Time Of Definitive Surgery Research Articles

Angioplasty with ductal stent: experience at Garrahan Hospital

To describe and evaluate the outcomes of ductal angioplasty with stent placement at a single high-complexity center during the period 2016-2022. A retrospective descriptive cross-sectional study was conducted, including patients under 3 months of age who underwent ductal stent implantation as initial palliative treatment. Demographic, clinical, and anatomical data were collected before the intervention. Mortality, intra- and post-procedural complications, need for re-intervention, intensive care requirements, and hospital stay were recorded. The characteristics at the time of definitive surgery are described. Discrete variables are presented as percentages, and continuous variables are presented with their medians and respective interquartile ranges. Twenty patients who underwent this treatment were reviewed, revealing a success rate of 80%. Complications due to stent dysfunction required surgical resolution. 95% of patients were dischargedfrom the institution after the procedure, and 17 patients reached a second definitive surgical stage. Three patients died afterthe procedure, but with no direct relation to it. Indications for ductal angioplasty with stent as an alternative treatment to systemic-pulmonary anastomosis by surgery are not yet fully defined; the strategy represents a valid alternative in appropriately selected patients. The presented experience shows results similar to international reference centers.

The Effect of Decompression on Histologic Diagnoses of Cystic Jaw Lesions.

The aim of this study is to investigate if and how decompression alters histopathologic diagnoses of cystic jaw lesions. A retrospective study was conducted on patients with a histologic diagnosis of an odontogenic cystic lesion that was surgically treated with decompression followed by a definitive surgery. The correlation between variables including age, gender, location of the lesion, decompression time and the change in histopathologic diagnosis following decompression was analyzed. Thirty-nine patients were included in the study. The mean decompression time was 7.87 ± 3.43 months. Post-decompression histologic examination at time of definitive surgery was consistent with the initial biopsy diagnosis in 83.33% (5 of 6) of odontogenic keratocysts (OKCs), 94.11% (16 of 17) of radicular cysts, 100% of dentigerous cysts, and 100% of residual cysts. The change in histopathologic diagnosis of the cystic lesions was not found to be statistically correlated with the study variables. Histopathologic diagnoses of odontogenic cystic lesions predominantly remain unchanged after decompression. A treatment protocol based on the initial diagnosis may be appropriate for odontogenic cystic lesions that are considered for decompression before definitive surgery.

Semiconstrained Distal Radioulnar Joint Arthroplasty: Functional Outcomes and Complications

Abstract Background: The semiconstrained distal radioulnar joint (DRUJ) prosthesis (Aptis Medical, Louisville, KY) is an option in the treatment of refractory DRUJ pathology that has shown promising results. Purpose: This study aims to evaluate the short- to midterm functional outcomes, complications, and factors affecting outcomes of semiconstrained DRUJ arthroplasty. Methods: We retrospectively reviewed 47 DRUJ arthroplasty procedures (on 46 consecutive patients) from a single surgeon between 2010 and 2022. Demographic data, range of motion, grip strength, and patient-reported outcome measures (PROMs: Quick Disability of the Arm, Shoulder, and Hand; Patient-Rated Wrist Evaluation; modified Mayo Wrist Score [mMWS]; and visual analog scale [VAS] for pain) were collected. Complications were classified as major (requiring surgery) or minor (treated conservatively). Results: The average follow-up was 3.37 years (standard deviation, 3.51; range, 0.04–15.62 years). A total of 30% of patients (n = 14) were followed for more than 5 years. Postoperatively, supination significantly increased and VAS pain scores improved significantly. Patients also experienced improved function in the operative wrist as assessed by the mMWS. Patients with prior DRUJ and/or triangular fibrocartilage complex surgery were more likely to have additional diagnoses at the time of definitive surgery and our postoperative outcomes varied based on prior surgery and additional diagnoses, with a trend toward higher pain levels and worse PROMs. The overall complication rate was 17%, with one major complication consisting of a posttraumatic periprosthetic ulna fracture. All other complications were minor. Implant survival was 100%. Conclusion: Semiconstrained DRUJ arthroplasty significantly improves pain levels and functional outcomes at short- to midterm follow-up. Patients who had undergone previous related surgeries were showed a trend toward higher postoperative pain levels and worse PROMs. Although complications were common, overall patient satisfaction and implant survivorship were high. Level of Evidence: IV

Can we counterbalance restricted access to innovation through specialized breast cancer care? The REAL-NOTE study

