Significant Difference In Median Time Research Articles

Beyond diagnosis: investigating hospital referral impact on biological treatment initiation, hospital admission, and surgery patterns in inflammatory bowel disease – a Danish population based study

Objectives Early biological treatment in patients with inflammatory bowel disease (IBD) is important in disease control. Previous studies have suggested that patients with IBD from Non-Academic Hospitals were less likely to receive biologics. The aims of this study were (1) to use the granular data in the clinical database, GASTROBIO, to study detailed differences in time from IBD diagnosis to first administration of biologics, hospital admission, and surgery in patients referred to Academic Hospitals versus to Non-Academic Hospitals, and (2) to explore differences in disease extent, behavior, and indication for biological treatment. Material and methods This was a retrospective cross-sectional descriptive population-based quality study of patients with IBD initiating biologics in the North Denmark Region between 2016 and 2018. Data from GASTROBIO were extracted, namely demographic data, time of diagnosis, biological treatments with indications, hospital admission, and surgery. Results Of the 146 patients included, 84 were from the Academic and 62 from the Non-Academic Hospitals. No significant differences in median time from diagnosis to (1) treatment, (2) hospital admission or (3) IBD surgery between the groups were observed. A higher percentage of patients with luminal Crohn’s disease were treated with biologics at the Academic Hospital (78% and 66%). Conclusions Based on the findings of this population-based study, we found no evidence that the referral area had a significant impact on the duration from diagnosis to the initiation of biological treatment, hospital admissions, or surgery. However, the data suggested that fewer patients with luminal Crohn’s disease were referred to biologics from Non-Academic Hospitals.

(102) A Preliminary Analysis of Outcomes and Complication Rates for Patients Undergoing Inflatable Penile Prosthesis Implantation Following Intracavernosal Injection Therapy With or Without Concurrent Anticoagulation

Abstract Introduction Medications, namely antiplatelets (AP) and anticoagulation (AC), are effective at avoiding fatal vascular complications and prolonging the lives of our patients. As such, more and more men seeking treatment for erectile dysfunction (ED) also take blood thinners. This is an interaction we must better understand to provide safe, individualized care to our patients and minimize peri-operative morbidity. Currently, there is no published information on whether differences exist in the escalation of treatment for patients with erectile dysfunction and on AC. A previous study has demonstrated no statistically significant difference in complications between AC and non-AC groups while on ICI, despite there being a higher rate of absolute bleeding events for AC patients. Objective To compare outcomes and complication rates in patients undergoing IPP implantation following ICI therapy with or without concurrent anticoagulation. Methods A retrospective observational study was undertaken. Electronic patient records from January to September 2021 were reviewed. Included patients were those who had either currently or previously utilized ICI therapy for ED treatment. ICI therapy surveys and Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) questionnaire were obtained. 85 patients met the inclusion criteria; 43 concurrently using AC during ICI therapy and 42 with no AC use. Patients who were unable to completely stop their AC medications a week before surgery due to cardiovascular concerns or recommendations, underwent bridging with a shorter half life and reversible AC. Extra measures taken during the IPP for such patients, including meticulous hemostasis, compression dressing and drain insertion. Additional data regarding IPP implantation as well as any complications or infections experienced following IPP surgery which were compared between the AC and no AC groups. Results Patient demographics, IPP implantation information and subsequent complication rates are listed below in Table 1. There was no statistically significant difference in the rate of patients who underwent IPP placement between the AC and no AC cohorts. Moreover, there was also no statistically significant difference in median time from date of initial ICI usage to time of IPP placement as well as median time from IPP placement to last follow-up. Among the 12 total patients who underwent IPP placement, none experienced any complications, including infection, mechanical failure, device removal or revision at any time point up to last follow-up (longest was 18 months). No statistically significant differences in EDITS score between both groups was observed. Conclusions These preliminary findings, while requiring large-scale follow up, show that there is no statistically significant difference in rate of patients opting for IPP surgery following initiation of ICI therapy regardless of concomitant AC usage as well as the rate of complications following IPP implantation. Lastly, there is no drawbacks in performing such procedure in this specific cohort of patients, provided that all necessary measures are taken into consideration to minimize bleeding complications. Disclosure No.

Clinical outcomes of baloxavir versus oseltamivir in immunocompromised patients.

Neuraminidase inhibitors, including oseltamivir, are the treatment standard for influenza. Baloxavir, a novel antiviral, demonstrated comparable outcomes to oseltamivir in outpatients with influenza. Baloxavir was equally effective as oseltamivir in a retrospective study of hospitalized patients with influenza at our institution. However, the efficacy of baloxavir in immunocompromised patients is unclear. We conducted a retrospective cohort study of immunocompromised adult patients hospitalized with influenza A who received baloxavir from January 2019 to April 2019 or oseltamivir from January 2018 to April 2018. Demographic and clinical outcomes were assessed. Primary outcomes were time from antiviral initiation to resolution of hypoxia and fever. Secondary outcomes were length of stay (LOS), intensive care unit (ICU) care, ICU LOS, and 30-day mortality. Of 95 total patients, 52 received baloxavir and 43 received oseltamivir. Other than younger age (57.5vs. 65; p = .035) and longer duration between vaccination and symptom onset (114vs. 86 days; p = .001) in the baloxavir group, baseline characteristics did not differ. H1 was the predominant subtype in the baloxavir group (65.3%) versus H3 in the oseltamivir group (85.7%). When comparing baloxavir to oseltamivir, there was no significant difference in median time from antiviral initiation to resolution of hypoxia (59.9vs. 42.5 h) and to resolution of fever (21.6vs. 26.6 h). There were no differences in secondary outcomes. Baloxavir was not associated with longer time to resolution of hypoxia or fever in comparison to oseltamivir. Results must be taken in context of variations in seasonal influenza subtype and resistance rates.

