fractions for cervical cancer patients.

INTRODUCTION AND OBJECTIVE:Studies have shown that patients treated with conventional radiation can have higher risk of gastrointestinal and genitourinary side effects. There are limited data showi...

PURPOSE We report on our early experience of our prospective multicenter phase 1 dose- escalation study of single-fraction stereotactic partial breast irradiation (S-PBI) for early stage breast cancer after partial mastectomy using a robotic stereotactic radiation system. METHODS AND MATERIALS Thirty women with in situ or invasive breast cancer stage 0, I, or II with tumor size

Introduction: Preeclampsia (PE) is a pregnancy specific disease with multisystem complications. In PE endothelial cell injury leads to alteration of various biochemical parameters. Levels of serum lactate dehydrogenase (LDH) & uric acid are known to be elevated in PE. This study was conducted to correlate these two parameters with severity parameters of PE such as blood pressure & proteinuria and to associate these parameters with severity of PE. Aim: To compare serum LDH and uric acid levels between healthy pregnant and preeclamptic women, and to correlate their levels with severity parameters such as BP & proteinuria. Materials and Methods: This is a case-control study conducted between normotensive pregnant (n=50) and preeclamptic women (27 mild PE & 23 severe PE). Serum uric acid was estimated by Uricase method and LDH by enzymatic method. ANOVA and Pearson’s correlation tests were used to analyse the data. The results are expressed as Mean + SD and P value Results: Serum uric acid (mild 7.53 + 1.35; severe 8.16 + 1.57) and LDH (mild 405.56 + 42.69; severe 735.22 + 108.36) levels were significantly elevated in PE group compared to controls (uric acid 4.53 + 1.30; LDH 227.68 + 58.85). The correlation analysis of LDH with systolic blood pressure (SBP) & proteinuria in severe PE group indicated a positive association. However, when uric acid was correlated, SBP associated negatively and proteinuria correlated positively. Conclusion: LDH can be used as a biochemical marker for severity of PE as its levels correlated with other severity parameters of PE unlike that of serum uric acid. Keywords: Preeclampsia, Lactate dehydrogenase, Uric acid.

Background and purpose To identify if, in intermediate risk prostate cancer (IR-PCa), the absolute percentage of biopsied tissue positive for pattern 4 disease (APP4) may be a predictor of outcome. Materials and methods 411 patients with IR-PCa were retrospectively reviewed. APP4 was calculated based on biopsy reports. Multivariable competing risk analysis was then performed on optimized APP4 cutpoints to predict for biochemical failure (BF), androgen deprivation use for BF (ADT-BF) and development of metastases (MD). Results Median follow-up for the cohort was 5.2 (Inter Quartile Range: 2.9–6.6) years. Median baseline PSA was 7.3 (5.3–9.8) ng/mL. 234 (56.9%) patients had T1 and 177 (43.1%) had T2 disease. Median APP4 was 2.00 (0.75–7.50)%. 38 (9.3%) patients experienced BF. The optimal cutpoint of APP4 for BF was >3.3% with an area under the curve (AUC) of 0.66. 17 (4.1%) received ADT-BF. The ADT-BF cutpoint was >6.6% with an AUC of 0.72. Eight (2.0%) developed MD. The MD cutpoint was >17.5% with an AUC of 0.86. Using APP4 >3.3 vs ≤ 3.3, log-transformed baseline PSA ln(PSA) (HR 2.5, 1.1–6.1; p = 0.037) and APP4 (HR 2.3, 1.1–4.7; p = 0.031) predicted for BF. Using APP4 >6.6 vs ≤ 6.6, ln(PSA) (HR 4.2, 1.4–12.4; p = 0.010) and APP4 (HR 3.7, 1.4–10.0; p = 0.009) were predictive of ADT-BF. APP4 >17.5 vs ≤ 17.5 alone was predictive of MD (HR 25.7, 4.9–135.3; p Conclusion APP4 cutpoints of >3.3%, >6.6% and >17.5% were strongly associated with increased risk of BF, ADT-BF and developing MD respectively. These findings may inform future practice when treating IR-PCa but require external validation.

Purpose To describe a technique of penile surface mold high-dose-rate (HDR) brachytherapy and early outcomes. Methods and Materials Five patients diagnosed with a T1aN0 squamous cell carcinoma of the penis were treated using a penile surface mold HDR brachytherapy technique. A negative impression of the penis was obtained using dental alginate. CT images were acquired of the penile impression; subsequently, a virtual model of the patient's penis was generated. The positive model was imported into a computer-assisted design program where catheter paths were planned such that an optimized offset of 5 mm from the penile surface was achieved. The virtual model was converted into a custom applicator. A total dose of 40 Gy was delivered in 10 fractions. Patients were followed at 1, 3, 6, and 12 months after treatment and then every 6 months thereafter. Toxicities were reported using Common Terminology Criteria for Adverse Events v4.0. Results All patients tolerated treatment well. Acute Grade 2 skin reactions were observed within the first month after treatment. Median followup was 35 months. Late Grade 1 skin toxicities were observed. One patient experienced a urethral stricture requiring dilatation. Two patients developed local recurrence. Conclusion This technique allows the delivery of penile HDR brachytherapy as an outpatient procedure with minimal discomfort to the patient during each application and is a repeatable and accurate setup. This technique warrants validation in larger series with longer followup.

