Synergy of EGFR and AURKA Inhibitors in KRAS-mutated Non-small Cell Lung Cancers.

The most common oncogenic driver mutations for non-small cell lung cancer (NSCLC) activate EGFR or KRAS. Clinical trials exploring treatments for EGFR- or KRAS-mutated (EGFRmut or KRASmut) cancers have focused on small-molecule inhibitors targeting the driver mutations. Typically, these inhibitors perform more effectively based on combination with either chemotherapies, or other targeted therapies. For EGFRmut NSCLC, a combination of inhibitors of EGFR and Aurora-A kinase (AURKA), an oncogene commonly overexpressed in solid tumors, has shown promising activity in clinical trials. Interestingly, a number of recent studies have indicated that EGFR activity supports overall viability of tumors lacking EGFR mutations, and AURKA expression is abundant in KRASmut cell lines. In this study, we have evaluated dual inhibition of EGFR and AURKA in KRASmut NSCLC models. These data demonstrate synergy between the EGFR inhibitor erlotinib and the AURKA inhibitor alisertib in reducing cell viability and clonogenic capacity in vitro, associated with reduced activity of EGFR pathway effectors, accumulation of enhanced aneuploid cell populations, and elevated cell death. Importantly, the erlotinib-alisertib combination also synergistically reduces xenograft growth in vivo. Analysis of signaling pathways demonstrated that the combination of erlotinib and alisertib was more effective than single-agent treatments at reducing activity of EGFR and pathway effectors following either brief or extended administration of the drugs. In sum, this study indicates value of inhibiting EGFR in KRASmut NSCLC, and suggests the specific value of dual inhibition of AURKA and EGFR in these tumors. SIGNIFICANCE: The introduction of specific KRAS G12C inhibitors to the clinical practice in lung cancer has opened up opportunities that did not exist before. However, G12C alterations are only a subtype of all KRAS mutations observed. Given the high expression of AURKA in KRASmut NSCLC, our study could point to a potential therapeutic option for this subgroup of patients.

A Preliminary Validation of an Optimal Cutpoint in Total Number of Patient-Reported Symptoms in Head and Neck Cancer for Effective Alignment of Clinical Resources with Patients' Symptom Burden.

Background: Patients with head and neck cancer (HNC) often experience high symptom burden leading to lower quality of life (QoL). Objective: This study aims to conceptually model optimal cutpoint by examining where total number of patient-reported symptoms exceeds patients' coping capacity, leading to a decline in QoL in patients with HNC. Methods: Secondary data analysis of 105 individuals with HNC enrolled in a clinical usefulness study of the NYU Electronic Patient Visit Assessment (ePVA)©, a digital patient-reported symptom measure. Patients completed ePVA and European Organization for Research and Treatment of Cancer (EORTC©) QLQ-C30 v3.0. The total number of patient-reported symptoms was the sum of symptoms as identified by the ePVA questionnaire. Analysis of variance (ANOVA) was used to define optimal cutpoint. Results: Study participants had a mean age of 61.5, were primarily male (67.6%), and had Stage IV HNC (53.3%). The cutpoint of 10 symptoms was associated with significant decline of QoL (F= 44.8, P<.0001), dividing the population into categories of low symptom burden (< 10 symptoms) and high symptom burden (≥ 10 symptoms). Analyses of EORTC© function subscales supported the validity of 10 symptoms as the optimal cutpoint (Physical: F=28.3, P<.0001; Role: F=21.6, P<.0001; Emotional: F=9.5, P=.003; Social: F=33.1, P<.0001). Conclusions: In HNC, defining optimal cutpoints in the total number of patient-reported symptoms is feasible. Implications for Practice: Cutpoints in the total number of patient-reported symptoms may identify patients experiencing a high symptom burden from HNC. Foundational: Using optimal cutpoints of the total number of patient-reported symptoms may help effectively align clinical resources with patients' symptom burden.

