Stereotactic Ablative Radiotherapy for Gynecological Oligometastatic and Oligoprogessive Tumors.

Importance: The role of stereotactic ablative radiotherapy (SABR) for gynecologic malignant tumors has yet to be clearly defined despite recent clinical uptake. Objective: To evaluate the outcomes of SABR in patients with oligometastatic and oligoprogressive gynecologic cancers. Design, Setting, and Participants: In this retrospective pooled analysis, patients with oligometastatic and oligoprogressive gynecologic cancers receiving SABR at 5 institutions from Canada and the US were studied. Data were collected from January 2011 to December 2020, and data were analyzed from January to December 2023. Exposure: Stereotactic ablative radiotherapy. Main Outcomes and Measures: Cumulative incidence of local and distant recurrence, chemotherapy-free survival (CFS), and overall survival (OS) probabilities after SABR were calculated using Kaplan-Meier methods. Univariable and multivariable analysis was conducted using Cox regression methods. Results: A total of 215 patients with 320 lesions meeting criteria were included in the analysis; the median (range) age at primary diagnosis was 59 (23-86) years. The median (range) follow-up from SABR was 18.5 (0.1-124.5) months. The primary site included the endometrium (n = 107), ovary (n = 64), cervix (n = 30), and vulva or vagina (n = 14). Local cumulative incidence of recurrence was 13.7% (95% CI, 9.4-18.9) and 18.5% (95% CI, 13.2-24.5) at 1 and 5 years, respectively. Distant cumulative incidence of recurrence was 48.5% (95% CI, 41.4-55.1) and 73.1% (95% CI, 66.0-79.0) at 1 and 5 years, respectively. OS was 75.7% (95% CI, 69.2-81.1) and 33.1% (95% CI, 25.3-41.1) at 1 and 5 years, respectively. The median CFS was 21.7 months (95% CI, 15.4-29.9). On multivariable analysis, local recurrence was significantly associated with nodal metastasis, lesion size, biologically effective dose, treatment indication, institution, and primary disease type. Distant progression-free survival was associated with nodal targets and lesion size. OS and CFS were significantly associated with lesion size. Conclusions and Relevance: In this study, SABR appeared to have excellent local control with minimal toxic effects in this large patient group, and certain patients may achieve durable distant control and OS as well. It may be possible to delay time to chemotherapy in select patient subtypes and therefore reduce associated toxic effects. Prospective multicenter trials will be critical to establish which characteristics procure the greatest benefit from SABR use and to define the ideal time to implement SABR with other oncologic treatments.

Management of inguinal lymph nodes in locally advanced, surgically unresectable, squamous cell carcinoma of the vulva.

OBJECTIVE: To assess clinical outcomes of inguinal lymph node surgical resection compared to primary groin radiotherapy for locally advanced, surgically unresectable vulvar cancer. METHODS: All patients treated with radiation for vulvar cancer were identified between Jan 1, 2000 - Dec 31, 2020 at 2 academic centres. Inclusion criteria were those treated with curative intent primary radiotherapy +/- chemotherapy, tumors >4 cm, and surgically unresectable squamous cell vulvar carcinoma. Groin recurrence-free survival (RFS) was compared for groin surgery and primary groin radiotherapy using the Kaplan Meier method and log rank test. Groin failures are described by treatment modality, radiation dose and lymph node size. RESULTS: Of 476 patients treated with radiation for vulvar cancer, 112 patients (23.5%) met inclusion and exclusion criteria. The median (95% CI) follow up was 1.9 (1.4-2.5) years. Complete clinical response was significantly higher (80.0%) in patients with surgical groin resection compared to patients treated with primary groin radiotherapy (58.2%) (p = 0.04). On multivariable analysis, after adjusting for clinical and/or radiologically abnormal lymph nodes (p = 0.67), surgical groin resection was significantly associated with lower groin recurrence (HR 0.2 (95%CI 0.05-0.92), p = 0.04). The 3-year groin recurrence-free survival (RFS) was significantly higher at 94.4% (87.1-100) in patients with surgical groin resection compared to 79.2% (69.1-90.9) in patients treated with primary radiation (p = 0.02). CONCLUSIONS: In locally advanced squamous cell vulvar cancer, surgical groin management improves groin RFS compared to radiotherapy alone.

The Burden of Back and Neck Strains and Sprains in Professional Baseball Players.