IntroductionThe KEYNOTE-522 (KN-522) trial showed that the addition of pembrolizumab to standard chemotherapy improved pathological complete response (pCR) and event-free survival (EFS) for patients with early triple negative breast cancer (TNBC). We analyzed results of a real-world cohort of patients treated in a certified Breast Unit, before the introduction of pembrolizumab, to see if high quality care can match outcomes brought by the addition of an innovative anticancer therapy. MethodsObservational, retrospective, single-center cohort study, with real-world data from an ongoing institutional database with prespecified variables. Inclusion criteria matched the ones from KN-522: previously untreated stage II or III TNBC, diagnosed between 2012 and 2022, who received neoadjuvant chemotherapy. The primary endpoints were pCR at the time of definitive surgery and EFS; overall survival (OS) was a secondary endpoint. ResultsTotal of 168 patients were included, median age 55 years, 55 % received neoadjuvant chemotherapy with dose dense anthracyclines and taxanes and 25 % carboplatin + paclitaxel, sequenced with dose dense anthracyclines. Most had Stage II disease (82.7 %), 47 % node + disease. pCR was achieved in 52.7 % cases. At 36 months, EFS was 83.3 % (95 % CI 75.1–89.0) and OS 89 % (95 % CI, 81.6 to 93.5). ConclusionsNotwithstanding the study limitations, outcomes of patients treated with chemotherapy without immunotherapy were numerically similar to the experimental arm of KN-522 trial. These data highlight that providing care by a specialized multidisciplinary team in a certified unit might be just as impactful as the incorporation of new technologies.

A pan-tumor prospective translational, Irish study, investigating the association of gut microbiome (GM) diversity with pathological complete response (pCR) after neoadjuvant treatment in early stage breast, rectal, and esophageal cancers.

TPS3188 Background: The gut microbiome (GM) is thought to influence host immunity by modulating multiple immunologic pathways. Studies have suggested that dysbiosis of the GM confers a predisposition to certain malignancies and influences response to immune checkpoint inhibitors. However, little is known about how the GM diversity influences complete pathological response to neo-adjuvant therapy in gastrointestinal (GI) and breast tumors. We hypothesize that a more diverse GM constitution at baseline will lead to improved pathological response at the time of definitive surgery. Methods: This is a cross institutional multi-centre Irish translational study investigating the impact of the GM diversity on the efficacy of neo-adjuvant therapy in GI and breast cancers by assessing its association with pathological response. The study population includes pts with early-stage breast, rectal or esophageal cancers commencing neo-adjuvant therapy (including chemotherapy, immunotherapy and chemo-radiation) and planned for definitive surgery. Exclusion criteria include prior allogenic tissue/solid organ transplantation and prior receipt of anti-cancer therapy. The study assessments will include fecal sampling of the GM prior to neo-adjuvant therapy, upon completion and again six months post completion of therapy. Fecal samples will be analysed by 16S RNA sequencing. Pathological response will be examined at time of surgery and patients will be classified as responders (complete pathological response) or non-responders. The primary endpoint of the study is to examine the association between the GM diversity and pathological response. Exploratory analysis will include the assessment of the association between cf-DNA and the GM diversity as well as an assessment of the association between cf-DNA at baseline and pCR. 120 patients will be recruited over 18 months. Species richness (Alpha Diversity) will be analysed using the Shannon diversity index and Jaccard similarity index will be used to calculate beta diversity. Following planned study recruitment, classification and clustering analysis will be performed with Principal Component Analysis (PCA) and Random Forest analysis. To assess the primary endpoint the association between GM and complete pathological response will be examined using logistic regression analysis adjusting for potential confounding factors in the final statistical analysis. Adjusted odds ratios (OR) and 95% confidence intervals will be presented. This is expected to read out in early 2025. Recruitment is ongoing, with 14 pts recruited to date. We demonstrate that it is feasible to accrue to translational studies in Ireland and we have streamlined screening and recruitment pathways to improve our methodology and recruitment numbers.

Myxofibrosarcoma: Outcomes, Prognostic Factors, and Role of Neoadjuvant Radiation Therapy

IntroductionMyxofibrosarcoma (MFS) is a subtype of soft tissue sarcoma with a highly infiltrative growth pattern that leads to a higher risk of inadvertent positive surgical margins and local relapse. Poorly defined tumor margins also pose a challenge for radiotherapy (RT) planning, in terms of treatment volumes and administration of pre- versus post-operative RT. This study aims to evaluate local control and patterns of recurrence in MFS patients treated with neoadjuvant RT followed by definitive surgical excision. Materials and methodsMultiple institutional databases were retrospectively searched for patients diagnosed with MFS between 2013-2021, who were exclusively treated with pre-operative radiotherapy followed by definitive surgery at our institution. The endpoints of the study were defined as local tumor recurrence (LR), distant metastasis (DM), or death from the date of definitive surgery. Results49 patients met the inclusion criteria and were included in the final study. The median age at diagnosis was 67 years, and 71% were male. The tumor was superficially located in 63% of patients and the mean tumor size at presentation was 7.8 cm. All patients received neoadjuvant RT and completed their planned course of treatment. Neoadjuvant chemotherapy was administered in 22% of patients. Inadvertent excision (IE) prior to definitive treatment was performed in 25 patients (51%), 84% of which had superficially located tumors.All margins were assessed using frozen section analysis at the time of definitive surgery, and 100% of patients had negative surgical margins, with 25% having no residual tumor. With a median follow-up of 4.7 years, a 5-year local control (LC) rate was 87%, and 5-year overall survival (OS) was 98%. Tumor depth was associated with DM (p <0.01). ConclusionDespite the infiltrative nature of MFS, preoperative RT followed by definitive surgical excision, especially in the setting of a reliable frozen section margin analysis, is associated with excellent local control.

