Significant Differences In Patient Characteristics Research Articles

Change in Lumbar Lordosis after Decompressive Surgery in Lumbar Spinal Stenosis Patients and Associations with Patient Related Outcomes 2 Years after Surgery. Radiological and Clinical Results from the NORDSTEN Spinal Stenosis Trial.

A prospective cohort study. The aim was to investigate changes in lumbar lordosis (LL) and its association to changes in patient reported outcome measures (PROMs) after decompressive surgery for lumbar spinal stenosis (LSS). Few studies have addressed change in LL after decompression surgery for LSS in relation to outcomes. Pre- and postoperative data from 310 patients having standing x-ray both before and 2 years after surgery were included. The patients were grouped based on the change in LL preoperatively to 2 years after surgery; group 1: <5 degrees (n=196), group 2: ≥5 <10 degrees (n=55) or group 3: ≥10 degrees (n=59) of change in LL. The changes in function, disability and pain were assessed by the Oswestry Disability Index (ODI), Numeric Rating Scale (NRS), and the Zurich claudication questionnaire (ZCQ). The three groups were compared regarding baseline variables using the ANOVA test for continuous variables and the chi-square test for categorical variables. The groups were further compared with a likelihood ratio test in relation to changes in PROMs 2 year after surgery and outcomes were adjusted for respective baseline PROMs, age, sex, smoking, BMI, Schizas and Pfirrmann scores. LL was significantly changed at group level 2 years after surgery with a mean difference of 2.2 (SD 9.4) degrees ( P =0.001). The three LL change groups did not show any significant differences in patient characteristics, function, disability, and pain at baseline. The two groups with a change of more than 5 degrees in LL 2 year after surgery (group 2 and 3) had significantly greater improvements in ODI ( P =0.022) and ZCQ function ( P =0.016) in the adjusted analyses, but was not significant for back and leg pain. Changed LL after decompressive surgery for LSS was associated with improved ODI and physical function.

Abstract PO2-12-03: Home-based Resistance Exercise Improves Fatigue and Functional Strength in Female Breast Cancer Survivors Post Chemotherapy

Abstract Introduction: Chemotherapy is associated with an increase in fatigue and loss of strength in female breast cancer (BCa) survivors. Strength training has been found to reverse these effects, however, the COVID pandemic added a complexity to clinic-based exercise intervention. The purpose of this study is to determine if a home-based resistance exercise program can attenuate these debilitating effects in a cohort of breast cancer survivors that have recently completed chemotherapy. Methods: Ten BCa survivors who completed chemotherapy within the previous 6 months were recruited to participate in a 12-week home-based resistance exercise proof of concept study. Exercise was performed 3 times per week, supervised via Zoom. Participants completed 2-3 sets of upper body and lower body exercises to volitional fatigue. Self-reported fatigue was measured using the respective subscale from the EORTC QLQ-C30. Strength was measured using hand grip dynamometry and isometric leg strength. Physical function was measured using the 6-minute walk test. Assessments were completed at baseline and end of study. As a comparison, age matched controls (AMCs) were recruited to complete cross-sectional analysis of each of these variables. A one-way analysis variance was done with Tukey’s post hoc test. Significance was set at p&amp;lt; 0.05. Results: BCa survivors were 46.4 ± 12.5 years old with a BMI of 28.11 ± 5.25. AMCs were 50.3 ±13.3 years old with a BMI of 30.8 ± 5.8. There was no significant difference in patient characteristics. A significant difference in self-reported fatigue was found between groups (F=18.52; p&amp;lt; 0.0001). Post hoc analysis found significant difference in fatigue between BCa survivors at baseline (48 ± 23) and the age matched controls (p&amp;lt; 0.0001). Exercise was able to significantly reduce fatigue in BCa survivors (21 ± 15; p=0.003) to levels not significantly different to AMCs (3.3 ± 7.5). A significant difference was also observed between groups for right-hand grip strength (F= 4.923; p=0.015) and left-hand grip strength (F=8.685, p=0.001). Post hoc analysis found a significant increase in right hand grip strength in the BCa survivor group following the intervention (p=0.012). Left hand grip strength was found to be significantly lower at baseline than AMCs (p=0.048). Left hand grip strength was significantly increased in BCa survivors at end of study (p&amp;lt; 0.001). Finally, a significant difference was observed between groups for isometric leg strength (F= 3.699; p=0.038). Post hoc analysis found a significant difference in leg strength in the BCa survivor group following intervention (pre: 105.9 ± 50.6 N-M; post: 158.4 ± 13.2 N-M; p=0.030) which was 16.5% higher than AMCs (127.4 ± 36.5 N-M). No significant difference was found in 6-minute walk distance. However, there was a 21% increase in the distance walked for BCa survivors after interventions (pre: 441.2 ± 66.5m; post: 501.4 ± 123m), identical to distances walked by AMCs (501.4 ± 90.8m). Conclusion: The results of our study suggest that a virtually supervised resistance exercise program can attenuate the negative effects of chemotherapy in BCa survivors to levels similar to their peers that never had breast cancer. Further research using powered sample sizes is needed to validate these results. Citation Format: Taylor Moncrief, Crisann Moon, Angela Gonzalez, Allison Stepanenko, Tiffany Cortes, Darpan Patel. Home-based Resistance Exercise Improves Fatigue and Functional Strength in Female Breast Cancer Survivors Post Chemotherapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-03.