Funding Acknowledgements Type of funding sources: None. BACKGROUND Intermediate-high risk (IHR) Pulmonary Embolism (PE) are a common disease witch could have a high mortality. Anticoagulation remains the first therapeutic option, but Catheter-directed therapies are being investigated as a safe and effective treatment option. PURPOSE To evaluate the safety and efficacy of Catheter-directed low-dose fibrinolysis infusion to treat IHR-PE. METHODS Retrospective analysis of 16 patients IHR-PE treated. After performing Right catheterization (RC) and angiogram, Pigtail catheters were located for intrapulmonary infusion of Alteplase 1mg/h/catheter for 24 h (25-30mg/day). Baseline and clinical characteristics, inicial and evolutive echocardiography, also clinical evaluation and echocardiography 6 months after discharge were evaluated. RESULTS The majority were women (11) and obese (93.8%), aged 22-74 years with cardiovascular risk factors: 5 hypertension, 3 Dyslipidemia, 2 smokers and 3 severe CKD . At admission 11 patients consulted for dyspnea and 5 for syncope; all were hemodynamic stable. 68.8% presented respiratory failure. All had bilateral PE (angiography) and elevation of Nt-proBNP and troponins. The echocardiographic at admission, and its evolution are shown in Table 1. The invasive measurement of pulmonary hypertension (PH) reflected greater severity than the estimated by echo: 5 (31.3%) Severe PH, 5 (31.3%) Moderate PH and 2 (12.5%) mild PH. At discharge all presented a decrease in PH and 15 (93.8%) improved RV function. 2 patients suffered bleeding complications (relation with femoral access): 1 not severe, 1 severe without mortality; none suffered intracranial hemorrhage. In the evaluation at 6-months: 13 patients (81.3%) where on functional Class I and without PH, 3 patients (18.8%) where in Class II and with mild-PH. CONCLUSION In short-term follow-up, intrapulmonary low-dose fibrinolysis reduces PA pressures and improves RV function, without an increased bleeding complications, especially if femoral access is avoided. However impact on long-term remains unclear. Table 1: Echocardiography evolution.RV function admissionNormal Function1 (6.3%)Mild Dysfunction9 (56.3%)Moderate Dysfunction6 (37.5%)RV Dilatation admissionDilatation 16 (100%)Not dilatation 0 (0%)PH Degree admissionMild PH6 (37.5%)Moderate PH5 (31.3%)Severe PH5 (31.3%)PH Degree 24h-postNot PH1 (6.3%)Mild PH10 (62.5%)Moderate/severe PH5 (31.3%)Improvement RV 24h-postYes14 (87.5%)Not2 (12.5%)RV function dischargeNormal Function16 (100%)Mild Dysfunction0 (0%)Moderate Dysfunction0 (0%)RV Dilatation dischargeDilatation 5 (31.3%)Not dilatation 11 (68.8%)PH Degree dischargeNot PH 9 (56.3%)Mild PH7 (43.8%)Moderate/severe PH0 (0%)RV Right Ventricular; PH: Pulmonary Hypertension

Key Points Question What is the hemoglobin transfusion threshold and target recommended for patients with cervical cancer undergoing curative-intent radiotherapy (RT)? Findings In this international Delphi consensus study, 39 experts in gynecologic radiation oncology did not agree on a hemoglobin transfusion threshold, highlighting significant variability in clinical practice. For both external beam RT and brachytherapy, a hemoglobin transfusion target of 9 or more g/dL and less than 12 g/dL, respectively, was agreed on by an 89% consensus. Meaning A liberal packed red blood cell transfusion strategy was recommended by consensus to overcome hypoxia-induced radioresistance in patients with cervical cancer receiving curative RT., Importance Packed red blood cell (PRBC) transfusions are used to treat anemia in patients with cervical cancer undergoing radiotherapy (RT) owing to concerns of hypoxia-induced radioresistance. In the absence of high-quality evidence informing transfusion practices for patients receiving external beam RT (EBRT) and brachytherapy, various arbitrary hemoglobin target levels are used worldwide. Objective To develop consensus statements to guide PRBC transfusion practices in patients with cervical cancer receiving curative-intent RT with EBRT and brachytherapy. Design, Setting, and Participants This international Delphi consensus study was completed between November 1, 2019, and July 31, 2020. A total of 63 international clinical experts in gynecologic radiation oncology were invited; 39 (62%) accepted and consented to participate. Consensus building was achieved using a 3-round anonymous Delphi consensus method. Participants rated their agreement or disagreement with statements using a 5-point Likert scale. An a priori threshold of 75% or more was required for consensus. Main Outcomes and Measures The preplanned primary outcome of this study was to assess hemoglobin transfusion thresholds and targets for both EBRT and brachytherapy by expert consensus. Results Response rates of 100% (39 of 39), 92% (36 of 39), and 97% (35 of 36) were achieved for the first, second, and third rounds of surveys, respectively. Twenty-three experts (59%) practiced in Canada, 11 (28%) in the United States, 3 (8%) in South America, 1 (3%) in Europe, and 1 (3%) in Asia. Consensus was reached for 44 of 103 statements (43%), which were combined to form the final 27-statement consensus guideline. No specific hemoglobin transfusion threshold was agreed on by consensus for EBRT or brachytherapy. By consensus (89% [31 of 35]), a hemoglobin transfusion target for patients who receive a PRBC transfusion should be 9 g/dL or more and less than 12 g/dL. Conclusions and Relevance This study presents the first international expert consensus guideline informing PRBC transfusion practices for patients with cervical cancer undergoing EBRT and brachytherapy. A minimum hemoglobin transfusion target of 9 g/dL was endorsed to balance tumor radiosensitivity with appropriate use of a scarce resource. Randomized clinical trials are required to evaluate the optimal transfusion threshold and target that maximize clinical benefit in this patient population., This international Delphi consensus study developed consensus statements to guide packed red blood cell transfusion practices for patients with cervical cancer receiving curative-intent radiotherapy with external beam radiotherapy and brachytherapy.

PURPOSE/OBJECTIVE(S) To validate the association between body composition and all-cause mortality in men treated with radiation therapy for localized prostate cancer (PCa). Secondarily, to integrate body composition as a factor to help classify patients by risk of all-cause mortality. MATERIALS/METHODS All participants of NRG/RTOG 9406 and NRG/RTOG 0126 with archived computed tomography that extended cranially to include the L4-L5 interface were included. Muscle mass and muscle density were estimated by measuring the cross-sectional area and average attenuation of the paired psoas muscles on a single slice at the level of L4-L5. Bone density was estimated by measuring the average attenuation of the vertebral body cancellous bone on a single slice at mid-L5. Adipose tissue density was estimated by measuring the average attenuation of the subcutaneous adipose tissue on a single slice at L4-L5. Survival analyses, including Cox proportional hazards models, were performed to assess the relationship between body composition variables and all-cause mortality. Recursive partitioning (RPA) was utilized to create a classification tree to classify NRG/RTOG 0126 participants by risk of death, and the discriminant ability of the classification model was validated using the NRG/RTOG 9406 data set. RESULTS Data from 2,066 men was included in this study (864 from NRG/RTOG 9406 and 1,202 from NRG/RTOG 0126). A total of 648 men died in the follow-up period and 51 (7.9%) were due to PCa. Psoas area, psoas density, and vertebral body density were individually associated with overall survival. In the final multivariable model, psoas area, comorbidity score, and age were associated with overall survival (Table). The RPA yielded a classification tree with 4 prognostic groups determined by age, comorbidity, and psoas cross-sectional area. When the RPA classification was applied to the NRG/RTOG 9406 validation set the discriminant ability was preserved (P < 0.001 groupwise log-rank). CONCLUSION The results of this study strongly support that body composition is related to all-cause mortality in men with localized PCa, with most deaths due to causes other than PCa. The inclusion of psoas cross-sectional area in the RPA classification tree suggests that body composition provides additive information to age and comorbidity status for mortality prediction. This study also confirms the feasibility of performing body composition analysis using archived CT scans using NRG Oncology clinical trial data sets. These methods can be applied to other NRG Oncology data sets to further explore how body composition is related to patient outcomes.