The Impact of Delayed Radical Prostatectomy on Recurrence Outcomes After Initial Active Surveillance: Results from a Large Institutional Cohort

Background and objectiveActive surveillance (AS) of prostate cancer (PCa) involves regular monitoring for disease progression. The aim is to avoid unnecessary treatment while ensuring appropriate and timely treatment for those whose disease progresses. AS has emerged as the standard of care for low-grade (Gleason grade 1, GG 1) PCa. Opponents are concerned that initial undersampling and delay of definitive management for patients with GG 2 disease may lead to adverse outcomes. We sought to determine whether the timing for definitive management of GG 2 PCa, either upfront or after initial AS, affects recurrence outcomes after radical prostatectomy (RP). MethodsParticipants were diagnosed with cT1–2N0/xM0/x, prostate-specific antigen (PSA) <20 ng/ml, and GG 1–2 PCa between 2000 and 2020 and underwent immediate RP for GG 2 or AS followed by delayed RP on upgrading to GG 2. The outcome was recurrence-free survival (RFS) after surgery, with recurrence defined as either biochemical failure (2 PSA measurements ≥0.2 ng/ml) or a second treatment. Multivariable Cox proportional-hazards regression models were used to calculate associations between the timing for definitive RP and the risk of recurrence, adjusted for age at diagnosis, percentage of positive biopsy cores (PPC), PSA density, PSA before RP, year of diagnosis, surgical margins, genomic risk score, and prostate MRI findings. Key findingsOf the 1259 men who met the inclusion criteria, 979 underwent immediate RP after diagnosis of GG 2, 190 underwent RP within 12 mo of upgrading to GG 2 on AS, and 90 men underwent RP >12 mo after upgrading to GG 2. The 5-yr RFS rates were 81% for the immediate RP group, 80% for the delayed RP ≤12 mo, and 70% for the delayed RP >12 mo group (univariate log-rank p = 0.03). Cox multivariable regression demonstrated no difference in RFS outcomes between immediate RP for GG 2 disease and delayed RP after upgrading on AS. PPC (hazard ratio [HR] per 10% increment 1.08, 95% confidence interval [CI] 1.02–1.15; p = 0.01) and PSA before RP (HR 1.06, 95% CI 1.03–1.09; p < 0.01) were significantly associated with the risk of recurrence. Conclusions and clinical implicationsPPC and PSA before RP, but not the timing of definitive surgery after upgrade to GG 2, were associated with the risk of PCa recurrence after RP on multivariable analysis. These findings support the safety of AS and delayed definitive therapy for a subset of patients with GG 2 disease. Patient summaryIn a large group of 1259 patients with low-grade prostate cancer, we found that delaying surgical treatment after an initial period of active surveillance resulted in no differences in prostate cancer recurrence. Our results support the safety of active surveillance for low-grade prostate cancer.

Biopsies for Soft-Tissue Sarcoma of the Hand: Dangers, Hazards, and Outcomes.

Excisional biopsies for soft-tissue sarcoma (STS) of the hand are commonly done outside of sarcoma centers and can compromise incorporation of the biopsy site into standard limb salvage or amputation flaps. We sought to identify risk factors for these suboptimal biopsies. We analyzed prospective data on all patients (N = 109) who underwent definitive resection of primary STS of the hand between 1995 and 2019 at our institution. Biopsies were classified by type (excisional vs. incisional/needle), whether they were done before referral, and whether the incision could be incorporated into standard limb salvage or amputation flaps (ILS biopsies) or not (NILS biopsies). Analyses examined potential predictors of NILS biopsies and whether outcomes differed by biopsy type. Biopsies done before referral (N = 91) were more likely to be excisional (79% vs. 17%). Excisional biopsies were associated with smaller tumor size (median, 2.0 vs. 3.15 cm; P = 0.025) and longer time to first intervention (1.88 vs. 1.17 months; P = 0.001). Forty-eight percent of excisional and 29% of incisional biopsy sites required soft-tissue coverage at the time of definitive surgery ( P = 0.07). Biopsy type was not associated with Musculoskeletal Tumor Society score or need for amputation. Risk factors for NILS biopsies included larger tumor size, deep tumor, and excisional biopsy. High-risk areas for NILS biopsies included the carpal tunnel, volar wrist, first webspace, radial palm, and proximal thumb. NILS biopsies were associated with positive margins, need for soft-tissue coverage, and lower Musculoskeletal Tumor Society scores. This study informs referral guidelines for patients with STS of the hand. Patients with tumors that are deep, large, or in high-risk locations should be referred to a sarcoma center before biopsy. If that is not possible, incisional biopsy in line with standard resection incisions or radiology-guided core needle biopsy is preferable to excisional biopsy. Prognostic study. Level II.