Pre-post implementation study of chronic diuretic clinical practice guideline for bronchopulmonary dysplasia in preterm infants

BackgroundChronic diuretics are frequently used (off-label) in preterm infants to manage evolving or established bronchopulmonary dysplasia (BPD). Chronic diuretic use, however, is limited by tolerance with no long-term safety and efficacy data, leading to wide variation in its use in preterm infants. ObjectiveTo determine the impact of the chronic diuretic clinical practice guideline (CPG) on the patterns of diuretic use, severity of BPD, and hospital length of stay (LOS) in preterm infants born less than 32 weeks gestation. MethodsSingle-center retrospective pre-post CPG cohort study in a level IV neonatal intensive care unit. Chronic diuretic CPG was implemented in November 2021 and the data was collected one year before (Pre-CPG) and one year after (Post-CPG). ResultsIn total, 73 infants (39 Pre-CPG, and 34 Post-CPG) were identified. There were no significant differences in patient characteristics at birth or in the use and duration of respiratory support between the two groups. Compared to Pre-CPG, the frequency of thiazide diuretic use was not decreased in Post-CPG (30.8 vs. 20.6 %, p = 0. 42), but the duration of use was significantly reduced (35 vs. 6 days, p = 0.01). Both frequency (20.5 vs. 2.9 %) and duration (28.5 vs. 4 days) of spironolactone were reduced in the Post-CPG (p < 0.05). Furosemide exposure (69.2 vs. 41.2 %, p = 0.02) and total doses [3.0 (0.0–8.0) vs. 0.0 (0.0–2.3), p = 0.003] were also significantly reduced in the Post-CPG. The incidence of any BPD at 36 weeks and LOS were similar between groups, while the incidence of moderate/severe BPD and home oxygen use were decreased in the Post-CPG. ConclusionsChronic diuretic CPG was associated with a reduction in diuretic exposure in preterm infants

Simultaneous Free Flap Breast Reconstruction Combined With Contralateral Mastopexy or Breast Reduction: A Propensity-Matched National Surgical Quality Improvement Program Study on Postoperative Outcomes.

Simultaneous free flap breast reconstruction combined with contralateral mastopexy or breast reduction can increase patient satisfaction and minimize the need for a second procedure. Surgeon concerns of increases in operative time, postoperative complications, and final breast symmetry may decrease the likelihood of these procedures being done concurrently. This study analyzed postoperative outcomes of simultaneous contralateral mastopexy or breast reduction with free flap breast reconstruction. By using the American College of Surgeons National Surgical Quality Improvement Program database (2010-2020), we analyzed 2 patient cohorts undergoing (A) free flap breast reconstruction only and (B) free flap breast reconstruction combined with contralateral mastopexy or breast reduction. The preoperative variables assessed included demographic data, comorbidities, and perioperative data. Using a neighbor matching algorithm, we performed a 1:1 propensity score matching of 602 free flap breast reconstruction patients and 621 with concurrent contralateral operation patients. Bivariate analysis for postoperative surgical and medical complications was performed for outcomes in the propensity-matched cohort. We identified 11,308 cases who underwent microsurgical free flap breast reconstruction from the American College of Surgeons National Surgical Quality Improvement Program database from the beginning of 2010 to the end of 2020. A total of 621 patients underwent a free flap breast reconstruction combined with contralateral mastopexy or breast reduction. After propensity score matching, there were no significant differences in patient characteristics, perioperative variables or postoperative medical complications between the 2 cohorts. Simultaneous free flap breast reconstruction combined with contralateral mastopexy or breast reduction can be performed safely and effectively without an increase in postoperative complication rates. This can improve surgeon competence in offering this combination of procedures as an option to breast cancer survivors, leading to better patient outcomes in terms of symmetrical and aesthetically pleasing results, reduced costs, and elimination of the need for a second operation.

Effect of early dose reduction of osimertinib on efficacy in the first-line treatment for EGFR-mutated non-small cell lung cancer.

Osimertinib is used as the first-line therapy for patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). However, early dose reduction is often required due to adverse events (AEs). This study aimed to evaluate the effect of early dose reduction of osimertinib on efficacy and safety.This was a retrospective study including patients with EGFR-mutated NSCLC who were started on osimertinib as the first-line therapy between August 2018 and December 2021. Patients whose doses were reduced to less than 80mg/day within 6 months of osimertinib initiation or started at 40mg/day were defined as the dose reduction group. The primary endpoint was progression-free survival (PFS). Factors affecting PFS were explored using the Cox proportional hazards model.A total of 85 patients were included in this study. No significant differences in patient characteristics were observed between the dose reduction (n = 25) and standard dose groups (n = 60). The median PFS in the dose reduction group was significantly prolonged compared with that in the standard dose group (26.0 months vs. 12.0 months, p = 0.03). Multivariable analysis of 84 patients, excluding a patient with unknown brain metastasis, revealed that EGFR exon 21 L858R mutation, malignant pleural effusion or pleural metastasis, liver metastasis, and dose reduction within 6 months were independent factors affecting PFS.Early dose reduction of osimertinib is an effective therapeutic strategy for prolonging PFS in patients with EGFR-mutated NSCLC.

Preoperative Chronic Inflammation Is a Risk Factor for Postoperative Complications Independent of Body Composition in Gastric Cancer Patients Undergoing Radical Gastrectomy.