(390) A Preliminary Analysis of Outcomes and Complication Rates for Patients Undergoing Inflatable Penile Prosthesis Implantation following Intracavernosal Injection Therapy With or Without Concurrent Anticoagulation

Abstract Introduction Medications, namely antiplatelets (AP) and anticoagulation (AC), are effective at avoiding fatal vascular complications and prolonging the lives of our patients. As such, more and more men seeking treatment for erectile dysfunction (ED) also take blood thinners. This is an interaction we must better understand to provide safe, individualized care to our patients and minimize peri-operative morbidity. Currently, there is no published information on whether differences exist in the escalation of treatment for patients with erectile dysfunction and on AC. A previous study has demonstrated no statistically significant difference in complications between AC and non-AC groups while on ICI, despite there being a higher rate of absolute bleeding events for AC patients. Objective To compare outcomes and complication rates in patients undergoing IPP implantation following ICI therapy with or without concurrent anticoagulation. Methods A retrospective observational study was undertaken. Electronic patient records from January to September 2021 were reviewed. Included patients were those who had either currently or previously utilized ICI therapy for ED treatment. ICI therapy surveys and Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) questionnaire were obtained. 85 patients met the inclusion criteria; 43 concurrently using AC during ICI therapy and 42 with no AC use. Patients who were unable to completely stop their AC medications a week before surgery due to cardiovascular concerns or recommendations, underwent bridging with a shorter half life and reversible AC. Extra measures taken during the IPP for such patients, including meticulous hemostasis, compression dressing and drain insertion. Additional data regarding IPP implantation as well as any complications or infections experienced following IPP surgery which were compared between the AC and no AC groups. Results Patient demographics, IPP implantation information and subsequent complication rates are listed below in Table 1. There was no statistically significant difference in the rate of patients who underwent IPP placement between the AC and no AC cohorts. Moreover, there was also no statistically significant difference in median time from date of initial ICI usage to time of IPP placement as well as median time from IPP placement to last follow-up. Among the 12 total patients who underwent IPP placement, none experienced any complications, including infection, mechanical failure, device removal or revision at any time point up to last follow-up (longest was 18 months). No statistically significant differences in EDITS score between both groups was observed. Conclusions These preliminary findings, while requiring large-scale follow up, show that there is no statistically significant difference in rate of patients opting for IPP surgery following initiation of ICI therapy regardless of concomitant AC usage as well as the rate of complications following IPP implantation. Lastly, there is no drawbacks in performing such procedure in this specific cohort of patients, provided that all necessary measures are taken into consideration to minimize bleeding complications. Disclosure No.

Femoral neck system as a safe alternative to cannulated compression screw and dynamic hip screw in femoral neck fractures: an early comparative study.

The femoral neck system (FNS) is a safe alternative to cannulated compression screw (CCS) and dynamic hip screw (DHS) in femoral neck fractures. A dual-centre retrospective cohort study was performed on femoral neck fractures (AO type 31-B) treated with closed reduction and internal fixation using FNS, DHS or CCS between April 2016 and April 2020. Exclusion criteria were as follows: patients aged below 16 years; chronic fractures beyond 7 days; pathological fractures; fracture extension to the intertrochanteric region or ipsilateral neck and shaft fractures; and open fractures. A total of 85 patients were identified: FNS (n = 28), DHS (n = 29) and CCS (n = 28). The FNS and CCS groups had a lower Garden and Pauwels classification compared to the DHS group (both P < 0.001). Both FNS and CCS groups were comparable in postoperative orthopaedic complications (10.7% [n = 3] vs. 3.6% [n = 1], adjusted P = 0.321). The DHS group had more postoperative orthopaedic complications than the FNS group, but this was not statistically significant (27.6% [n = 8] vs. 10.7% [n = 3], adjusted P = 0.321). There were no significant differences in median time to radiological union or median femoral neck shortening at union (both P > 0.05) among the three groups. The new DePuy Synthes FNS is a safe alternative to CCS with comparable complication rates for femoral neck fractures that are less displaced and more stable. The FNS also appears to be a safe alternative to DHS in the fixation of femoral neck fractures for the few cases of high-energy femoral neck fractures.

Clinically significant outcome thresholds and rates of achievement by shoulder arthroplasty type and preoperative diagnosis