PURPOSE/OBJECTIVE(S) Stereotactic Body Radiation Therapy (SBRT) is a standard therapeutic option for men with prostate adenocarcinoma. The median age of prostate cancer in the US is 66 but patients as young as 35 have been reported. Many younger patients will have surgery rather than SBRT for localized prostate cancer but some will be treated with SBRT. There is a paucity of data on the outcomes of this younger subset. This study reports outcomes on patients younger than 50 treated with SBRT at a single institution and compares outcomes to older patients. MATERIALS/METHODS Between April 2006 and December 2020, 3626 patients with prostate cancer were treated with inhomogeneous-dosed SBRT using a robotic linear accelerator and followed at an academic institution. 3173 (87.51%) of patients were treated with a median dose of 3500cGY (3500-3625) delivered over 5 consecutive fractions prescribed to the 83-85% isodose line, and the remaining 453 (12.49%) other patients receiving a median dose of 4500cGY (4500-5400) to the pelvis in conventional fractionation followed by a 3 fraction SBRT boost of 2100 cGY (1950-2100) over 3 consecutive fractions. Androgen deprivation Therapy (ADT) was prescribed in 865 (23.86%) of these cases. The mean age was 67.3 years old. 47 patients were younger than 50 years old (mean age 46.6). 3,579 patients were 50 or older. Patients were divided into prognostic D'Amico risk groups with 44.68%, 48.94%, 6.38% of patients falling in the low, intermediate, and high-risk stratifications in the younger cohort and 24.76%, 56.83%, 18.41% in the older cohort respectively. Pretreatment PSA was 1.72 - 43.2 (median: 5.4) in the younger group and 0.3 - 661 (median: 6.5) in the older group. In the younger group, Gleason scores were 6 in 48.94%, 7 in 46.81%, and 8-10 in 4.25%. 44 younger patients were treated with SBRT alone. 3 patients also received supplemental external beam radiation (median dose 4500cGY) and 5 patients (10.6%) received Androgen Deprivation Therapy (ADT) as part of their treatment regimen. In the older group, Gleason scores were 6 in 30.57%, 7 in 54.06%, and 8-10 in 15.37%. 3129 were treated with SBRT alone. 450 patients also received supplemental external beam radiation (median dose 4500cGY) and 860 patients (24.03%) received Androgen Deprivation Therapy (ADT) as part of their treatment regimen. RESULTS At 64.8 months (range 7 months - 177 months) the 5-year biochemical relapse free survival was 98% in younger patients compared to 99% in older patients using the Phoenix definition of biochemical failure. The 5-year median post treatment PSA was 0.15 in the younger patients and 0.20 in the older patients. There were no significant differences in biochemical relapse free survival between the groups. CONCLUSION This represents the largest series evaluating outcomes in very young patients treated with definitive SBRT for prostate cancer. With 5-year follow up, SBRT is an effective treatment for this younger subset of patients. Continued follow up will be required to see if these results remain durable.

Purpose/Objective(s) Adjuvant radiation plays a significant role in reducing locoregional recurrences in uterine cancers. Standard treatment consists of daily radiation for 5 weeks which can be challenging for patients and the healthcare system, especially during the COVID pandemic. Hypofractionated radiotherapy has been evaluated and established in other pelvic malignancies. This study aims to evaluate the acute urinary and bowel toxicities, and patient reported outcomes following stereotactic hypofractionated adjuvant radiation for endometrial cancer. Materials/Methods This is a prospective phase I/II trial in which patients with endometrial cancer planned for adjuvant radiation received 30 Gy in 5 fractions, every other day or once weekly. Treatment was delivered at two centers with volumetric arc radiation therapy with a body-vacuum immobilization, bowel enema and 3D image-guidance. Toxicity assessment, outcomes and patient reported quality of life (QOL, EORTC core QLQ-C30 and endometrial EN24) were collected at baseline, fractions (F) 3 and 5, and at regular follow-up intervals. Higher scores represent better global QOL/health status or worse symptoms (scale 0 – 100). Changes in QOL over time were investigated with linear mixed-effects models. A P-value threshold of 0.05 was used for statistical significance. A change in QOL score of ≥ 10 points was considered clinically significant. Results The median age of the 41 enrolled patients is 66 (range: 51 – 88). Histologies included 29 endometrioid adenocarcinoma, 8 serous/clear cell, 1 carcinosarcoma, and 3 dedifferentiated. Thirty patients had stage 1 disease while 3 had stage 2 and 8 stage 3. Seven patients received sequential chemotherapy and 3 had additional vault brachytherapy. Median follow-up is 9 months, with worst toxicity (GI or GU) of grade 1 and 2 in 63% and 24% respectively. No patients have experienced a grade 3 or higher toxicity. Patient-reported diarrhea and gastrointestinal domain scores were statistically significantly worse than baseline at F5 (mean paired difference = 27.2; 8.7, P Conclusion Stereotactic hypofractionated radiation for uterine cancers is feasible and well-tolerated with short-term follow-up. Longer follow-up and future randomized studies are needed to further evaluate this treatment.

Brachytherapy is often used in gynecologic cancer treatment to provide high radiation doses to tumors and spare nearby healthy tissues. Intracavitary applicators, including tandem-and-ovoid and tandem-and-ring, are commonly used to position the radioactive sources appropriately. Three-dimensional (3D) transrectal ultrasound (TRUS) imaging has been demonstrated to allow for consistent delineation of the clinical target volume; however, the ability to visualize applicators and relevant structures following applicator insertion has not been investigated. We propose the use of a 3D TRUS system to visualize applicators at the time of placement. In two patient images, the key components of the tandem-and-ovoid applicators were clearly visualized, as well as the uterus, cervix, and vagina, with the potential to identify the tumor and organs-at-risk in these images. Although the tandem-and-ring applicator (one patient) obscured the cervix and anterior anatomy, the posterior applicator edges were visualized and we propose combining the 3D TRUS image with a 3D transabdominal ultrasound (TAUS) image for more complete visualization of the necessary structures. We designed a multimodality application-specific pelvic phantom to assess the feasibility of the image fusion and performed preliminary feasibility assessment on a tandem-and-ovoids applicator and a tandem-and-ring applicator with an interstitial ring cap. The resulting phantom images showed promising features for future image fusion. Intraoperative assessment of applicator placement has the potential to improve the treatment quality and reduce the risk of complications from overexposure of nearby normal tissues, as well as provides a promising approach for accessible image-guided brachytherapy, facilitating broader adoption to healthcare cost-constrained settings.