The purpose of this study was to investigate the association between preoperative inflammation and postoperative complications in gastric cancer patients having elective gastrectomy. Participants in this study were those who underwent radical gastrectomy between April 2008 and June 2018 and were diagnosed with stage I-III primary gastric cancer. Preoperative CRP values were used to divide the patients into two groups: the inflammation group comprised individuals having a CRP level of ≥0.5 mg/dL; the other was the non-inflammation group. The primary outcome was overall complications of Clavien-Dindo grade II or higher after surgery. Using propensity score matching to adjust for background, we compared the postoperative outcomes of the groups and conducted a multivariate analysis to identify risk variables for complications. Of 951 patients, 852 (89.6%) were in the non-inflammation group and 99 (10.4%) were in the inflammation group. After matching, both groups included 99 patients, and no significant differences in patient characteristics were observed between both groups. The inflammation group had a significantly greater total number of postoperative complications (p = 0.019). The multivariate analysis revealed that a preoperative CRP level of ≥0.5 mg/dL was an independent risk factor for total postoperative complications in all patients (odds ratio: 2.310, 95% confidence interval: 1.430-3.730, p < 0.001). In conclusion, in patients undergoing curative resection for gastric cancer, preoperative inflammation has been found to be an independent risk factor for overall complications after surgery. Patients with chronic inflammation require preoperative treatment to reduce inflammation because chronic inflammation is the greatest risk factor for postoperative complications.

A207 SLING-FIBER PRESERVATION DURING POEM IS AN INDEPENDENT FACTOR IN REDUCING POST-POEM GERD SYMPTOMS: A CANADIAN SINGLE-CENTER RETROSPECTIVE STUDY

Abstract Background Gastroesophageal reflux disease (GERD) after peroral endoscopic myotomy (POEM) has been a limiting factor with POEM procedure. Preservation of the sling-fiber during POEM was reported to reduce post-POEM GERD in Japan, but there are no reports of this technique in a western population. Aims The aim is to investigate the association of sling-fiber preservation during POEM and post-POEM GERD symptoms at our institution, which is a large therapeutic endoscopy referral center in Canada. Methods This is a retrospective, single-center study of patients who underwent POEM from October 2017 to January 2023 at our center. The initial cohort of patients were treated by conventional POEM until June 2021, after which a second cohort underwent POEM with sling-fiber preservation, as the techniques advanced. The primary outcome was the rate of positive GERD symptoms after POEM. The secondary outcomes were clinical success rate, adverse events rate, use of PPI at follow-up. Multivariate regression was performed to identify factors that reduce post-POEM GERD symptoms. Results 148 POEM cases (52.5±15.6y/o, female:61(43%)) were included in this study. There was no significant difference in patient characteristics between the groups. The mean procedure time (108.6±34.5 vs 109.1±45.7 min, P=0.93) and rate of adverse events (20% vs 18%, P=0.85) were similar between the traditional and modified groups. In the sling fiber preservation group, gastric myotomy length was significantly longer (2.2±0.7 vs 1.6±0.8 cm, Pampersand:003C0.05) yet the GERD symptom rate at follow-up was significantly lower (22% vs 42%, Pampersand:003C0.05), although PPI use was similar (52% vs 48%, P=0.73). The clinical success rate was similar between groups (88% vs 84%, P=0.6). Regression analysis indicated that, after adjusting for other risk factors of post-POEM GERD, sling-fiber preservation during POEM had an odds ratio of 0.24 (95%CI:0.07-0.85, Pampersand:003C0.05) for post-POEM GERD symptoms. Conclusions Sling-fiber preservation during POEM effectively reduces post-POEM GERD symptoms, despite a longer gastric myotomy length. It stands as a independent factor in reducing post-POEM GERD symptoms. Hence, sling-fiber preservation may be a beneficial solution for reducing post-POEM GERD symptoms in Western populations. Outcomes of conventional POEM and sling-fiber preservation POEM POEM; Peroral endoscopic myotomy, SD; standard deviation, GERD; gastroesophageal reflux disease, PPI; proton pump inhibitor Funding Agencies None

A Prospective Analysis of the Effects of a Powder-Type Hemostatic Agent on the Short-Term Outcomes after Liver Resection.

Background and Objectives: Postoperative bleeding is a significant cause of morbidity and mortality following liver resection. Therefore, it is crucial to minimize bleeding during liver resection and effectively manage it when it occurs. Arista® AH (Becton, Dickinson and Company, Franklin Lakes, NJ, USA) is a microporous polysaccharide hemosphere (MPH), a new plant-derived polysaccharide powder hemostat that can be applied to the entire surgical field. This study prospectively assessed the effectiveness of Arista for bleeding control when applied intraoperatively to the liver resection surface. Materials and Methods: Data were collected at Seoul National University Bundang Hospital for patients who underwent liver resection owing to malignant hepatocellular carcinoma or benign liver diseases. We compared the outcomes between 45 patients managed with Arista® AH (data were prospectively collected between September 2022 and May 2023) and 156 patients managed without the use of Arista® AH (data were retrospectively collected between January 2021 and December 2021). Results: There were no significant differences in patient characteristics between the two groups. The estimated blood loss (EBL) was significantly lower in the Arista® AH group compared with the control group (495.56 ± 672.7 mL vs. 691.9 ± 777.5 mL, p = 0.049). The mean postoperative hospital stay was significantly shorter in the Arista® AH group (5.93 ± 1.88 days vs. 6.94 ± 4.17 days, p = 0.024). The time to Jackson-Pratt drain removal was also significantly shorter in the Arista® AH group (4.64 ± 1.31 days vs. 5.30 ± 2.87 days, p = 0.030). The patient subgroup was divided into four categories based on the type of resection and the presence or absence of cirrhosis. Within the subgroup of major resections in non-cirrhotic patients, the Arista® AH group demonstrated significantly better outcomes compared to the control group, showed lower EBL, reduced need for blood transfusions, decreased volume of drain fluid collected within 48 h, earlier removal of drains, and shorter hospital stays. In contrast, for the other subgroups such as minor resection (both non-cirrhotic and cirrhotic) and major resection with cirrhosis, the differences between the Arista® AH and control groups in various parameters like EBL, blood transfusion rates, drain fluid volume, time to drain removal, and duration of hospital stay were not statistically significant. Conclusions: Arista® AH significantly improved intraoperative blood management and postoperative recovery in patients undergoing liver resection, particularly in non-cirrhotic patients who underwent major resection.

The Prevalence of Titanium Dioxide Particles in Synovial Fluid Samples Drops after European Union Ban

Due to health concerns, the European Union has banned the use of titanium dioxide nanoparticles in consumables in February 2022, with a 6-month transitional period ending in August 2022. We studied the prevalence of titanium dioxide nanoparticles in synovial fluid samples during and after the transitional period. A total of 302 samples were collected as a consecutive series between 1 April 2022 and 15 June 2023 from patients visiting the department of rheumatology at VieCuri Medical Centre in Venlo, The Netherlands. The samples were primarily collected for diagnostic purposes and only clinical waste material was used for this study. From each sample, up to 40 μl of fluid was analysed with Raman spectroscopy for the presence of titanium dioxide particles. The trend in prevalence was calculated with a 3-month wide moving average. A total of 13 out of 302 samples (4.3%) contained titanium dioxide (TiO2). The prevalence of TiO2 decreased between the transitional period and the period after the ban (p = 0.0154, with a relative risk ratio of 4.9 (95% CI 1.35–17.74). There was no significant difference in patient characteristics between the TiO2 positive and the TiO2 negative group. These results are hinting towards a possible relationship between the EU-ban and the identified decrease in prevalence.

Janus kinase inhibitors vs. abatacept about safety and efficacy for patients with rheumatoid arthritis-associated interstitial lung disease: a retrospective nested case-control study

BackgroundInterstitial lung disease (ILD) related to rheumatoid arthritis (RA) is among the leading causes of death and an essential prognostic factor. There is only limited evidence for the safety of anti-rheumatic drugs for patients with RA-ILD. The aim of this study is to investigate the safety and efficacy of Janus kinase inhibitors (JAKis) by comparing it with abatacept (ABT) in patients with RA-ILD.MethodsThis single centre, retrospective nested case–control study enrolled patients with RA-ILD treated with JAKi or ABT. To determine the safety of the two drugs for existing ILD, we compared their drug persistency, incidence rates of pulmonary complications, and change of chest computed tomography (CT) image. For their efficacy as RA treatment, disease activity scores and prednisolone (PSL)-sparing effect were compared. We performed propensity score matching to match the groups’ patient characteristics.ResultsWe studied 71 patients with RA-ILD (ABT, n = 45; JAKi, n = 26). At baseline, the JAKi group had longer disease duration, longer duration of past bDMARD or JAKi use and higher usual interstitial pneumonia rate. After propensity score matching, no significant differences in patient characteristics were found between the two groups. No significant difference in the drug persistency rate for the first 2 years (ABT, 61.9%; JAKi, 42.8%; P = 0.256) was observed between the two matched groups. The incidence rate of pulmonary complications did not differ significantly between the two groups (P = 0.683). The CT score did not change after the treatment for the ABT group (Ground-glass opacities (GGO): P = 0.87; fibrosis: P = 0.78), while the GGO score significantly improved for the JAKi group (P = 0.03), although the number was limited (ABT: n = 7; JAKi: n = 8). The fibrosis score of the JAKi group did not change significantly.(P = 0.82). Regarding the efficacy for RA, a significant decrease in disease activity scores after the 1-year treatment was observed in both groups, and PSL dose was successfully tapered, although no significant differences were observed between the two drugs.ConclusionsJAKi is as safe and effective as ABT for patients with RA-ILD. JAKi can be a good treatment option for such patients.

Correlation between the histopathological findings of gallbladder samples and clinical outcomes within the framework of a hybrid study

Background: This study focuses on the histopathological characteristics of benign and potentially malignant lesions of the gallbladder, with a specific emphasis on the efficacy of cholecystectomy as a secondary preventive measure in specific clinical contexts. The aim is to contribute to the development of improved preventive and therapeutic approaches. Methodology: This research study employed a hybrid approach of retrospective and prospective data analysis on cholecystitis during the year 2023. Various variables were analyzed to explore their associations with clinical outcomes. Results: The study included 63 patients, with no statistically significant differences in age between male and female patients. Analysis of the length, width, and thickness of the gallbladder wall did not reveal statistically significant differences (p &gt; 0.05). Correlation analysis showed weak connections between age and gallbladder characteristics. The average recovery time was 4.46 days, and the duration of hospitalization positively correlated with age (p&lt;0.001). Regression analysis indicated an association between symptoms and age and the duration of hospitalization (p = 0.015, p&lt;0.001). Logistic regression demonstrated an accuracy of 61.9%, with high precision in predicting stays longer than 3 days. Chi-square tests confirmed statistically significant differences in histopathological diagnoses related to comorbidities (p = 0.021). Conclusion: Gender-specific approaches in postoperative treatment of patients with gallbladder issues highlight significant differences in patient characteristics, while the analysis of comorbidities reveals a connection between hypertension and pathological changes in the gallbladder.

Chronological improvement of survival in patients with advanced gastric cancer over 15 years.

Recent trials have reported a median overall survival (OS) of 11-17 months in patients with advanced gastric cancer (AGC). However, it is unclear how recently approved drugs contribute to patient prognosis. We aimed to evaluate the characteristics and survival in patients with AGC over the past 15 years. Retrospective study. We evaluated data of 1355 patients with AGC who received first-line chemotherapy between January 2005 and March 2019 at a single institution. We compared the characteristics and survival rates across four periods: January 2005-December 2007 (period A), January 2008-February 2011 (period B), March 2011-May 2015 (period C), and June 2015-March 2019 (period D). The median follow-up duration was 13.1 months, with 312, 333, 393, and 317 patients in periods A, B, C, and D, respectively. There were no significant differences in patient characteristics between the four periods, except for the proportion of patients who underwent prior gastrectomy and human epidermal growth factor receptor 2 (HER2) testing. Patients in period D had significantly longer OS than those in period A [median: 15.7 versus 12.4 months; adjusted hazard ratio (aHR): 0.79; p = 0.02]. The mean OS in patients with liver metastasis (LM) in period D was remarkably longer than that in patients in period A (median: 19.3 versus 12.4 months; aHR: 0.61; p < 0.01), while that in patients with peritoneal metastasis showed limited improvement. Clinical strategy changes, including gastrectomy, HER2 testing, and approval of new drugs, may be associated with improved OS in patients with AGC. In the last 4 years, a remarkable improvement has been observed in patients with LM.

Endovascular Treatment for Ruptured Intracranial Aneurysms with Intracerebral Hematoma—Clinical Propriety of Less Invasive Treatment

Endovascular treatment of ruptured intracranial aneurysms (rIAs) accompanied by intracerebral hematoma (ICH) can be challenging because the ICH can be enlarged due to intraoperative anticoagulation during the endovascular procedure. This retrospective study aimed to compare the outcomes of aneurysmal subarachnoid hemorrhage with and without ICH treated by endovascular procedures. We reviewed 62 patients who underwent endovascular treatment of rIAs between January 2015 and April 2023. The patients were divided into 2 groups: those with ICH (group H; n= 13) and those without ICH (group N; n= 49). The patient demographics, aneurysm characteristics, World Federation of Neurosurgical Societies (WFNS) grade, complications (e.g., symptomatic vasospasm, hydrocephalus), and outcomes were assessed stratified by the presence of ICH. In group H, age, sex, complications, WFNS grade, and hematoma volume were also analyzed in relation to the outcomes at discharge. None of these patients required removal of ICH after endovascular treatment of the rIA. We found no significant differences in patient characteristics, aneurysm morphologies, WFNS grade, or overall outcomes between the 2 groups. In contrast, only a poor WFNS grade was significantly associated with poor outcomes (modified Rankin scale score ≥3) in group H (P= 0.04), and the ICH volume was not significantly different between those with good (6.2 ± 5.8 mL) and poor (14.6 ± 10.4 mL) outcomes in group H (P= 0.20). Endovascular treatment without hematoma evacuation did not adversely affect the outcomes of rIAs with ICH when the clinical condition and aneurysm morphology permitted. Surgical invasion might be avoidable with this less-invasive strategy without worsening the outcomes.

Risk-Adjusted Therapies Yield Equivalent Outcomes for Adolescents and Young Adults (AYAs) Treated for Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (T-ALL) on Children's Oncology Group (COG) Studies AALL0434 and AALL1231

Introduction Previous clinical trials have reported that adolescent and young adult (AYA) patients treated for T-cell acute lymphoblastic leukemia (T-ALL) have lower disease-free survival (DFS) and overall survival (OS) and increased toxicity as compared to younger patients. Results for the AYA cohort treated on two COG international phase 3 trials for T-ALL are reported here. Patients and Methods AALL0434 enrolled 1562 T-ALL patients (2007-2014) and AALL1231 enrolled 615 T-ALL patients (2014-2019) treated on augmented BFM (ABFM) regimens. AYA patients were defined as age ≥16 years of age (AALL0434: n=226; AALL1231: n = 107). Both studies allowed enrollment up to age 31 years. On AALL0434, participants were randomized to receive escalating dose methotrexate (CMTX) without leucovorin rescue + pegaspargase or high dose MTX (HDMTX) + leucovorin rescue. Intermediate and high-risk patients were randomized to receive or not receive six 5-day courses of nelarabine (Nel). Risk group assignments in AYA vs non-AYA patients can be found in Table 1. On AALL1231, participants were randomized to receive or not receive bortezomib in Induction and Delayed Intensification. Key differences between AALL0434 and AALL1231 ABFM backbones included the use of prednisone in induction in AALL0434 versus dexamethasone in AALL1231, and cranial radiation therapy in the majority of AALL0434 participants versus only in patients with central nervous system involvement in AALL1231. Results On AALL0434, the 4-year DFS for AYA was 81% compared to 84% for those &amp;lt;16 years old (P=0.5965), and OS was 88% and 90% respectively (P=0.3478). AYA patients randomized to CMTX (n=70) had a superior DFS compared to those randomized to HDMTX (n=72) with 4-year DFS 96% versus 78% respectively (P=0.0038). No disadvantage was seen among AYA subjects who received nelarabine versus those who did not, as shown by a 4-year DFS 85% versus 89%, respectively (N=54) (P=0.8116), albeit the sample size was small. On AALL1231, the 4-year EFS for AYA (n=107) was 82.7±3.9% compared to 82.2 ±1.7% for non-AYA (n=508) (P=0.727), and OS was 86.5 ±3.5% and 88.4 ±1.5% respectively (P=0.553). No difference in outcome was seen for AYA patients randomized to receive/not receive bortezomib. Combined outcome data for AALL0434 and AAL1231 demonstrates 4-year EFS for AYA (n=333) of 82.2+2.4% vs 83.9+0.9% for non-AYA (n=1844) (P=0.52) (Figure 1) and OS of 87.5+2.1% vs 90+0.8% respectively (P=0.19). Significant differences in patient characteristics in AALL0434 were higher initial white blood counts (P=0.0004) and higher risk group category (P=0.0002) for AYA patients. There were no significant differences in the AALL0434 AYA cohort compared to younger patients in CNS disease status, race, ethnicity, remission status at end of induction, or day 29 end of induction minimal residual disease (MRD). Toxicity rates were not significantly different in non-AYA vs AYA patients with the exception of upper respiratory infection (9.4% vs 1.8%; P=0.0001) and osteonecrosis (4.8% vs 17.7%; P&amp;lt;0.0001) in AALL0434. Rates of sepsis, catheter-related infection, and other infections were not significantly different between AYA and younger patients in AALL0434. Analysis of patient characteristics and toxicity rates in AALL1231, as well as analysis of the combined toxicity data for AALL0434 and AAL1231, are currently underway and will be presented at the meeting. Conclusion COG AALL0434 and AALL1231 show outstanding overall outcomes for AYA patients with no significant difference in survival between AYA and non-AYA patients on either study, despite differences in the ABFM backbones and the higher risk features seen among the AYA group in AALL0434. There were similar occurrences of therapy-related toxicities for AYA and non-AYA study participants on AALL0434. Despite small numbers, CMTX holds a survival advantage for AYA T-ALL patients, with no survival disadvantage seen among AYA T-ALL patients who received Nel. Bortezomib does not offer significant benefit for AYA T-ALL patients.

Enhanced Support Services Including Nurse Navigation Mitigate Socioeconomic Disparities in the Treatment of Patients with Acute Lymphoblastic Leukemia

Background: Despite recent advances in therapy (especially in the pediatric population), the treatment of acute lymphoblastic leukemia (ALL) in adult patients remains extremely challenging with only an estimated 30-40% of patients achieving long-term remission. Therefore, it is imperative to identify barriers that may impact delivery of therapy and lead to disparities of outcomes. One area of concern that has been consistently identified is the impact of socioeconomic disparities on the delivery of care. The primary objective of this study is to determine whether increased neighborhood socioeconomic disadvantage as measured by the Area Deprivation Index (ADI) impacts overall survival (OS) in patients with ALL. Methods: All patients who presented to the Levine Cancer Institute, a tertiary hospital-based specialty practice, from January 1, 2016 to December 31, 2022 were eligible for inclusion. Patients were included for final analysis if they were aged ≥ 18 years, and had a verified new diagnosis of ALL. All patients received supportive care per institutional standards including nurse navigation, social work, and financial counseling with referral to Financial Toxicity Tumor Board if indicated. Patient demographic, treatment, and disease characteristics were summarized with frequencies (and percentages) or medians (and ranges). Correlation between national and state ADIs were assessed with Spearman's rank correlation coefficient. National and state ADI were analyzed as continuous ranks and as quartile (median for both national and state ADI; quartiles for national ADI). Kaplan-Meier methods were used to summarize OS and estimate landmark survival rates. Cox proportional-hazards models estimated hazard ratios and 95% confidence intervals associated with ADI. Multivariable models with adjustments for clinical covariates included age at diagnosis, risk group, and treatment received (including Oncology Nurse Navigation [ONN] services). Results: A total of 100 patients were found to meet criteria for inclusion. Specific characteristics of the analyzed population are listed in Table 1. The population had a median age of 54 years and were primarily treated per three treatment paradigms (standard adult intensive (57%), pediatric-based (14%), and reduced-intensity (28%)). Overall median follow-up (95% CI) was 52.2 months (44.1, 55.5) with a median OS of 51.4 months (25.3 to non-estimable) and median relapse free survival (RFS) of 22.8 months (17.0 to 35.7). When dichotomized by median ADI, there was no significant difference in patient characteristics in the two groups including age, gender, race/ethnicity, ALL type, insurance type, induction regimen, and receipt of ONN services. In univariate modeling, ADI as a continuous variable was not found to be associated with OS (HR 1.01; 95% CI 0.99-1.02, P=0.321) or RFS (HR 1.01; 95% CI 0.99-1.02, P=0.288). This lack of association remained true when dichotomized by median ADI into high and low ADI areas (OS HR 1.01; 95% CI 0.58-1.79, P=0.966; RFS HR 1.17; 95% CI 0.70-1.94, P=0.552), as well as by splitting ADI into quartiles (Figure 1). A multivariate model including age at diagnosis, ALL type, ONN services received, and treatment regimen similarly showed no association between ADI and OS (p=0.221) and RFS (p=0.453). Of particular interest is the high extent of navigation services received in this population (62.8% of patients in areas of less disadvantage, and 73.5% of patients from areas of higher disadvantage). Patients who received navigation services also appeared to be a higher risk population, as multi-variable modeling confirmed both decreased OS (HR 2.11; 95% CI 1.12-4.00, P=0.023) and RFS (HR 2.08; 95% CI 1.17-3.71, P=0.012) when compared to those who were not deemed by the nurse navigators to need this service. Conclusions: Contrary to larger database derived studies, patients with ALL treated at our center did not show differences in OS or RFS when compared by neighborhood disadvantage. This is likely a consequence of the strong support systems available at this institution in nurse navigation and financial toxicity related programs which help mitigate some of the risk factors for disparate outcomes. These findings should be validated in a larger cohort with prospective data with a particular focus on designing sustainable and realistic options to be utilized at community-based and underserved systems.

Using rapid response system trigger clusters to characterize patterns of clinical deterioration among hospitalized adult patients

BackgroundMany rapid response system (RRS) events are activated using multiple triggers. However, the patterns in which multiple RRS triggers occur together to activate RRS events are unknown. The purpose of this study was to identify these patterns (RRS trigger clusters) and determine their association with outcomes among hospitalized adult patients. MethodsRRS events among adult patients from January 2015 to December 2019 in the Get With The Guidelines- Resuscitation registry’s MET module were examined (n = 134,406). Cluster analysis methods were performed to identify RRS trigger clusters. Pearson’s chi-squared and ANOVA tests were used to examine differences in patient characteristics across RRS trigger clusters. Multilevel logistic regressions were used to examine the associations between RRS trigger clusters and outcomes. ResultsSix RRS trigger clusters were identified. Predominant RRS triggers for each cluster were: tachypnea, new onset difficulty in breathing, decreased oxygen saturation (Cluster 1); tachypnea, decreased oxygen saturation, staff concern (Cluster 2); respiratory depression, decreased oxygen saturation, mental status changes (Cluster 3); tachycardia, staff concern (Cluster 4); mental status changes (Cluster 5); hypotension, staff concern (Cluster 6). Significant differences in patient characteristics were observed across clusters. Patients in Clusters 3 and 6 had an increased likelihood of in-hospital cardiac arrest (p < 0.01). All clusters had an increased risk of mortality (p < 0.01). ConclusionsWe discovered six novel RRS trigger clusters with differing relationships to adverse patient outcomes. RRS trigger clusters may prove crucial in clarifying the associations between RRS events and adverse outcomes and aiding in clinician decision-making during RRS events.

Assessment of Return to Sport After ACL Reconstruction With Soft Tissue Autograft in Adolescent Athletes: Quadriceps Versus Hamstring Tendon.

Quadriceps tendon soft tissue autograft represents an increasingly popular graft option for anterior cruciate ligament reconstruction (ACLR), particularly for adolescents, some of whom have an open physis, precluding use of graft options with bone plugs. The purpose of this study was to quantify return-to-sport performance assessments in adolescents at 6 months after ACLR with all-soft tissue quadriceps tendon autograft (ACLR-Q) versus hamstring tendon autograft (ACLR-HS). It was hypothesized that ACLR-Q would be associated with improved hamstring strength and hamstring-to-quadriceps (HS:Q) ratios compared with ACLR-HS, albeit with decreased quadriceps strength. Cross-sectional study; Level of evidence, 3. Included were patients aged 12 to 19 years who underwent primary ACLR by a single surgeon and who completed a return-to-sport performance assessment between 5 and 9 months postoperatively. The performance assessment included manual muscle strength tests (hamstring, quadriceps, hip abductor and adductor), dynamic balance test (Y-balance), and functional hop tests (single hop, triple hop, crossover hop, 6-m timed hop). Data were converted to limb symmetry indices, and limb symmetry index deficits were compared between the ACLR-Q and ACLR-HS cohorts using the Student t test or Wilcoxon-Mann-Whitney test. An initial cohort of 90 ACLR-Q patients was compared with 54 ACLR-HS patients, with no significant differences in patient characteristics. Differences in meniscal repair rates, however, prompted use of propensity score matching on age, sex, body mass index, meniscectomy, and meniscal repair to produce comparable subcohorts. The matching resulted in 67 ACLR-Q and 52 ACLR-HS patients. Hamstring strength deficits were significantly greater in ACLR-HS versus ACLR-Q patients (-40.5% vs -5.7%; P < .001). Quadriceps strength deficits were significantly greater in ACLR-Q versus ACLR-HS patients (-12.8% vs -0.4%; P < .001). ACLR-Q patients had a significantly greater HS:Q ratio on the operative knee (P < .001) and significantly higher Y-balance composite score deficits (-2.9% vs -0.4%; P = .01) than ACLR-HS patients. There were no significant differences in hop test performance between groups. Adolescent athletes who underwent ACLR-Q showed significantly greater quadriceps strength deficits but significantly smaller hamstring strength deficits than those who underwent ACLR-HS, leading to more favorable HS:Q ratios in ACLR-Q patients at 6 months postoperatively.

Comparison of two preserved cartilage iliac crest cortical-cancellous bone blocks graft harvesting techniques in children: A prospective, double-blind, randomized clinical trial

PurposeTo compare donor-site morbidity for alveolar bone grafting results following cartilage-preserving outer and inner cortico-cancellous iliac crest (OCIC and ICIC) bone block grafting in children. Materials and methodsPatients were randomly divided into two groups and prospectively reviewed. In the OCIC and ICIC groups, cortico-cancellous bone blocks were harvested at outer and inner iliac crest respectively. Patient characteristics and surgical parameters were compared; pain intensity and duration, lateral femoral cutaneous nerve (LFCN) injury, gait disturbance, scar and contour satisfaction were analysed postoperatively. ResultsForty-nine consecutive patients (OCIC, 24; ICIC, 25) were included. There were no significant differences in patient characteristics or donor-site surgical parameters. The mean pain score on the first post-operative day was significantly lower in the OCIC group (3.75±1.70) than in the ICIC group (5.20±2.08) (p=0.012). The pain duration was similar in the two groups (median: 5 days). Temporary LFCN injury only occurred in 3 patients in the ICIC group. Postoperatively, the duck and circle gaits were observed in the OCIC and ICIC groups, respectively. There were no significant differences in the claudication duration, scar and contour satisfaction between the groups. ConclusionOCIC bone graft harvesting is marginally advantageous in children due to less early postoperative donor-site pain and a lower risk of nerve damage.

Long-term oncological outcomes of robotic versus laparoscopic approaches for right colon cancer: a systematic review and meta-analysis.

The short-term outcomes of robotic right hemicolectomy for right colon cancer have been extensively studied in comparison to conventional laparoscopic right hemicolectomy. However, the long-term oncological outcomes of the two approaches have not been investigated, except in single-center retrospective studies. Therefore, this meta-analysis aimed to investigate the long-term oncological outcomes of robotic right hemicolectomy compared with those of laparoscopic right hemicolectomy for right colon cancer. We searched PubMed, EMBASE, and Cochrane Library for studies comparing robotic right hemicolectomy with conventional laparoscopic right hemicolectomy for right colon cancer from the date of database inception to August 2022. For survival data extraction, hazard ratios (HRs) with 95% confidence intervals (CI) were calculated using random- or fixed-effects models from the Kaplan-Meier survival curves in the included studies. All calculations and statistical tests were performed using Review Manager software, version5.4. A total of 523 patients (robotic right hemicolectomy, 230; laparoscopic right hemicolectomy, 293) from five studies were included in this meta-analysis. There were no significant differences in patient characteristics between the two groups. In terms of pathological characteristics, TNM stage was not different and revealed no differences in the number of harvested lymph nodes even though a larger number of lymph nodes were harvested in the robotic group in one study. Pooled analyses demonstrated no significant difference in disease-free survival (HR0.72, 95%CI 0.46-1.13, p = 0.15) and overall survival (HR0.73, 95%CI 0.48-1.13, p = 0.16) between robotic and laparoscopic right hemicolectomy for right colon cancer. Robotic right hemicolectomy for right colon cancer is comparable with conventional laparoscopic right hemicolectomy in terms of long-term oncological survival. More prospective, multicenter, randomized trials are necessary to determine the oncologic safety of robotic right hemicolectomy.

Physician and Patient-Reported Outcomes of a Phase III Trial of Ultra-Hypofractionated vs. Moderate Hypofractionated Radiotherapy to the Whole Breast after Breast-Conserving Surgery

To report a final analysis evaluating physician and patient-reported outcomes of early breast cancer patients receiving moderate hypofractionation or ultra-hypofractionated whole breast radiotherapy (RT). Between April 4, 2018, and February 11, 2020, patients with localized breast cancer (T1-T3, N0-N1, and M0) managed with breast-conserving surgery (BCS) were enrolled. Patients were randomized to receive whole breast RT with moderate hypofractionation to 40 Gy in 15 fractions (Arm A) or ultra-hypofractionation to 25 Gy in 5 fractions (Arm B). An optional concurrent integrated boost to 48 Gy on Arm A or 30 Gy on Arm B was allowed. Early toxicity (<3 months), late toxicity (> 3 months), quality of life (QOL), cosmesis, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and deterioration of cosmesis were analyzed. One hundred and seven patients were randomized to moderate hypofractionation (n = 54) or ultra-hypofractionation (n = 53). With a median follow-up of 36 months, no significant differences in patient characteristics were noted between the two arms. There were no patients with a grade ≥3 or higher toxicity. Grade 2 toxicities were 7.4% in Arm A and 7.5% in Arm B, and primarily consisted of radiation dermatitis (6 patients), fibrosis (1 patient) and lymphedema (1 patient). The average Harvard Cosmesis score and overall QoL were similar between arms at all time points, with no patients developing cosmetic deterioration. Patient-reported moderate to severe radiation skin burns were more commonly reported in Arm A (21.05%) vs. Arm B (6.25%) at the end of treatment (EOT) (p = 0.078). At EOT, patients receiving moderate hypofractionation had higher mean toxicity scores in breast tenderness (2.66 vs. 1.5, p = 0.018), skin flaking or peeling (0.63 vs. 0.06, p = 0.035), blistering (0.74 vs. 0.06, p = 0.028), pruritis (2.53 vs. 0.87, p < 0.001), erythema (4.24 vs. 2.0, p <0.001), telangiectasias (1.0 vs. 0.28, p = 0.021). Additionally, patients receiving moderate hypofractionation reported significantly worse changes from baseline at EOT in breast tenderness (-2.25 vs. -.86, p = 0.02), telangiectasia (-0.81 vs. 0.18, p = 0.012), skin discoloration (-4.31 vs. -1.04, p < 0.001), skin flaking or peeling (-.55 vs. 0.04, p = 0.053), blistering (-0.82 vs. -0.07, p = 0.033), and pruritus (-2.27 vs. -.67, p = 0.002). There was a return to baseline in all patient-reported breast domains by 3 months (p >0.05) in both arms. Ultra-hypofractionated whole breast irradiation, consisting of 25 Gy in 5 fractions, provided comparable provider assessed toxicity and cosmetic outcomes to 40 Gy in 15 fractions. At the EOT assessment, ultra-hypofractionation had a better patient reported toxicity profile. Our findings provide further evidence to support daily ultra-hypofractionated whole breast radiotherapy as an appropriate treatment option for early-stage breast cancer.