The impact of an oncology urgent care center on health-care utilization.

INTRODUCTION: Studies suggest that many emergency department (ED) visits and hospitalizations for patients with cancer may be preventable. The Centers for Medicare & Medicaid Services has implemented changes to the hospital outpatient reporting program that targets acute care in-treatment patients for preventable conditions. Oncology urgent care centers aim to streamline patient care. Our cancer center developed an urgent care center called the direct referral unit in 2011. METHODS: We abstracted visits to our adjacent hospital ED and direct referral unit from January 2014 to June 2018. Patient demographics, cancer and visit diagnoses, visit charges, and 30-day therapy utilization were assessed. RESULTS: An analysis of 13 114 visits demonstrated that increased direct referral unit utilization was associated with decreased monthly ED visits (P < .001). Common direct referral unit visit diagnoses were dehydration, nausea and vomiting, abdominal pain, and fever. Patients receiving active cancer treatment more frequently presented to the direct referral unit (P < .001). The average charges were $2221 for the direct referral unit and $10 261 for the ED. CONCLUSION: The association of decreased ED visits with increased direct referral unit utilization demonstrates the potential for urgent care centers to reduce acute care visits. Many patients presented to our direct referral unit with preventable conditions, and these visits were associated with considerable cost savings, supporting its use as a cost-effective method to reduce acute care costs.

The ENGAGE study: a 3-arm randomized hybrid type 1 effectiveness and implementation study of an in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic services in childhood cancer survivors.

BACKGROUND: Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and screening guidelines for genetic carriers. Access to genetic services is limited in many places, which leaves many genetic carriers unidentified and at risk for late diagnosis of cancers and poor outcomes. This poses a problem for childhood cancer survivors, as this is a population with an increased risk for subsequent malignant neoplasms (SMN) due to cancer therapy or inherited cancer predisposition. The ENGaging and Activating cancer survivors in Genetic services (ENGAGE) study evaluates the effectiveness of an in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic testing in childhood cancer survivors compared to usual care options for genetic testing. METHODS: The ENGAGE study is a 3-arm randomized hybrid type 1 effectiveness and implementation study within the Childhood Cancer Survivor Study population which tests a clinical intervention while gathering information on its delivery during the effectiveness trial and its potential for future implementation among 360 participants. Participants are randomized into three arms. Those randomized to Arm A receive genetic services via videoconferencing, those in Arm B receive these services by phone, and those randomized to Arm C will receive usual care services. DISCUSSION: With many barriers to accessing genetic services, innovative delivery models are needed to address this gap and increase uptake of genetic services. The ENGAGE study evaluates the effectiveness of an adapted model of remote delivery of genetic services to increase the uptake of recommended genetic testing in childhood cancer survivors. This study assesses the uptake in remote genetic services and identify barriers to uptake to inform future recommendations and a theoretically-informed process evaluation which can inform modifications to enhance dissemination beyond this study population and to realize the benefits of precision medicine. TRIAL REGISTRATION: This protocol was registered at clinicaltrials.gov (NCT04455698) on July 2, 2020.

Patient-Caregiver Portal System in Palliative Oncology: Assessment of Usability and Perceived Benefit.

BACKGROUND: The engagement of family caregivers in oncology is not universal or systematic. OBJECTIVE: We implemented a process intervention (ie, patient-caregiver portal system) with an existing patient portal system to (1) allow a patient to specify their caregiver and communication preferences with that caregiver, (2) connect the caregiver to a unique caregiver-specific portal page to indicate their needs, and (3) provide an electronic notification of the dyad's responses to the care team to inform clinicians and connect the caregiver to resources as needed. METHODS: We assessed usability and satisfaction with this patient-caregiver portal system among patients with cancer receiving palliative care, their caregivers, and clinicians. RESULTS: Of 31 consented patient-caregiver dyads, 20 patients and 19 caregivers logged in. Further, 60% (n=12) of patients indicated a preference to communicate equally or together with their caregiver. Caregivers reported high emotional (n=9, 47.3%), financial (n=6, 31.6%), and physical (n=6, 31.6%) caregiving-related strain. The care team received all patient-caregiver responses electronically. Most patients (86.6%, 13/15 who completed the user experience interview) and caregivers (94%, 16/17 who completed the user experience interview) were satisfied with the system, while, of the 6 participating clinicians, 66.7% agreed "quite a bit" (n=1, 16.7%) or "very much" (n=3, 50%) that the system allowed them to provide better care. CONCLUSIONS: Our findings demonstrate system usability, including a systematic way to identify caregiver needs and share with the care team in a way that is acceptable to patients and caregivers and perceived by clinicians to benefit clinical care. Integration of a patient-caregiver portal system may be an effective approach for systematically engaging caregivers. These findings highlight the need for additional research among caregivers of patients with less advanced cancer or with different illnesses.

Uptake of Genetic Research Results and Patient-Reported Outcomes With Return of Results Incorporating Web-Based Predisclosure Education.

PURPOSE: We developed a web-based education intervention as an alternative to predisclosure education with a genetic counselor (GC) to reduce participant burden and provider costs with return of genetic research results. METHODS: Women at three sites who participated in 11 gene discovery research studies were contacted to consider receiving cancer genetic research results. Participants could complete predisclosure education through web education or with a GC. Outcomes included uptake of research results, factors associated with uptake, and patient-reported outcomes. RESULTS: Of 819 participants, 178 actively (21.7%) and 167 passively (20.4%) declined return of results; 474 (57.9%) were enrolled. Most (60.3%) received results although this was lower than the 70% uptake we hypothesized. Passive and active decliners were more likely to be Black, to have less education, and to have not received phone follow-up after the invitation letter. Most participants selected web education (88.5%) as an alternative to speaking with a GC, but some did not complete or receive results. Knowledge increased significantly from baseline to other time points with no significant differences between those who received web versus GC education. There were no significant increases in distress between web and GC education. CONCLUSION: Interest in web-based predisclosure education for return of genetic research results was high although it did not increase uptake of results. We found no negative patient-reported outcomes with web education, suggesting that it is a viable alternative delivery model for reducing burdens and costs of returning genetic research results. Attention to attrition and lower uptake of results among Black participants and those with less formal education are important areas for future research.

Significant Reduction in Length of Stay in Deep Inferior Epigastric Perforator Flap Breast Reconstruction With Implementation of Multimodal ERAS Protocol.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) implementation achieves earlier recovery, reduced hospital length of stay (LOS) and improved outcomes in patients undergoing deep inferior epigastric perforator (DIEP) free flaps. We sought to review our ERAS protocols and their impact on our patients' LOS compared with the literature. METHODS: This was a retrospective review of a single surgeon's experience from 2017 to 2021 of patients undergoing DIEP free-flap breast reconstruction with LOS as the primary outcome. Complication rates and patient demographics are described as secondary outcomes. RESULTS: One hundred twenty-one patients underwent DIEP free-flap breast reconstruction. After adapting ERAS protocols, there has been a 0.98 [SD, 0.17; confidence interval [CI], -1.3 to -0.64; P < 0.001) day decrease in length of stay comparing pre-ERAS to post-ERAS implementation. Length of stay has routinely decreased from an average discharge on day 4.17 (SD, 1.1; range, 3-8 days) in 2017 to discharge on day 2.91 (SD, 1.1; range, 1-5 days) in 2021. Seventy-five percent of patients in 2021 were hospitalized for 3 or fewer days compared with 75% of patients in 2017 hospitalized for 4 or more days. One patient experienced a flap failure. Our study supports successful discharge on postoperative days 2-3 compared with postoperative days 3-4 in the current literature. CONCLUSIONS: The implementation of our ERAS protocol for DIEP free-flap breast reconstruction has resulted in a shorter LOS compared with contemporary literature. The ERAS protocols can be efficiently adopted in microsurgical DIEP breast reconstruction to achieve a shorter LOS without jeopardizing patient outcomes.

Eliminating children's tobacco smoke exposure: a pathway to bioverified abstinence among low-income maternal smokers in the Babies Living Safe and Smokefree (BLiSS) trial.

BACKGROUND: Identifying behavioral pathways to smoking cessation in high-risk populations, such as low-income maternal smokers, could reduce tobacco disparities. The previous "BLiSS" multilevel intervention trial demonstrated efficacy of the BLiSS intervention in facilitating low-income maternal smokers' bioverified abstinence. This present study examined four putative pathways measured at 3-month end of treatment (Time 2) that could account for the observed intervention effect on smoking abstinence through 12 months (Time 2 - Time 3). METHODS: Nutritionists in community clinics delivering safety net nutrition promotion programs across Philadelphia, Pennsylvania, USA, were trained by trial principal investigators to deliver a brief tobacco intervention informed by the American Academy of Pediatrics best practice guidelines ("Ask, Advise, Refer [AAR]"). After referral, 396 eligible participants were randomized to either a multimodal behavioral intervention (AAR + MBI) or a parallel attention control (AAR + control). Random effects regression analysis tested mediation. RESULTS: Elimination of children's tobacco smoke exposure (TSE) at Time 2 was the only significant mediator of longitudinal smoking abstinence through Time 3. AAR + MBI mothers were more likely to eliminate their children's TSE by Time 2 (OR = 2.11, 95%CI 1.30, 3.42), which was significantly associated with Time 3 abstinence (OR = 6.72, CI 2.28, 19.80). Modeling showed a significant total effect of AAR + MBI on abstinence (OR = 6.21, CI 1.86, 20.71), a direct effect of AAR + MBI on abstinence (OR = 4.80, CI 1.45, 15.94) and an indirect effect through TSE elimination (OR = 1.29, CI 1.06, 1.57). CONCLUSIONS: Integrating smoking cessation interventions with counseling prior to the quit attempt that is designed to facilitate adoption of smokefree home policies and efforts to eliminate children's TSE could enhance the likelihood of long-term abstinence in populations of smokers with elevated challenges quitting smoking.

Using Pointwise Mutual Information for Breast Cancer Health Disparities Research With SEER-Medicare Claims.

Identification of procedures using International Classification of Diseases or Healthcare Common Procedure Coding System codes is challenging when conducting medical claims research. We demonstrate how Pointwise Mutual Information can be used to find associated codes. We apply the method to an investigation of racial differences in breast cancer outcomes. We used Surveillance Epidemiology and End Results (SEER) data linked to Medicare claims. We identified treatment using two methods. First, we used previously published definitions. Second, we augmented definitions using codes empirically identified by the Pointwise Mutual Information statistic. Similar to previous findings, we found that presentation differences between Black and White women closed much of the estimated survival curve gap. However, we found that survival disparities were completely eliminated with the augmented treatment definitions. We were able to control for a wider range of treatment patterns that might affect survival differences between Black and White women with breast cancer.

Benefits versus drawbacks of delaying surgery due to additional consultations in older patients with breast cancer.

BACKGROUND: Additional evaluations, including second opinions, before breast cancer surgery may improve care, but may cause detrimental treatment delays that could allow disease progression. AIMS: We investigate the timing of surgical delays that are associated with survival benefits conferred by preoperative encounters versus the timing that are associated with potential harm. METHODS AND RESULTS: We investigated survival outcomes of SEER Medicare patients with stage 1-3 breast cancer using propensity score-based weighting. We examined interactions between the number of preoperative evaluation components and time from biopsy to definitive surgery. Components include new patient visits, unique surgeons, medical oncologists, or radiation oncologists consulted, established patient encounters, biopsies, and imaging studies. We identified 116 050 cases of whom 99% were female and had an average age of 75.0 (SD = 6.2). We found that new patient visits have a protective association with respect to breast cancer mortality if they occur quickly after diagnosis with breast cancer mortality subdistribution Hazard Ratios [sHRs] = 0.87 (95% Confidence Interval [CI] 0.76-1.00) for 2, 0.71 (CI 0.55-0.92) for 3, and 0.63 (CI 0.37-1.07) for 4+ visits at minimal delay. New patient visits predict worsened mortality compared with no visits if the surgical delay is greater than 33 days (CI 14-53) for 2, 33 days (CI 17-49) for 3, and 44 days (CI 12-75) for 4+. Medical oncologist visits predict worse outcomes if the surgical delay is greater than 29 days (CI 20-39) for 1 and 38 days (CI 12-65) for 2+ visits. Similarly, surgeon encounters switch from a positive to a negative association if the surgical delay exceeds 29 days (CI 17-41) for 1 visit, but the positive estimate persists over time for 3+ surgeon visits. CONCLUSION: Preoperative visits that cause substantial delays may be associated with increased mortality in older patients with breast cancer.

Timing of Unplanned Reoperation After Lower Extremity Free Flap Reconstruction: What Are the Roles of Procedure Indication and Defect Etiology?

BACKGROUND: Advancements in lower extremity (LE) microsurgery have allowed for the expansion of indications for LE reconstructions. This project aims to better understand the temporal pattern and risk factors associated with LE free flap failure based on the clinical indication. MATERIALS AND METHODS: We analyzed all patients undergoing LE free flap reconstruction from the American College of Surgeons National Surgical Quality Improvement Program 2012-2019 prospectively collected data to determine rates and timing of reoperation. Free flaps were stratified by indication, type, and timing of reoperation. Weibull survival models were used to compare rates of takebacks among time intervals. Multivariable logistic regression was used to identify independent predictors for unplanned reoperation. RESULTS: Four hundred seven of LE free flaps were analyzed. There was a 14.5% rate (59/407) of unplanned reoperation within the first 30 postoperative days (PODs) after surgery. When stratified by the indication necessitating reoperation, patients with an underlying vascular indication had the highest rate of reoperation (40.9%). The reoperation rates were significantly different between indications (P < 0.05) The mean daily proportion of patients experiencing reoperation was highest during POD 0 to 2 (1.47% reoperations per day), which dropped significantly during POD 3 to 10 (0.55% per day) and again during POD 11 to 30 (0.28% per day, P < 0.05). African American race as well as malignant, prosthetic/implant, and wound/infectious indications were significant independent predictors for unplanned reoperation. CONCLUSIONS: Lower extremity reconstruction is an important reconstructive option for the coverage of a myriad of defects. Understanding the differences between postoperative reoperation timelines among indication subtypes is important for updated flap monitoring protocols, optimizing ERAS pathways, and beginning dangle protocols.

Racial survival disparities in head and neck cancer clinical trials.

BACKGROUND: Survival disparities between Black and White head and neck cancer patients are well documented, with access to care and socioeconomic status as major contributors. We set out to assess the role of self-reported race in head and neck cancer by evaluating treatment outcomes of patients enrolled in clinical trials, where access to care and socioeconomic status confounders are minimized. METHODS: Clinical trial data from the Radiation Therapy Oncology Group studies were obtained. Studies were included if they were therapeutic trials that employed survival as an endpoint. Studies that did not report survival as an endpoint were excluded; 7 Radiation Therapy Oncology Group Studies were included for study. For each Black patient enrolled in a clinical trial, a study arm-matched White patient was used as a control. RESULTS: A total of 468 Black participants were identified and matched with 468 White study arm-specific controls. White participants had better outcomes than Black participants in 60% of matched pairs (P < .001). Black participants were consistently more likely to have worse outcomes. When outcomes were measured by progression-free survival or disease-free survival, the failure rate was statistically significantly higher in Black participants (hazard ratio [HR] = 1.50, P < .001). Failure was largely due to locoregional failure, and Black participants were at higher risk (subdistribution HR =1.51, P = .002). The development of distant metastasis within the paired cohorts was not statistically significantly different. CONCLUSION: In this study of clinical trial participants using self-reported race, Black participants consistently had worse outcomes in comparison to study arm-specific White controls. Further study is needed to confirm these findings and to explore causes underlying this disparity.

Critical Importance of the First Postoperative Days After Head and Neck Free Flap Reconstruction: An Analysis of Timing of Reoperation Using the National Surgical Quality Improvement Program Database.

BACKGROUND: Head and neck free flaps remain associated with considerable rates of take-back and prolonged hospital length of stay. However, there have been no studies on a national level benchmarking the timeline and predictors of head and neck free flap take-back. METHODS: Patients undergoing head and neck free flap reconstruction from the American College of Surgeons National Surgical Quality Improvement Program 2012-2019 database were analyzed to determine the rates of take-back. Timing and rates of unplanned head and neck free flap take-backs were stratified by tissue type and postoperative day (POD) over the first month. Weibull survival models were used to compare rates of take-backs among time intervals. Multivariable logistic regression was used to identify the independent predictors of take-back. RESULTS: Three thousand nine hundred six head and neck free flaps were analyzed. The mean daily proportion of patients experiencing take-back during PODs 0 to 1 was 0.95%; this dropped significantly to a mean daily proportion of 0.54% during POD 2 (P < 0.01). In addition, there were significant drops in take-back when comparing POD 2 (0.54%) to POD 3 (0.26%) and also when comparing POD 4 (0.20%) with PODs 5 to 30 (0.032% per day) (P < 0.05). The soft tissue and osseous flap populations demonstrated a similar trend in unplanned take-back. CONCLUSION: This is the first national study to specifically analyze the timing of take-back in the head and neck reconstruction population. These data highlight the importance of flap monitoring during the first 5 PODs, with ERAS pathway optimization aiming for discharge by the end of the first postoperative week.

The critical need to implement and utilize patient-reported measures of function in cancer care delivery.

The study by Smith et al. on the Patient-Reported Outcomes Measurement Information System (PROMIS) Cancer Function Brief 3D Profile shows that it can be used to measure how an individual functions and how his or her function changes during cancer treatments. This is important because most patients will experience a decline in function during cancer treatment and will struggle to fully participate in their life roles. Strong evidence demonstrates that rehabilitation improves function for individuals with cancer; rehabilitation is relatively underutilized. We suggest that using the PROMIS tool as a repeated measure throughout cancer treatment will help to identify those with functional decline who will benefit most from rehabilitation.

Data Quality of Automated Comorbidity Lists in Patients With Mental Health and Substance Use Disorders.

EHRs provide an opportunity to conduct research on underrepresented oncology populations with mental health and substance use disorders. However, a lack of data quality may introduce unintended bias into EHR data. The objective of this article is describe our analysis of data quality within automated comorbidity lists commonly found in EHRs. Investigators conducted a retrospective chart review of 395 oncology patients from a safety-net integrated healthcare system. Statistical analysis included κ coefficients and a condition logistic regression. Subjects were racially and ethnically diverse and predominantly used Medicaid insurance. Weak κ coefficients ( κ = 0.2-0.39, P < .01) were noted for drug and alcohol use disorders indicating deficiencies in comorbidity documentation within the automated comorbidity list. Further, conditional logistic regression analyses revealed deficiencies in comorbidity documentation in patients with drug use disorders (odds ratio, 11.03; 95% confidence interval, 2.71-44.9; P = .01) and psychoses (odds ratio, 0.04; confidence interval, 0.02-0.10; P < .01). Findings suggest deficiencies in automatic comorbidity lists as compared with a review of provider narrative notes when identifying comorbidities. As healthcare systems increasingly use EHR data in clinical studies and decision making, the quality of healthcare delivery and clinical research may be affected by discrepancies in the documentation of comorbidities.

Multilevel Intervention for Low-Income Maternal Smokers in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Objectives. To test the efficacy of Babies Living Safe and Smokefree (BLiSS), a multilevel intervention initiated in a citywide safety net health system to improve low-income maternal smokers' abstinence and reduce child tobacco smoke exposure. Methods. This randomized controlled trial in Philadelphia, Pennsylvania (2015-2020), recruited low-income maternal smokers who received a brief smoking intervention (Ask, Advise, Refer [AAR]) from nutrition professionals in the Special Supplemental Nutrition Program for Women, Infants, and Children before randomization to (1) a multilevel intervention (AAR + multimodal behavioral intervention [MBI]; n = 199) or (2) an attention control intervention (AAR + control; n = 197). Results. AAR + MBI mothers had significantly higher 12-month bioverified abstinence rates than did AAR + control mothers (odds ratio [OR] = 9.55; 95% confidence interval [CI] = 1.54, 59.30; P = .015). There were significant effects of time (b = -0.15; SE = 0.04; P < .001) and condition by time (b = -0.19; SE = 0.06; P < .001) on reported child exposure favoring AAR + MBI, but no group difference in child cotinine. Presence of other residential smokers was related to higher exposure. Higher baseline nicotine dependence was related to higher child exposure and lower abstinence likelihood at follow-up. Conclusions. The multilevel BLiSS intervention was acceptable and efficacious in a population that experiences elevated challenges with cessation. Public Health Implications. BLiSS is a translatable intervention model that can successfully improve efforts to address the persistent tobacco-related burdens in low-income communities. Trial Registration. Clinical Trials.gov identifier: NCT02602288. (Am J Public Health. 2022;112(3):472-481. https://doi.org/10.2105/AJPH.2021.306601).

Postoperative Complications Associated with the Choice of Reconstruction in Head and Neck Cancer: An Outcome Analysis of 4,712 Patients from the ACS-NSQIP Database.

BACKGROUND: Microsurgical free flaps have largely supplanted pedicled flaps as the gold standard for head and neck cancer reconstruction. However, incidence of postoperative complications after accounting for patient comorbidities based on choice of reconstruction has not been well-defined in the literature in recent years. METHODS: Patients undergoing head and neck reconstruction were identified in the 2011-2016 ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program) database and stratified into groups by free flap, myocutaneous pedicled flap, and other reconstruction. Demographics were analyzed and covariates balanced using overlap propensity score-based weighting. Logistic regression was used for binary outcomes and Gamma generalized linear model was used for length of stay. RESULTS: A total of 4,712 patients met inclusion criteria out of which 1,297 patients (28%) underwent free flap, 208 patients (4%) pedicled flap, and 3,207 patients (68%) had other, or no reconstruction performed. After adjusting for patient and disease-specific factors, pedicled flap reconstruction was associated with a higher risk of deep vein thrombosis (odds ratio [OR] = 2.64, confidence interval [CI] 1.02-6.85, p = 0.045), sepsis (OR = 2.95, CI 1.52-5.71, p = 0.001), and infection (OR = 2.03, CI 1.39-2.96, p <0.001) compared with free flap reconstruction. Free flaps had the longest mean operative time compared with the other two groups (unadjusted 578 vs. 440 vs. 326, p <0.001). Pedicled flaps had a lower incidence of bleeding requiring transfusion (adjusted OR = 0.65, CI 0.50-0.85, p = 0.002), and lower incidence of prolonged mechanical ventilation (adjusted OR = 0.33, CI 0.12-0.92, p = 0.034) compared with free flaps. There was no difference in rates of reoperation, hospital readmission, or hospital length-of-stay between pedicled and free flaps. CONCLUSION: Myocutaneous pedicled flaps are associated with higher overall short-term postoperative complications compared with free flaps in head and neck reconstruction, which demonstrate a more favorable morbidity profile without significantly impacting hospital readmission, reoperation, or length-of-stay.

Prospective randomized trial to compare the safety, diagnostic yield and utility of 22-gauge and 19-gauge endobronchial ultrasound transbronchial needle aspirates and processing technique by cytology and histopathology.

INTRODUCTION: Endobronchial ultrasound (EBUS)-guided transbronchial needle aspirate (TBNA) is a widely used method of minimally invasive lymph node sampling. The benefit of processing samples by cytologic methods versus "core biopsy" is unclear. It is unknown if safety or diagnostic yield varies by needle gauge. MATERIALS AND METHODS: Between June 2018 and July 2019, 40 patients (56 lesions) undergoing EBUS TBNA lymph node evaluation were enrolled in this single-center prospective trial. Patients were chosen by permuted block randomization to undergo EBUS TBNA starting with 22-gauge (22g) or 19-gauge (19g) needles. Separate samples were sent for processing by cytologic methods and histopathology. Surgical pathologists and cytopathologists were blinded to needle size. The primary endpoint was diagnostic yield. Secondary endpoints compared specimen adequacy by rapid onsite evaluation (ROSE), sample adequacy for molecular testing, sample quality, and safety. RESULTS: Diagnostic yield for histopathologic examination was 87.5% and 83.9% for 19g and 22g respectively (P = 0.625). There was no significant difference in diagnostic yield by cytologic examination based on needle size. There was no significant difference in slide quality. Molecular adequacy for core-biopsy was 77% and 80% for 22g and 19g needles, respectively. Molecular adequacy for cytology cell block was 77% and 80% for 22g and 19g needles, respectively. There were no significant procedural complications. CONCLUSION: Both the 22g and 19g EBUS TBNA needles provided a similar diagnostic yield and clinical utility for ancillary testing. Processing techniques by cytologic methods or "core biopsy" showed no significant impact in diagnostic yield or utility of molecular testing.

Feasibility and Outcomes of Renal Mass Biopsy for Anatomically Complex Renal Tumors.

OBJECTIVE: To compare the feasibility and outcomes of renal mass biopsies (RMB) of anatomically complex vs non-complex renal masses. METHODS: Our institutional renal tumor database was queried for patients who underwent RMB between 2005 and 2019 and with available nephrometry score. Complex masses were: (1) small (<2 cm), (2) entirely endophytic (nephrometry E=3), (3) hilar (h) or (4) partially endophytic (E=2) and anterior. Demographic and pathologic data were compared. Biopsies were deemed adequate if they resulted in a diagnosis. Concordance with surgical pathology was assessed. These were both presented using proportions. Factors associated with biopsy outcomes were identified using multivariable logistic regression. RMB sensitivity and specificity were calculated using contingency methods. RESULTS: A total of 306 RBMs were included, 179 complex and 127 non-complex. A total of 199 (65%) had an extirpative procedure. Complex lesions were less likely to have an adequate biopsy (89% vs 96%, P = .03), and to be concordant with final surgical pathology from an oncologic standpoint (89% vs 97%, P = .03). There was no significant difference in concordance of histology (76% vs 86%, P = .10) or grade (48 vs 51%, P = .66). On multivariable analyses, only male gender was associated with biopsy adequacy (OR 3.31, 95% CI 1.28-8.55, P = .01). Our overall sensitivity was 93%, specificity 93%, and accuracy 93%. There were no significant differences over time in biopsy outcomes during the study period. CONCLUSION: RMB of complex lesions is associated with excellent diagnostic yield, albeit lower than non-complex lesions. RMB should not be deferred in cases of anatomically complex lesions where additional data could improve clinical decision-making.