Background Transoral surgery (TOS), particularly transoral robotic surgery (TORS) has become the preferred modality in the United States for the treatment of early stage oropharyngeal cancer, largely due to assumptions of fewer toxicities and improved quality of life compared to primary radiotherapy (RT). However, these assumptions are based on retrospective analysis, a subset of which utilize primary RT groups not limited to T1-2 stage tumors for which transoral robotic surgery is FDA approved. Thus, there is potential for underestimating survival and overestimating toxicity, including treatment related mortality, in primary RT. Methods Consecutive cases of early T-stage (T1–T2) oropharyngeal cancer presenting to the London Health Sciences Centre between 2014 and 2018 treated with RT or chemoradiation (CRT) were reviewed. Patient demographics, treatment details, survival outcomes and toxicity were collected. Toxicities were retrospectively graded using the Common Terminology Criteria for Adverse Events criteria. Results A total of 198 patients were identified, of which 82% were male and 73% were HPV-positive. Sixty-eight percent of patients experienced a grade 2 toxicity, 48% a grade 3 and 4% a grade 4. The most frequent toxicities were dysphagia, neutropenia and ototoxicity. The rates of gastrostomy tube dependence at 1 and 2 years were 2.5% and 1% respectively. There were no grade 5 (fatal) toxicities. HPV-positive patients experienced improved 5-year overall survival (86% vs 64%, p = 0.0026). Conclusions Primary RT or CRT provides outstanding survival for early T-stage disease, with low rates of severe toxicity and feeding tube dependence. This study provides a reference for comparison for patients treated with primary transoral surgery.

Background Patients with high-risk prostate cancer are at increased risk of lymph node metastasis and are thought to benefit from whole pelvis radiotherapy (WPRT). There has been recent interest in the use of hypofractionated radiotherapy in treating prostate cancer. However, toxicity and cancer outcomes associated with hypofractionated WPRT are unclear at this time. This phase II study aims to investigate the impact in quality of life associated with hypofractionated WPRT compared to conventionally fractionated WPRT. Methods Fifty-eight patients with unfavourable intermediate-, high- or very high-risk prostate cancer will be randomized in a 1:1 ratio between high-dose-rate brachytherapy (HDR-BT) + conventionally fractionated (45 Gy in 25 fractions) WPRT vs. HDR-BT + hypofractionated (25 Gy in 5 fractions) WPRT. Randomization will be performed with a permuted block design without stratification. The primary endpoint is late bowel toxicity and the secondary endpoints include acute and late urinary and sexual toxicity, acute bowel toxicity, biochemical failure-, androgen deprivation therapy-, metastasis- and prostate cancer-free survival of the hypofractionated arm compared to the conventionally fractionated arm. Discussion To our knowledge, this is the first study to compare hypofractionated WPRT to conventionally fractionated WPRT with HDR-BT boost. Hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if demonstrated to be well-tolerated and effective. Trial registration This trial was prospectively registered in ClinicalTrials.gov as NCT04197141 on December 12, 2019.

Background Patients with resected oral cavity squamous cell carcinoma (OCSCC) are often treated with adjuvant radiation (RT) ± concomitant chemotherapy based on pathological findings. Standard RT volumes include all surgically dissected areas, including the tumour bed and dissected neck. RT has significant acute and long-term toxicities including odynophagia, dysphagia, dermatitis and fibrosis. The goal of this study is to assess the rate of regional failure with omission of radiation to the surgically dissected pathologically node negative (pN0) hemi-neck(s) compared to historical control, and to compare oncologic outcomes, toxicity, and quality of life (QoL) profiles between standard RT volumes and omission of RT to the pN0 neck. Methods This is a multicentre phase II study randomizing 90 patients with T1–4 N0–2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). Patients will be stratified based on overall nodal status (nodal involvement vs. no nodal involvement) and use of concurrent chemotherapy. The primary endpoint is regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence of 20% or less will be achieved. Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL. Discussion This study will provide an assessment of omission of RT to the dissected pN0 hemi-neck(s) on oncologic outcomes, QoL and toxicity. Results will inform the design of future definitive phase III trials. Trial registration Clinicaltrials.gov identifier: NCT03997643. Date of registration: June 25, 2019, Current version: 2.0 on July 11 2020.

Purpose To determine factors associated with need for post-procedural catheterization in prostate cancer patients treated with 15 Gy high dose-rate brachytherapy boost (HDR-BT). Material and methods Patients treated with 15 Gy HDR-BT followed by EBRT were retrospectively evaluated for development of urinary retention and hematuria requiring catheterization in the first 30 days post procedure. Clinical characteristics and treatment details were obtained and used as independent variables under study. Univariable and multivariable logistic regression analysis were used to determine predictors of post brachytherapy complications and a classification tree for risk of urinary retention was created using recursive partitioning analysis (RPA). Results A total of 425 patients treated with 15 Gy HDR-BT were included in this analysis. 27 patients (6.3%) required catheter placement due to acute urinary retention and thirteen other patients (3%) developed hematuria requiring urinary catheter insertion ± continuous bladder irrigation. Number of needles, prostate volume and prior use of ADT, alpha-blockers or 5α-reductase inhibitors were statistically associated with urinary retention in the univariable logistic regression analysis. In multivariable analysis, prostate volume, previous use of alpha-blocker, and use of ADT remained significant. In the RPA, populations were identified in which the rate of urinary retention ranged from 2% to 50% depending on presence of one or more of these risk factors. Conclusion The overall rate of acute urinary complications post HDR brachytherapy is low, but the individual risk of urinary retention can increase depending on the number of risk factors present. A more patient-directed retention risk estimation can be performed by using the classification risk tree presented here.

We present the case of a woman diagnosed with coronavirus disease 2019 (COVID-19) while undergoing chemoradiation for locally advanced cervix cancer. This diagnosis had implications for the treatment of her cancer, and a number of important decisions had to be made. We present the issues that arose and how her oncologic care was managed.

