Impact of chemoradiotherapy on PD1/PDL1 expression and clinical outcomes in gastroesophageal cancers.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4031-4031
Author(s):  
Arsen Osipov ◽  
Quanlin Li ◽  
Shant Thomassian ◽  
Lakshmanan Annamalai ◽  
Jennifer Holmes Yearley ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Clinical Outcomes ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Death Receptor ◽  
Cox Proportional Hazards ◽  
Gastrointestinal Malignancies ◽  
Expression Levels ◽  
Gastric Cancer Patients ◽  
The Impact

4031 Background: Expression of the immune modulating proteins, programmed death receptor-1 (PD1) and its ligand (PDL1), in gastrointestinal malignancies is associated with poor prognosis. PD1/PDL1 expression levels have also been identified as predictors of response to checkpoint inhibition. Minimal data is available on how expression of PD1 and PDL1 is influenced by chemoradiotherapy (CRT). In this study, we investigated the relationship between PDL1/PD1 expression, CRT, and clinical outcomes in gastroesophageal (GE) cancer. Methods: With IRB approval, we identified 28 patients with gastric cardia or GE junction tumors who underwent neoadjuvant standard CRT followed by surgical resection. Pre-CRT biopsies and post-CRT surgical specimens were analyzed using quantitative immunohistochemistry for the expression of PDL1 and PD1. Samples were categorized as trace-low (TL) or moderate-high (MH) expressors of PDL1 and PD1. The impact of these and other clinical and pathologic variables on overall survival (OS) was assessed using multivariate cox proportional hazards modeling. Co-expression of PDL1 and PD1 in matched samples was determined by regression analysis. Results: Following CRT, PDL1 and PD1 expression increased in 54% and 32% of patients, respectively. On multivariate analysis, patients with MH expression of PD1 after CRT irrespective of pre-CRT expression levels had a significant decrease in OS compared to those with TL expression (median survival 23.1 vs 74.1 months; HR,3.31; CI,1.05-10.35; p = 0.039). In patients with gastric confined tumors, an increase in PD1 expression from TL to MH after CRT was associated with significantly lower OS rates (p = 0.003). Regression analysis of PD1 to PDL1 was significant (p < 0.01) both before and after CRT, with a correlation coefficient of 0.34 in pre-CRT and 0.49 in post-CRT specimens. Conclusions: Elevated expression of PD1 is associated with poor OS in patients with GE cancer. Neoadjuvant CRT upregulates both PDL1 and PD1. In gastric cancer patients, this led to significantly worse survival. These data identify potential mechanisms of resistance and suggest a role for checkpoint inhibitors in combination with CRT.

scholarly journals Impact of Pathological Stratification on the Clinical Outcomes of Advanced Well-Differentiated/Dedifferentiated Liposarcoma Treated with Trabectedin

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1453
Author(s):  
Chiara Fabbroni ◽  
Giovanni Fucà ◽  
Francesca Ligorio ◽  
Elena Fumagalli ◽  
Marta Barisella ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Proportional Hazards ◽  
Case Series ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Low Grade ◽  
High Grade ◽  
Retrospective Case ◽  
Well Differentiated ◽  
The Impact

Background. We previously showed that grading can prognosticate the outcome of retroperitoneal liposarcoma (LPS). In the present study, we aimed to explore the impact of pathological stratification using grading on the clinical outcomes of patients with advanced well-differentiated LPS (WDLPS) and dedifferentiated LPS (DDLPS) treated with trabectedin. Patients: We included patients with advanced WDLPS and DDLPS treated with trabectedin at the Fondazione IRCCS Istituto Nazionale dei Tumori between April 2003 and November 2019. Tumors were categorized in WDLPS, low-grade DDLPS, and high-grade DDLPS according to the 2020 WHO classification. Patients were divided in two cohorts: Low-grade (WDLPS/low-grade DDLPS) and high-grade (high-grade DDLPS). Results: A total of 49 patients were included: 17 (35%) in the low-grade cohort and 32 (65%) in the high-grade cohort. Response rate was 47% in the low-grade cohort versus 9.4% in the high-grade cohort (logistic regression p = 0.006). Median progression-free survival (PFS) was 13.7 months in the low-grade cohort and 3.2 months in the high-grade cohort. Grading was confirmed as an independent predictor of PFS in the Cox proportional-hazards regression multivariable model (adjusted hazard ratio low-grade vs. high-grade: 0.45, 95% confidence interval: 0.22–0.94; adjusted p = 0.035). Conclusions: In this retrospective case series, sensitivity to trabectedin was higher in WDLPS/low-grade DDLPS than in high-grade DDLPS. If confirmed in larger series, grading could represent an effective tool to personalize the treatment with trabectedin in patients with advanced LPS.