Esophago-Vascular Fistulae in Children: Five Survivors, Literature Review, and Proposal for Management

IntroductionEsophago-vascular fistulae in children are almost uniformly fatal with death occurring by exsanguination. We present a single centre series of five surviving patients, a proposal for management and literature review. Materials and methodsPatients were identified from surgical logbooks, surgeon recollection and discharge coding data. Demographics, symptoms, co-morbidities, radiology, management and follow up details were recorded. ResultsFive patients (1M, 4F) were identified. Four were aorto-esophageal and one caroto-esophageal. Median age at initial presentation was 44 (8–177) months. Four patients had cross sectional imaging prior to surgery. Median time from presentation to combined entero-vascular surgery was 15 (0–419) days. Four patients required repair on cardio-pulmonary bypass with four undergoing staged surgical procedures. All required combined esophageal and cardio-vascular surgery.Length of PICU stay following combined surgery was 4 (2–60) days and overall hospital stay was 53 (15–84) days. Median follow up was 51 (17–61) months.Two patients had esophageal atresia and trachea-esophageal fistula managed as neonates. Three had no co-morbidities. Four had esophageal foreign bodies:1 esophageal stent, 2 button batteries, 1 chicken bone. One patient had a complication following colonic interposition. Four patients required an esophagostomy at the time of definitive surgery. All patients were alive and well at last follow up with one having successful reconnection surgery. ConclusionIn this series, outcomes were favourable. Multidisciplinary discussion and surgery are mandatory. If hemorrhage is controlled at presentation, then survival to discharge is possible but the magnitude of surgical intervention is both significant and very high risk. Level of evidenceLevel 3.

First Experience of Patent Ductus Arteriosus Stenting in Neonate with Pulmonary Atresia and Intact Ventricular Septum in North Sulawesi, Indonesia

Abstract: Stenting of patent ductus arteriosus (PDA) is a minimally invasive catheter-based temporary palliative procedure, and it serves as an alternative to surgical shunt in neonates with duct dependent pulmonary perfusion, such as pulmonary atresia. This presentation aimed to report the first experience of PDA stenting in a neonate with pulmonary atresia in North Sulawesi, Indonesia. We reported a female neonate patient, weighing 3775 grams, referred from primary hospital with suspect congenital heart disease. The patient was born at 40 weeks of gestational age by caesarean section delivery from a primigravid mother aged 23 years with inertia uteri and strangulation of nuchal cord. At birth, she cried immediately and her APGAR score was 6-7. On her first day of life, she looked cyanotic, therefore she was referred to Prof. Dr. R. D. Kandou Hospital. Physical examination showed that she had perioral cyanotic and peripheral cyanotic with SpO2 58%. Chest X-ray showed cardiomegaly. Echocardiography revealed pulmonary atresia with PDA with intact ventricular septum. PDA stenting was done on her second day of admission. After the procedure, she was clinically stable with SpO2 80%, and was treated with intravenous antibiotic, and intravenous heparin and aspirin enterally. On the third day post procedure, she was discharged and no complication was found. PDA stenting in patient with duct-dependent pulmonary circulation appeared to be an alternative to surgery. It provided bridging palliation until the time of definitive surgery. The effectiveness of the procedure was highlighted by the fact that all the patients showed significant improvement in arterial saturation and pulmonary vascular marking. In conclusion, PDA stenting is considered feasible, safe and associated with lower mortality rates and shorter hospital length of stay than systemic-pulmonary surgical shunt procedure. Early detection and timely management are imperative to save the life. Keywords: patent ductus arteriosus stenting; pulmonary atresia

A prospective translational study investigating the association of gut microbiome (GM) diversity with pathological complete response (pCR) after neoadjuvant treatment in early stage rectal and esophageal cancers.

