Follow-up for human papillomavirus-related oropharynx cancer concentrated on unequal symptom change (FOCUS): Prospective patient-reported outcome collection.

BACKGROUND: Post-treatment surveillance recommendations for oropharyngeal cancer do not vary with p16 status despite the differences in outcomes. The optimal algorithm personalizing follow-up for these patients remains undefined. Here, we evaluate the feasibility and utility of incorporating electronic patient-reported outcomes (ePROs) and circulating tumor DNA (ctDNA) into routine surveillance for patients treated for p16+ oropharynx cancer. METHODS: A prospective registry was developed in which ePROs and ctDNA were incorporated into routine surveillance among patients with oropharynx cancer. ePROs were emailed monthly for 1 year and blood HPV ctDNA testing was performed every 3-6 months. The primary objective was to assess patient compliance with ePRO-based surveillance with adequate compliance defined as ≥85% of patients completing monthly ePROs. Sensitivity, specificity, and positive/negative predictive values to detect recurrence were calculated for ePROs, HPV ctDNA, or the combination. RESULTS: Of 122 patients who initially expressed interest, 76 completed the electronic consent process and 44/76 (58%) were compliant with monthly surveys over 1 year; thus adequate compliance was not achieved. Technical difficulties associated with ePRO receipt through email largely limited participation. Provider feedback was significantly associated with heightened ePRO compliance. One hundred and six patients had ctDNA testing with a mean number of three tests per patient. Sensitivity to detect recurrence was 75% for the combination of ePROs and ctDNA. CONCLUSION: Despite lower than anticipated compliance with ePROs, our findings show promise for incorporation of HPV ctDNA into surveillance paradigms for HPV-related oropharynx cancer with suggestions of methods to optimize ePRO formats for personalized surveillance.

Lymphadenectomy After Melanoma-A National Analysis of Recurrence Rates and Risk of Lymphedema.

INTRODUCTION: Treatment for melanoma after a positive sentinel lymph node biopsy includes nodal observation or lymphadenectomy. Important considerations for management, however, involve balancing the risk of recurrence and the risk of lymphedema after lymphadenectomy. METHODS: From the Merative MarketScan Research Databases, adult patients were queried from 2007 to 2021. International Classification of Disease, Ninth (ICD-9) and Tenth (ICD-10) Editions, diagnosis codes and Current Procedural Terminology codes were used to identify patients with melanoma diagnoses who underwent an index melanoma excision with a positive sentinel lymph node biopsy (SLNB). Main outcomes were completion lymph node dissection (CLND) utilization after a positive SLNB, developing lymphedema with or without CLND, and nodal basin recurrence 3 months or more after index excision. Subanalyses stratified by index excision year (2007-2017 and 2018-2021) and propensity score matched were additionally conducted. Demographics and comorbidities (measured by Elixhauser index) were recorded. RESULTS: A total of 153,085,453 patients were identified. Of those, 359,298 had a diagnosis of melanoma, and 202,456 patients underwent an excision procedure. The study cohort comprised 3717 patients with a melanoma diagnosis who underwent an excision procedure and had a positive SLNB. The mean age of the study cohort was 49 years, 57% were male, 41% were geographically located in the South, and 24% had an Elixhauser index of 4+. Among the 350 patients who did not undergo CLND, 10% experienced recurrence and 22% developed lymphedema. A total of 3367 patients underwent CLND, of which 8% experienced recurrence and 20% developed lymphedema. Completion lymph node dissection did not significantly affect risk of recurrence [odds ratio (OR), 1.370, P = 0.090] or lymphedema (OR, 1.114, P = 0.438). After stratification and propensity score matching, odds of experiencing lymphedema (OR, 1.604, P = 0.058) and recurrence (OR, 1.825, P = 0.058) after CLND were not significantly affected. Rates of CLND had significantly decreased (P < 0.001) overtime, without change in recurrence rate (P = 0.063). CONCLUSIONS: Electing for nodal observation does not increase the risk of recurrence or reduce risk of lymphedema. Just as CLND does not confer survival benefit, its decreased utilization has not increased recurrence rate.

A national analysis of burn injuries among homeless persons presenting to emergency departments.