Thromboembolism (TE) in patients (pts) with bladder cancer treated with checkpoint inhibitors (CPIs).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5042-5042
Author(s):  
Iris Yeong- Fung Sheng ◽  
Shilpa Gupta ◽  
Chandana A. Reddy ◽  
Dana E Angelini ◽  
Pauline Funchain ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Upper Limb ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Cleveland Clinic ◽  
Cox Proportional Hazards ◽  
High Risk Population ◽  
Kaplan Meier ◽  
Tract Disease ◽  
The Impact

5042 Background: Most pts with bladder cancer will be treated with immunotherapy. There is concern for increased TE risk with CPIs in this already high risk population. We present the first analysis of the incidence and outcomes of venous (VTE) and arterial (ATE) thromboembolism in pts with bladder cancer treated with CPIs. Methods: Consecutive pts with bladder cancer treated with CPIs at the Cleveland Clinic from 1/2015 to 12/2019 were identified and TE events noted. Overall survival (OS) was estimated using Kaplan-Meier method and the impact of VTE on OS was evaluated using Cox proportional hazards regression. Results: Of 274 pts, 72% were men (median age 73.3 years, 89% white), 82% had pure UC, 92% had lower tract disease, and 67% had a Bajorin score ≥1 (median KPS 90, 61% visceral metastases), 59% had prior systemic therapy (median 1, range 0-4) and 36% had prior TE (14% ATE, 19% VTE, 0.4% both). At CPI initiation, 24% were on antiplatelet therapy, and 15% on therapeutic anticoagulation. CPI (median doses 5, range 8.5-59) included: 40% atezolizumab, 3% nivolumab, 57% pembrolizumab. VTE occurred in 14% (n = 37), including 8% DVT, 4% PE, 2% both. DVT locations were 56% lower limb, 26% upper limb, 15% visceral vein, 4% visceral+upper limb. 2% (n = 5) had ATE (1% CVA, 0.4% visceral, 0.4% left subclavian). 92% of VTE and all ATE occurred within 6 months of CPI initiation. The incidence of TE was 10.9% (95%CI 6.6%—15.1%) at 6 months and 19.8% (95%CI 13.3%-26.4%) at 12 months. 82% of VTE (mean 6 days) and all ATE (mean 5 days) resulted in hospitalization. Multivariate analysis showed TE (HR 2.296, 95%CI 1.451-3.632, p = 0.0004), Bajorin score 1 (HR 1.490, 95%CI 1.036-2.142, p = 0.0315), and Bajorin score 2 (HR 3.50, 95%CI 2.14-5.74, p < 0.0001) were independently associated with worse OS. Conclusions: CPIs in bladder cancer pts are associated with a high TE risk, especially within six months of initiation. TE is associated with worsened survival. Further investigation into the risk factors for CPI-associated TE is needed to identify if benefits exist from thromboprophylaxis.

scholarly journals Clinical Outcomes of Patients with Combined Idiopathic Pulmonary Fibrosis and Emphysema in the IPF-PRO Registry

Lung ◽  
2022 ◽  
Author(s):  
Hyun J. Kim ◽  
Laurie D. Snyder ◽  
Megan L. Neely ◽  
Anne S. Hellkamp ◽  
David L. Hotchkin ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Clinical Outcomes ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Models ◽  
Baseline Variable ◽  
Former Smokers ◽  
The Impact ◽  
Baseline Covariates