BackgroundClinically significant outcome (CSO) benchmarks have been previously established for shoulder arthroplasty by assimilating preoperative diagnoses and arthroplasty types. The purpose of this study was to establish unique CSO thresholds and compare the time-to-achievement of these for reverse shoulder arthroplasty (RSA) for osteoarthritis (GHOA), RSA for rotator cuff arthropathy (RCA), and total shoulder arthroplasty (TSA) for GHOA. Materials & MethodsConsecutive patients who underwent elective RSA for GHOA, TSA for GHOA, or RSA for RCA between February 2015 and May 2020, with 2-year minimum follow-up, were retrospectively identified from a prospectively maintained single surgeon registry. The American Shoulder and Elbow Surgeons (ASES) score was administered preoperatively and postoperatively at 2-week, 6-week, 3-month, 6-month, 1-year, and 2-year timepoints. Satisfaction and subjective overall improvement anchor questionnaires were administered at the time of final follow-up. Distribution-based methods was used to calculate the Minimal Clinically Important Difference (MCID), and anchor-based methods were used to calculate the Substantial Clinical Benefit (SCB) and the Patient Acceptable Symptom State (PASS) for each patient group. Median time to achievement, individual incidence of achievement at each time point, and cumulative incidence of achievement calculated using Kaplan-Meier survival curve analysis with interval censoring were compared between groups for each CSO. Cox-regression analyses were also performed to determine which patient factors were significantly associated with early or delayed achievement of CSOs. ResultsThere were 471 patients eligible for study analysis: 276 RSA for GHOA, 107 TSA for GHOA, 88 RSA for RCA. The calculated MCID, SCB, and PASS scores differed for each group. There were no significant differences in median time to achievement of any CSO between groups. Log-rank testing revealed that cumulative achievements significantly differed between groups for MCID (P = 0.014) but not for SCB (P = 0.053) or PASS (P = 0.620). On cox regression analysis, TSA patients had earlier achievement of SCB, whereas TSA and RSA for GHOA patients had earlier achievement of MCID. At two-years, a significantly higher percentage of RSA for GHOA patients achieved MCID and SCB compared to RSA for RCA (MCID:100%, 95.5%, P = 0.003, SCB:94.6%, 86.4%, P = 0.036). ConclusionCalculated CSO thresholds differ according to preoperative diagnosis and shoulder arthroplasty type. Patients undergoing TSA and RSA for GHOA achieve CSOs earlier than RSA for RCA patients, and a significantly higher percentage of RSA for GHOA patients achieve CSOs by 2 years compared to RSA for RCA patients.

Oral versus intravenous acetaminophen for perioperative pain management in adult patients undergoing non-cardiac surgery: A quantile segmented regression analysis

Study objectiveDetermine whether preferential use of perioperative enteral acetaminophen is associated with changes in perioperative pain, narcotic administration, or time to meeting criteria for post anesthesia care unit (PACU) discharge, compared to preferential parenteral administration. DesignRetrospective Cohort with quantile segmented regression analysis. Groups determined by date of surgery, one year pre-initiative and one year post-initiative. SettingOperating room and PACU of a tertiary academic medical center. PatientsAdult (age > 18 years), ASA status 1–5, non-pregnant patients undergoing non-cardiac surgery of less than six hours duration admitted to the PACU postoperatively. InterventionsA multidisciplinary initiative to preferentially utilize enteral over parenteral acetaminophen. MeasurementsThe primary outcome was narcotic consumption in the PACU. Secondary outcomes were intraoperative narcotic administration, pain score on PACU admission and discharge, and time to meeting criteria for PACU discharge. Results24,701 patients were included in the analysis; 12,379 had surgery prior to the initiative and 12,322 after. Enteral acetaminophen administration increased preoperatively from 13.49% to 26.84%, and postoperatively from 43.16% to 51.45%, while intraoperative parenteral APAP use dropped from 43.23% to 6.81%. Quantile Segmented regression analysis after adjusting for period (pre versus postintervention), day, age, gender, inpatient status, and ASA class demonstrated a decrease in adjusted median perioperative acetaminophen dose (−175 mg P < 0.001), with no significant difference in level change of intraoperative or PACU narcotic administration. There was no significant difference in median time to meet criteria for PACU discharge, though there was a significant change in the slope, (−0.36, p = 0.007.)Median pain scores measured on a standard 0–10 numeric rating scale at PACU admission did not change, while median pain scores at PACU discharge decreased slightly (−0.24 p < 0.001). There was no change in the probability of PONV. Conclusion: In adult patients undergoing non-cardiac surgery of <6 h duration, preferential use of enteral rather than parenteral acetaminophen is associated with non-inferior outcomes in narcotic requirements, pain scores, time to PACU discharge, and probability of PONV when compared with routine parenteral administration. Further studies are needed to validate these findings.

Real world early experience of precision neoadjuvant systemic therapy in patients with resectable NSCLC: Single institution experiences and perspectives.

e20594 Background: The incidence of early-stage NSCLC is increasing with lung cancer screening. However, up to 55% of NSCLC patients (pts) who undergo curative surgery die of recurrence. Neoadjuvant chemoimmunotherapy increases pathological clinical response and reduces tumor recurrences in resectable NSCLC pts without known EGFR/ALK alterations in March 2022. The uptake of this practice is low and there is an unmet need in incorporating effective targeted therapies for driver oncogenes in pts with early-stage NSCLC. As precision neoadjuvant therapy holds the great promise in improving surgical and pathological outcomes and cure rate, the objective of this study was to develop a clinical workflow to timely coordinate the care between oncology specialties and biomarker testing in pts with early-stage NSCLC. Methods: This study included early-stage NSCLC pts with no biomarker testing (Cohort A, 15) and biomarker testing (Cohort B, 19). Driver genomic alterations with targeted therapy in the metastatic setting were identified by next generation sequencing (NGS). Descriptive analysis was used for the type and frequency of each mutation and unpaired t-test was used for time interval analysis. Results: In Cohort A, 10/15 (67%) pts received neoadjuvant chemotherapy (4) or chemoimmunotherapy (6) before surgery, 3 proceeded to surgery, and 2 received concurrent chemoradiation for unresectable tumor. Of 19 pts in Cohort B, 2 did not have biomarker testing due to small tumor size. Of the 17 pts who had NGS testing, 7 (41%) had a targetable oncogene: EGFR l858R (2), EML4-ALK (1), MET amplification (1), RET fusion (1), and EGFR E20in (2). Two received matched targeted therapies on clinical trials. Median (range) dates for NGS testing were 12 (6-44) and for NGS report from pathologic diagnosis were 48 (17-93). Barriers for getting a matched neoadjuvant therapy included no matched targeted therapy (2), tumor progression (1), unresectable tumor (1), and patient preference (1). Of the pts that underwent surgery, there was no statistically significant difference in median time (range) to diagnosis between Cohort A [N = 12, 33 (7-100) days] and Cohort B [N = 8, 34 (9-82) days] (p = 0.74). The median time (range) to surgery from pathologic diagnosis was shorter in Cohort B [78 (29-137)] than Cohort A [166 (56-201)] (p = 0.0002). The difference was due to more pts in the Cohort A receiving neoadjuvant therapy than the biomarker cohort [10/12 (83%) vs 2/7 (25%)]. Conclusions: In this analysis, time to pathological diagnosis were similar between Cohorts A and B. Time for NGS testing was also comparable for standard of care in metastatic disease. However, time to NGS results from pathological diagnosis was longer than anticipated in Cohort B, which is an area of improvement in our workflow in prospective clinical evaluation for precision neoadjuvant treatment of early-stage NSCLC.