TPS819 Background: The gut microbiome (GM) is thought to influence host immunity by modulating multiple immunologic pathways. Studies have suggested that dysbiosis of the GM confers a predisposition to certain malignancies and influences response to immune checkpoint inhibitors. However, little is known about how the GM diversity influences complete pathological response to neoadjuvant therapy in gastrointestinal (GI) tumours. We hypothesize that a more diverse GM constitution at baseline will lead to improved pathological response at the time of definitive surgery. Methods: We designed a cross-institutional multi-center translational study investigating the impact of the GM diversity on the efficacy of neoadjuvant therapy in GI cancers by assessing its association with pathological response. The study population will consist of patients with an early-stage rectal or esophageal cancer due to commence neoadjuvant therapy (including chemotherapy and chemoradiation) and planned for definitive surgery. Patients who received prior chemotherapy/monoclonal antibodies/immune checkpoint inhibitors or radiation will be excluded. The study assessments will include fecal sampling of the GM prior to neoadjuvant therapy, upon completion and again six months post completion of therapy. Fecal samples will be analysed by 16S RNA sequencing. Pathological response will be examined at time of surgery and patients will be classified as responders (complete pathological response) or non-responders. The primary endpoint of the study is to examine the association between the GM diversity and pathological response. 120 patients will be recruited over 18 months. Results: Species richness (Alpha Diversity) will be analysed using the Shannon diversity index and Jaccard similarity index to calculate beta diversity. Classification and clustering analysis will be performed with Principal Component Analysis (PCA) and Random Forest analysis. Comparison of taxa or functions between clinical cohorts will be performed using the two tailed Z test and corrected using the false discovery rate to determine Q-values. The association between GM and complete pathological response will be examined using logistic regression analysis adjusting for potential confounding factors. Adjusted odds ratios (OR) and 95% confidence intervals will be presented. Conclusions: This study will show preliminary insights into the role of GM as a potential biomarker for neoadjuvant therapy efficacy in patients with GI cancers. Recruitment is on-going.

Stenting of Ductus Arteriosus for Duct-Dependent Pulmonary Circulation: An Emergency and Life Saving Procedure

BACKGROUND: Critical congenital heart defect with ductal-dependent pulmonary flow presents as a life-threatening condition. The patency of ductus arteriosus is required to supply blood flow into the lung. Stent implantation into ductus arteriosus has been proposed as non-surgical management for critical congenital heart disease with duct-dependent. CASE DESCRIPTION: We present full-term newborns who had critical congenital heart disease with ductal-dependent pulmonary blood blow and successfully managed with ductal stenting. Patient A, a 13-days-old male newborn had Tetralogy of Fallot-Pulmonary Atresia, restrictive Ventricular Septal Defect (VSD) and patent ductus arteriosus (PDA). Patient B, a 5-days-old female newborn had Tricuspid Atresia, restrictive VSD, PDA, and multiple congenital anomaly. Patient C, a 2-days-old female newborn had PA-IVS, PDA with stretched Patent Foramen Ovale (PFO). Prostaglandin-E1 infusion was started at first and stopped 6 hours prior to the procedure. All patients underwent ductus arteriosus stenting via femoral artery approach with drug-eluting stent. Pulmonary vascular markings were increased and oxygen saturations were improved in all of the patient. 5-month follow up, patients were in stable condition and prepared for surgical correction. DISCUSSION: Ductal stenting in patient with duct-dependent pulmonary circulation appears to be an alternative to surgery. It provides bridging palliation until the time of definitive surgery. The effectiveness of the procedure was highlighted by the fact that all the patients showed a significant improvement in arterial saturation and pulmonary vascular marking. CONCLUSION: Stenting of ductus arteriosus is feasible and safe with great result. Early detection and timely management are imperative to save the life. KEYWORDS: critical congenital heart defect, ductus arteriosus, ductal stenting, ductal-dependent pulmonary blood flow

Preoperative Imaging of Intraneural Ganglion Cysts: A Critical Systematic Analysis of the World Literature

Advancements in imaging and an understanding of the pathomechanism for intraneural ganglion cyst formation have led to increased awareness and recognition of this lesion. However, the precise role of imaging has been advocated for but not formally evaluated. We performed a systematic review of the world literature to study the frequency of imaging used to diagnose intraneural ganglion cysts at different sites and compared trends in identifying joint connections. We identified 941 cases of intraneural ganglion cysts, of which 673 had published imaging. Magnetic resonance imaging (MRI, n= 527) and ultrasonography (US, n= 123) were the most commonly reported. They occurred most frequently in the common peroneal nerve (n= 570), followed by the ulnar nerve at the elbow (n= 88), and the tibial nerve at the ankle (n= 58). A joint connection was identified in 375 cases (48%), with 62% of MRIs showing a joint connection, followed by 16% on US, and 6% on computed tomography (CT). MRI was statistically more likely to identify a joint connection than was US (P < 0.01). In the last decade, joint connections have been identified with increasing frequency using preoperative imaging, with up to 75% of cases reporting joint connections. Preoperative imaging plays an important role in establishing the diagnosis of intraneural ganglion cyst as well as treatment planning. Imaging has proved superior to the sole reliance of operative exposure to identify a joint connection, which is necessary to treat the underlying disease. Failure to identify cyst connections on imaging can result in an inability to truly address the underlying pathoanatomy at the time of definitive surgery, leading to a risk for clinical recurrence. Therefore, management should be guided by an intersection between new knowledge presented in the literature, clinical expertise, and surgeon experience.