Background: Coronavirus disease 2019 (COVID-19) is a novel disease associated with a cytokine-mediated, severe, acute respiratory syndrome. Tocilizumab and lenzilumab are recombinant monoclonal antibodies against IL-6 and granulocyte macrophage colony-stimulating factor, respectively, and have been proposed as a potential treatment for acute, hypoxic respiratory failure associated with COVID-19. Results & methodology: We present the case of a 68-year-old man with COVID-19 who was initially treated with hydroxychloroquine and lenzilumab, but continued to develop hypoxemia, requiring an increase in respiratory support with an associated rise in serum inflammatory markers. He was subsequently treated with tocilizumab with marked clinical improvement and a decrease in acute phase reactants within 48 h. Discussion & conclusion: This case demonstrates the effective use of tocilizumab in the treatment of COVID-19 and suggests the superiority of tocilizumab over lenzilumab in the management of this cytokine-mediated syndrome.

Recent phase II clinical trials suggest that stereotactic ablative radiation therapy (SABR) can potentially improve survival for patients with oligometastatic cancer. However, these studies have mostly enrolled primaries other than gynecologic malignancies. While level I evidence is limited, recent publications exploring the use of SABR for oligometastatic gynecologic cancers have indicated a potential role for this treatment in para-aortic lymph node recurrences, and in visceral and brain metastases. The use of SABR for recurrences in the pelvis presents a number of challenges as these patients have often received previous radiation treatment. In these settings, care must be taken to avoid trespassing normal tissue tolerance with SABR leading to toxicity, especially as the potential benefit of SABR in this setting is not based on high-level evidence. Although SABR is feasible and in general safe for oligometastatic gynecologic malignancies, insufficient data are available to indicate whether it is associated with improved survival. Clinical judgment that incorporates patient and tumor factors is needed to determine if SABR is appropriate for selecting patients. Future directions include combining SABR with novel systemic therapies, determining optimal sequencing of treatments, and generating more robust randomized data pertaining to the use of SABR for oligometastatic gynecologic cancers.

Background and purpose: Declining prostate brachytherapy utilization has been reported in several studies, despite strong evidence for efficacy and safety compared to alternatives. We sought to evaluate contemporary trends in brachytherapy, external beam radiotherapy (EBRT) and prostatectomy utilization in a publicly funded healthcare system. Materials and methods: Men with localized prostate cancer diagnosed and treated between 2006 and 2017 in Ontario, Canada were identified using administrative data. Men received EBRT, brachytherapy (monotherapy or boost) or prostatectomy as initial definitive management. Multivariable logistic regression evaluated patient-, tumour-, and provider-factors on treatment utilization. Results: 61,288 men were included. On multivariable regression, the odds of receiving brachytherapy boost increased 24% per year (odds ratio [OR]:1.24, 95% CI 1.22–1.26, p < 0.01), brachytherapy monotherapy increased 3% per year (OR:1.03, 95% CI:1.02–1.04, p < 0.01), and prostatectomy declined by 6% per year (OR:0.94, 95% CI 0.93–0.95, p < 0.01). Treatment year was not significant on multivariable modelling of EBRT. In a separate multivariable model limited to those who received radiotherapy, if the first radiation oncologist seen performed brachytherapy, the OR of receiving brachytherapy monotherapy over EBRT was 5.66 (95% CI: 5.11–6.26, p < 0.01) and 2.88 (95% CI: 2.60–3.19, p < 0.01) for brachytherapy boost over EBRT alone. Substantial geographic, provider and patient variation in treatment receipt was observed. Conclusion: We found increasing brachytherapy utilization, largely driven by increasing utilization of brachytherapy boost. To our knowledge, this is the first report of increasing brachytherapy use in the era of dose escalated EBRT.

Purpose The purposes of this study were to investigate the pattern of relapse in patients with low- or intermediate-risk prostate cancer treated with 19-Gy high-dose-rate brachytherapy (HDR-BT) and to calculate the dose received by the area of recurrence. Methods and Materials Patients included in this analysis were treated under a Phase II randomized trial that evaluated the role of 19-Gy HDR-BT monotherapy in low- and intermediate-risk prostate cancers. Multiparametric prostate MRI and prostate biopsy were performed in patients with suspicious local recurrence. The site of local relapse was compared with the initial site of disease. The dose received by the site of recurrence was investigated through registration of the posttreatment multiparametric prostate MRI with the HDR-BT treatment plan. Results Eight of 87 treated patients were found to have local recurrence after 19-Gy HDR-BT. Seven of the eight recurrences were at the site of initial bulk disease. Seven patients were found to have a more aggressive histology in the posttreatment biopsy. The mean volume of prostate that had received 100% of prescription dose was 97%. Mean dose to area of recurrence was 29.1 Gy, whereas dose to 98% and dose to 90% of the recurrence were 21.6 Gy and 23.2 Gy, respectively. Conclusions The relapse pattern after a single 19-Gy HDR-BT is predominantly associated with the site of initial disease. This lends some rationale to future strategies of further focused dose escalation to initial site of disease, notwithstanding the fact that the calculated biologically equivalent dose using linear–quadratic assumptions is already very high.

Aims Radiotherapy plays a fundamental role in the treatment of cancer. Currently, the Brazilian public health system cannot match the national radiotherapy demand and many patients requiring radiotherapy are never exposed to this treatment. This study estimated the number of preventable deaths in the public health system if access to radiotherapy was universal. Materials and methods Incidence rates for the year 2016 provided by Instituto Nacional de Cancer were used in this analysis. The number of untreated patients requiring radiotherapy was obtained through the difference between the total number of patients requiring radiotherapy and the total amount of delivered radiotherapy treatments in the public health system. The number of deaths for the three most common cancers in each gender due to radiotherapy shortage was calculated. Initially, the total number of patients per cancer type was divided in stages using Brazilian epidemiological data. Subsequently, previously published tree arm diagrams were used to define the rate of patients requiring radiotherapy in each specific clinical setting. Finally, the clinical benefit of radiotherapy in overall survival was extracted from studies with level 1 evidence. Results Over 596 000 cancer cases were expected in Brazil in 2016. The public health system covers more than 75% of the Brazilian population and an estimated 111 432 patients who required radiotherapy in 2016 did not receive this treatment. Breast, colorectal and cervix cancers are the most frequent malignant tumours in women and prostate, lung and colorectal in men. The number of deaths due to a radiotherapy shortage in the year 2016 for these types of cancer were: (i) breast: 1011 deaths in 10 years; (ii) cervix: 2006 deaths in 2 years; (iii) lung: 1206 deaths in 2 years; (iv) prostate, intermediate risk: 562 deaths in 13 years; high risk: 298 deaths in 10 years; (v) colorectal: 0 deaths, as radiotherapy has no proven benefit in overall survival. Conclusion Thousands of cancer patients requiring radiotherapy do not have access to this treatment in the Brazilian public health system. The shortage of radiotherapy has a significant detrimental effect on cancer survival; over 5000 deaths would probably be prevented in the most common cancer types if radiotherapy access was universal.