Impact of newly diagnosed prostate cancer at time of evaluation for renal transplantation.

Systematic screening for prostate cancer is widely recommended in candidates for renal transplant at the time of listing. There are concerns that overdiagnosis of low-risk prostate cancer may result in reducing access to transplant without demonstrated oncological benefits. The objective of the study was to assess the outcome of newly diagnosed prostate cancer in candidates for transplant at the time of listing, and its impact on transplant access and transplant outcomes according to treatment options. This retrospective study was conducted over 10 years in 12 French transplant centers. Patients included were candidates for renal transplant at the time of prostate cancer diagnosis. Demographical and clinical data regarding renal disease, prostate cancer, and transplant surgery were collected. The primary outcome of the study was the interval between prostate cancer diagnosis and active listing according to treatment options. Overall median time from prostate cancer diagnosis to active listing was 25.0 months [16.4-40.2], with statistically significant differences in median time between the radiotherapy and the active surveillance groups (p=.03). Prostate cancer treatment modalities had limited impact on access and outcome of renal transplantation. Active surveillance in low-risk patients does not seem to compromise access to renal transplantation, nor does it impact oncological outcomes.

Abstract WP3: The Use Of Monitored Anesthesia Care In Place Of Nurse Administered Conscious Sedation Does Not Result In Delays To Emergent Thrombectomy.

Introduction: There has been considerable emphasis on the use of monitored anesthesia care (MAC) versus general anesthesia for emergent mechanical thrombectomy (EMT). However, due to concerns over potential delays many centers do not involve anesthesia services but instead rely on nurse administered conscious sedation (NACS). Since our center switched from NACS to MAC in 2020, we decided to investigate the impact of this switch on our thrombectomy procedures. Methods: Using a prospectively maintained Comprehensive Stroke Center quality improvement database, we reviewed our hospital EMT cases from June 2018 to April 2020 (pre-anesthesia involvement, NACS only) and May 2020 to March 2022 (post-anesthesia involvement). Main inclusion criteria were evidence of a proximal LVO and emergent transport for EMT. Variables reviewed included, time to arterial access from neurointerventional suite arrival, time to first pass, and time to TICI 2b/3. Median outcomes were compared using Mann-Whitney U test. Results: From June 2018 through April 2020 there were a total of 146 LVO cases that received EVT, compared to a total of 209 LVO cases receiving EVT from May 2020 to March 2022. The median time to arterial access from arrival in the neurointerventional suite was significantly longer before anesthesia involvement (June 2018 to April 2020, 16 minutes) compared to the period after anesthesia involvement (May 2020 to March 2022, 10 minutes) (p &lt; 0.0001). There was no significant difference in median time to first pass between the pre-anesthesia (25 minutes) versus post-anesthesia (26 minutes) time frame (p = 0.43). Median time to TICI 2b/3 was faster post-anesthesia (35 minutes) versus pre-anesthesia (40 minutes) involvement (p = 0.19). Conclusion: Our data suggests faster arterial access for EMT and no significant increase in time to first pass or final recanalization after starting to use anesthesia services. The reasons for this are likely multifactorial but may include the offloading of operator responsibilities for managing sedation, blood pressure, and airway security in these often critically ill LVO stroke patients.

Abstract B127: Impact of race on the outcomes of advanced stage non-small cell lung cancer in an equal access setting