STUDY DESIGN: A retrospective case series study. OBJECTIVE: To analyze the epidemiology of diagnoses of back and neck strains and sprains among Major League (MLB) and Minor League (MiLB) Baseball players. BACKGROUND: Baseball players perform unique sets of repetitive movements that may predispose to neck and back strains and sprains. Data are lacking concerning the epidemiology of these diagnoses in this population. MATERIALS AND METHODS: De-identified data on neck/back strains and sprains were collected from all MLB and MiLB teams from 2011 to 2016 using the MLB-commissioned Health and Injury Tracking System database. Diagnosis rates of conditions related to cervical, thoracic, and lumbar musculature and their impact on days missed due to injury, player participation, and season or career-ending status were assessed. Injury rates were reported as injuries per 1000 athlete exposures (AEs). RESULTS: There were 3447 cases of neck/back strains and sprains in professional baseball players from 2011 to 2016. Seven hundred twenty-one of these occurred in MLB versus 2726 in MiLB. Of injuries 136 were season-ending (26 in MLB, 110 in MiLB); 22 were career-ending (2 in MLB, 20 in MiLB). The total days missed were 39,118 (8838 from MLB and 30,280 from MiLB). Excluding season or career-ending injuries, the mean days missed were 11.8 (12.7 and 11.6 in MLB and MiLB, respectively). The median days missed were 4 (3 and 5 in MLB and MiLB, respectively). Combining MLB and MiLB, the pitcher injury rate was 1.893 per 1000 AEs versus 0.743 per 1000 Aes for other position players ( P < 0.0001). CONCLUSION: There was a high incidence of neck/back strains and sprains in MLB and MiLB players, with nearly 40,000 aggregate days missed in our 6-year study period. The median days missed were lower than the mean days missed, indicating rightward outliers. Pitchers had over double the rates of injuries compared with other position players. LEVEL OF EVIDENCE: Level III.

Prognostic Effect of Mismatch Repair Status in Early-Stage Endometrial Cancer Treated With Adjuvant Radiation: A Multi-institutional Analysis.

PURPOSE: The aim of this work was to report the effect of mismatch repair (MMR) status on outcomes of patients with stage I-II endometrioid endometrial adenocarcinoma (EEC) who receive adjuvant radiation therapy. METHODS AND MATERIALS: This is a multi-institutional retrospective cohort study across 11 institutions in North America. Patients with known MMR status and stage I-II EEC status postsurgical staging were included. Overall survival (OS) and recurrence-free survival (RFS) rates were estimated via the Kaplan-Meier method. Univariable and multivariable analyses were performed via Cox proportional hazard models for RFS and OS. Statistical analyses were conducted using SPSS version 27. RESULTS: In total, 744 patients with a median age at diagnosis of 65 years (IQR, 58-71) were included. Most patients were White (69.4%) and had Federation of Obstetrics and Gynecology 2009 stage I (84%) and Federation of Obstetrics and Gynecology grade 1 to 2 (73%). MMR deficiency was reported in 234 patients (31.5%), whereas 510 patients (68.5%) had preserved MMR. External beam radiation therapy with or without vaginal brachytherapy was delivered to 186 patients (25%), whereas 558 patients (75%) received vaginal brachytherapy alone. At a median follow-up of 43.5 months, the estimated crude OS and RFS rates for the entire cohort were 92.5% and 84%, respectively. MMR status was significantly correlated with RFS. RFS was inferior for MMR deficiency compared with preserved MMR (74.3% vs 88.6%, P < .001). However, no difference in OS was seen (90.8% vs 93.2%, P = .5). On multivariable analysis, MMR deficiency status was associated with worse RFS (hazard ratio, 1.86; P = .001) but not OS. CONCLUSIONS: MMR status was independently associated with RFS but not OS in patients with early-stage EEC who were treated with adjuvant radiation therapy. These findings suggest that differential approaches to surveillance and/or treatment based on MMR status could be warranted.

Hypofractionated Radiotherapy in Gynecologic Malignancies-A Peek into the Upcoming Evidence.