Abstract Purpose To assess the impact of concomitant emphysema on outcomes in patients with idiopathic pulmonary fibrosis (IPF). Methods The IPF-PRO Registry is a US registry of patients with IPF. The presence of combined pulmonary fibrosis and emphysema (CPFE) at enrollment was determined by investigators’ review of an HRCT scan. Associations between emphysema and clinical outcomes were analyzed using Cox proportional hazards models. Results Of 934 patients, 119 (12.7%) had CPFE. Compared with patients with IPF alone, patients with CPFE were older (median 72 vs 70 years); higher proportions were current/former smokers (88.2% vs 63.7%), used oxygen with activity (49.6% vs 31.9%) or at rest (30.8% vs 18.4%), had congestive heart failure (13.6% vs 4.8%) and had prior respiratory hospitalization (25.0% vs 16.7%); they had higher FVC (median 71.8 vs 69.4% predicted) and lower DLco (median 35.3 vs 43.6% predicted). In patients with CPFE and IPF alone, respectively, at 1 year, rates of death or lung transplant were 17.5% (95% CI: 11.7, 25.8) and 11.2% (9.2, 13.6) and rates of hospitalization were 21.6% (14.6, 29.6) and 20.6% (17.9, 23.5). There were no significant associations between emphysema and any outcome after adjustment for baseline variables. No baseline variable predicted outcomes better in IPF alone than in CPFE. Conclusion Approximately 13% of patients in the IPF-PRO Registry had CPFE. Physiologic characteristics and comorbidities of patients with CPFE differed from those of patients with IPF alone, but the presence of emphysema did not drive outcomes after adjustment for baseline covariates. Trial registration ClinicalTrials.gov, NCT01915511; registered August 5, 2013.

Any regression of tumor (ART) within 12 weeks versus RECIST 1.1 response category as an intermediate endpoint to assess the activity of immune checkpoint inhibitors (ICIs) for metastatic urothelial carcinoma (mUC).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 473-473
Author(s):  
Catherine Curran ◽  
Gregory Russell Pond ◽  
Amin Nassar ◽  
Sarah Abou Alaiwi ◽  
Bradley Alexander McGregor ◽  
...  
Keyword(s):  
Survival Data ◽  
Tumor Size ◽  
Proportional Hazards ◽  
Checkpoint Inhibitors ◽  
Cox Proportional Hazards ◽  
P Value ◽  
Prognostic Effect ◽  
Recist 1.1 ◽  
Metastatic Urothelial Carcinoma ◽  
The Impact

473 Background: Many ICIs are approved to treat mUC following platinum-based chemo and as 1st-line therapy for selected patients (pts). While RECIST 1.1 responses are generally durable and associated with prolonged survival, the benefit of ICIs extends beyond this group of pts. Stable disease (SD) consists of a heterogeneous population of pts with both increase and decrease in tumor size and is confounded by the impact of pre-ICI disease pace. We hypothesized that in the setting of ICIs, any regression of tumor (ART) within 12 weeks may capture early benefit and correlate with survival more comprehensively than RECIST 1.1. Methods: mUC pts who received an ICI following platinum-based chemo at DFCI were eligible for analysis. Pts were required to have tumor size changes, RECIST 1.1 response by week 12 and survival data available. Demographics and prognostic factors were collected. Descriptive stats were calculated, and univariable Cox proportional hazards regression analysis was conducted to examine the prognostic effect of ART and RECIST 1.1 with overall survival (OS). Results: 104 pts were evaluable. The median age was 66 (range 34-89). 71% were male. The numbers of pts with ART and RECIST1.1 partial response (PR) were 45 (43.3%) and 32 (30.1%), respectively. Univariable analyses identified an association between ART and RECIST 1.1 response with OS (p<0.001). The 1-year OS (95% CI) for ART vs. no ART was 83.6 % (68.7, 91.8) and 35.9 % (23.1, 48.8), while the 1-year OS (95% CI) for RECIST 1.1 response vs. no response was 81.3% (62.9, 91.1) and 45.6% (32.9, 57.4), respectively. RECIST 1.1 category was not significantly associated with OS (p-value=0.68) after adjusting for ART; however, statistically, ART associated with OS (p=0.002) after adjusting for RECIST 1.1 category. The modest size of this cohort is a limitation. Conclusions: ART within 12 weeks is identified early and is robustly associated with OS in pts with mUC receiving post-platinum ICIs. ART may serve as a more optimal intermediate endpoint for survival compared to RECIST 1.1 in the setting of ICIs. Evaluating this endpoint in other malignancies is warranted.

scholarly journals Multicenter, Observational Cohort Study Evaluating Third-Generation Cephalosporin Therapy for Bloodstream Infections Secondary to Enterobacter, Serratia, and Citrobacter Species

Antibiotics ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. 254 ◽  
Author(s):  
Caroline Derrick ◽  
P. Brandon Bookstaver ◽  
Zhiqiang K. Lu ◽  
Christopher M. Bland ◽  
S. Travis King ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Outcomes ◽  
Proportional Hazards ◽  
Bloodstream Infections ◽  
Cox Proportional Hazards ◽  
Third Generation ◽  
Cox Proportional Hazards Regression ◽  
Proportional Hazards Regression ◽  
Definitive Therapy ◽  
The Impact