Abstract Introduction: Immunotherapy has improved outcomes in patients with advanced stage lung cancer. However, the studies which led to approval of these therapies did not include a substantial number of Black patients. Studies focusing on racial disparities in advanced stage non-small cell lung cancer (NSCLC) patients treated with immune checkpoint inhibitors (ICIs) report conflicting data. In an equal access setting, some studies have demonstrated improved outcomes in Black patients. Very few studies have high or equal representation of Black patients, and these studies lack detail on access to care, such as time to treatment initiation (TTI) in this target population. To our knowledge, this study is one of few with almost equal representation of Black and White patients. Methods: This was an IRB approved retrospective study of stage IV NSCLC patients &amp;gt; 18 years who received immunotherapy-based systemic therapy at Vidant Medical Center between 2014 and 2021. Analyses were done utilizing IBM PSAW (SPSS Version 28). Associations between race and other demographic characteristics were examined using chi-square tests. Kaplan-Meier curves were generated to determine overall survival (OS) and progression-free survival (PFS) stratified by race. Multivariate Cox proportional hazards model was applied to determine predictors of OS and PFS. A p-value &amp;lt; 0.05 was deemed statistically significant. Results: Of 194 patients who met the eligibility criteria, 42.3% were Black (n=82). On Kaplan-Meier analysis, there was no difference in median PFS (6.30 versus 7.90 months; log-rank p=0.977) and OS (9.50 versus 11.77 months; log-rank p=0.457) between White and Black patients respectively. On multivariate analysis, there was no difference in PFS (HR: 0.98; 95% CI: 0.68,1.43; p=0.928) or OS (HR: 1.01; 95% CI: 0.67,1.51; p=0.969) when controlling for race, sex, age at diagnosis, pack years, marital status, insurance type, histology, and Charlson Comorbidity Index (CCI). The most frequently administered ICIs were pembrolizumab (74.7%), nivolumab (13.4%), atezolizumab (8.8%), nivolumab plus ipilimumab (1.5%), and durvalumab (1.5%). There was no difference in treatment selection between Black and White patients (p=0.184; chi-square). Median time to initial overall cancer treatment initiation (28.00 days versus 22.00 days; p=0.159) did not differ, but there was a significant difference in median time to immunotherapy initiation (34.00 versus 27.00 days; p=0.042) between White and Black patients respectively. Conclusion: Although race was expected to permeate patient outcomes, OS and PFS did not differ between Black and White patients. The significantly shorter time to immunotherapy treatment for Black patients is an unexpected finding. In our study we highlighted that equitable access reduces disparities, bridges gaps in care, and improves patient outcomes, regardless of race. Further studies with equitable representation of diverse racial groups are warranted to better understand how race impacts cancer outcomes. Citation Format: Melisa Pasli, Radhamani Kannaiyan, Praveen Namireddy, Mahvish Muzaffar. Impact of race on the outcomes of advanced stage non-small cell lung cancer in an equal access setting [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B127.

Outcomes following surgical resection of cystic intracranial meningiomas.

Cystic meningiomas are rare, accounting for 2-7% of all intracranial meningiomas. Little is known regarding whether these meningiomas behave differently compared to solid meningiomas. We sought to study this relatively uncommon imaging appearance of meningioma and to evaluate its clinical significance. A single-institution retrospective cohort study of surgically-treated meningioma patients between 2000 and 2019 was conducted. Cystic meningioma was defined as a tumor with an intratumoral or peritumoral cyst present on preoperative imaging. Demographics, preoperative imaging, histopathology characteristics, operative data, and surgical outcomes were reviewed. Imaging variables, histopathology and outcomes were reported for cystic meningiomas and compared with non-cystic meningiomas. Univariate/multivariable analyses were conducted. Of 737 total meningiomas treated surgically, 38 (5.2%) were cystic. Gross total resection (GTR) was achieved in 84.2% of cystic meningioma patients. Eighty-two percent of cystic meningiomas were WHO grade I (n = 31), 15.7% were grade II and 2.6% were grade III. Most cystic meningiomas had low Ki-67/MIB-1 proliferation index (n = 24, 63.2%). A total of 18.4% (n = 7) patients with cystic meningioma had recurrence compared to 12.2% (n = 80) of patients with non-cystic meningioma (p = 0.228). No significant difference in median time to recurrence was observed between cystic and non-cystic meningiomas (25.4, Q1:13.9, Q3:46.9months vs. 13.4, Q1:8.6, Q3:35.5months, p = 0.080). A small portion of intracranial meningiomas have cystic characteristics on imaging. Cystic meningiomas are frequently WHO grade I, have low proliferation index, and had similar outcomes compared to non-cystic meningioma. Cysts in meningioma may not be a surrogate to determine aggressive meningioma behavior.

Randomized Double-Blind Comparative Study of First Global Denosumab Biosimilar in Oncology

Abstract Purpose The aim of this study was to compare first global biosimilar denosumab for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Methods It was a randomized, double-blind, comparative clinical study. Total of 136 patients of solid tumor were dosed (i.e., 102 subjects in study arm and 34 subjects in the reference arm) with initial double-blind period of 24 weeks (primary efficacy) followed by open-label phase till week 36. Primary endpoint was the incidence of first on-study SRE including hypercalcemia of malignancy with co-primary endpoint of median time to first on-study SRE. Secondary endpoints included mean number and time to first and subsequent on-study SREs (week 12, 24, 36), incidence/proportion of patients with first and subsequent on-study SREs (week 24, 36), change from baseline in nuclear bone scan, quality of life assessment, pharmacokinetics, pharmacodynamic, and safety. Results In biosimilar study arm, 06 (5.83%) patients suffered SRE from baseline to week 24 compared with 02 (5.71%) patients in reference arm with one (0.97%) patient showing pathological fracture in study arm and one (2.86%) patient having spinal cord compression in reference arm. There was no statistically significant difference in median time to first SRE, mean number of SRE/patient in both arms and improvement in bone repair on nuclear scan at 12, 24 and 36 weeks. Though the study arm showed better health-related quality of life (HRQoL), mean change in HRQoL was statistically not different in both the arms. Pharmacodynamics, serum bone-specific alkaline phosphatase, pharmacokinetic and safety evaluation did not show any statistical difference between arms. Conclusion There was no clinically meaningful difference in the biosimilar denosumab and reference product after detailed efficacy and safety evaluation.

Adding Cyclophosphamide to Bortezomib and Dexamethasone was not Associated With Improved Outcomes of Patients With Newly Diagnosed Light Chain Amyloidosis: A Retrospective Study

IntroductionBefore 2021, the combination of bortezomib, cyclophosphamide, and dexamethasone (VCd) was one of the most used upfront therapy for systemic immunoglobulin light chain (AL) amyloidosis. Recently, daratumumab in combination with VCd resulted in improved outcomes compared to VCd. However, it's still unclear the role of cyclophosphamide in this combination. Materials and MethodsWe conducted this retrospective single-institutional study to compare the outcomes of upfront bortezomib and dexamethasone with or without cyclophosphamide (VD vs. VCd). ResultsOf 136 total patients, 62 received VD and 74 received VCd. The median age was 64 and the median number of organs involved was 2. Hematologic response was achieved among 73.4% patients in the VD arm and 85.9% in the VCd arm at 3 months (P = .15). Best organ response was not different between 2 arms (34.1% vs. 52.9% for VD and VCd arms, respectively; P = .28). After a median follow-up of 24.4 months, 2-year OS for VD and VCd arm was 70.6% and 84.6% respectively. The median overall survival was 70 months for VD arm and not reached for VCd arm (P = .30). There was no statistically significant difference in median time to next therapy (9.3 vs. 13.5 months for VD and VCd arms, respectively. P = .99). Conclusionthe addition of cyclophosphamide to VD was not associated with improved outcomes of patients with AL amyloidosis in this retrospective study.

Factors Associated With Surgical Site Infections After Fasciotomy in Patients With Compartment Syndrome.

Introduction:Fasciotomy is the standard of care to treat acute compartment syndrome (ACS). Although fasciotomies often prevent serious complications, postoperative complications can be notable. Surgical site infection (SSI) in these patients is as high as 30%. The objective of this study was to determine factors that increase the risk of SSI in patients with ACS.Methods:A retrospective review of 142 patients with compartment syndrome over 10 years was done. We collected basic demographics, mechanism of trauma, time to fasciotomy, incidence of SSI, use of prophylactic antibiotics, and type and time to wound closure. Statistical analysis of continuous variables was done using the Student t-test, ANOVA, multivariable regression model, and categorical variables were compared using the chi-square test.Results:Twenty-five patients with ACS (17.6%) developed infection that required additional treatment. In the multivariate regression model, there were significant differences in median time to closure in patients with infection versus those without, odds ratio: 1.06 (Confidence Interval 95% [1.00 to 1.11]), P = 0.036. No differences were observed in infection based on the mechanism of injury, wound management modality, or the presence of associated diagnoses.Conclusion:In patients with ACS, the time to closure after fasciotomy is associated with the incidence of SSI. There seems to be a golden period for closure at 4 to 5 days after fasciotomy. The ability to close is often limited by multiple factors, but the correlation between time to closure and infection in this study suggests that it is worth exploring different closure methods if the wound cannot be closed primarily within the given timeframe.

Patterns and timing of recurrence in esophageal squamous cell carcinoma patients treated with neoadjuvant chemoradiotherapy plus esophagectomy

BackgroundTumor regression grade (TRG) after neoadjuvant therapy is reportedly predictive of prognosis in esophageal cancer patients, as lack of a response to neoadjuvant therapy is associated with a poor prognosis. However, there is little information available on the timing and pattern of recurrence after esophagectomy for thoracic esophageal squamous cell carcinoma (TESCC) that takes into consideration TRG after neoadjuvant chemoradiotherapy (NACRT). Here, in an effort to gain insight into a treatment strategy that improves the prognosis of NACRT non-responders, we evaluated the patterns and timing of recurrence in TESCC patients, taking into consideration TRG after NACRT.MethodsA total of 127 TESCC patients treated with NACRT and esophagectomy between 2009 and 2017 were enrolled in this observational cohort study. TRGs were assigned based on the proportion of residual tumor cells in the area (TRG1, ≥1/3 viable cancer cells; 2, < 1/3 viable cancer cells; 3, no viable cancer cells). We retrospectively investigated the timing and patterns of recurrence and the prognoses in TESCC patients, taking into consideration TRG after NACRT.ResultsThe 127 participating TESCC patients were categorized as TRG1 (42 patients, 33%), TRG2 (56 patients, 44%) or TRG3 (29 patients, 23%). The locoregional recurrence rate was higher in TRG1 (36.4%) patients than combined TRG2–3 (7.4%) patients. Patients with TRG3 had better prognoses, though a few TRG3 patients experienced distant recurrence. There were no significant differences in median time to first recurrence or OS among patients with locoregional or distant recurrence. There was a trend toward better OS in TRG2–3 patients with recurrence than TRG1 patients with recurrence, but the difference was not significant.ConclusionsNACRT non-responders (TRG1 patients) experienced higher locoregional recurrence rates and earlier recurrence with distant or locoregional metastasis. TRG appears to be useful for establishing a strategy for perioperative treatments to improve TESCC patient survival, especially among TRG1 patients. (303 words).

A Retrospective Study of Hospice Enrollment in Patients with Diffuse Large B Cell Lymphoma within the Veterans Health Administration

IntroductionDiffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkins lymphoma (NHL), constituting 25% of NHL cases. (CA Cancer J Clin PMID: 27618563) Patients with aggressive hematological malignancies (HM) including lymphomas and leukemias have substantial palliative care needs that entail symptoms management and Hospice as an essential component of end of life (EoL) care. Despite significant improvement in treatment options, patients with relapsed refractory (RR) HM have suboptimal EoL care, (Blood PMID: 28774879 and Hematology Am Soc Hematol Educ Program PMID: 33275720) compared to patients with solid malignancies. (J Clin Oncol PMID: 25154824) The purpose of this study was to assess for Hospice enrollment in patients with DLBCL within the Veterans Health Administration (VHA).MethodsTrained abstractors performed a retrospective chart review of 3274 randomly selected patients with an ICD code for lymphoma treated within the VHA between 01/01/2011 and 12/31/2017. During the study period, 1699 veterans were confirmed to have a diagnosis of DLBCL, out of which 830 deceased patients were analyzed for this study. (Figure 1) Rates of palliative care consults, Hospice discussions, and Hospice enrollment were compared by age, race and outcomes of first line treatments using the Chi-Squared test of independence. Overall survival (OS) and time from Hospice to death were compared for the same variables with the Wilcoxon-Mann-Whitney test. A significance level of 0.05 was used for this study and all tests were two-tailed.ResultsThe median age at diagnosis was 70 years. The predominant population was white males. At the time of diagnosis, approximately three fourths had an ECOG performance status of 0 to 2. Over 50% were diagnosed at stage III-IV and had an IPI score of 4 or 5. (Table 1) Within the study, 63%, 60% and 52% of patients were introduced to palliative care, had Hospice discussions, and enrolled in Hospice respectively. The median OS from date of diagnosis to death was 461 days, and the median time from Hospice enrollment to death for those with a known Hospice enrollment date was 12 days. (Table 2) There was no statistically significant difference in palliative care or Hospice usage, median OS or median time in Hospice to death, by age or race. Patients with complete response (CR) to first line treatment had longer median OS in comparison to the four other groups: patients who received no first line treatments, who began a first line treatment which was interrupted by death, who were RR after first line treatment and those with an unknown treatment response. Patients who did not receive any first line treatments, RR patients or those with an unknown treatment response were more likely to have a palliative care consult, discuss Hospice with a provider and enroll in Hospice (p-value <0.005). There were no statistically significant differences in median time within Hospice between the successful treatment group and any of the other four groups.ConclusionIn this retrospective study, more than half of deceased patients with DLBCL within the VHA utilized Hospice services. There was no difference in Hospice use based on age or race, indicating equal access to care. Limitations of this study include a predominant male population and equal health care access that may limit generalizability of our finding to the non-Veterans population. Early recognition of high-risk patients may correlate with earlier enrollment to Hospice and increased lengths of stay in Hospice for patients with aggressive HM. Future educational interventions are needed to improve Hospice utilization for EoL care in patients with HM. [Display omitted] DisclosuresNooruddin: AstraZeneca: Research Funding.

Hospital in the Home Delivery of Conditioning Therapy for Allogeneic Haematopoietic Stem Cell Transplantation: A Novel Single Centre Patient Focused Approach

Introduction: High dose therapy with Allogeneic Haematopoietic Stem Cell Transplantation (AlloHSCT) has traditionally been performed as an inpatient procedure. However, with improvements in supportive care and patient selection it is possible to safely deliver conditioning chemotherapy in an outpatient setting (Subirà M et al., 2003). While deemed an “outpatient procedure” this method is currently delivered on large day units which requires the patient to attend daily, often only spending the night at home.To reduce these daily visits The Royal Melbourne Hospital (RMH) Bone Marrow Transplant department in collaboration with the Hospital in the Home (HIH) department developed an innovative program to safely deliver Fludarabine chemotherapy as part of conditioning for AlloHSCT in the patient's home. This process involved a daily patient review by a HIH Doctor as well as twice daily visits by a HIH nurse to administer chemotherapy and supportive care in the comfort of the patient's home. Here we report on the safety outcomes of HIH AlloHSCT vs inpatient (IP) care, specifically complications and outcomes.Methods: A retrospective case note audit identified 395 consecutive AlloHSCT patients who received Fludarabine based conditioning between 2011 and 2017 at the RMH. Of these 130 received Fludarabine as part of the HIH Program and 265 as a traditional IP.Results: Of those treated as HIH patients, median age was 51 years (range 18-69). 59% patients were male (n=77) and 41% Female (n=53). Underlying disease groups included Leukaemia (n=53; 40%), Lymphoma (n=35; 27%), Myelodysplatic/Myeloproliferative (n=28; 21%), Myeloma (n=11; 9%) and Non-malignant (n=3; 3%). 2% of patients had myeloablative conditioning (n=2) and 98% received Reduced Intensity Conditioning (n=128). 57% (n=73) received stem cells from a sibling (Sib), 41% (n=54) from Voluntary Unrelated Donors (VUD) and 2% (n=3) from Umbilical Cord Donors.Median total Length of Stay (LOS) for HIH patients was 27 days (Range 10-97) with a median of 5 days (range 2-8) at home as part of this. The LOS for those receiving fludarabine as an IP was not significantly different at 26 days (range 5-174; p=0.209). Total number of IP Bed days saved through the HIH program was 682. There was no significant difference in median time to neutrophil engraftment (HIH 20 vs IP 17 days; p =0.95) or platelet engraftment (HIH 23 vs IP 20 days; p=0.99). Having chemotherapy as a HIH patient had no effect on outcome (HR 1.01). There is no difference in Overall Survival (OS) between the two groups (HIH 17 vs IP 16 months - see Figure 1) while Median OS was not reached.Of the 130 patients who were treated in the HIH Program only 11 had an unplanned admission before Day 0 of their AlloHSCT. Reasons for readmission included suspected infection (n=8; only one culture positive), vasovagal (n=1) and anxiety (n=2). Of note, four of these admissions arose in the first three months of the program with the other seven readmissions occurring over the following six years, with a readmission rate of approximately 5% (7/126 patients).Conclusion: The HIH delivery of chemotherapy and supportive care as part of conditioning for AlloHSCT in the patient's home is both safe and effective. It resulted in a median of five bed days saved per patient (Total number of bed days saved = 682), allowing the department to increase bed capacity without the costs associated with building a new ward. Additionally, the risk of complications was low (approximately 5%) and those that did occur were safely managed.Figure 1 - Comparison of Survival Between HIH and IP AlloHSCT Patients [Display omitted] DisclosuresRoutledge:Celgene: Honoraria; Gilead: Honoraria; Bristol-Myers Squibb: Honoraria. Ritchie:Amgen Inc.: Honoraria.