Purpose/Objective(s) Historically, caution has been warranted when irradiating large target volumes particularly those in close proximity to organs at risk. Prior literature has demonstrated an increased incidence of GI and GU toxicity when men with large prostates were treated with conventionally fractionated radiation therapy. However, there is very limited data regarding the clinical outcomes when SBRT is used as a definitive treatment modality. We explore the long term oncologic, toxicity, and patient reported outcomes of men treated with definitive SBRT with ultra-large prostate glands (≥ 100 cc.) Materials/Methods From 2006 to 2020, a total of 3,393 patients with low and intermediate risk prostate cancer were treated with definitive robotic-SBRT. We performed a retrospective review to identify all patients in this cohort with pre-treatment prostate volumes ≥ 100 cc. Prostate volume was measured at the time of treatment regardless of ADT incorporation. All patients were treated to a total dose of 35-36.25 Gy in 5 fractions. All patients had a minimum of 2 years follow-up and were given pre- and post-treatment EPIC questionnaires at defined intervals. Biochemical control was assessed using the Phoenix definition. Late toxicity was defined using CTCAE version 5.0 and was characterized as occurring ≥ 6 months post treatment. Results A total of 67 patients were identified with ≥ 100 cc prostate glands. Of these, 18 patients received ADT prior to treatment. Overall, the median prostate volume was 139.37 cc (range 100.1 – 227 cc). The D'Amico risk classification was low (n = 19) and intermediate (n = 48). The median age was 70 years (range 54 – 87 years) and the median pretreatment PSA was 8.7 ng/ml. The mean pre-treatment EPIC bowel and urinary scores were 87.8 and 79.7, respectively. One-month following SBRT, mean EPIC bowel and urinary scores worsened to 83.6 and 76.5, respectively. Three months following SBRT, mean epic bowel and urinary scores continued to decline to 83.2 and 77.1, respectively. However, bowel and bladder symptomatology improved by 1 year to 86.16 and 77.19, and by 2 years improved above baseline to 90.00 and 85.78, respectively. There were no high grade (3+) GI toxicities observed, though one grade 3 urinary retention was identified. Excellent oncologic outcomes were observed with a 5-year median PSA nadir of 0.6 ng/mL and a biochemical relapse free survival (bRFS) of 100% at 5 years. Conclusion SBRT has been demonstrated to be oncologically effective with minimal toxicity, and has become a more ubiquitous radiation option in men with localized prostate cancer. Although there is a historical reticence for treatment of men with large glands, we report excellent clinical outcomes. Five-year bRFS was 100% and grade 3+ urinary toxicity was 2%. Although EPIC scores transiently dropped at 1 and 3 months following SBRT, resolution was seen by 1 year following treatment. The use of SBRT for the treatment of localized prostate cancer in men with ultra-large prostate gland is feasible with minimal toxicity.

PURPOSE/OBJECTIVE(S) Decipher is a prognostic 22-gene genomic classifier (GC) prospectively validated post-prostatectomy. Herein, we validate the performance of the GC in pre-treatment biopsy samples within the context of three randomized phase III high-risk definitive radiotherapy trials. MATERIALS/METHODS Following a pre-specified and approved CTEP-CCSC analysis plan (NRG-GU-TS006), we obtained all available formalin-fixed paraffin-embedded tissue from biopsy specimens from the NRG biobank from patients enrolled on NRG/RTOG 9202, 9413, and 9902 phase III randomized trials. After central review, the highest-grade tumors were profiled on clinical-grade whole-transcriptome arrays and GC scores were obtained. The primary objective was to validate the independent prognostic ability of GC for distant metastases (DM), and secondary was prostate cancer-specific mortality (PCSM) and overall survival (OS), with Cox multivariable analyses (MVA). RESULTS GC scores were obtained on 385 samples (n = 90 on 9202, n = 172 on 9413, and n = 123 on 9902), of which 265 passed microarray quality control (69%) and had a median follow-up of 11 years (interquartile range, 9, 13). On MVA, the GC (per 0.1 unit) was independently associated with DM (HR 1.24, 95% CI 1.11-1.39), PCSM (HR 1.27, 95% CI 1.13-1.43), and OS (HR 1.12, 95% CI 1.05-1.20) after adjusting for age, PSA, Gleason score, cT-stage, trial, and randomized treatment arm. For categorical GC, on MVA, GC score ≥ 0.45 (representing the intermediate and high GC categories) had worse DM (HR 2.18, 95% CI 1.25-3.80), PCSM (HR 2.34, 95% CI 1.31-4.16), and OS (HR 1.45, 95% CI 1.03-2.04) outcomes as compared to those with low GC. Cumulative incidence of distant-metastasis at 10-years was 29% (95% CI 20-38%) for intermediate/high GC vs 13% (95% CI 7-18%) for low GC. For the subset with GC > 0.85, the threshold for inclusion in the intensification study of NRG GU009 (PREDICT-RT), at 5-years and 10-years DM was 29% (95% CI 7-52%) and 41% (95% CI 17-66%). GC had similar prognostic ability in patients receiving short-term or long-term androgen-deprivation therapy (ADT). CONCLUSION This is the first validation of any gene expression biomarker on pre-treatment biopsy samples from prospective randomized trials and demonstrates an independent association of GC score with DM, PCSM, and OS. High-risk prostate cancer is a heterogeneous disease state and GC can improve risk stratification to help personalize shared decision-making. NRG-GU009/PREDICT-RT will further determine the optimal therapy based on GC score. NCT04513717.

A 46-year-old, right-handed, African American man presented to the emergency department after 1 week of persistent hiccups and 3 days of nausea and vomiting. His family member also noted that he had been experiencing right-hand tremor and gait imbalance for the last 3 months. Over the 6 months prior to presentation, the patient's coworkers had noticed that he was completing his work more slowly, that he was forgetting how to perform simple tasks, and that several times he had come to work at the wrong hours. The patient had a history of HIV diagnosed 10 years earlier and reported good adherence to an antiretroviral regimen consisting of tenofovir, emtricitabine, and atazanavir boosted by ritonavir, without any changes for several years. His viral load was undetectable when tested 8 months prior to presentation.