Objectives: There is debate on whether the use of third-generation cephalosporins (3GC) increases the risk of clinical failure in bloodstream infections (BSIs) caused by chromosomally-mediated AmpC-producing Enterobacterales (CAE). This study evaluates the impact of definitive 3GC therapy versus other antibiotics on clinical outcomes in BSIs due to Enterobacter, Serratia, or Citrobacter species. Methods: This multicenter, retrospective cohort study evaluated adult hospitalized patients with BSIs secondary to Enterobacter, Serratia, or Citrobacter species from 1 January 2006 to 1 September 2014. Definitive 3GC therapy was compared to definitive therapy with other non-3GC antibiotics. Multivariable Cox proportional hazards regression evaluated the impact of definitive 3GC on overall treatment failure (OTF) as a composite of in-hospital mortality, 30-day hospital readmission, or 90-day reinfection. Results: A total of 381 patients from 18 institutions in the southeastern United States were enrolled. Common sources of BSIs were the urinary tract and central venous catheters (78 (20.5%) patients each). Definitive 3GC therapy was utilized in 65 (17.1%) patients. OTF occurred in 22/65 patients (33.9%) in the definitive 3GC group vs. 94/316 (29.8%) in the non-3GC group (p = 0.51). Individual components of OTF were comparable between groups. Risk of OTF was comparable with definitive 3GC therapy vs. definitive non-3GC therapy (aHR 0.93, 95% CI 0.51–1.72) in multivariable Cox proportional hazards regression analysis. Conclusions: These outcomes suggest definitive 3GC therapy does not significantly alter the risk of poor clinical outcomes in the treatment of BSIs secondary to Enterobacter, Serratia, or Citrobacter species compared to other antimicrobial agents.

scholarly journals Clinical Implications of Size of Cavities in Patients With Nontuberculous Mycobacterial Pulmonary Disease: A Single-Center Cohort Study

2021 ◽  
Vol 8 (3) ◽  
Author(s):  
Hye-Rin Kang ◽  
Eui Jin Hwang ◽  
Sung A Kim ◽  
Sun Mi Choi ◽  
Jinwoo Lee ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Pulmonary Disease ◽  
Clinical Outcomes ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
University Hospital ◽  
Study Cohort ◽  
National University ◽  
Seoul National University ◽  
The Impact

Abstract Background The presence of cavities is associated with unfavorable prognosis in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD). However, little is known about the characteristics of such cavities and their impact on clinical outcomes. The aim of this study was to investigate the size of cavities and their implications on treatment outcomes and mortality in patients with NTM-PD. Methods We included patients diagnosed with NTM-PD at Seoul National University Hospital between January 1, 2007, and December 31, 2018. We measured the size of cavities on chest computed tomography scans performed at the time of diagnosis and used multivariable logistic regression and Cox proportional hazards regression analysis to investigate the impact of these measurements on treatment outcomes and mortality. Results The study cohort comprised 421 patients (noncavitary, n = 329; cavitary, n = 92) with NTM-PD. During a median follow-up period of 49 months, 118 (35.9%) of the 329 patients with noncavitary and 64 (69.6%) of the 92 patients with cavitary NTM-PD received antibiotic treatment. Cavities &gt;2 cm were associated with worse treatment outcomes (adjusted odds ratio, 0.41; 95% CI, 0.17–0.96) and higher mortality (adjusted hazard ratio, 2.52; 95% CI, 1.09–5.84), while there was no difference in treatment outcomes or mortality between patients with cavities ≤2 cm and patients with noncavitary NTM-PD. Conclusions Clinical outcomes are different according to the size of cavities in patients with cavitary NTM-PD; thus, the measurement of the size of cavities could help in making clinical decisions.

scholarly journals 1319. Assessment of Spectrum Score-Based Antibiotic De-Escalation in Patients with Nosocomial Pneumonia

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S748-S748
Author(s):  
Daniel T Ilges ◽  
Elizabeth Neuner ◽  
Tamara Krekel ◽  
David J Ritchie ◽  
Nicholas B Hampton ◽  
...  
Keyword(s):  
Regression Analysis ◽  
Treatment Failure ◽  
Proportional Hazards ◽  
Cox Regression ◽  
Multivariate Regression Analysis ◽  
Cox Proportional Hazards ◽  
Empiric Antibiotic Therapy ◽  
Cox Regression Analysis ◽  
Patient Admissions ◽  
The Impact