P377 Inadequate response with advanced therapies in real-world patients with Ulcerative Colitis – Results of a German claims database study

Abstract Background Therapeutic management of Ulcerative Colitis (UC) is challenging, and clinicians are often obliged to attempt a variety of therapies in sequence until an adequate clinical response is achieved. However, real-world data regarding response rates in UC treatment are rare, particularly for later lines of therapy. Thus, this study aimed to investigate the incidence of inadequate response to advanced therapies in patients with UC. Methods This retrospective study was based on claims data from a regional German sickness fund covering the period from 01/2014-06/2019. Patients were included if they had at least two outpatient diagnoses in two different quarters or one inpatient diagnosis of UC (ICD-10: K51) and started a newly introduced advanced therapy (adalimumab, golimumab, infliximab, tofacitinib, vedolizumab) in 01/2015-06/2019. Patients were followed from treatment initiation (index date) until the end of the study period or loss to follow-up (median = 23.4 months). Proxies of inadequate response included: discontinuation (a supply gap of &amp;gt;60 days), switch, escalation (as dose increase exceeding 1.5 times the recommended maintenance dose), augmentation with 5-ASA, corticosteroid (CS) dependency (two CS prescriptions were observed starting more than 14 weeks after the index date), UC-related hospitalization, or UC-related surgery. CS dependency and treatment escalation were only assessed in the maintenance phase. Inadequate response in the analyzed sample was evaluated by means of Kaplan-Meier survival analysis. Results Among 574 UC patients (median age: 39 years; female: 53.5%), in whom an advanced therapy was initiated, 458 (79.8%) received an anti-TNF therapy, 113 (19.7%) vedolizumab and 3 (0.5%) tofacitinib. According to the available baseline period, 72 (12.4%) patients were identified as biologic-experienced. Most patients received CS (86.4%) and/or 5-aminosalicylic acids (81.7%) in the 12-month pre-index period. The median time to inadequate response to the initiated advanced therapy was 4.8 months (IQR: 2.6-11.9; Figure 1) with an inadequate response over 12 months in 75% (Figure 2). There was no significant difference in median time to inadequate response between biologic-naïve and biologic-experienced patients (4.9 vs. 4.7 months; p-value = 0.285). During the observable follow-up period, 172 (61%) patients switched from their index agent to another advanced therapy. Conclusion From the real-world settings in Germany, we found an inadequate response in UC-patients starting an advanced therapy in 75% of patients over 12 months. There is a need for more effective therapies among these patients.

Impact of systemic therapy sequencing on overall survival for patients with advanced BRAF-mutated melanoma.

9552 Background: Both immune checkpoint inhibitors (ICI) and BRAF targeted therapy (TT) are effective treatments for patients with advanced BRAF-mutated melanoma. However, the choice of first-line (1L) therapy is at the discretion of treating oncologists without clear guidance from current available data or established guidelines. Utilizing prospectively collected data from the Canadian Melanoma Research Network (CMRN) database, we provide real-world evidence to highlight the impact of sequencing these therapies. Methods: Prospective data from 9 cancer centres in Canada was retrieved from the CMRN database for patients with unresectable/metastatic melanoma, with BRAF targetable subtypes, who received at least one-cycle of 1L palliative-intent ICI or TT, and at least 1-year of follow-up. We categorized patients into 2 groups: 1L BRAF±MEK inhibitors with/without subsequent PD-1±CTLA-4 inhibitors (1L-TT), or vice versa (1L-ICI). The primary study outcome was overall survival (OS). Survival outcomes were analyzed through Kaplan-Meier methods, and multivariable Cox analysis was utilized to account for potential confounders. Results: Our study (N=235) included 152 and 83 patients in 1L-TT and 1L-ICI groups, respectively. Combined BRAF-MEK inhibitors accounted for 59% of the 1L-TT group, whereas single-agent IO accounted for 66% of the 1L-ICI group. There were 93 patients who received second-line (2L) therapy, with a non-significant trend of 1L-TT group receiving more 2L therapy compared to 1L-ICI group (65% vs. 43%, P=0.404). Neither treatment group showed significant differences in median time on 1L therapy (P=0.645) or 2L therapy (P=0.686). The 1L-ICI group was associated with a favourable median overall survival (OS) compared to 1L-TT group (19.3 vs. 10.0 months, P=0.031). Specifically, the ICI only group had the highest median OS, followed by TT-ICI sequence, ICI-TT sequence, and TT only groups respectively (not reached vs. 38.3 vs. 16.9 vs. 6.1 months, P&lt;0.001). However, this OS benefit (HR 0.89, 95% 0.51-1.53, P=0.644) was non-significant upon controlling for confounders such as baseline metastatic sites &gt;2 (HR 2.07, 95%CI 1.24-3.46, P=0.006) and ECOG ≥2 (HR 3.47, 95%CI 2.02-5.97, P&lt;0.001) in multivariable Cox analysis. Conclusions: There was no significant difference in OS between 1L-TT and 1L-IO groups. Rather, OS is driven mostly by the patient’s clinical status and tumour-associated features. Our study provides real-world evidence in an understudied area. Further studies are needed to validate our findings to inform guideline development.[Table: see text]