Radiotherapy (RT) has a fundamental role in the treatment of gynecologic malignancies, including cervical and uterine cancers. Hypofractionated RT has gained popularity in many cancer sites, boosted by technological advances in treatment delivery and image verification. Hypofractionated RT uptake was intensified during the COVID-19 pandemic and has the potential to improve universal access to radiotherapy worldwide, especially in low-resource settings. This review summarizes the rationale, the current challenges and investigation efforts, together with the recent developments associated with hypofractionated RT in gynecologic malignancies. A comprehensive search was undertaken using multiple databases and ongoing trial registries. In the definitive radiotherapy setting for cervical cancers, there are several ongoing clinical trials from Canada, Mexico, Iran, the Philippines and Thailand investigating the role of a moderate hypofractionated external beam RT regimen in the low-risk locally advanced population. Likewise, there are ongoing ultra and moderate hypofractionated RT trials in the uterine cancer setting. One Canadian prospective trial of stereotactic hypofractionated adjuvant RT for uterine cancer patients suggested a good tolerance to this treatment strategy in the acute setting, with a follow-up trial currently randomizing patients between conventional fractionation and the hypofractionated dose regimen delivered in the former trial. Although not yet ready for prime-time use, hypofractionated RT could be a potential solution to several challenges that limit access to and the utilization of radiotherapy for gynecologic cancer patients worldwide.

Clinical Validation of Human Papilloma Virus Circulating Tumor DNA for Early Detection of Residual Disease After Chemoradiation in Cervical Cancer.

PURPOSE: Most cervical cancers are caused by human papilloma virus (HPV), and HPV circulating tumor DNA (ctDNA) may identify patients at highest risk of relapse. Our pilot study using digital polymerase chain reaction (dPCR) showed that detectable HPV ctDNA at the end of chemoradiation (CRT) is associated with inferior progression-free survival (PFS) and that a next-generation sequencing approach (HPV-seq) may outperform dPCR. We aimed to prospectively validate HPV ctDNA as a tool for early detection of residual disease. METHODS: This prospective, multicenter validation study accrued patients with stage IB-IVA cervical cancer treated with CRT between 2017 and 2022. Participants underwent phlebotomy at baseline, end of CRT, 4-6 weeks post-CRT, and 3 months post-CRT for HPV ctDNA levels. Plasma HPV genotype-specific DNA levels were quantified using both dPCR and HPV-seq. The primary end point was 2-year PFS. RESULTS: With a median follow-up of 2.2 (range, 0.5-5.5) years, there were 24 PFS events among the 70 patients with HPV+ cervical cancer. Patients with detectable HPV ctDNA on dPCR at the end of CRT, 4-6 weeks post-CRT, and 3 months post-CRT had significantly worse 2-year PFS compared with those with undetectable HPV ctDNA (77% v 51%, P = .03; 82% v 15%, P < .001; and 82% v 24%, P < .001, respectively); the median lead time to recurrence was 5.9 months. HPV-seq showed similar results as dPCR. On multivariable analyses, detectable HPV ctDNA on dPCR and HPV-seq remained independently associated with inferior PFS. CONCLUSION: Persistent HPV ctDNA after CRT is independently associated with inferior PFS. HPV ctDNA testing can identify, as early as at the end of CRT, patients at high risk of recurrence for future treatment intensification trials.

Recent breakthroughs in understanding the cerebellum's role in fetal alcohol spectrum disorder: A systematic review.

Exposure to alcohol during fetal development can lead to structural and functional abnormalities in the cerebellum, a brain region responsible for motor coordination, balance, and specific cognitive functions. In this systematic review, we comprehensively analyze a vast body of research conducted on vertebrate animals and humans over the past 13 years. We identified studies through PubMed and screened them following PRISMA guidelines. Data extraction and quality analysis were conducted using Covidence systematic review software. A total of 108 studies met our inclusion criteria, with the majority (79 studies) involving vertebrate animal models and 29 studies focusing on human subjects. Animal models included zebrafish, mice, rats, sheep, and non-human primates, investigating the impact of ethanol on cerebellar structure, gene/protein expression, physiology, and cerebellar-dependent behaviors. Additionally, some animal studies explored potential therapeutic interventions against ethanol-induced cerebellar damage. The human studies predominantly adopted cohort designs, exploring the effects of prenatal alcohol exposure on cerebellar structure and function. Certain human studies delved into innovative cerebellar-based diagnostic approaches for fetal alcohol spectrum disorder (FASD). The collective findings from these studies clearly indicate that the cerebellum is involved in various neurophysiological deficits associated with FASD, emphasizing the importance of evaluating both cerebellar structure and function in the diagnostic process for this condition. Moreover, this review sheds light into potential therapeutic strategies that can mitigate prenatal alcohol exposure-induced cerebellar damage.

A Case of Chronic Undiagnosed 2:1 Isolated Atrial Flutter in a Patient With an Autoimmune Disease.

Atrial flutter (AFL) is typically associated with structural heart diseases or metabolic abnormalities. However, isolated symptomatic AFL, which occurs without abnormal heart anatomy, remains a rare occurrence and is underrepresented in the literature. This case report highlights the significance of recognizing and investigating symptoms suggestive of arrhythmias, especially in patients with autoimmune conditions.

Stereotactic Body Radiation Therapy for Gynecologic Malignancies: A Case-Based Radiosurgery Society Practice Review.

PURPOSE: The use of stereotactic body radiation therapy (SBRT) for gynecologic malignancies is controversial. We discuss certain circumstances when highly precise SBRT may be a useful tool to consider in the management of selected patients. METHODS AND MATERIALS: Case selection included the following scenarios, the first 2 with palliative intent, para-aortic nodal oligorecurrence of ovarian cancer, pelvic sidewall oligorecurrence of cervical cancer, and inoperable endometrial cancer boost after intensity modulated radiation to the pelvis treated with curative intent. Patient characteristics, fractionation, prescription dose, treatment technique, and dose constraints were discussed. Relevant literature to these cases was summarized to provide a framework for treatment of similar patients. RESULTS: Treatment of gynecologic malignancies with SBRT requires many considerations, including treatment intent, optimal patient selection, fractionation selection, tumor localization, and plan optimization. Although other treatment paradigms including conventionally fractionated radiation therapy and brachytherapy remain the standard-of-care for definitive treatment of gynecologic malignancies, SBRT may have a role in palliative cases or those where high doses are not required due to the unacceptable toxicity that may occur with SBRT. CONCLUSIONS: A case-based practice review was developed by the Radiosurgery Society to provide a practical guide to the common scenarios noted above affecting patients with gynecologic malignancies.

Treatment times for delivering adjuvant breast radiotherapy at a cancer centre in Ontario, Canada.

BACKGROUND: Time is a valuable commodity that impacts hospital flow, patient experience and economic resources. This study aims to identify factors that affect daily treatment time over a course of radiation therapy (RT) in patients who underwent adjuvant breast RT. METHODS: In all adjuvant breast/chestwall RT patients treated from October 2017 to May 2018, daily set-up, beam delivery time, and overall treatment times were collected. A multivariable linear regression analysis was conducted to identify significant predictive factors related to treatment time. A general linear regression model was used to determine whether there was a learning curve effect throughout the course of treatment that decreased treatment time as patient and staff familiarity with the treatment procedure increased. RESULTS: A total of 567 patients were included with a median age of 61 years. The average overall treatment time for 2-field and 4-field RT was 8.3 (SD 2.4) and 13.1 (SD 5.6) minutes, respectively. Factors that significantly increased overall treatment times in patients prescribed 2-field RT were: bilateral techniques, breath-hold (BH) techniques, prone techniques (PR), reverse decubitus techniques (RD), wide tangents techniques, the use of bolus and number of segments delivered. (p < 0.05). Factors that significantly increased overall treatment times in patients who received 3-field and 4-field RT were: wide tangents volumes, a higher number of monitor units (MUs), bilateral techniques and BH techniques (p < 0.05). Older patients (≥60) who underwent 3-field and 4-field RT demonstrated a statistically significant increase in set-up time (p < 0.0001). Overall treatment time decreased from 10.0 to 9.3 min over the course of treatment, suggesting a minor learning curve (p = 0.009). CONCLUSION: The use of bilateral RT, BH, PR, RD, wide tangents, bolus, increasing treatment volumes, and increasing plan complexity were associated with increased treatment times. Future research should quantify the impact of other factors (BMI, mobility, patient care assessments, and imaging protocols) and utility of technological tools (time-predicting models, machine learning tools, and operations research models) on treatment time to optimize RT scheduling and improve resource management.

The Lumbosacral Fractional Curve vs Maximum Coronal Cobb Angle in Adult Spinal Deformity Patients with Coronal Malalignment: Which Matters More?

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: In patients undergoing adult spinal deformity (ASD) surgery we sought to: 1) report preoperative and postoperative lumbosacral fractional (LSF) curve and maximum coronal Cobb angles and 2) determine their impact on radiographic, clinical, and patient-reported outcomes (PROs). METHODS: A single-institution cohort study was undertaken. The LSF curve was the cobb angle between the sacrum and most tilted lower lumbar vertebra. Coronal/sagittal vertical axis (CVA/SVA) were collected. Patients were compared between 4 groups: 1) Neutral Alignment (NA); 2) coronal malalignment only (CM); 3) Sagittal malalignment only (SM); and 4) Combined-Coronal-Sagittal-Malalignment (CCSM). Outcomes including postoperative CM, postoperative coronal vertical axis, complications, readmissions, reoperation, and PROs. RESULTS: A total of 243 patients underwent ASD surgery with mean total instrumented levels of 13.5. Mean LSF curve was 12.1±9.9°(0.2-62.3) and mean max Cobb angle was 43.0±26.5° (0.0-134.3). The largest mean LSF curves were seen in patients with CM (14.6°) and CCSM (13.1°) compared to NA (12.1°) and SM (9.5°) (p=0.100). A higher LSF curve was seen in patients with fusion to the sacrum and instrumentation to the pelvis (p=0.009), and a higher LSF curve was associated with more TLIFs (p=0.031). Postoperatively, more TLIFs were associated with greater amount of LSF curve correction (p<0.001). Comparing the LSF and the max Cob angle among Qiu types, the highest mean max Cobb angle was in Qiu Type B patients (p=0.025), whereas the highest mean LSF curve was in Qiu Type C patients (p=0.037). Moreover, 82.7% of patients had a LSF curve opposite the max Cobb angle. The LSF curve was larger than the max Cobb angle in 22/243 (9.1%) patients, and most of these 22 patients were Qiu Type A (59.1%). Regarding correction, the max Cobb angle achieved more correction than the LSF curve, judged by the percent improved from preop (54.5% Cobb vs. 46.5% LSF, p=0.025) in patients with max cobb>20° and LSF curve >5°. The LSF curve underwent greater correction in Qiu Type C patients (9.2°) compared to Type A (5.7°) and Type B (5.1°) (p=0.023); however, the max Cobb angle was similarly corrected among Qiu Types: Type A 21.8°, Type B 24.6°, and Type C 25.4° (p=0.602). Minimal differences were seen comparing the preop/postop/change in LSF curve and max Cobb angle regarding postop CM, postop CVA, complications, readmissions, reoperation, and PROs. CONCLUSIONS: The LSF curve was highest in patients with CM, CCSM, and Qiu Type C curves. Most patients had a LSF curve opposite the max Cobb angle. The max Cobb angle was more often corrected than the LSF curve. The LSF curve underwent greater correction among Qiu Type C patients, whereas the max Cobb angle was similarly corrected among all Qiu Types. No clear trend was seen regarding postoperative complications and PROs between the LSF curve and max Cobb angle.

Clinical implementation of magnetic resonance imaging simulation for radiation oncology planning: 5 year experience.

PURPOSE: Integrating magnetic resonance (MR) into radiotherapy planning has several advantages. This report details the clinical implementation of an MR simulation (MR-planning) program for external beam radiotherapy (EBRT) in one of North America's largest radiotherapy programs. METHODS AND MATERIALS: An MR radiotherapy planning program was developed and implemented at Sunnybrook Health Sciences Center in 2016 with two dedicated wide-bore MR platforms (1.5 and 3.0 Tesla). Planning MR was sequentially implemented every 3 months for separate treatment sites, including the central nervous system (CNS), gynecologic (GYN), head and neck (HN), genitourinary (GU), gastrointestinal (GI), breast, and brachial plexus. Essential protocols and processes were detailed in this report, including clinical workflow, optimized MR-image acquisition protocols, MR-adapted patient setup, strategies to overcome risks and challenges, and an MR-planning quality assurance program. This study retrospectively reviewed simulation site data for all MR-planning sessions performed for EBRT over the past 5 years. RESULTS: From July 2016 to December 2021, 8798 MR-planning sessions were carried out, which corresponds to 25% of all computer tomography (CT) simulations (CT-planning) performed during the same period at our institution. There was a progressive rise from 80 MR-planning sessions in 2016 to 1126 in 2017, 1492 in 2018, 1824 in 2019, 2040 in 2020, and 2236 in 2021. As a result, the relative number of planning MR/CT increased from 3% of all planning sessions in 2016 to 36% in 2021. The most common site of MR-planning was CNS (49%), HN (13%), GYN (12%), GU (12%), and others (8%). CONCLUSION: Detailed clinical processes and protocols of our MR-planning program were presented, which have been improved over more than 5 years of robust experience. Strategies to overcome risks and challenges in the implementation process are highlighted. Our work provides details that can be used by institutions interested in implementing an MR-planning program.

The Impact of Racial Disparities on Outcome in Patients With Stage IIIC Endometrial Carcinoma: A Pooled Data Analysis.

OBJECTIVE: To report the impact of race on clinical outcomes in patients with stage IIIC endometrial carcinoma. MATERIALS AND METHODS: A retrospective multi-institutional study included 90 black and 568 non-black patients with stage IIIC endometrial carcinoma who received adjuvant chemotherapy and radiation treatments. Overall survival (OS) and recurrence-free survival (RFS) were calculated by the Kaplan-Meier method. Propensity score matching (PSM) was conducted. Statistical analyses were conducted using SPSS version 27. RESULTS: The Median follow-up was 45.3 months. black patients were significantly older, had more nonendometrioid histology, grade 3 tumors, and were more likely to have >1 positive paraaortic lymph nodes compared with non-black patients (all P <0.0001). The 5-year estimated OS and RFS rates were 45% and 47% compared with 77% and 68% for black patients versus non-black patients, respectively ( P <0.001). After PSM, the 2 groups were well-balanced for all prognostic covariates. The estimated hazard ratios of black versus non-black patients were 1.613 ( P value=0.045) for OS and 1.487 ( P value=0.116) for RFS. After PSM, black patients were more likely to receive the "Sandwich" approach and concurrent chemoradiotherapy compared with non-black ( P =0.013) patients. CONCLUSIONS: Black patients have higher rates of nonendometrioid histology, grade 3 tumors, and number of involved paraaortic lymph nodes, worse OS, and RFS, and were more likely to receive the "Sandwich" approach compared with non-black patients. After PSM, black patients had worse OS with a nonsignificant trend in RFS. Access to care, equitable inclusion on randomized trials, and identification of genomic differences are warranted to help mitigate disparities.

Clinical and neuroimaging markers of neurodegeneration in first-degree relatives of patients with REM sleep behavior disorder with and without isolated rapid eye movement sleep without atonia: A case-control clinical and dopamine PET study.

OBJECTIVES: The current study aimed to examine the neurodegenerative implication of isolated REM sleep without atonia (RSWA) among first-degree relatives of patients with REM sleep behaviour disorder (RBD). METHODS: This cross-sectional case-control study recruited three groups of subjects: First-degree relatives of RBD patients with isolated RSWA (n = 17), first-degree relatives of RBD patients without isolated RSWA (n = 18), and normal controls who did not have any RWSA and family history of RBD (n = 15). Prodromal Parkinson's Disease likelihood ratio by the updated MDS Research Criteria and striatal dopaminergic transmission function of the subjects as assessed by triple-tracer (18F-DOPA, 11C-Raclopride, and 18F-FDG) PET/CT scan were used as proxy markers of neurodegeneration. RESULTS: In contrary to our hypothesis, the three groups did not differ in their pre- or post-striatal dopaminergic transmission function, and their Prodromal Parkinson's Disease likelihood ratio. However, they differed significantly in their frequency of a having first-degree relatives with Parkinson's disease or dementia of Lewy body (first-degree relativess with RSWA vs first degree relatives without RSWA vs normal controls = 58.8% vs 22.2% vs 0%, p = 0.001). CONCLUSION: FDRs of RBD patients with isolated RSWA did not have increased neurodegenerative markers compared to FDRs of RBD patients without isolated RSWA and normal control, despite an paradoxical increase in frequency of Parkinson's disease or dementia of Lewy body among their family compared to FDRs of RBD patients without isolated RSWA. Further longitudinal follow-up study will be needed to ascertain their long-term prognosis.

Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial.

PURPOSE: Radiation dermatitis (RD) is common in patients undergoing breast radiotherapy. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. We aimed to conduct a confirmatory randomized controlled trial in patients at risk of RD. METHODS: Patients were randomly assigned to receive MF or standard care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type, dose fractionation, and administration of boost/bolus. The primary end point was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events v5.0. Secondary end points included patient- and clinician-reported outcomes. RESULTS: Between January 2020 and May 2022, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared with standard care (n = 39/251, 15.5%; 95% CI, 11.3 to 20.6% v n = 57/125, 45.6%; 95% CI, 36.7 to 54.8% respectively, odds ratio (OR): 0.20, P < .0001). Benefits of MF remained significant in patients who developed G 3 RD (n = 7, 2.8%; 95% CI, 1.1 to 5.7% v n = 17, 13.6%; 95% CI, 8.1 to 20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9 to 12.0% v n = 24, 19.2%; 95% CI, 12.7 to 27.1%, OR: 0.36). When evaluating the combined patient and health care provider score using Radiation-Induced Skin Reaction Assessment Scale, the MF arm had significantly lower scores (P < .0001). Individual items on the Radiation-Induced Skin Reaction Assessment Scale also favored the MF for both patient- and clinician-reported outcomes. Blistering/peeling, erythema, pigmentation, and edema were significantly reduced in the MF arm. Three patients removed the film prematurely because of rash (n = 2) and excessive pruritus (n = 1). CONCLUSION: MF significantly reduces RD in patients undergoing breast radiotherapy.

How common is acute pelvic fixation failure after adult spine surgery? A single-center study of 358 patients.

OBJECTIVE: There is a paucity of literature on pelvic fixation failure after adult spine surgery in the early postoperative period. The purpose of this study was to determine the incidence of acute pelvic fixation failure in a large single-center study and to describe the lessons learned. METHODS: The authors performed a retrospective review of adult (≥ 18 years old) patients who underwent spinal fusion with pelvic fixation (iliac, S2-alar-iliac [S2AI] screws) at a single academic medical center between 2015 and 2020. All patients had a minimum of 3 instrumented levels. The minimum follow-up was 6 months after the index spine surgery. Patients with prior pelvic fixation were excluded. Acute pelvic fixation failure was defined as revision of the pelvic screws within 6 months of the primary surgery. Patient demographics and operative, radiographic, and rod/screw parameters were collected. All rods were cobalt-chrome. All iliac and S2AI screws were closed-headed screws. RESULTS: In 358 patients, the mean age was 59.5 ± 13.6 years, and 64.0% (n = 229) were female. The mean number of instrumented levels was 11.5 ± 5.5, and 79.1% (n = 283) had ≥ 6 levels fused. Three-column osteotomies were performed in 14.2% (n = 51) of patients, and 74.6% (n = 267) had an L5-S1 interbody fusion. The mean diameter/length of pelvic screws was 8.5/86.6 mm. The mean number of pelvic screws was 2.2 ± 0.5, the mean rod diameter was 6.0 ± 0 mm, and 78.5% (n = 281) had > 2 rods crossing the lumbopelvic junction. Accessory rods extended to S1 (32.7%, n = 117) or S2/ilium (45.8%, n = 164). Acute pelvic fixation failure occurred in 1 patient (0.3%); this individual had a broken S2AI screw near the head-neck junction. This 76-year-old woman with degenerative lumbar scoliosis and chronic lumbosacral zone 1 fracture nonunion had undergone posterior instrumented fusion from T10 to pelvis with bilateral S2AI screws (8.5 × 90 mm); i.e., transforaminal lumbar interbody fusion L4-S1. The patient had persistent left buttock pain postoperatively, with radiographically confirmed breakage of the left S2AI screw 68 days after surgery. Revision included instrumentation removal at L2-pelvis and a total of 4 pelvic screws. CONCLUSIONS: The acute pelvic fixation failure rate was exceedingly low in adult spine surgery. This rate may be the result of multiple factors including the preference for multirod (> 2), closed-headed pelvic screw constructs in which large-diameter long screws are used. Increasing the number of rods and screws at the lumbopelvic junction may be important factors to consider, especially for patients with high risk for nonunion.

Postoperative coronal malalignment after adult spinal deformity surgery: incidence, risk factors, and impact on 2-year outcomes.