Intra-articular distal tibial fractures cause a major burden to individual patients and also stresses the public health care system

Background and purposeIntra-articular distal tibial fractures are most commonly caused by high-energy trauma. Additional difficulties are related to accompanying soft-tissue injuries. The purpose of this study was to evaluate the consequences of different types of distal tibial fractures to the individual patient and to the public health care system. Patients and methods126 patients with operatively treated intra-articular distal tibial fracture were identified between 2012 and 2016. Thirty-one (25%) were open fractures. Acute treatment, timing of definitive surgery, total number of surgical procedures, complications, need for soft-tissue reconstructions, hospital stay, and number of follow-up visits were recorded related to AO/OTA fracture types. Results112 patients (89%) were treated with a staged treatment protocol. Of these patients, 74 first received an external fixation device. The definitive fracture fixation was performed on average 8 days after the trauma. Soft-tissue flap reconstruction was needed in 19 patients (15%). Additionally, 7 patients required split-thickness skin grafting. Total hospital stay ranged from 2 to 87 days (median 14 days). The median ward treatment period was 12 days in B2–3 group, 13 days in C1–2 group, and 18 days in C3 group. The median of 2 (range 1–13) surgical procedures were performed. InterpretationIntra-articular distal tibial fractures cause a major burden to individual patients and stresses the public health care system due to a frequent need for several surgical procedures because of soft-tissue injuries and complications. AO/OTA type C3 fractures had the greatest burden, as patients required several consecutive operations and prolonged hospital stays.

MP17-16 LONG-TERM OUTCOMES FOR PATIENTS WITH ANAPLASTIC BILATERAL WILMS TUMORS ENROLLED ON COG AREN0534

You have accessJournal of UrologyCME1 May 2022MP17-16 LONG-TERM OUTCOMES FOR PATIENTS WITH ANAPLASTIC BILATERAL WILMS TUMORS ENROLLED ON COG AREN0534 Rodrigo L.P. Romao, Jennifer H. Aldrink, Brett Tornwall, Kathleen Kieran, Andrew Murphy, Andrew Davidoff, Daniel Benedetti, Jeffrey Dome, Elizabeth Perlman, Ethan Smith, Conrad Fernandez, James Geller, Jack Brzezinski, Lindsay Renfro, Marcus Malek, David Mansur, Elizabeth Mullen, Nicholas Cost, Robert C. Shamberger, and Peter F. Ehrlich Rodrigo L.P. RomaoRodrigo L.P. Romao More articles by this author , Jennifer H. AldrinkJennifer H. Aldrink More articles by this author , Brett TornwallBrett Tornwall More articles by this author , Kathleen KieranKathleen Kieran More articles by this author , Andrew MurphyAndrew Murphy More articles by this author , Andrew DavidoffAndrew Davidoff More articles by this author , Daniel BenedettiDaniel Benedetti More articles by this author , Jeffrey DomeJeffrey Dome More articles by this author , Elizabeth PerlmanElizabeth Perlman More articles by this author , Ethan SmithEthan Smith More articles by this author , Conrad FernandezConrad Fernandez More articles by this author , James GellerJames Geller More articles by this author , Jack BrzezinskiJack Brzezinski More articles by this author , Lindsay RenfroLindsay Renfro More articles by this author , Marcus MalekMarcus Malek More articles by this author , David MansurDavid Mansur More articles by this author , Elizabeth MullenElizabeth Mullen More articles by this author , Nicholas CostNicholas Cost More articles by this author , Robert C. ShambergerRobert C. Shamberger More articles by this author , and Peter F. EhrlichPeter F. Ehrlich More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002550.16AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Anaplastic histology in the setting of bilateral Wilms tumor (BWT) is associated with poor prognosis - NWTS-5 4-year EFS and OS were 43.8% and 55.2%, respectively. AREN0534 sought to improve outcomes for BWT. We analyzed the events and long-term outcomes for the rare subgroup of patients with BWT and anaplasia. METHODS: AREN0534 was open to enrollment from 2009 to 2015. Patients with focal(FA) or diffuse(DA) anaplasia were included in this sub-analysis. Location of relapse, progression and 7-year EFS and OS with 95% CI are reported. RESULTS: There were 25 patients with anaplastic BWT (17 DA and 8 with FA). 1/8 patients with FA had bilateral FA and 4/17 patients with DA had bilateral DA. There were 18 females and 7 males; median age of enrollment was 43.1 months (24.1- 113.7). For FA, 7-year EFS was 62.5%(95% CI, 24.99-100) and OS was 87.5%(95% CI, 62.8-100). One patient with FA died from local relapse due to FHWT in the contralateral kidney at 5 years off therapy. A second patient with stage II FA had progressive disease while on therapy. This patient did not have nodes sampled. Pathology at progression was DA. For DA, 7-year EFS was 58.8% (95% CI, 25.7-91.9) and OS was 70.1% (95% CI, 36.5-100). 7 patients had events, 3 with local tumor progression (all died) and 4 with relapse (2 died). All 4 relapses had initial positive surgical margins and occurred within a year of ending therapy. The sites of relapse were local (2), and lung only (2). Of the 10 patients who were without an event, 5 had positive margins. CONCLUSIONS: Patients with BWT and anaplasia often have discordant pathology. Late events are rare. Margin status at the time of definitive surgery does not seem to impact outcomes in the context of contemporary multimodal therapy including radiation to positive margins. Source of Funding: This project was supported by grants CA98543 (Children’s Oncology Group Chair’s grant) and CA98413 (COG SDC grant) from the National Institutes of Health. U10CA180899 © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e292 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rodrigo L.P. Romao More articles by this author Jennifer H. Aldrink More articles by this author Brett Tornwall More articles by this author Kathleen Kieran More articles by this author Andrew Murphy More articles by this author Andrew Davidoff More articles by this author Daniel Benedetti More articles by this author Jeffrey Dome More articles by this author Elizabeth Perlman More articles by this author Ethan Smith More articles by this author Conrad Fernandez More articles by this author James Geller More articles by this author Jack Brzezinski More articles by this author Lindsay Renfro More articles by this author Marcus Malek More articles by this author David Mansur More articles by this author Elizabeth Mullen More articles by this author Nicholas Cost More articles by this author Robert C. Shamberger More articles by this author Peter F. Ehrlich More articles by this author Expand All Advertisement PDF DownloadLoading ...

Curative Intent Surgery of Oral Malignant Melanoma and Regional Lymph Node Biopsy Assessment in 25 Dogs: 2006-2017.

Medical records were searched for dogs that had received curative intent surgery for oral malignant melanoma and ipsilateral excisional regional lymph node biopsy. Twenty-seven dogs were operated on and 25 dogs of these dogs met the inclusion criteria of signalment, post-excision margin status, presence of metastasis for each biopsied lymphocentrum, survival time post-excision, presence of recurrence or metastasis at follow-up or at death/euthanasia, location of the primary tumor, and any postoperative adjuvant treatment. These 25 dogs had complete tumor excision with tumor-free margins and 19 (76%) had postoperative adjuvant therapy. Median survival time after excision for the dogs in this study was 335.5 days. Results of this study support previous work that documents prolonged survival time following complete excision of oral malignant melanoma with tumor-free surgical margins in dogs. Additionally, 4 dogs (16%) had histologically confirmed regional lymph node metastasis at the time of definitive surgery.

C39. Ductus Arteriosus Stenting: A Promising and Life Saving Procedure for Ductal-Dependent Pulmonary Blood Flow

Abstract Background Duct-dependant congenital heart disease in newborn presents as a life-threatening emergency and the survival depends on patency of the ductus arteriosus. Stent implantation into ductus arteriosus has been proposed as non-surgical management for critical congenital heart disease with duct-dependent. Case Summary We present full-term newborn babies who had critical congenital heart disease with ductal-dependent pulmonary blood blow and successfully managed with ductal stenting. Patient A, a 13-days-old male had Tetralogy of Fallot-Pulmonary Atresia and restrictive Ventricular Septal Defect (VSD). Patient B, a 3-days-old male had Pulmonary Atresia-Intact Ventricular Septum (PA-IVS) with Patent Foramen Ovale (PFO). Patient C, a 5-days-old female had Tricuspid Atresia with restrictive VSD and multiple congenital anomaly. Patient D, a 2-days-old female had PA-IVS with PFO stretch. Prostaglandin-E1 infusion was started at first and stop 6 hours prior to the procedure. Ductus arteriosus stenting using drug-eluting stent and femoral artery approach was successful in all 4 patients. All patient had improvement of oxygen saturation and good post-procedure outcome. Discussion Ductal stenting in patient with duct-dependent pulmonary circulation appears to be an alternative to surgery. It provides a bridging palliation in cyanotic congenital heart disease until the time of definitive surgery. Stenting of ductus arteriosus is feasible and safe with good result, thus early recognition and timely management are important to save the life.

C39. Ductus Arteriosus Stenting: A Promising and Life Saving Procedure for Ductal-Dependent Pulmonary Blood Flow