INTRODUCTION: Burn injuries among the homeless are increasing as record numbers of people are unsheltered and resort to unsafe heating practices. This study characterizes burns in homeless encounters presenting to US emergency departments (EDs). METHODS: Burn encounters in the 2019 Nationwide Emergency Department Sample (NEDS) were queried. ICD-10 and CPT codes identified homelessness, injury regions, depths, total body surface area (TBSA %), and treatment plans. Demographics, comorbidities, and charges were analyzed. Discharge weights generated national estimates. Statistical analysis included univariate testing and multivariate modeling. RESULTS: Of 316,344 weighted ED visits meeting criteria, 1919 (0.6%) were homeless. Homeless encounters were older (mean age 44.83 vs. 32.39 years), male-predominant (71% vs. 52%), and had more comorbidities, and were more often White or Black race (p < 0.001). They more commonly presented to EDs in the West and were covered by Medicaid (51% vs. 33%) (p < 0.001). 12% and 5% of homeless burn injuries were related to self-harm and assault, respectively (p < 0.001). Homeless encounters experienced more third-degree burns (13% vs. 4%; p < 0.001), though TBSA % deciles were not significantly different (34% vs. 33% had TBSA % of ten or lower; p = 0.516). Homeless encounters were more often admitted (49% vs. 7%; p < 0.001), and homelessness increased odds of admission (OR 4.779; p < 0.001). Odds of transfer were significantly lower (OR 0.405; p = 0.021). CONCLUSION: Homeless burn ED encounters were more likely due to assault and self-inflicted injuries, and more severe. ED practitioners should be aware of these patients' unique presentation and triage to burn centers accordingly.

Upfront neck dissection for treatment selection and improvement in quality of life as a novel treatment paradigm for deintensification in HPV+ OPSCC.

PURPOSE: Locoregionally advanced HPV+ oropharyngeal squamous cell carcinoma (OPSCC) has excellent cure rates, although current treatment regimens are accompanied by acute and long-term toxicities. We designed a phase II de-escalation trial for patients with HPV+OPSCC to evaluate the feasibility of an upfront neck dissection to individualize definitive treatment selection to improve quality of life without compromising survival. METHODS: Patients with T1-3, N0-2 HPV+ OPSCC underwent an upfront neck dissection with primary tumor biopsy. Patients with a single lymph node less than six centimeters, with no extracapsular spread(ECS), and no primary site adverse features underwent transoral surgery (Arm A). Patients who had two or more positive lymph nodes with no ECS, or those with primary site adverse features were treated with radiation alone (Arm B). Patients who had ECS in any lymph node were treated with chemoradiation (Arm C). The primary endpoint was quality of life at 1 year compared to a matched historical control. RESULTS: Thirty-four patients were enrolled and underwent selective neck dissection. Based on pathologic characteristics, 14 patients were assigned to arm A, 10 patients to arm B, and 9 to arm C. A significant improvement was observed in HNQOL compared to historical controls (-2.6 vs -11.9, p=0.034). With a median follow-up of 37 months, the 3-year overall survival was 100% and estimated 3-year estimated progression free survival was 96% (95% CI: 76-99%). CONCLUSION: A neck dissection driven treatment paradigm warrants further research as a de-intensification strategy.

Updated Trends and Outcomes in Autologous Breast Reconstruction in the United States, 2016-2019.

INTRODUCTION: Autologous breast reconstruction (ABR) has increased in recent decades, although concerns for access remain. As such, our goal is to trend national demographics and operative characteristics of ABR in the United States. METHODS: Using the National Inpatient Sample, 2016-2019, the International Classification of Disease , Tenth Edition codes identified adult female encounters undergoing ABR. Demographics and procedure-related characteristics were recorded. Discharge weights generated national estimates. Statistical analysis included univariate testing and multivariate regression modeling. RESULTS: A total of 52,910 weighted encounters met the criteria (mean age, 51.5 ± 10.0 years). Autologous breast reconstruction utilization increased (Δ = +5%), 2016-2019, primarily driven by a rise in deep inferior epigastric perforator (DIEP) reconstructions (Δ = +28%; incidence rate ratio [IRR], 1.070; P < 0.001), which were predominant throughout the study period (69%). More recent surgery year, bilateral reconstruction, higher income levels, commercial insurance, and care in the South US region increased the odds of DIEP-based ABR ( P ≤ 0.036). Transverse rectus abdominis myocutaneous flaps, bilateral reconstructions, higher comorbidity levels, and experiencing complications increased the length of stay ( P ≤ 0.038). Most ABRs (75%) were privately insured. The rates of immediate reconstructions increased over the study period (from 26% to 46%; IRR, 1.223; P < 0.001), as did the rates of bilateral reconstructions (from 54% to 57%; IRR, 1.026; P = 0.030). The rates of ABRs performed at teaching hospitals remained high (90% to 93%; P = 0.242). CONCLUSIONS: As of 2019, ABR has become more prevalent, with the DIEP flap constituting the most common modality. With the increasing ABR popularity, efforts should be made to ensure geographic and financial accessibility.

