Immune related adverse events and their treatment in melanoma patients receiving ipilimumab.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14598-e14598 ◽  
Author(s):  
Gerardo Cabanillas
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Immune Checkpoint Inhibitor ◽  
Insurance Coverage ◽  
Female Gender ◽  
Gastrointestinal Diseases ◽  
Categorical Variables ◽  
Continuous Variables ◽  
Regular Care ◽  
Melanoma Patients

e14598 Background: Ipilimumab is an immune checkpoint inhibitor approved for the treatment of melanoma. Immune-related adverse events (irAEs) may occur as adverse effects. Most reports on irAEs are from clinical trials, which may not reflect community clinical practice and outcomes. We used a health insurance based database to identify irAEs and their treatment among patients with melanoma that received Ipilimumab, as part of regular care. Methods: We identified all melanoma patients aged 18 and older who received Ipilimumab from the Truven Health Analytics Marketscan database between 2011 and 2014. Patients had continuous insurance coverage from the period of six months prior to Ipilimumab and three months after. We further assessed the treatment for each irAEs. IrAEs were defined base on claims with one or more 228 ICD-9 codes; irAEs had to occur within a 6-month window before treatment. We used summary statistics such as means and standard deviations for continuous variables, frequencies and percentages for categorical variables. Results: The cohort included 1225 patients. Median age was 60 years, 62% were male; 343 (35.44%) patients had one or more irAEs, and 48.6% (211) were treated at least once. Young age and female gender were associated with a higher likelihood of having an irAEs. Endocrinopathies and gastrointestinal diseases were the most common irAEs. The most frequent irAEs was colitis in 27% of patients, followed by hypothyroidism 26%. Six different drugs were used to treat irAEs, and corticosteroids being the most frequently prescribed. Few patients with colitis received Infliximab 14%; and cyclosporine was prescribed in one patient with pancreatitis Conclusions: One third of the patients with melanoma treated with Ipilimumab in the community developed irAEs. Corticosteroids were the most frequent drugs used to treat irAEs. Our results show that toxicity remains high with the use of this agent in clinical practice.

scholarly journals MO152CORRELATION OF PERCEIVED FRAILTY WITH MEASURED FRAILTY IN AN ADULT HAEMODIALYSIS POPULATION

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Ruth Fergie ◽  
Jennifer McCaughan ◽  
Peter Eves ◽  
Siddesh Prabhavalkhar ◽  
Girish Shivashankar ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Basic Education ◽  
Physiological Stress ◽  
Care Home ◽  
Adverse Outcomes ◽  
Categorical Variables ◽  
Chronic Haemodialysis ◽  
Continuous Variables ◽  
Clinical Frailty Scale ◽  
Dialysis Unit

Abstract Background and Aims Frailty is a measure of physiological reserve and the ability to respond to physiological stress. Increasing frailty predicts adverse health outcomes in patients with end stage renal disease (ESRD) Despite this, frailty is not routinely measured in clinical practice where clinician perception of frailty is used to inform decision making. The Clinical Frailty Scale (CFS) is a clinical judgement-based score that is a useful screening tool for frailty. Increasing frailty measured by CFS is predictive of adverse outcomes in patients with advanced chronic kidney disease (CKD) including falls, worsening disability, care home admissions, hospitalizations and ultimately mortality. It has been widely used in the assessment of patients with COVID-19 to help inform decisions regarding ceiling of care. This study aimed to assess the correlation between clinician perception of frailty and frailty as measured using the CFS. Method Frailty was assessed for all patients undergoing in centre hospital haemodialysis (n=53) in a single dialysis unit in Northern Ireland. A CFS score was calculated for all patients by a clinician who routinely uses the CFS in clinical practice. Patients with a score of 1-3 were classified as not frail, 4-5 as intermediately frail and 6-9 as frail. Nephrologists received basic education about frailty. They were then asked to categorize their patients as non-frail, intermediately frail or frail. The relationship between measured and perceived frailty was assessed using percent agreement. Participant characteristics of frail patients who were misclassified as intermediately frail or non-frail by clinicians were compared to those patients correctly classified as non-frail by clinicians. