Single-institution Prospective Study Research Articles

High-sensitivity C-reactive protein as prognostic and predictive marker in metastatic non-small cell lung carcinoma : A prospective single center study.

e21101 Background: Systemic inflammation has been linked to incidence, progression, and poor outcomes in various cancers including non-small cell lung carcinoma (NSCLC). High-sensitivity CRP (hs-CRP) assays, generally used to assess cardiovascular risk, have rarely been evaluated in lung cancer studies. This study aimed to evaluate if baseline and on-treatment measurements of serum hs-CRP could provide prognostic and predictive information for patients with metastatic NSCLC treated with chemotherapy. Methods: In this single institutional prospective study 85 patients with metastatic NSCLC without targetable alterations who were treated with chemotherapy were included between 1st January 2020 and 31st December 2020, with a minimum follow-up duration of 6 months. Patients with coronary artery disease, active infections, autoimmune conditions, and chronic liver disease were excluded. Measurements of hs-CRP for all patients were done at baseline and every 12 weeks while on treatment. Patients were grouped by changes in hs-CRP levels compared to baseline levels as reduction (≥ 20% decline), and non-reduction (< 20% decline) to assess association with radiologic response and progression- free survival (PFS). Results: Pre-treatment hs-CRP values were elevated for the majority (92.9% patients with ≥ 1 mg/L, 70.6% with ≥ 3 mg/L, and 42.3% with ≥ 10 mg/dL). No significant association was detected between the pre-treatment hs-CRP value and the number of metastatic sites (P = 0.4), histology (P = 0.3), or smoking status (P = 0.7). At a median follow-up of 13.7 months, the median PFS was 7.8 months (95% confidence interval [CI] 5.3 - 10.3). Patients with hs-CRP ≥10 mg/L had shorter PFS than those with hs-CRP < 10 mg/L (Median PFS 7.5 months [95% CI 4.9 - 10] vs. 8.4 months [95% CI 0.1 - 17.4]; hazard ratio [HR] 1.8, 95% CI 1-3.4, P = 0.04). hs-CRP reduction (≥20% decline) after 12 weeks of treatment initiation predicted radiological response (P < 0.001). Median PFS was 14.7 months (95% CI 7.4 – 22.1) in patients who demonstrated hs-CRP reduction (≥20% decline) at 12 weeks compared to 3.1 months (95% CI 2.3 – 3.9) in patients who did not (HR 0.17, 95% CI 0.08 - 0.33, P < 0.001). Conclusions: Elevated hs-CRP at baseline was found to be a poor prognostic factor, while hs-CRP reduction by 20% or more on treatment predicted radiologic response and longer PFS in metastatic NSCLC patients treated with chemotherapy. Our findings of potential predictive and prognostic value of hs-CRP in metastatic NSCLC warrant validation in larger prospective studies.

Hearing Loss After Cisplatin-based Chemoradiotherapy for Locally Advanced Head and Neck Cancer: A Prospective Single-institution Study.

A single-institution prospective study was conducted to evaluate hearing loss rate after intensity modulated radiotherapy with concomitant cisplatin-based chemotherapy (CRT) for locally advanced head and neck cancer and identify cochlear dosimetric parameters associated with hearing loss risk. Hearing assessment, patients' characteristics, tumor-related variables, and cochlear quantitative dosimetric factors for adults with locally advanced head and neck cancer treated with CRT were prospectively collected. Each patient repeated audiometry at baseline (pre-CRT), 1 month after CRT, and then every 3 to 6 months. For each cochlea minimum dose (Dmin), mean dose (Dmean), and maximum dose (Dmax) were extracted from treatment plans. Logistic analysis was used for multivariate modeling. The relation between cochlear dosimetric factors and significant hearing loss was also analyzed with receiver operating characteristic (ROC) curves. Between January 2016 and December 2018, 35 patients (70 cochleae) were included. Most patients (n=29; 82.9%) had primary cancer in a low-risk region (oral cavity, oropharynx, larynx). All patients completed the programmed CRT. During follow-up, significant hearing loss was recorded in 13 cases (37.1%). The ROC areas for significant hearing loss in relation to Dmin, Dmean, and Dmax were 0.70, 0.66, and 0.66, respectively. A dose-dependent relationship was noted between cochlear Dmin and significant hearing loss. Dmin <14.4 Gy is associated with reduced rates of significant hearing loss after concomitant cisplatin-based CRT in patients with locally advanced head and neck cancer.

MP51-12 THE ADDED VALUE OF MICROUS FOR THE PREOPERATIVE STAGING OF PROSTATE CANCER: AN UPDATE OF A SINGLE-INSTITUTIONAL PROSPECTIVE SERIES

You have accessJournal of UrologyCME1 May 2022MP51-12 THE ADDED VALUE OF MICROUS FOR THE PREOPERATIVE STAGING OF PROSTATE CANCER: AN UPDATE OF A SINGLE-INSTITUTIONAL PROSPECTIVE SERIES Vittorio Fasulo, Edoardo Beatrici, Luca Disconzi, Pier Paolo Avolio, Nicola Frego, Pietro Diana, Marco Paciotti, Davide Maffei, Alessandro Uleri, Cesare Saitta, Paola Arena, Giuseppe Chiarelli, Andrea Gobbo, Alberto Saita, Rodolfo Hurle, Massimo Lazzeri, Giorgio Guazzoni, Paolo Casale, Nicolò Maria Buffi, and Giovanni Lughezzani Vittorio FasuloVittorio Fasulo More articles by this author , Edoardo BeatriciEdoardo Beatrici More articles by this author , Luca DisconziLuca Disconzi More articles by this author , Pier Paolo AvolioPier Paolo Avolio More articles by this author , Nicola FregoNicola Frego More articles by this author , Pietro DianaPietro Diana More articles by this author , Marco PaciottiMarco Paciotti More articles by this author , Davide MaffeiDavide Maffei More articles by this author , Alessandro UleriAlessandro Uleri More articles by this author , Cesare SaittaCesare Saitta More articles by this author , Paola ArenaPaola Arena More articles by this author , Giuseppe ChiarelliGiuseppe Chiarelli More articles by this author , Andrea GobboAndrea Gobbo More articles by this author , Alberto SaitaAlberto Saita More articles by this author , Rodolfo HurleRodolfo Hurle More articles by this author , Massimo LazzeriMassimo Lazzeri More articles by this author , Giorgio GuazzoniGiorgio Guazzoni More articles by this author , Paolo CasalePaolo Casale More articles by this author , Nicolò Maria BuffiNicolò Maria Buffi More articles by this author , and Giovanni LughezzaniGiovanni Lughezzani More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002626.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: A stratification of patients with prostate cancer (PCa) before robotic-assisted radical prostatectomy (RARP) allows performing a tailor-made surgery, providing a nerve-sparing procedure even in those patients with high-risk PCa. Since the accuracy of clinical parameters to determine extraprostatic extension (EPE) is moderate, there is urgent need for imaging tools capable of providing a more accurate assessment. Our goal is to evaluate the added value of microUS in the preoperative prediction of EPE. METHODS: This is a prospective single-institutional cohort study enrolling patients with biopsy-proven PCa scheduled for RARP. Patients with PSA>20ng/mL and prostate volume>100 mL were excluded. All patients underwent microUS prior to RARP. MRI-derived features (curvilinear contact length (CCL), capsular bulging, visible extracapsular extension (ECE), as well as microUS features such as the presence of hypoechoic halo and obliteration of the vesicle-prostatic angle) were tested as predictors of EPE. Multivariable logistic regression models were fitted to test the accuracy of clinical parameters (total PSA, ISUP biopsy and digital rectal examination [DRE]) plus microUS parameters for the prediction of EPE. RESULTS: Overall, 184 patients were prospectively recruited. Besides CCL, all predictors were associated with non-organ- confined disease (p<0.001). Final pathology showed that 57.1% and 42.9% had respectively a pT2 and a pT3 or greater disease. The rate of non-organ-confined disease increased from 37.1%, in those individuals with only 1 predictor (OR 2.68), to 93.3% in those where 4 predictors were simultaneously observed (OR 63.5). At MLRM, the most significant risk factors for EPE were visible ECE (OR 5.21), positive DRE (OR 3.49), capsular bulge (OR 2.45), and PSA (OR 1.06). The clinical model alone showed an AUC of 0.804 as compared to 0.84 for the model including both clinical and microUS parameters (Figure1). The DeLong test for equality showed a difference between the two curves (p=0.0470). CONCLUSIONS: Our findings suggest that microUS may represent an accurate tool for the evaluation of non-organ confined PCa. Future studies should externally validate our findings and determine the impact of this tool in the surgical and oncological outcomes of RARP. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e880 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Vittorio Fasulo More articles by this author Edoardo Beatrici More articles by this author Luca Disconzi More articles by this author Pier Paolo Avolio More articles by this author Nicola Frego More articles by this author Pietro Diana More articles by this author Marco Paciotti More articles by this author Davide Maffei More articles by this author Alessandro Uleri More articles by this author Cesare Saitta More articles by this author Paola Arena More articles by this author Giuseppe Chiarelli More articles by this author Andrea Gobbo More articles by this author Alberto Saita More articles by this author Rodolfo Hurle More articles by this author Massimo Lazzeri More articles by this author Giorgio Guazzoni More articles by this author Paolo Casale More articles by this author Nicolò Maria Buffi More articles by this author Giovanni Lughezzani More articles by this author Expand All Advertisement PDF DownloadLoading ...

Contrast-Enhanced Ultrasonography for Differential Diagnosis of Benign and Malignant Thyroid Lesions: Single-Institutional Prospective Study of Qualitative and Quantitative CEUS Characteristics.

Objectives To extend and revise the diagnostic value of contrast-enhanced ultrasonography (CEUS) for differentiation between malignant and benign thyroid nodules. Methods This single-institution prospective study aims to compare CEUS qualitative and objective quantitative parameters in benign and malignant thyroid nodules. Consecutive cohort of 100 patients was examined by CEUS, 68 out of them were further analysed in detail. All included patients underwent cytological and/or histopathological verification of the diagnosis. Results Fifty-five (81%) thyroid nodules were benign, and 13 (19%) were malignant. Ring enhancement pattern was strongly associated with a benign aetiology (positive predictive value 100%) and heterogeneous enhancement pattern with malignant aetiology (positive predictive value 72.7%). The shape of the TIC (time-intensity curve) was more often identical in the benign lesion (98.2%) than in malignant lesions (69.2%), p=0.004. Conclusions This study indicates that CEUS enhancement patterns were significantly different in benign and malignant lesions. Ring enhancement was a very strong indicator of benign lesions, whereas heterogeneous enhancement was valuable to detect malignant lesions.

The Clinical Impact of Neoadjuvant Endocrine Treatment on Luminal-like Breast Cancers and Its Prognostic Significance: Results from a Single-Institution Prospective Cohort Study.

Purpose: Neoadjuvant endocrine treatment (NET) has become a useful tool for the downstaging of luminal-like breast cancers in postmenopausal patients. It enables us to increase breast- conserving surgery (BCS) rates, provides an opportunity for us to assess in vivo NET effectiveness, and allows us to study any biological changes that may act as valid biomarkers. The purpose of this study was to evaluate the safety and effectiveness of NET, and to assess the role of Ki67 proliferation rate changes as an indicator of endocrine responsiveness. Methods: From 2016 to 2020, a single-institution cohort of patients, treated with NET and further surgery, was evaluated. In patients with Ki67 ≥ 10%, a second core biopsy was performed after four weeks. Information regarding histopathological and clinical changes was gathered. Results: A total of 115 estrogen receptor-positive (ER+)/HER2-negative patients were included. The median treatment duration was 5.0 months (IQR: 2.0–6.0). The median maximum size in the surgical sample was 40% smaller than the pretreatment size measured by ultrasound (p < 0.0001). The median pretreatment Ki67 expression was 20.0% (IQR: 12.0–30.0), and was reduced to 5.0% (IQR: 1.8–10.0) after four weeks, and to 2.0% (IQR: 1.0–8.0) in the surgical sample (p < 0.0001). BCS was performed on 98 patients (85.2%). No pathological complete responses were recorded. A larger Ki67 fold change after four weeks was significantly related to a PEPI score of zero (p < 0.002). No differences were observed between luminal A- and B-like tumors, with regard to fold change and PEPI score. Conclusions: In our cohort, NET was proven to be effective for tumor size and Ki67 downstaging. This resulted in a higher rate of conservative surgery, aided in therapeutic decision making, provided prognostic information, and constituted a safe and well-tolerated approach.

Diagnostic Yield of Transbronchial Cryobiopsy Guided by Radial Endobronchial Ultrasound and Fluoroscopy in the Radiologically Suspected Lung Cancer: A Single Institution Prospective Study.

Simple SummaryThe morphological diagnosis of peripheral lung lesions is challenging due to the anatomical location of these lesions and to the biopsy techniques that are currently available. Transbronchial forceps biopsies guided by fluoroscopy alone, or additional with radial mini probe endobronchial ultrasound (RP-EBUS), were well-known standardised procedures with an unsatisfactory diagnostic yield. Transbronchial cryobiopsy is a novel technique of lung parenchyma biopsy for the diagnosis of interstitial lung diseases, which has a very high diagnostic yield (80–96%) and relatively low incidence of complications (3–26%). Due to these reasons, transbronchial cryobiopsy guided by RP-EBUS and fluoroscopy in peripheral lung lesions are under active investigation, but still, there is limited data as only a few clinical trials of transbronchial cryobiopsy are published around the world. Our study showed that transbronchial cryobiopsy is a potentially safe procedure when obtaining a larger size of samples. Furthermore, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy were 85.1%, 100%, 100%, 12.5%, and 93% for TBCB as well as 91.5%, 100%, 100%, 20.0% and 96.7% for the combined procedures, respectively.Transbronchial cryobiopsy (TBCB) is being studied in the diagnosis of peripheral lung lesions; however, there are only a few clinical studies around the world. The aim of our study was to evaluate the diagnostic values and safety of transbronchial cryobiopsy for radiologically suspected peripheral lung cancer. The prospective clinical study was executed from September 2019 to September 2021 at a tertiary clinical centre in Lithuania. A total of 48 patients out of 102 underwent combined procedures of transbronchial forceps biopsy (TBFB) and TBCB. Diagnostic values and safety outcomes of TBFB and TBCB were analysed. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were 72.9%, 100%, 100%, 7.7%, and 88.0% for TBFB, 85.1%, 100%, 100%, 12.5%, and 93% for TBCB, as well as 91.5%, 100%, 100%, 20.0% and 96.7% for the combined procedures, respectively, with a significantly higher accuracy for cryobiopsies compared to forceps biopsies (p < 0.05). The diagnostic values for transbronchial cryobiopsies were similar, irrespective of the radial mini probe endobronchial ultrasound (RP-EBUS) position, lesion size or bronchus sign, however, the sensitivity of the combined procedures in cases with RP-EBUS adjacent to the target was significantly higher compared to TBFB (86.2% vs. 64.3%, p = 0.016). Samples of cryobiopsies were significantly larger than forceps biopsies (34.62 mm2 vs. 4.4 mm2, p = 0.001). The cumulative diagnostic yield of transbronchial cryobiopsy was 80.0% after the second biopsy and reached a plateau of 84.1% after four biopsies. No severe bleeding, pneumothorax, respiratory failure or death was registered in our study. TBCB is a potentially safe procedure, which increases diagnostic values in diagnosing peripheral lung lesions compared to TBFB.

Evaluation of Adverse Effects in Nursing Mothers and Their Infants After COVID-19 mRNA Vaccination.

Background and Objectives: Breastfeeding women are generally excluded from clinical trials with new vaccines. The objective of the study was to explore whether the BNT162b2 mRNA and mRNA-1273 COVID-19 vaccines are safe for breastfeeding mothers and their breastfed infants. Methods: A convenience sample prospective cohort single institution study was performed on breastfeeding health care professionals, who were exposed to second dose of SARS-CoV2 vaccine at the beginning of the study period. They and their breastfed children's symptoms were followed up through online questionnaires for 14 days. Results: Of the 95 finally included participants, only 1 was lost to follow-up on day 7. Mean age of the mothers was 35.9 ± 3.9 years and that of their infants was 14.6 ± 12.1 months. At least one adverse event was reported by 85% (95% confidence interval [CI]: 76-91.5%) of the mothers. The most frequent was injection site pain in 81% of cases. Moreover, 31% (95% CI: 22-41%) observed some event in their breastfed children. Most frequently, 19% (95% CI: 13-30%) of the children were irritable. During the 14 days of follow-up, 36% of the children (95% CI: 27-46%) were diagnosed with respiratory infection. Conclusions: Most mothers' reactions were mild and transitory, generally limited to the first 3 days after vaccination. Many children's events were associated with concomitant infectious processes and we did not detect a notable peak on any particular day of follow-up. Neither mothers nor their infants developed serious adverse events nor were they diagnosed with COVID-19 within the study period.

Abstract P5-14-20: Neoadjuvant endocrine therapy (NET) during COVID-19: Single institution survey of patients’ perspectives

Abstract Background: Coronavirus disease 2019 (COVID-19) resulted in a global pandemic, which led to deferral of surgeries for early stage breast cancer during March - June 2020. Institutional guidelines were developed to use neoadjuvant endocrine therapy (NET) as a bridge to surgery. As a follow up to initial data presented at SABCS 2020 demonstrating patient acceptance of NET, the present study provides results from a survey which explored psychosocial factors associated with medication compliance. Objective: Primary objective was to identify any barriers to compliance with NET. Method: This was a single institution, prospective study that surveyed patients diagnosed with DCIS and early stage breast cancer at Perlmutter Cancer Center at NYU Langone Hospital and NYU Langone Hospital - Long Island from March 15, 2020 - June 1, 2020. Questions were based on the Beliefs about Medicines Questionnaire specific for endocrine therapy (BMQ-AET) and the Medication Adherence Report Scale. Responses were recorded on a Likert scale and included 7 questions regarding perceptions about breast cancer treatment, 10 questions addressing experience with NET, and 5 questions gauging at adherence to NET. Inclusion criteria were males and females older than 18 years old, with an initial diagnosis of DCIS or early stage HR+ Her2/neu- breast cancer, who were prescribed NET. Descriptive statistics were calculated and subgroups were compared using Fisher’s exact tests. Analyses were performed using SAS version 9.4. Results: From March 15 - June 1, 2020, 13 patients were diagnosed with DCIS and 29 patients with HR+ Her2/neu- breast cancer for whom NET was recommended. Demographics are shown in Table 1. All 42 patients were female with an average age of 60.9 years. Majority of patients were post-menopause (74%) and predominantly white (64%), with an income of less than $60,000 (52.4%). Average NET duration was 6.7 weeks. Survey responses displayed in Table 2 indicate statistically significant p values in bold. Patients &amp;gt;50 years old, post-menopause and invasive breast cancer had a stronger belief that NET would be helpful, resulting in greater perception to breast cancer treatment and higher adherence to NET. Patients treated with NET for greater than 4 weeks also felt that NET would make them feel well compared to ≤4 weeks. Interestingly, no significant differences in responses based on education or income level were observed. Conclusion: COVID-19 pandemic presented a unique opportunity to use NET, which is often underutilized outside of clinical trials. In this single institution prospective study, we found that post-menopause patients greater than 50 years old with invasive breast cancer perceived hormonal therapy as beneficial to their health, resulting in increased medication compliance. These findings can be used when counseling patients currently treated with NET as well as those patients may be appropriate for NET in the post-COVID era. Table 1.Demographics of early stage breast cancer patients diagnosed during COVID-19.DCIS (n=13)Invasive Breast Cancer (n=29)Total (n=42)Menopause Status (n, %)Pre-menopause7 (53.8)4 (13.8)11 (26.2)Post-menopause6 (46.2)25 (86.2)31 (73.8)Diagnosis (n, %)Self-Palpated06 (20.7)6 (14.3)Screening13 (100)23 (79.3)36 (85.7)Age (n, %)≤504 (30.8)4 (13.8)8 (19)50+9 (69.2)25 (86.2)34 (80.9)Average Age (range)54.9 (40 – 72)63.6 (32 – 85)60.9 (32 – 85)Race (n, %)White7 (53.8)20 (69%)27 (64.3)Non-White6 (46.2)9 (31%)15 (35.7)Education (n, %)K-121 (7.7)6 (20.7)7 (16.7)College and Graduate12 (92.3)23 (79.3)35 (83.3)Income (n, %)$0 – $60,0005 (38.5)17 (58.6)22 (52.4)$&amp;gt;60,0017 (53.8)12 (41.3)19 (45.2)No response1 (7.7)01 (2.4)NET in Weeks (n, %)≤45 (38.5)7 (24.1)12 (28.6)4+8 (61.5)22 (75.9)30 (71.4) Table 2.Perceptions of breast cancer and hormonal therapy.Perceptions About Hormonal TherapyPerceptions About Breast Cancer TreatmentAdherence To Hormonal TherapyMy health at present depends on me taking hormone treatment (p-value)Hormone treatment is a mystery to me (p-value)My health in the future will depend on me taking hormone treatment (p-value)Taking hormone treatment makes me feel I am taking positive steps to remain well (p-value)How much do you feel that your current hormone therapy can help? (p-value)How much do you feel that you need your current hormone therapy? (p-value)I miss out on a dose (p-value)I stop taking medication for a while (p-value)Age &amp;gt;50 vs. ≤500.04020.56510.00580.08330.04770.87370.04831.0000Post-Menopause vs. Pre-Menopause0.00330.02720.00530.13380.00060.24520.01661.0000Invasive vs. DCIS0.00381.00000.00450.16480.01810.00011.00000.0133Non-White vs. White0.47420.04340.76400.05220.91430.77730.61280.1369Duration of NET: ≤4 vs. &amp;gt;4 weeks0.43190.49971.00000.02840.11390.75430.05220.8833Screening vs. Self-Palpated0.51100.02560.62571.00000.44230.05930.47760.6353K-12 vs. College/Graduate0.43660.65400.16151.00000.41450.67531.00000.8321Income: ≤$60,000 vs. &amp;gt;$60,0000.54590.27860.59900.85690.09530.07000.78980.0581 Citation Format: Julie Huang, Joshua Feinberg, Meredith Akerman, Anthony Pasquarella, Abhinav Rohatgi, Bahram Dabiri, Jordan Baum, Shubhada Dhage, Amber Guth, Nina D'Abreo. Neoadjuvant endocrine therapy (NET) during COVID-19: Single institution survey of patients’ perspectives [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-14-20.

Abstract P3-20-07: Uncontrolled hypertension and the development of lymphedema after breast cancer surgery

Abstract Introduction: Breast cancer is the most common type of cancer among women in the United States with more than 281,550 new cases in 2021. Definitive treatment for early/localized disease includes a combination of surgery, radiation and systemic therapy with high cure rates but significant potential morbidity. Lymphedema (LE) is the chronic swelling of tissue due to damage caused by breast cancer surgery and/or radiation therapy, occurring in approximately 25-60% of patients who undergo axillary dissection with or without radiation. LE is a morbid disease that decreases patient quality of life and has limited treatment options. Thus, identifying risk factors to prevent the development of LE is crucial. To our knowledge, uncontrolled hypertension has not been previously studied as a potential risk factor for the development of arm lymphedema after breast cancer treatment. Methods: In this single institution prospective cohort study, women were enrolled before their surgery for stage 0-III breast cancer. Baseline interviews were conducted and data including ethnic background, weight, medical comorbidities, and medications were collected. Breast cancer clinicopathologic features and treatment were also recorded. Bilateral arm measurements and blood pressure (BP) readings were taken at baseline and intervals of 3 months for up to 5 years after surgery. An increase in volume &amp;gt;5% from baseline was classified as lymphedema. The association between baseline BP and development of lymphedema was tested with univariate Cox regression model. Results: 176 women were enrolled between 1999 and 2004, of which 46% were Caucasian, 42% African American, 12% other. The average age at enrollment was 51 years. 68% were overweight or obese. 11% had Stage 0, 33% Stage I, 42% Stage II, and 14% had Stage III breast cancer. The most common type of surgery was mastectomy (52%) with remaining patients undergoing lumpectomy. Most patients underwent nodal evaluation with 55% receiving axillary node dissection, 40% receiving sentinel node biopsy or axillary node sampling, and 6% undergoing no nodal surgery. 57% of patients underwent chemotherapy and 53% received radiation therapy. At baseline, 65% of the patients reported a history of hypertension, of which approximately 50% were taking antihypertensive medications and 57% had uncontrolled blood pressure (defined as office BP ≥ 140/90). Using the 5% cutoff, 27% of patients developed lymphedema within 5 years after surgery, of which 14% occurred within the first year. Women who were obese, had mastectomy or more than 9 LNs removed were at higher risk of developing LE. Age, ethnicity and cancer stage had no association with the development of LE (Table 1). Women with uncontrolled or controlled hypertension did not have a higher risk for LE compared to those that were normotensive with hazard ratios of 0.82 (95%CI: 0.39, 1.76; p value 0.616) and 0.70 (95%CI: 0.31, 1.59; p value 0.396) respectively. Conclusion: Baseline uncontrolled or controlled hypertension does not increase the risk for the development of LE after surgery and radiation for breast cancer. Further analysis of BP control over time as another risk factor for the development of LE in this dataset is also planned. Identifying BP control as a risk factor for LE would aid in prevention efforts to decrease the development of this morbidity in breast cancer survivors. Table 1. Univariate Cox regression hazard ratios (HR) for development of lymphedema with 5% cutoffVariableEvent/nHR (95% CI)P valueAge at enrollment48/1741.00 (0.98-1.02)0.984RaceCaucasian19/81Ref.African American23/741.53 (0.83-2.82)0.171Other6/201.17 (0.47-2.93)0.741StageI13/58Ref.04/190.74 (0.24-2.29)0.605II25/741.39 (0.71-2.71)0.341III6/251.22 (0.46-3.20)0.693BMINormal9/52Ref.Underweight1/32.95 (0.37-23.43)0.306Overweight15/551.73 (0.76-3.95)0.195Obesity23/652.21 (1.02-4.78)0.044Number of Nodes Removed&amp;lt;917/87Ref.≥931/891.92 (1.06-3.47)0.031ChemotherapyNo20/76Ref.Yes28/1000.95 (0.54-1.69)0.873Radiation therapyNo24/81Ref.Yes23/940.72 (0.41-1.28)0.264Breast surgeryLumpectomy18/84Ref.Mastectomy30/911.84 (1.02-3.31)0.042Nodal surgerySNB or ALN sampling15/70Ref.No axillary surgery2/100.81 (0.19-3.57)0.786ALND31/961.55 (0.83-2.86)0.167 Citation Format: Elizabeth Weisberg, Hadeel Assad, Lydia Choi-Kim, Tammy DeMeere, Hyejeong Jang, Wei Chen, Mary Ann Kosir. Uncontrolled hypertension and the development of lymphedema after breast cancer surgery [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-20-07.

Predicting Post-Discharge Opioid Consumption After Total Hip and Knee Arthroplasty in the Opioid-Naïve Patient

BackgroundPain catastrophizing, anxiety, and depression are associated with poor outcomes after total hip (THA) and total knee (TKA) arthroplasty. The goal of this study is to determine the relationship between post-operative pain scores and opioid consumption; and the association among pre-operative measures of anxiety, depression, and pain catastrophizing and post-operative opioid consumption in patients undergoing THA and TKA. MethodsThis is a single-institution prospective cohort study of 243 opioid-naïve patients undergoing elective, primary THA (n = 123) or TKA (n = 120) for osteoarthritis. Pre-operatively, patients completed the PROMIS-29 (Patient-Reported Outcomes Measures Information System; physical function/anxiety/depression/fatigue/sleep disturbance/social activities/pain interference/pain intensity) and Pain Catastrophizing Scale. Post-operatively, patients completed a weekly survey for 12 weeks determining morphine-milligram-equivalent (MME) opioid consumption, opioid cessation, and visual analog scale pain scores. Multivariable regression models determined the association between pre-operative scores and post-operative opioid consumption. ResultsMean (±standard deviation) total opioid consumption and duration was 75.1 ± 112.0 MME and 1.7 ± 1.7 weeks in THA and 384.7 ± 473.3 MME and 4.3 ± 3.5 weeks in TKA. Visual analog scale pain scores (0-100) after opioid cessation were 28.0 ± 22.9 in THA and 30.7 ± 25.8 in TKA. Multivariable regression showed that each unit increase in PROMIS-29 fatigue T-score was associated with 8.4 hours longer opioid usage in THA (P = .008) and 15.1 hours longer in TKA (P = .036), as well as 12.7 MME additional opioids in TKA (P = .027). There were no significant associations with other PROMIS-29 domains or the Pain Catastrophizing Scale. ConclusionOpioid use duration is different for THA and TKA and may correlate with pain scores. Only pre-operative fatigue was associated with post-operative opioid consumption. These findings should inform THA and TKA post-operative pain management pathways.

Virtual postoperative visits following robotic gynecologic surgery: a study of patient satisfaction, safety, and feasibility.

Since the onset of the COVID-19 pandemic the use of telehealth has burgeoned. Numerous surgical specialties have already adopted the use of virtual postoperative visits, but there is data lacking in both robotics and gynecology. In this single-institution prospective cohort study we sought to evaluate the patient satisfaction, feasibility and safety of postoperative telehealth visits following robotic gynecologic surgery. Thirty-three patients undergoing robotic gynecologic procedures participated in a postoperative telehealth visit approximately 2 weeks following surgery, of which 27 completed a survey which assessed participant satisfaction with the telehealth visit, overall health-related quality of life following surgery, exposure to telehealth visits, and social determinants of health. The mean satisfaction score was just below ‘excellent’. Only 2 participants (6.3%) required an in-person visit. Postoperative telehealth visit satisfaction score was significantly associated only with BMI (Pearson r = 0.45, p = 0.018). These data suggest that telehealth visits following robotic gynecologic procedures appear to be safe and feasible, and are associated with a high level of patient satisfaction.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11701-021-01354-w.

P557 Robotic surgery significantly improves outcomes for patients with inflammatory bowel disease

Abstract Background Patients with Inflammatory Bowel Disease (IBD) have a high likelihood of both surgical treatment at a young age and repetitive operative interventions. Therefore, development of novel surgical techniques to minimize operative trauma are crucial for this group of patients. Robotic Surgery represents the newest minimally invasive technology available to reduce the impact of surgery, but has mostly been used for colorectal cancer rather than for benign conditions. The purpose of this study was to assess the feasibility and clinical outcomes of robotic surgery for patients with IBD. Methods This is a single-institution prospective study evaluating all IBD patients undergoing robotic surgery between October 2020 to November 2021 at our trust. Demographic data, perioperative and 30-day postoperative outcomes were assessed. The feasibility of the techniques and clinical outcomes were documented and data were analysed. Results A total of ninety robotic cases were performed from October 2020 to November 2021. Of these, 20 were IBD (75% Crohn’s disease). The M:F ratio was 1:1; median age was 41 (18–79) years, BMI of 25 (16–37) kg/m2. Eighty-four per cent of patients were treated with a biologic agent in the preceding 60 days. The 2 most commonly performed procedures were Right Hemicolectomy with intracorporeal anastomosis (44%) and subtotal colectomy with end ileostomy (22%). There were no conversions to open surgery. Return of gut function, as defined by tolerating oral diet and passing flatus, was noted within 48 hours in 85% of the patients (n=17). There was minimal blood loss and all patients were discharged on their baseline Hb with no need for iron replacement therapy or blood transfusion. The median length of hospital stay was 4.5 days (3–10). There was no reported mortality. The 30-day readmission rate was 5% (n=1). Conclusion Robotic surgery for patients with IBD is feasible, safe and improves clinical and surgical outcomes. This novel approach ensures that surgery remains minimally invasive, leading to a significant reduction in length of hospital stay, a rapid postoperative recovery and an earlier return of gut function.

A prospective observational study assessing the feasibility and factors affecting same-day discharge in patients undergoing robotic-assisted surgery for gynecological cancers.

Although robotic-assisted surgery is being increasingly used in the management of gynecologic cancers, most surgeons discharge patients on the next day of surgery citing concerns about immediate post-operative complications. Present study was conducted to evaluate the safety, factors influencing and quality of life for gynaecological cancer patients undergoing same-day discharge after robotic-assisted surgery. This is single institutional prospective observational study as pragmatic cohort including all well-selected gynecological cancer patients undergoing robotic-assisted surgery from September 2017 to June 2019. Patients were divided into two study groups [Same-day discharge (SDD) group vs. Next-day discharge (NDD) group] according to day of discharge. The entire cohort included 152 patients (38 in SDD group and 114 in NDD group). The difference between both SDD vs. NDD was significant for parameters including Age ≥ 70years (0% vs. 18.4%, p: 0.010); Operative time > 60min (39.5% vs. 60.5%, p: 0.024); patients with third-party insurance covering surgery (2.6% vs. 25.4%, p: 0.005) and place of residence ≥ 60km from hospital (13.1% vs. 51.8%, p: < 0.0001). The quality of life was similar in both groups and none of the patients required readmission or emergency room visits. Same-day discharge after robot-assisted surgery in gynecologic cancer patients is a safe and feasible option. Younger patients, short surgical time, surgery early in the day, no claim for third-party insurance, residing nearby hospital within 60km radius were influencing factors favouring same-day discharge.

Use of high-resolution micro-ultrasound to predict extraprostatic extension of prostate cancer prior to surgery: a prospective single-institutional study

We aim to evaluate the accuracy of micro-ultrasound (microUS) in predicting extraprostatic extension (EPE) of Prostate Cancer (PCa) prior to surgery. Patients with biopsy-proven PCa scheduled for robot-assisted radical prostatectomy (RARP) were prospectively recruited. The following MRI-derived microUS features were evaluated: capsular bulging, visible breach of the prostate capsule (visible extracapsular extension; ECE), presence of hypoechoic halo, and obliteration of the vesicle-prostatic angle. The ability of each feature to predict EPE was determined. Overall, data from 140 patients were examined. All predictors were associated with non-organ-confined disease (p < 0.001). Final pathology showed that 79 patients (56.4%) had a pT2 disease and 61 (43.3%) ≥ pT3. Rate of non-organ-confined disease increased from 44% in those individuals with only 1 predictor (OR 7.71) to 92.3% in those where 4 predictors (OR 72.00) were simultaneously observed. The multivariate logistic regression model including clinical parameters showed an area under the curve (AUC) of 82.3% as compared to an AUC of 87.6% for the model including both clinical and microUS parameters. Presence of ECE at microUS predicted EPE with a sensitivity of 72.1% and a specificity of 88%, a negative predictive value of 80.5% and positive predictive value of 83.0%, with an AUC of 80.4%. MicroUS can accurately predict EPE at the final pathology report in patients scheduled for RARP.

Echocardiographic Assessment of Right Ventricular Systolic Function in Postoperative Tetralogy of Fallot Patients with Special Emphasis on Right Ventricular-Global Longitudinal Strain

Background: Limitations of echocardiography have long been known for the assessment of right ventricular (RV) systolic function in postoperative tetralogy of Fallot (TOF) patients. In this study, we evaluated the role of RV-global longitudinal strain (GLS) for the assessment of RV systolic function. Materials and Methods: It was a single institution prospective observational study of ninety postoperative TOF patients. Detailed 2-dimensional echocardiography along with RV-GLS using speckle tracing imaging was done at baseline and after 1 year. The children were divided into three groups based on duration since total correction, i.e., group A (6 months to 5 years), group B (6–10 years), and group C (&gt;10 years) to assess the differences in RV systolic function. Furthermore, correlation of RV-GLS with RV-fractional area change (FAC), tricuspid annular plane systolic excursion, and tricuspid valve tissue Doppler imaging s' velocity was done. Results: In group A patients, a statistically significant increase in RV systolic function was seen over a period of 1 year. However, in group B and C patients, no significant change was seen. There was a strong positive correlation of RV-GLS only with RV-FAC during the first follow-up (r = 0.41, P &lt; 0.01) and second follow-up periods (r = 0.67, P &lt; 0.01). Conclusion: RV-GLS has a strong positive correlation with RV-FAC, and it detects preclinical regional myocardial dysfunction even when the RV-FAC is normal and thus must be included in the evaluation of postoperative TOF children.

Association of human papillomavirus in penile cancer: A single-center analysis.

ABSTRACTIntroduction:Human papillomavirus (HPV) is a known risk factor of penile cancer (PeCa). However, studies evaluating its true association are limited. In this study, we aimed to estimate HPV prevalence and its true association with PeCa in terms of molecular biological activities.Materials and Methods:This single-institutional prospective observational study was conducted between June 2016 and August 2019. We included 40 men with PeCa as a study group and 20 age-matched uncircumcised men who underwent circumcision for phimosis as a control group. Both the groups underwent deoxyribonucleic acid isolation for HPV subtyping followed by evaluation of relative E6/E7 messenger ribonucleic acid (mRNA) expression profile and relative telomerase activity in tissue samples. HPV-16 and -18 were categorized as high-risk, whereas HPV-6 and -11 were categorized as low-risk subtypes.Results:The mean (±standard deviation) age of PeCa was 51 ± 15.9 years. The majority of patients had stage II disease, and the most common procedure done was partial penectomy. The overall prevalence of HPV in PeCa was 42.5% (n = 17) as compared to 20% (n = 4) in controls. Among the subtypes, the most common subtype was HPV-16 noted in 33.3% (8/24) of cases, followed by HPV-18 in 29.2% (7/24) of cases. PeCa tissues had a significantly higher relative E7 mRNA expression for HPV-18 than the control group (P = 0.016). The mean relative telomerase activity was significantly higher in the PeCa tissues than the control group (138.66 vs. 14.46, P < 0.001). A significantly higher relative telomerase activity was noted in the PeCa tissues positive for high-risk HPV subtypes than controls (141.90 vs. 14.46, P = 0.0008), but not between high-risk HPV-positive and HPV-negative PeCa cases (141.90 vs. 137.03, P = 0.79). High-risk subtypes were not associated with tumor stage (P = 0.76) or lymph node metastasis (P = 0.816).Conclusions:HPV was associated in 42.5% of PeCa cases based on our experience from a single institution. PeCa tissues had a higher relative E7 mRNA expression for HPV-18 and relative telomerase activity as compared to controls suggesting their potential role as surrogate markers of virus-induced tumorigenesis.

Comparison of Antegrade Percutaneous Intramedullary K-wire Fixation and Transverse Pinning for Treatment of Unstable Displaced Metacarpal Neck and Shaft Fractures: A Prospective Interventional Study

Introduction: Metacarpal fractures account for upto 10% of all body fractures and 36% of all hand fractures in adolescents, young adults, and active adults. Fractures of the metacarpal shaft and neck are common in all metacarpal fractures after direct trauma, roadside accidents, or sports injuries. The ratio of the shaft to the neck is 1:2. Closed reduction and plaster of paris cast can be used to treat the majority of these fractures conservatively. Unstable and comminuted fractures necessitate surgery. Aim: To compare the clinical, functional and radiological outcomes in antegrade intramedullary fixation and transverse pinning of metacarpal fractures in patients of unstable and displaced metacarpal shaft and neck fractures. Materials and Methods: A single-institutional prospective interventional study identified 60 cases of metacarpal fractures between November 2019 to August 2021. Each of the cases met the inclusion criteria for closed extra-articular fractures, displaced and unstable fractures of the metacarpal bone. The patients were divided into two groups having 30 subjects each, randomly allotted to two groups (Antegrade intramedullary K-wiring and Transverse Pinning). Outcomes were compared for range of movement by the American Society of Hand Surgeons Total Active Motion score (ASSH TAM), Visual Analog Scale (VAS), and radiological parameters (Angulation). Patients were followed-up for 12 weeks. Complications were listed in terms of pin site infection. Results: Most of the patients were found to be in the third decade of life. The fracture union was achieved at 8±2 weeks. Clinical evaluation done by VAS score which was found to be statistically insignificant between two groups (p-value=0.243). Radiological assessment evaluated by measuring postoperative angulation between two groups was found to be statistically insignificant (p-value=0.248). Difference in functional evaluation between the two groups done by ASSH TAM was found to statistically significant between the groups (p-value=0.036). Conclusion: Both antegrade intramedullary K-wiring and transverse pinning demonstrate good and comparable results for extra-articular neck and shaft metacarpal fractures. However, the former is superior in terms of final range of motion as per ASSH TAM score.

Comparison of ultrasound and magnetic resonance imaging findings in evaluation of fetal congenital anomalies: A single-institution prospective observational study

BackgroundThis study aimed to compare the ultrasound (USG) and fetal magnetic resonance imaging (MRI) findings in the evaluation of congenital fetal anomalies and to determine whether the management is changes significantly if MRI is combined with USG. MethodsIn this prospective observational cohort study, we performed fetal MRI in 90 consecutive cases of fetuses diagnosed or suspected as having congenital anomalies on a prior level II USG scan. We then compared the USG and MRI findings of each anomaly according to the diagnostic information yielded by each modality. ResultsOf 90 fetuses examined during 1 year study period, MRI and USG findings were equivalent in 13.3% of cases. MRI provided additional information in 68.8% cases, of which pregnancy management was changed in 5.6% cases. MRI provided additional information but did not change management in 63.3% of cases. USG provided additional information but did not change pregnancy management in 17.8% of cases. The difference was statistically significant with a p value of .000. ConclusionFetal MRI is a significantly better modality than USG for detecting additional findings in anomalies of specific organ systems. Because of its high diagnostic yield for central nervous system (CNS) anomalies, it can be combined with USG for this subgroup. For non-CNS anomalies of genitourinary system, thorax, or in syndromic/complex malformations/conjoint twin pregnancy, it may be used as an adjunct to USG on a case to case basis. MRI has the potential to change the pregnancy management in few cases, but benefit is small to advocate a complete integration of MRI and USG for fetal anomaly scanning at present.

Evaluation of a 3D-Printed Transoral Robotic Surgery Simulator Utilizing Artificial Tissue.

Transoral robotic surgery (TORS) poses challenges for operators in training, with limited robot access on a platform requiring distinct surgical skills. Few simulators exist, and current virtual reality training modules exclude head and neck simulations. This study evaluates the construct validity for a novel low-cost TORS simulator. Single institution prospective observational study. Using 3D-printed oral cavity structures and replaceable artificial tissue components, a modular TORS simulator was constructed for short-duration hands-on simulations with the da Vinci SI robot. Sixteen surgeons of differing robotic skill levels, no experience (novice), prior experience, and formal robot training, participated in simulated tonsil and tongue base tumor resections. Video recordings of each participant were graded by a blinded robotically trained surgeon using a 35-point Global Evaluative Assessment of Robotic Surgery (GEARS) criterion adapted for the TORS simulator. Operators reporting formal robotic training or prior robot experience achieved significantly higher mean total GEARS scores compared to novice operators (32 vs. 20.5; P < .001). Overall, mean total GEARS scores correlated with reported experience level; novice operators scored 54% of total points at 19 (4.5), operators with prior experience scored 82.3% of total points at 28.8 (2.6), and robotically trained operators scored 97.1% of total points at 34 (1.7). With a GEARS criterion, our simulator successfully differentiated novice from experienced and robotically trained operators of the da Vinci SI robot during simulated tonsillectomy and base of tongue resections. These findings support the construct validity of this prototype simulator and offer a foundation for further testing of predictive validity. 2 Laryngoscope, 132:1588-1593, 2022.

Prevalence and impact of airway diseases on clinical outcomes in idiopathic pulmonary fibrosis.

Background/AimsThe prevalence and effects of airway diseases, including asthma, eosinophilic bronchitis (EB), chronic obstructive pulmonary disease (COPD), and asthma-COPD overlap (ACO) have not been thoroughly studied in patients with idiopathic pulmonary fibrosis (IPF). This study aimed to evaluate the prevalence of airway diseases in patients with IPF and to identify the differences in symptoms based on the presence of airway diseases.MethodsThis single-institution prospective cohort study was conducted from June 2017 to September 2018, at the Seoul National University Hospital. Spirometry with bronchodilator, methacholine bronchial provocation test, induced sputum with eosinophil stain, and exhaled nitric oxide were performed to confirm the presence of airway disease. The modified Medical Research Council (mMRC) dyspnea scale, COPD assessment test (CAT), St. George’s Respiratory Questionnaire (SGRQ), EuroQol-5 dimension (EQ-5D) index, and cough-specific quality of life questionnaire (CQLQ) data were collected to assess symptom severity.ResultsTotal 147 patients with IPF were screened, and 70 patients were analyzed. The prevalence of airway diseases in the participants was as follows: 5.0% had COPD, 1.7% had asthma, 3.3% had ACO, and 1.7% had EB. The mMRC, CAT, SGRQ, EQ-5D, and CQLQ scores did not differ regardless of combined airway disease. After 3 months, the SGRQ (p = 0.028) and CQLQ (p = 0.030) scores were significantly higher in patients with airway disease than in those without.ConclusionsThe prevalence of airway diseases in patients with IPF is low, but when airway diseases are accompanied by IPF, symptom severity and quality of life may worsen rapidly.