Abstract Background Duct-dependant congenital heart disease in newborn presents as a life-threatening emergency and the survival depends on patency of the ductus arteriosus. Stent implantation into ductus arteriosus has been proposed as non-surgical management for critical congenital heart disease with duct-dependent. Case Summary We present full-term newborn babies who had critical congenital heart disease with ductal-dependent pulmonary blood blow and successfully managed with ductal stenting. Patient A, a 13-days-old male had Tetralogy of Fallot-Pulmonary Atresia and restrictive Ventricular Septal Defect (VSD). Patient B, a 3-days-old male had Pulmonary Atresia-Intact Ventricular Septum (PA-IVS) with Patent Foramen Ovale (PFO). Patient C, a 5-days-old female had Tricuspid Atresia with restrictive VSD and multiple congenital anomaly. Patient D, a 2-days-old female had PA-IVS with PFO stretch. Prostaglandin-E1 infusion was started at first and stop 6 hours prior to the procedure. Ductus arteriosus stenting using drug-eluting stent and femoral artery approach was successful in all 4 patients. All patient had improvement of oxygen saturation and good post-procedure outcome. Discussion Ductal stenting in patient with duct-dependent pulmonary circulation appears to be an alternative to surgery. It provides a bridging palliation in cyanotic congenital heart disease until the time of definitive surgery. Stenting of ductus arteriosus is feasible and safe with good result, thus early recognition and timely management are important to save the life.

Options to Determine Pathological Response of Axillary Lymph Node Metastasis after Neoadjuvant Chemotherapy in Advanced Breast Cancer.

Simple SummaryNeoadjuvant therapy instituted prior to definitive surgery helps to reduce the tumor burden in the breast and axilla. De-escalation of surgery in the axilla may allow removal of just the involved nodes and sentinel nodes for determination of pathological response of previously biopsy proven positive axillary nodes. In order to attain the optimal surgical results with minimum risk of complications, it is important to choose the accurate method of identification of these positive nodes. In this review, we examine the different options to assure identification of the nodes deemed positive before neoadjuvant therapy, at the time of definitive surgery.Increasing use of neoadjuvant therapy in large tumors or node positive disease in breast cancer patients or hormone negative and HER 2 overexpressing cancers often gives rise to complete clinical response, with resolution of disease in the breast and axilla. These results have raised important questions to deescalate loco-regional surgical treatment options with minimum recurrence risk and treatment related morbidity. Although there is excellent prognosis following clinical response, the primary goal of surgery still remains to confirm complete pathological response in the biopsied node that was previously positive and now clinically/radiologically negative (ycN0). Biopsied lymph nodes are often marked with a clip to allow future identification at the time of definitive surgery. The goal of lymph node surgery in oncology is that it should be accurate, hence the significance of localizing the biopsied node. This article aims to review the different options to localize the deemed positive node at the time of definitive surgery, in order to help determine pathological response after neoadjuvant therapy.

EMonarcHER: A phase 3 study of abemaciclib plus standard adjuvant endocrine therapy in patients with HR+, HER2+, node-positive, high-risk early breast cancer.

TPS596 Background: Hormone receptor positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC) with high-risk characteristics has a high risk of disease recurrence. Novel therapeutic options for this population are urgently needed. Abemaciclib is an oral, selective, and potent CDK4 &amp; 6 inhibitor administered on a continuous schedule which is approved for HR+, HER2- advanced BC (ABC) as monotherapy and in combination with endocrine therapy (ET). Abemaciclib combined with ET demonstrated a statistically significant improvement in invasive disease-free survival (IDFS) in participants (pt) with HR+, HER2-, node-positive, high risk early breast cancer (EBC) and also clinical activity in HR+, HER2+ ABC. The eMonarcHER trial investigates whether abemaciclib plus ET will improve IDFS in pts with HR+, HER2+, node-positive, high risk EBC. Methods: eMonarcHER is a phase 3 global, randomized, double-blinded, placebo (PB)-controlled trial in participants with HR+, HER2+, node-positive, high risk EBC who have completed adjuvant HER2-targeted therapy (tx). Eligible participants are randomized 1:1 to receive either abemaciclib 150 mg twice daily or PB, plus standard ET. Study intervention period will be ≤26 cycles (approximately 2 years) followed by ≤8 years of ET as medically indicated. Participants must have undergone definitive surgery of the primary breast tumor and have high-risk disease. High-risk disease is defined as (i) detection of residual axillary nodal disease at the time of definitive surgery in participants with prior neoadjuvant (neoadj) tx; or (ii) in patients not receiving neoadj tx, must have either ≥4 pathologically positive axillary lymph nodes (pALNs), or 1-3 pathological pALNs and either: histologic Grade 2-3 and/or primary invasive tumor size ≥5 cm. Participants must have received either adjuvant pertuzumab plus trastuzumab with chemotherapy or adjuvant T-DM1. Stratification factors include treatment with neoadj tx, menopausal status, and region. The study is powered at approximately 80% to detect the superiority of abemaciclib plus ET over PB plus ET in terms of IDFS (as defined by the STEEP system) at a 1-sided α =.025 using a log-rank test. Assuming a hazard ratio of 0.73, this requires approximately 324 events at final IDFS analysis. Key secondary objectives include overall survival, distant relapse free survival, safety, pharmacokinetics, and patient-reported outcomes. The study is planned to start in March 2021. Approximately 525 centers in 23 countries plan to enroll ̃2450 participants. Clinical trial information: NCT04752332.