PURPOSE: To evaluate the incidence, risk factors, and patient-reported outcomes (PROs) of adult spinal deformity (ASD) patients with postoperative coronal malalignment. METHODS: A single-institution, retrospective cohort study of ASD patients undergoing ≥ 6 level fusions from 2015 to 2019 was undertaken. The primary outcome was postoperative coronal malalignment, defined as C7-coronal vertical axis (CVA) > 3 cm. Secondary outcomes included: complications, readmissions, reoperations, and 2-year PROs. RESULTS: A total of 243 ASD patients undergoing spinal surgery had preoperative and immediate postoperative measurements, and 174 patients (72%) had 2-year follow-up. Mean age was 49.3 ± 18.3yrs and mean instrumented levels was 13.5 ± 3.9. Mean preoperative CVA was 2.9 ± 2.7 cm, and 90 (37%) had preoperative coronal malalignment. Postoperative coronal malalignment occurred in 43 (18%) patients. Significant risk factors for postoperative coronal malalignment were: preoperative CVA (OR 1.21, p = 0.001), preoperative SVA (OR 1.05, p = 0.046), pelvic obliquity (OR 1.21; p = 0.008), Qiu B vs. A (OR 4.17; p = 0.003), Qiu C vs. A (OR 7.39; p < 0.001), lumbosacral fractional (LSF) curve (OR 2.31; p = 0.021), max Cobb angle concavity opposite the CVA (OR 2.10; p = 0.033), and operative time (OR 1.16; p = 0.045). Postoperative coronal malalignment patients were more likely to sustain a major complication (31% vs. 14%; p = 0.01), yet no differences were seen in readmissions (p = 0.72) or reoperations (p = 0.98). No significant differences were seen in 2-year PROs (p > 0.05). CONCLUSIONS: Postoperative coronal malalignment occurred in 18% of ASD patients and was most associated with preoperative CVA/SVA, pelvic obliquity, Qiu B/C curves, LSF curve concavity to the same side as the CVA, and maximum Cobb angle concavity opposite side of the CVA. Postoperative coronal malalignment was significantly associated with increased complications but not readmission, reoperation, or 2-year PROs.

GEC-ESTRO (ACROP)-ABS-CBG Consensus Brachytherapy Target Definition Guidelines for Recurrent Endometrial and Cervical Tumors in the Vagina.

PURPOSE: Representatives from the Gynecologic Groupe European de Curietherapie-European Society for Radiation Therapy and Oncology (GYN GEC-ESTRO), the American Brachytherapy Society (ABS), and the Canadian Brachytherapy Group (CBG) met to develop international consensus recommendations for target definitions for image-guided adaptive brachytherapy for vaginal recurrences of endometrial or cervical cancer. METHODS AND MATERIALS: Seventeen radiation oncologists and 2 medical physicists participated. Before an in-person meeting each participant anonymously contoured 3 recurrent endometrial/cervical cancer cases. Participants contoured the residual gross primary tumor volume (GTV-Tres), a high-risk clinical target volume (CTV-THR), and an intermediate-risk clinical target volume (CTV-TIR), on T2-weighted magnetic resonance images (MRIs). All contours were drawn using Falcon EduCase. Contours were reviewed at an in-person meeting during which a consensus document was created defining agreed-upon target definitions (Trial 1). After establishing these definitions, the group was sent one of the cases again (recurrent cervical cancer vaginal recurrence) and asked to contour the targets again (Trial 2). The Computerized Environment for Radiation Research (CERR) software (The Mathworks, Natwick, MA) was used to analyze the contours. Kappa statistics were generated to assess level of agreement between contours. A conformity index (CI), defined as the ratio between the intersection and union volume of a given pair of contours, was calculated. A simultaneous truth and performance level estimation (STAPLE) contour was created for the CTV-THR and CTV-TIR for the postmeeting case. RESULTS: Consensus definitions for GTV-Tres, CTV-THR, and CTV-TIR were established. Kappa statistics (Trial 1/Trial 2) for GTV-Tres, CTV-THR, and CTV-TIR were 0.536/0.583, 0.575/0.743 and 0.522/0.707. Kappa statistics for Trial 2 for the CTV-THR and CTV-TIR showed "substantial" agreement while the GTV-Tres remained at moderate agreement. CONCLUSIONS: This consensus provides recommendations to facilitate future collaborations for MRI-guided adaptive brachytherapy target definitions in endometrial/cervical vaginal recurrences.