Bone metastases cause pain, suffering and impaired quality of life (QoL). Palliative radiotherapy (RT) and/or chemotherapy are effective methods in controlling pain, reducing analgesics use and improving QoL. This study goal was to investigate the changes in QoL scores among patients who responded to palliative treatment.A prospective study evaluating the role of radiation therapy in a public academic hospital in São Paulo-Brazil recorded patients' opioid use, pain score, Portuguese version of QLQ-BM22 and QLQ-C30 before and 2 months after radiotherapy. Analgesic use and pain score were used to calculate international pain response category. Overall response was defined as the sum of complete response (CR) and partial response (PR). CR was defined as pain score of 0 with no increase in analgesic intake whereas PR was defined as pain reduction ≥2 without analgesic increase or analgesic reduction in ≥25% without increase in pain at the treated site.From September 2014 to October 2015, 25 patients with bone metastases responded to RT or chemotherapy (1 CR, 24 PR). There were 8 male and 17 female patients. The median age of the 25 patients was 59 (range, 22 to 80) years old. Patient's primary cancer site was breast [11], prostate [5], lung [2], others [7]. For QLQ-BM 22, the mean scores of 4 categories at baseline were: pain site (PS) 39, pain characteristics (PC) 61, function interference (FI) 49 and psycho-social aspects (PA) 57. At 2 month follow up, the scores were PS 27, PC 37, FI 70 and PA 59. Statistical significant improvement (P0.05) was seen in PS, PC, FI but not PA. In the QLQ-C30, the scores were not statistically different for all categories, except for pain that demonstrated a 33 point decrease in the median pain score domain (66 to 33).Responders to RT at 2 months presented improvement in BM22 and C30 pain domains, and also improvement in functional interference domain of the BM22 questionnaire.

Background To evaluate the dosimetric performance of multi-channel vaginal cylinder (MCVC) against interstitial brachytherapy (ISBT) for the treatment of vaginal tumors. Methods Vaginal tumors with extension of > 0.5 cm and ≤ 2 cm from the lateral vaginal wall and/or ≤ 1 cm in height above the vaginal vault were retrospectively selected from a ISBT registry trial database. The selected patients were treated with ISBT and targets included the intermediate (IRCTV) or high-risk (HRCTV) clinical target volumes. For technique comparison, a 35 mm MCVC was registered with the interstitial intra-vaginal cylinder. Bladder and rectum contours were transferred from the ISBT to the MCVC-BT plans. Vaginal mucosa was achieved by 3 mm uniform expansion from cylinder surface. Both the ISBT and MCVC-BT plans were optimized using the Inverse Planning Simulated Annealing optimization algorithm. After normalizing target D90 to 700 cGy, dose to organs at risk were measured and compared between ISBT and MCVC plans. Results Six interstitial patient plans met the inclusion criteria for this study. Four patients had vaginal primaries and two recurrent cancers in the vagina. Lower doses to bladder and rectum were seen with ISBT plans. In half of the MCVC plans, the rectal dose met the recommended constraints. For plans in which the rectal constraint was not met, the target volumes were abutting the rectum and had a cranial-caudal length ≥ 5 cm. Dose to vaginal mucosa was lower in ISBT plans directed to the HRCTVs, although no difference was seen in circumferential IRCTVs. Conclusions Overall, ISBT results in decreased dose to OARs as compared to MCVC. However, MCVC BT results in acceptable doses to OARs with possible improvement in vaginal doses for circumferential targets. Careful consideration to tumor geometry and location may help guide optimal techniques in vaginal tumor brachytherapy.

Background Echinococcus multilocularis is a destructive zoonotic cestode with low human incidence. Hydatid disease classically presents with hepatic or lung involvement with infrequent extrahepatic bone destruction. Diagnosis is challenging due to its latency and mimicry. Fig.1: Case 1 - X-ray imaging of the pelvis shows osseous destruction of the iliac crest secondary to known osteomyelitis status post left ilium debridement. Fig.2: Case 1 - Magnetic resonance imaging demonstrates extensive osteomyelitis throughout left ilium. Stable scattered focal fluid collections seen throughout the left lower quadrant. Methods CASE 1: A 57 year-old Albanian male with diabetes, latent TB, and left iliac lytic lesion presented with 4 weeks of left flank pain and was treated with 6 weeks of IV Ceftriaxone and Flagyl. 2 years later he returned with flank pain and purulent lumbar drainage. Hip x-ray suggested chronic osteomyelitis, with left psoas fluid collections on CT. Bartonella, Q fever, Brucella, HIV, AFB and fungal serologies were negative. Hemipelvis debridement revealed structures concerning for hydatid disease. Echinococcus IgG was equivocal. Histopathology was consistent with Echinococcus multilocularis species, and albendazole was started. On follow-up, he presented with left hip tenderness and toe extensor weakness. Labs showed mild leukocytosis. CT revealed progressive destruction of the left iliac with sacroiliac extension concerning for abscess. CASE 2: A 36 year-old female presented with lung and liver cysts, progressive dyspnea, and non-productive cough. She lived in Africa, Asia, and Europe and consumed local street food and unpasteurized milk. Hobbies included spelunking and swimming in freshwater lakes. She had exposure to stray animals, but denied bites or scratches. Over 4 years dyspnea progressed to orthopnea. MR abdomen revealed a 10x6x12cm liver cyst and chest CT showed 2 fluid-attenuating lesions in the LLL and RLL, measuring 4.9 x 6.0 cm and 6.8 x 4.3 cm respectively. Echinococcus, Bartonella, Q fever, Brucella, HIV, AFB and fungal serologies were negative. Schistosomiasis serology was equivocal. Fig. 3: Case 2 - MRI abdomen demonstrating 10x6x12cm liver cyst Fig. 4: Case 2 - Chest CT showed 2 dominant fluid attenuating lesions within the LLL and RLL. The larger lesion in RLL measures 6.8 x 4.3 cm. The left lower lobe lesion measures 4.9 x 6.0 cm. Results Patient 1 underwent type I hemipelvectomy. Patient 2 underwent pulmonary segmentectomy and liver lobectomy. Both were continued on albendazole. Fig. 5: Case 1 - Photo taken during debridement of left ileac and hip. Note presence of white cysts discovered intraoperatively. Fig. 6: Case 1 - Histopathologic slides (H&E stain) demonstrating hooks and scolices consistent with Echinococcus multilocularis. A. Hooklet (100x magnification). B. Hydatid cyst with black-staining structures suggestive of degenerating hooklets. C. Zoomed detail of cyst wall. D. Degenerating hydatid cyst and hooklets. Conclusion Equivocal IgG serology does not exclude infection. History and clinical presentation are key to diagnosis, but histopathology remains the gold standard. Hydatid bone infection progresses insidiously and frequently recurs, depending upon excision and debridement. Finally, echinococcosis demands aggressive long-term therapy and surveillance. Disclosures Claudia R. Libertin, MD, Pfizer, Inc. (Grant/Research Support, Research Grant or Support)

A 25-year-old Filipino woman living in the USA was evaluated for a 5-month history of left eye pain and a subsequent orbital mass. Histopathological analysis of the lacrimal mass showed a mixed inflammatory process with necrotising granulomas and positive cultures for Mycobacterium tuberculosis. She was treated with antituberculosis therapy, with resolution of symptoms. Tuberculosis dacryoadenitis is extremely rare in the USA and other developed countries. It requires a high degree of clinical suspicion with special attention to the patient’s history to make the correct diagnosis. It can be treated successfully with antituberculosis therapy.