Abstract Background Hospital-acquired and ventilator-associated pneumonia (HAP/VAP) cause significant morbidity and mortality. Guidelines recommend broad-spectrum empiric antibiotic therapy, including treatment for Pseudomonas aeruginosa (PSAR) and methicillin-resistant Staphylococcus aureus (MRSA), followed by de-escalation (DE). This study sought to assess the impact of DE on treatment failure. Methods This single-center retrospective cohort study screened all adult patients with a discharge diagnosis code for pneumonia from 2016–2019. Patients were enrolled if they met pre-defined criteria for HAP/VAP ≥48 hours after admission. Date of pneumonia diagnosis was defined as day 0. Spectrum scores were calculated, and DE was defined as a score reduction on day 3 versus day 1. Patients with DE were compared to patients with no de-escalation (NDE). Data were compared using chi-square, Mann-Whitney U, or T-tests. The primary outcome was composite treatment failure, defined as all-cause mortality or re-admission for pneumonia within 30 days of diagnosis, analyzed using a Cox proportional hazards analysis to control for confounding variables. Figure 1. Study Schematic Table 1. Spectrum Score Assignment Results Of 11860 admissions screened, 1812 unique patient-admissions were included (1102 HAP, 710 VAP). Fewer patients received DE (876 DE vs. 1026 NDE). Groups were well-matched at baseline, although more patients receiving DE had respiratory cultures ordered (56.6% vs. 50.6%, P=0.011). Patients receiving DE experienced a 65% and 44% reduction in anti-MRSA and anti-PSAR therapies by day 3, respectively. There was no difference in composite treatment failure (35.0% DE vs. 33.8% NDE, P=0.604). DE was not associated with treatment failure on Cox multivariate regression analysis (HR 1.13, 95% CI 0.97-1.33, P=0.149). Patients receiving DE had fewer antimicrobial days (median 9 vs. 11, P&lt; 0.0001), episodes of Clostridioides difficile (2.2% vs. 3.8%, P=0.046), and days of hospitalization (median 20 vs. 22 days, P=0.006). Figure 2: Median Spectrum Scores (SS) Days 0 to 28 Table 2: Cox Regression Analysis Conclusion DE and NDE resulted in similar rates of composite treatment failure at 30 days; however, DE was associated with fewer antimicrobial days, episodes of C. difficile, and days of hospitalization. Spectrum scores can objectively identify DE, but further studies are needed to fully understand their utility in this context. Disclosures Tamara Krekel, PharmD, BCPS, BCIDP, Merck (Speaker’s Bureau) David J. Ritchie, PharmD, BCPS (AQ-ID), AbbVie (Speaker’s Bureau)Merck (Speaker’s Bureau)

scholarly journals Clinical Implications of Size of Cavities in Patients With Nontuberculous Mycobacterial Pulmonary Disease: A Single-Center Cohort Study

2020 ◽  
Author(s):  
Hye-Rin Kang ◽  
Eui Jin Hwang ◽  
Sung A Kim ◽  
Sun Mi Choi ◽  
Jinwoo Lee ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Pulmonary Disease ◽  
Clinical Outcomes ◽  
Proportional Hazards ◽  
Cox Proportional Hazards ◽  
University Hospital ◽  
Study Cohort ◽  
Poor Prognostic Factor ◽  
National University ◽  
The Impact

Abstract BackgroundThe presence of cavities is a poor prognostic factor in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD). However, little is known about the characteristics of such cavities and their impact on clinical outcomes. The aim of this study is to investigate the size of cavities and their implications on treatment outcomes and mortality in patients with NTM-PD.MethodsWe included patients diagnosed with NTM-PD at Seoul National University Hospital between 1 January 2007 and 31 December 2018. We measured the size of cavities on chest computed tomography scans performed at the time of diagnosis, and used multivariable logistic regression and Cox-proportional hazards regression analysis to investigate the impact of these measurements on treatment outcomes and mortality. ResultsThe study cohort comprised 421 patients (non-cavitary, n=329; cavitary, n=92) with NTM-PD. During a median follow-up period of 49 months, 118 (35.9%) of the 329 patients with non-cavitary and 64 (69.6%) of the 92 patients with cavitary NTM-PD received antibiotic treatment. Cavities >2 cm were associated with worse treatment outcomes (adjusted odds ratio, 0.38; 95% confidence interval [CI], 0.16–0.86) and higher mortality (adjusted hazard ratio, 2.50; 95% CI, 1.04–6.02), while there was no difference in treatment outcomes and mortality between patients with cavities <2 cm and patients with non-cavitary NTM-PD. ConclusionsClinical outcomes are different according to the size of cavities in patients with cavitary NTM-PD; thus the measurement of the size of cavities could help in making clinical decisions.

Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 110-110 ◽  
Author(s):  
Sean Khozin ◽  
Mark S. Walker ◽  
Monika Jun ◽  
Li Chen ◽  
Edward Stepanski ◽  
...  
Keyword(s):  
Autoimmune Disease ◽  
Real World ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
Rank Test ◽  
The Impact

110 Background: Anecdotal and early evidence suggest ICIs are being used in patients with advanced malignancies and history of AD, despite such patients being typically excluded from traditional clinical trials. We compared the outcomes of patients with or without AD, all of whom had ICI treatment for aNSCLC. Methods: We conducted a retrospective, observational cohort study using de-identified, curated data in ASCO’s CancerLinQ. Patients with Stage III or IV NSCLC who received ≥1 dose of an ICI and had ≥2 visits from Jan 2011 to Nov 2018 were included. AD status prior to ICI treatment was identified using ICD-9/ICD-10 codes or AD medications (including steroids). Symphony claims data were linked via tokenization to build cohorts. Time to treatment discontinuation (TTD), time to next treatment (TTNT), real-world progression-free survival (rwPFS) and overall survival (OS) were compared across the two cohorts using the log-rank test. Cox Proportional Hazards Model was used to adjust for covariates. Adverse events (AEs) were compared using Chi-Square and Fisher’s Exact Test. Active AD was defined as evidence of autoimmune disease in the year prior to starting ICIs. Results: Among 2425 patients with aNSCLC treated with ICIs, AD was present in 22% (N=538). Median OS in all patients was 12.4 months (95% CI 11.3-13.5). TTD, TTNT, rwPFS and OS did not differ between the two cohorts (Table). There was no association between AD status and outcomes. There was no increased incidence of AEs in the AD group; however a sub-analysis among patients with active AD showed higher rates of select AEs including endocrine, GI and blood disorders. Conclusions: This analysis demonstrates that patients with evidence of AD prior to receiving ICI have similar outcomes compared to patients with no evidence of AD. Further research is needed to better understand the impact of active AD on the risk of AEs and patient outcomes. [Table: see text]

scholarly journals Impact of an Intermediate Respiratory Care Unit on Clinical Outcomes of COVID-19 Patients

2020 ◽  
Author(s):  
Guillermo Suarez-Cuartin ◽  
Merce Gasa ◽  
Guadalupe Bermudo ◽  
Yolanda Ruiz-Albert ◽  
Marta Hernandez-Argudo ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Cox Proportional Hazards ◽  
Respiratory Support ◽  
Respiratory Care ◽  
High Dose ◽  
Risk Of Death ◽  
Systemic Corticosteroids ◽  
The Impact

Abstract Background: Many severe COVID-19 patients require respiratory support and monitoring. An intermediate respiratory care unit (IMCU) may be a valuable element for optimizing patient care and limited health-care resources management. We aim to assess the impact of an IMCU in the management of severe COVID-19.Methods: Observational, retrospective study including patients admitted to the IMCU due to COVID-19 pneumonia during the months of March and April 2020. Patients were stratified based on their requirement of transfer to the intensive care unit (ICU) and on survival status at the end of follow-up. A multivariable Cox proportional hazards method was used to assess risk factors associated with mortality.Results: A total of 253 patients were included. Of them, 68% were male and median age was 65 years (IQR 18 years). Ninety-two patients (36.4%) required ICU transfer. Patients transferred to the ICU had a higher mortality rate (44.6% Vs 24.2%; p<0.001). Multivariable proportional hazards model showed that age ³65 years (HR 4.14; 95%CI 2.31-7.42; p<0.001); chronic respiratory conditions (HR 2.34; 95%CI 1.38-3.99; p=0.002) and chronic kidney disease (HR 2.96; 95%CI 1.61-5.43; p<0.001) were independently associated with mortality. High-dose systemic corticosteroids followed by progressive dose tapering showed a lower risk of death (HR 0.15; 95%CI 0.06-0.40; p<0.001). Conclusions: IMCU allow to safely and effectively manage severe COVID-19 patients requiring respiratory support and non-invasive monitoring, therefore reducing ICU burden. Older age and chronic respiratory or renal conditions are associated with worse clinical outcomes, while treatment with systemic corticosteroids may have a protective effect on mortality.

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