Risk Factors for Hardware Removal Following Bimaxillary Surgery: A National Database Analysis.

Orthognathic surgery typically relies on the rigid fixation of fracture fragments using metal hardware. Though hardware is usually intended to be implanted permanently, the removal of hardware (ROH) is sometimes indicated for a variety of reasons. The authors sought to identify risk factors for ROH following orthognathic surgery. The authors conducted a retrospective analysis of the Merative MarketScan Research Databases, 2007-2021 using Current Procedural Terminology (CPT) and International Classification of Disease (ICD-9 and ICD-10) codes to identify patients who underwent an index Le Fort 1 osteotomy and bilateral sagittal split osteotomy operation on the same day. Statistical analysis involved χ2, Shapiro-Wilk, Wilcoxon-Mann-Whitney, Poisson regression, and multivariable logistic regression tests. 4698 patients met the inclusion criteria. The mean age at surgery was 25 years, and 57% were female. ROH occurred in 5.9% of patients. The mean time to hardware removal was 190.5±172.4 days. In a multivariate logistic regression, increased odds of ROH were associated with older patient age [OR: 1.02 (1.01-1.03), P=0.046], sleep apnea [OR: 1.62 (1.13-2.32), P=0.018], and craniofacial syndrome and/or cleft diagnoses [OR: 1.88 (1.14-2.55), P<0.001]. In the same model, postoperative oral antibiotic prophylaxis was not associated with ROH (P=0.494). The incidence of all-cause complications [IRR: 1.03 (1.01-1.05), P<0.001] rose over the study period, while the incidence of ROH did not change significantly (P=0.281). Patients at elevated risk should be counseled on the increased possibility of a second operation for ROH before having orthognathic surgery to ensure expectations and health care utilization decisions align with the evidence.

The Effect of Wire Versus Magnetic Seed Localization on Lumpectomy Cavity Size.

PURPOSE: Our purpose was to assess whether an association exists between surgical localization technique and lumpectomy cavity size on radiation therapy planning computed tomography (CT) scan. METHODS AND MATERIALS: A single-institution retrospective review was conducted of women undergoing breast conserving surgery with wire or magnetic seed guided lumpectomy followed by adjuvant radiation therapy from 2018 to 2021. Patients of a surgeon only performing 1 localization technique or undergoing bracketed localization were excluded. The primary outcome was lumpectomy cavity size on simulation CT. Confounding due to imbalance in patient and tumor factors was addressed with overlap weights derived from a propensity score analysis and used in a weighted multivariable analysis. Secondary outcomes included positive margins, total pathologic volume, boost delivery, and boost modality. RESULTS: Of 617 women who received lumpectomy during the study period, 387 were included in final analysis. Tumors of patients undergoing seed localization were more likely unifocal, assessable by ultrasound, and smaller. Seed use rates ranged from 27.7% to 70.7% per surgeon. There was no difference in positive margins (6.4 vs 5.4%, P = .79) or second surgeries (9.4 vs 8.1%, P = .79) between groups. Close margin rates were similar for ductal carcinoma in situ (P = .35) and invasive carcinoma (P = .97). In unadjusted bivariable analyses, wire localization was associated with larger total pathology volume (P = .004), but localization technique showed no association with CT cavity volume (P = .15). After adjusting for potentially confounding variables, multivariable analysis failed to show an association between localization technique and either CT cavity (P = .35) or total path volume (P = .08). There was no difference in indicated-boost delivery (P = .15) or electron boost (P = .14) by localization technique. CONCLUSIONS: There was no significant difference in CT cavity size by localization technique, suggesting choice between surgical techniques does not impede radiation therapy boost delivery.

Investigating potential disparities in clinical trial eligibility and enrollment at an NCI-designated comprehensive cancer center.

BACKGROUND: Although barriers to trial accrual are well-reported, few studies have explored trial eligibility and trial offers as potential drivers of disparities in cancer clinical trial enrollment. METHODS: We identified patients with gastrointestinal (GI) or head/neck (HN) malignancies who were seen as new patients at the University of Michigan Health Rogel Cancer Center in 2016. By exhaustive review of the electronic medical record, we assessed the primary outcomes: (1) eligibility for, (2) documented offer of, and (3) enrollment in a clinical trial. All 41 of the clinical trials available to these patients were considered. Independent variables included clinical and non-clinical patient-related factors. We assessed associations between these variables and the primary outcomes using multivariable regression. RESULTS: Of 1446 patients, 43% were female, 15% were over age 75, 6% were Black. 305 (21%) patients were eligible for a clinical trial. Among eligible patients, 154 (50%) had documentation of a trial offer and 90 (30%) enrolled. Among the GI cohort, bivariate analyses demonstrated that older age was associated with decreased trial eligibility. Bivariate analyses also demonstrated that Black race was associated with increased trial offer. After adjustment, patients 75 or older were less likely to be eligible for a clinical trial in the GI cohort; however, we found no significant associations between race and any of the outcomes after adjustment. Among eligible GI patients, we found no significant associations between non-clinical factors and enrollment. Among the HN cohort, bivariate analyses demonstrated that female sex, older age, Black race, and unpartnered marital status were associated with decreased likelihood of trial offer; however, we found no significant associations between race, age, and marital status and any of the outcomes after adjustment. We found no significant associations between non-clinical factors and eligibility after adjustment; however, women were less likely to be offered and to enroll in a clinical trial in the HN cohort. CONCLUSION: Factors associated with eligibility, documented offer, and enrollment differed between disease site cohorts at our institution. Future work is needed to ensure the equitable inclusion of women and elderly patients in clinical trials.

Patterns of recurrence in head and neck squamous cell carcinoma to inform personalized surveillance protocols.

BACKGROUND: Development of evidence-based post-treatment surveillance guidelines in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) is limited by comprehensive documentation of patterns of recurrence and metastatic spread. METHODS: A retrospective analysis of patients diagnosed with R/M HNSCC at a National Cancer Institute-designated cancer center between 1998- 2019 was performed (n = 447). Univariate and multivariate analysis identified patterns of recurrence and predictors of survival. RESULTS: Median overall survival (mOS) improved over time (6.7 months in 1998-2007 to 11.8 months in 2008-2019, p = .006). Predictors of worse mOS included human papillomavirus (HPV) negativity (hazard ratio [HR], 1.8; 95% confidence interval [CI], 1.2-2.6), high neutrophil/lymphocyte ratio (HR, 2.1 [1.4-3.0], disease-free interval (DFI) ≤6 months (HR, 1.4 [1.02-2.0]), and poor performance status (Eastern Cooperative Oncology Group, ≥2; HR, 1.91.1-3.4). In this cohort, 50.6% of recurrences occurred within 6 months of treatment completion, 72.5% occurred within 1 year, and 88.6% occurred within 2 years. Metachronous distant metastases were more likely to occur in patients with HPV-positive disease (odds ratio [OR], 2.3 [1.4-4.0]), DFI >6 months (OR, 2.4 [1.5-4.0]), and body mass index ≥30 (OR, 2.3 [1.1-4.8]). Oligometastatic disease treated with local ablative therapy was associated with improved survival over polymetastatic disease (HR, 0.36; 95% CI, 0.24-0.55). CONCLUSION: These data regarding patterns of distant metastasis in HNSCC support the clinical utility of early detection of recurrence. Patterns of recurrence in this population can be used to inform individualized surveillance programs as well as to risk-stratify eligible patients for clinical trials. PLAIN LANGUAGE SUMMARY: After treatment for head and neck cancer (HNC), patients are at risk of recurrence at prior sites of disease or at distant sites in the body. This study includes a large group of patients with recurrent or metastatic HNC and examines factors associated with survival outcomes and recurrence patterns. Patients with human papillomavirus (HPV)-positive HNC have good survival outcomes, but if they recur, this may be in distant regions of the body and may occur later than HPV-negative patients. These data argue for personalized follow-up schedules for patients with HNC, perhaps incorporating imaging studies or novel blood tests.

Use of Local Antibiotic Delivery Systems in Tissue Expander and Implant-Based Breast Reconstruction: A Systematic Review of the Literature.

Background: Periprosthetic infections are a debilitating complication of alloplastic breast reconstruction. Local antibiotic delivery for prophylaxis and infection clearance has been used by other surgical specialties but rarely in breast reconstruction. Because local delivery can maintain high antibiotic concentrations with lower toxicity risk, it may be valuable for infection prophylaxis or salvage in breast reconstruction. Methods: A systematic search of the Embase, PubMed, and Cochrane databases was performed in January 2022. Primary literature studies examining local antibiotic delivery systems for either prophylaxis or salvage of periprosthetic infections were included. Study quality and bias were assessed using the validated MINORS criteria. Results: Of 355 publications reviewed, 8 met the predetermined inclusion criteria; 5 papers investigated local antibiotic delivery for salvage, and 3 investigated infection prophylaxis. Implantable antibiotic delivery devices included polymethylmethacrylate, calcium sulfate, and collagen sponges impregnated with antibiotics. Non-implantable antibiotic delivery methods used irrigation with antibiotic solution into the breast pocket. All studies indicated that local antibiotic delivery was either comparable or superior to conventional methods in both the salvage and prophylaxis settings. Conclusions: Despite varied sample sizes and methodologies, all papers endorsed local antibiotic delivery as a safe, effective method of preventing or treating periprosthetic infections in breast reconstruction.

Racial Disparities in Postoperative Breast Reconstruction Outcomes: A National Analysis.

BACKGROUND: Studies have shown that Black patients are more likely to experience complications following breast reconstruction compared to other racial groups. Most of these studies have been conducted on patient populations focusing on either autologous or implant-based reconstruction without possible predictive indicators for complication disparities for all types of reconstruction procedures. The aim of this study is to elucidate disparities among patient demographics by identifying predictors of complications and postoperative outcomes among different racial/ethnic patients undergoing breast reconstruction utilizing multi-state, multi-institution, and national level data. METHODS: Patients in the Optum Clinformatics Data Mart that underwent all billable forms of breast reconstruction were identified via CPT codes. Demographics, medical history, and postoperative outcome data were collected by querying relevant reports of CPT, ICD-9, and ICD-10 codes. Outcomes analysis was limited to the 90-day global postoperative period. A multivariable logistic-regression analysis was performed to ascertain the effects of age, patient reported ethnicity, coexisting conditions, and reconstruction type on the likelihood of any common postoperative complication occurring. Linearity of the continuous variables with respect to the logit of the dependent variable was confirmed. Odds ratios and corresponding 95% confidence intervals were calculated. RESULTS: From over 86 million longitudinal patient records, our study population included 104,714 encounters for 57,468 patients who had undergone breast reconstruction between January 2003 and June 2019. Black race (relative to White), autologous reconstruction, hypertension, type II diabetes mellitus, and tobacco use were independent predictors of increased likelihood of complication. Specifically, the odds ratios for complication occurrence for Black, Hispanic, and Asian ethnicity (relative to White) were 1.09, 1.03, and 0.77, respectively. Black patients had an overall breast reconstruction complication rate of 20.4%, while the corresponding rate for White, Hispanic, and Asian patients were 17.0%, 17.9%, and 13.2%, respectively. CONCLUSION: Our analysis of a national-level database shows that Black patients undergoing implant-based or autologous reconstruction have increased risk of complications, likely due to multifactorial components that play a role in the care of this patient population. While higher rates of comorbidities have been cited as a possible cause, providers must consider racial influences involving cultural context, historical mistrust in medicine, and physician/health institution factors that may drive this disparity of outcomes among our patients.

Radiation for Early Glottic Cancer.

Multidisciplinary evaluation of early-stage glottic cancer facilitates optimal treatment with either surgery or radiation therapy. Standard of care radiation treatment of early-stage glottic cancer continues to be three-dimensional opposed lateral fields to include the whole larynx. Modern radiation treatment techniques are allowing studies to examine the efficacy and toxicity of altered doses and treatment volumes. Advanced techniques, such as stereotactic body radiation therapy or single-vocal cord irradiation, are not yet considered standard of care for early-stage glottic cancer and should be performed at institutions with clinical trials to ensure adequate expertise and quality assurance.

Initial Feasibility and Acute Toxicity Outcomes From a Phase 2 Trial of 18F-Fluorodeoxyglucose Positron Emission Tomography Response-Based De-escalated Definitive Chemoradiotherapy for p16+ Oropharynx Cancer: A Planned Interim Analysis.

PURPOSE: 18F-Fluorodeoxyglucose positron emission tomography (FDG-PET) parameters are prognostic of oncologic outcomes in human papillomavirus-associated oropharyngeal squamous cell carcinoma (OPSCC). We used FDG-PET imaging biomarkers to select patients for de-escalated chemoradiotherapy (CRT), hypothesizing that acute toxicity will be improved with de-escalation. METHODS AND MATERIALS: This is a planned interim initial feasibility and acute toxicity report from a phase 2, prospective, nonrandomized study, which enrolled patients with stage I-II p16+ OPSCC. All patients started definitive CRT to 70 Gy in 35 fractions, and those who met de-escalation criteria on midtreatment FDG-PET at fraction 10 completed treatment at 54 Gy in 27 fractions. We report the acute toxicity and patient-reported outcomes for 59 patients with a minimum follow-up of 3 months. RESULTS: There were no statistically significant differences between baseline patient characteristics in the standard and de-escalated cohorts. There were 28 of 59 (47.5%) patients who met FDG-PET de-escalation criteria and collectively received 20% to 30% less dose to critical organs at risk known to affect toxicity. At 3 months posttreatment, patients who received de-escalated CRT lost significantly less weight (median, 5.8% vs 13.0%; P < .001), had significantly less change from baseline in penetration-aspiration scale score (median, 0 vs 1; P = .018), and had significantly fewer aspiration events on repeat swallow study (8.0% vs 33.3%, P = .037) compared with patients receiving standard CRT. CONCLUSIONS: Approximately half of patients with early-stage p16+ OPSCC are selected for de-escalation of definitive CRT using midtreatment FDG-PET biomarkers, which resulted in significantly improved rates of observed acute toxicity. Further follow-up is ongoing and will be required to determine whether this de-escalation approach preserves the favorable oncologic outcomes for patients with p16+ OPSCC before adoption.

Tumor immune microenvironment alterations using induction cetuximab in a phase II trial of deintensified therapy for p16-positive oropharynx cancer.

BACKGROUND: We sought to characterize early changes in CD8+ tumor-infiltrating lymphocytes and tumor transcriptomes after induction cetuximab in a cohort with p16-positive oropharyngeal cancer on a phase II clinical de-escalation trial. METHODS: Tumor biopsies were obtained before and 1 week after a single cetuximab loading dose in eight patients enrolled in a phase II trial of cetuximab and radiotherapy. Changes in CD8+ tumor-infiltrating lymphocytes and transcriptomes were assessed. RESULTS: One week after cetuximab, five patients (62.5%) had an increase in CD8+ cell infiltration with a median (range) fold change of +5.8 (2.5-15.8). Three (37.5%) had unchanged CD8+ cells (median [range] fold change of -0.85 [0.8-1.1]). In two patients with evaluable RNA, cetuximab induced rapid tumor transcriptome changes in cellular type 1 interferon signaling and keratinization pathways. CONCLUSIONS: Within 1 week, cetuximab induced measurable changes in pro-cytotoxic T-cell signaling and immune content.

Use of Antibiotic-impregnated Polymethylmethacrylate (PMMA) Plates for Prevention of Periprosthetic Infection in Breast Reconstruction.

Periprosthetic infections remain a major challenge for breast reconstruction. Local antibiotic delivery systems, such as antibiotic beads and spacers, have been widely used within other surgical fields, but their use within plastic surgery remains scarce. In this study, we demonstrate the use of antibiotic-impregnated polymethylmethacrylate (PMMA) plates for infection prophylaxis in tissue expander (TE)-based breast reconstruction. Methods: A retrospective review of patients who underwent immediate breast reconstruction with prepectoral TEs over the span of 5 years performed by two surgeons was completed, revealing a total of 447 patients. Data pertaining to patient demographics, operative details, and postoperative outcomes were recorded. Fifty patients underwent TE reconstruction with the addition of a PMMA plate (Stryker, Kalamazoo, Michigan) impregnated with tobramycin and vancomycin. Antibiotic plates were removed at the time of TE-to-implant exchange. Patient-matching analysis was performed using the 397 patients without PMMA plates to generate a 50-patient nonintervention cohort for statistical analysis. Results: The intervention cohort (n = 50) and 1:1 patient-matched nonintervention cohort (n = 50) demonstrated no statistically significant differences in patient demographics or operative characteristics other than PMMA plate placement. The rate of operative periprosthetic infection was 4% in the intervention group and 14% in the nonintervention group (P = 0.047). The rate of TE explantation was also reduced in the intervention group (6% versus 18%; P = 0.036). Follow-up averaged 9.1 and 8.9 months for the intervention and nonintervention groups, respectively (P = 0.255). Conclusion: Local antibiotic delivery using antibiotic-impregnated PMMA plates can be safely and effectively used for infection prevention with TE-based breast reconstruction.

Machine Learning Model of Emergency Department Use for Patients Undergoing Treatment for Head and Neck Cancer Using Comprehensive Multifactor Electronic Health Records.

PURPOSE: To use a hybrid method, combining statistical profiling, machine learning (ML), and clinical evaluation to predict emergency department (ED) visits among patients with head and neck cancer undergoing radiotherapy. MATERIALS AND METHODS: Patients with head and neck cancer treated with radiation therapy from 2015 to 2019 were identified using electronic health record data. Records from 60 days before 90 days after treatment were analyzed. Statistical profiling and ML were used to create a predictive model for ED visits during or after radiation therapy. A comprehensive set of variables were studied. Multiple ML models were developed including extreme gradient-boosted decision tree and generalized logistic regression with comparison of multiple predictive performance metrics. RESULTS: Of the 1,355 patients studied, 13% had an ED visit during or after treatment. Our hybrid methodology enabled evidence-based winnowing of candidate features from 141 to 11 with clinically applicable, evidence-based thresholds. Extreme gradient boosting had the highest area under the curve (0.81 ± 0.06) with a sensitivity of 0.89 ± 0.10 and exceeded generalized logistic regression (area under the curve 0.64 ± 0.02). Significant predictors of ED visits during treatment included increasingly complex opioid use, number of prior ED visits, tumor volume, rate of change of blood urea nitrogen, total bilirubin, body mass index, and distance from hospital. CONCLUSION: Our approach combining bootstrapped statistical profiling and ML importance analysis supported integration of clinician input to identify a distilled set of phenotypical characteristics for developing ML models predicting which patients undergoing head and neck cancer radiation therapy were at risk for ED visits.

Transversus abdominus plane blocks do not reduce rates of postoperative prolonged opioid use following abdominally based autologous breast reconstruction: a nationwide longitudinal analysis.

Background: The transversus abdominus plane (TAP) block reduces postoperative donor site pain in patients undergoing autologous breast reconstruction with an abdominally based flap. This study aimed to determine the effect of TAP blocks on rates of conversion to chronic opioid use. Methods: The Clinformatics Data Mart was queried from 2003 to 2019, extracting adult encounters for abdominally based free and pedicled flaps based on common procedural terminology (CPT) codes. Patients were excluded if they had filled a narcotic prescription 1 year to 30 days prior to surgery. The exposure variable-TAP block-was identified by CPT codes. Outcomes were evaluated using morphine milligram equivalents (MME) from prescriptions filled between 30 days prior to and 30 days after surgery. Chronic opioid use (COU) was defined as receiving 4 unique prescriptions or a 60-day supply between 30 and 180 days after surgery. Results: Of the 4091 patients, (mean age 51.2 ± 9.0 years), 181 (4.4%) had a TAP block placed. Perioperative MMEs/day, postoperative COU, and length of stay did not differ in patients who received a TAP block (p = 0.142; p = 0.271). Significant predictors of risk of conversion to COU included younger age, pedicled abdominal flap, Elixhauser comorbidity index score > 3, filling a psychiatric medication prescription, and filling a benzodiazepine prescription. Conclusions: In patients undergoing autologous breast reconstruction with abdominally based flap reconstruction, TAP blocks do not decrease perioperative MME/day, conversion to chronic opioid use, or length of stay. These data suggest that intraoperative TAP block placement may be a low-yield opioid-reduction strategy.Level of evidence: Level III, risk/prognostic study.

Development and Clinical Implementation of an Automated Virtual Integrative Planner for Radiation Therapy of Head and Neck Cancer.

Purpose: Head and neck (HN) radiation (RT) treatment planning is complex and resource intensive. Deviations and inconsistent plan quality significantly affect clinical outcomes. We sought to develop a novel automated virtual integrative (AVI) knowledge-based planning application to reduce planning time, increase consistency, and improve baseline quality. Methods and Materials: An in-house write-enabled script was developed from a library of 668 previously treated HN RT plans. Prospective hazard analysis was performed, and mitigation strategies were implemented before clinical release. The AVI-planner software was retrospectively validated in a cohort of 52 recent HN cases. A physician panel evaluated planning limitations during initial deployment, and feedback was enacted via software refinements. A final second set of plans was generated and evaluated. Kolmogorov-Smirnov test in addition to generalized evaluation metric and weighted experience score were used to compare normal tissue sparing between final AVI planner versus respective clinically treated and historically accepted plans. A t test was used to compare the interactive time, complexity, and monitor units for AVI planner versus manual optimization. Results: Initially, 86% of plans were acceptable to treat, with 10% minor and 4% major revisions or rejection recommended. Variability was noted in plan quality among HN subsites, with high initial quality for oropharynx and oral cavity plans. Plans needing revisions were comprised of sinonasal, nasopharynx, P-16 negative squamous cell carcinoma unknown primary, or cutaneous primary sites. Normal tissue sparing varied within subsites, but AVI planner significantly lowered mean larynx dose (median, 18.5 vs 19.7 Gy; P < .01) compared with clinical plans. AVI planner significantly reduced interactive optimization time (mean, 2 vs 85 minutes; P < .01). Conclusions: AVI planner reliably generated clinically acceptable RT plans for oral cavity, salivary, oropharynx, larynx, and hypopharynx cancers. Physician-driven iterative learning processes resulted in favorable evolution in HN RT plan quality with significant time savings and improved consistency using AVI planner.

Optimizing Palliative Focal Radiation Therapy Dose in Cutaneous T-Cell Lymphoma: How Low Can You Go?

PURPOSE: Primary cutaneous T-cell lymphomas (CTCLs) are radiosensitive tumors with variable and often relapsing courses. Local disease can be treated with low-dose focal palliative radiation therapy (RT), though little data supports the use of a specific dose. This study assesses clinical outcomes after focal RT to a total dose of 4 Gy, 8 Gy, or 12 Gy. METHODS AND MATERIALS: An International Review Board-approved, retrospective, single-institution study was performed of 225 lesions in 41 patients with primary CTCL treated with low-dose focal RT from 2015 to 2020. Patient, tumor, and treatment characteristics were reviewed. The primary outcome was freedom from treatment failure (FFTF), defined as time to requiring local retreatment, and secondary outcomes included response rates and toxicities. RESULTS: Of the 225 lesions, 90 received 4 Gy, 106 received 8 Gy, and 29 received 12 Gy. Lesions treated with 12 Gy (96%) or 8 Gy (92%) had a significantly higher 1-year FFTF compared with 4 Gy (77%) (P = .034). Overall response rate and complete response rate were not significantly different between different doses (P = .117), though there was a trend toward higher overall response rate at initial assessment with 8 Gy versus 4 Gy (91.5% vs 82.2%, P = .057). Toxicity was low, with 7.1% of lesions having grade 2 or higher radiation dermatitis. CONCLUSIONS: In primary CTCL lesions treated with focal palliative RT, a dose response was noted favoring 8 to 12 Gy, with 1-year FFTF rates over 90%. However, 4 Gy resulted in substantially better outcomes than previously reported, with 77% requiring no further treatment at 1 year and comparable response rates to higher doses. While our data substantiates 8 to 12 Gy as the standard of care, it also suggests that 4 Gy should be considered an acceptable alternative in situations with concern for radiation toxicities, such as with fragile or heavily pretreated skin.