Purpose/objective To report biochemical control associated with single fraction 15 Gy high-dose-rate brachytherapy (HDR-BT) boost followed by external beam radiation (EBRT) in patients with intermediate-risk prostate cancer. Materials and methods A retrospective chart review of all patients with intermediate-risk disease treated with a real-time ultrasound-based 15 Gy HDR-BT boost followed by EBRT between 2009 and 2016 at a single quaternary cancer center was performed. Freedom from biochemical failure (FFBF), cumulative incidence of androgen deprivation therapy use for biochemical or clinical failure post-treatment (CI of ADT) and metastasis-free survival (MFS) outcomes were measured. Results 518 patients met the inclusion criteria for this study. Median age at HDR-BT was 67 years (IQR 61–72). 506 (98%) had complete pathologic information available. Of these, 146 (28%) had favorable (FIR) and 360 (69%) had unfavorable (UIR) intermediate-risk disease. 83 (16%) received short course hormones with EBRT + HDR. Median overall follow-up was 5.2 years. FFBF was 91 (88–94)% at 5 years. Five-year FFBF was 94 (89–99)% and 89 (85–94)% in FIR and UIR patients, respectively (p = 0.045). CI of ADT was 4 (2–6)% at 5 years. Five-year CI of ADT was 1 (0–3)% and 5 (2–8)% in FIR and UIR patients, respectively (p = 0.085). MFS was 97 (95–98)% at 5 years. Five-year MFS was 100 (N/A-100)% and 95 (92–98)% in FIR and UIR patients, respectively (p = 0.020). Conclusion In this large cohort of intermediate-risk prostate cancer patients, 15 Gy HDR-BT boost plus EBRT results in durable biochemical control and low rates of ADT use for biochemical failure.

[Background]: Adhesion formation is a major problem when a mesh is exposed to intraabodminal viscera, with potential severe complications (bowel occlusion, fistulas or abscesses). New methods for preventing adhesions from a polypropylene mesh placed intra-abdominally or to solve difficult situations, such as when the peritoneum cannot be closed during a TAPP repair for an inguinal hernia, are still being seeked. This study mimics in an animal model a situation that can be found in clinical practice during laparoscopic inguinal hernioplasty. A polypropylene mesh could be exposed to the intra-abdominal cavity even when the peritoneum is closed due to different circumstances, with no options to guarantee the prosthetic material of being exposed to the intrabdominal viscera. Different options have been suggested to solve these situations, being proposed in this study to cover the visceral surface of the mesh with an absorbable sponge containing thrombin, fibrinogen, and clotting factors (Tachosil®, Nycomed, Takeda, Osaka, Japan), to assess its use as a barrier to prevent postoperative adhesion formation., [Material and methods]: Thirty Wistar white rats (300–450 mg) were included in this study as experimental animals, being randomized into three groups (A, B, and C). We performed a bilateral prosthetic repair with conventional polypropylene mesh (2 × 2 cm, 82 kD). Prosthesis fixation was performed as follows. Group A: absorbable suture; group B: metal staples; group C: metal tackers. A piece of insulating absorbable sponge (Tachosil® 5 × 5 cm) was placed to cover the visceral surface of mesh placed at the right side of each animal. After 10 days, we performed a gross examination (by laparoscopy and laparotomy), measuring the quantity and the quality of the adhesions. Samples were taken for histopathological analysis. [Results]: Tachosil®-treated prostheses showed a statistically significant decrease in the quality of the adhesion found (p, [Conclusions]: The use of Tachosil® as a barrier material led to the absence of strong adhesions as it prevented direct contact between the mesh and the internal organs, preventing major problems associated with strong adhesions.

Although uncommon, Brucella infection can occur outside the areas of high endemicity, such as the USA. In the southern USA, hunters of wild swine are at risk for brucellosis. We present a case of a patient with fever, headache and constitutional symptoms that were ongoing for 11 months. He was diagnosed with neurobrucellosis. The patient was treated successfully with intravenous ceftriaxone, oral doxycycline and oral rifampin therapy. He had persistent neurological sequelae after completing treatment. This case illustrates the high index of suspicion needed to diagnose neurobrucellosis in a non-endemic country because initial symptoms can be subtle. The disease can be treated successfully, but long-lasting neurological sequelae are common.

Glioblastoma is a common aggressive primary malignant brain tumor, and is nearly universal in progression and mortality after initial treatment. Re-irradiation presents a promising treatment option for progressive disease, both palliating symptoms and potentially extending survival. Highly conformal radiation techniques such as stereotactic radiosurgery and hypofractionated radiosurgery are effective short courses of treatment that allow delivery of high doses of therapeutic radiation with steep dose gradients to protect normal tissue. Patients with higher performance status, younger age, and longer interval between primary treatment and progression represent the best candidates for re-irradiation. Multiple studies are also underway involving combinations of radiation and systemic therapy to bend the survival curve and improve the therapeutic index. In the multimodal treatment of recurrent high-grade glioma, the use of surgery, radiation, and systemic therapy should be highly individualized. Here we comprehensively review radiation therapy and techniques, along with discussion of combination treatment and novel strategies.

Ventricular tachycardia (VT) commonly occurs in patients with ischemic or nonischemic cardiomyopathy and requires antiarrhythmic drugs, ablation, or advanced circulatory support. However, life-threatening VT may be refractory to these therapies, and may cause frequent implantable cardioverter defibrillator (ICD) discharges. Left cardiac sympathetic denervation reduces the occurrence of these fatal arrhythmias by inhibiting the sympathetic outflow to the cardiac tissue. We present a 69-year-old man with nonischemic cardiomyopathy, life-threatening VT, and hemodynamic instability with numerous ICD discharges, who remained refractory to antiarrhythmic drug therapy and ablation attempts. He was effectively treated with bilateral cardiac sympathectomy. Six months later, he remained free of VT with no ICD discharges.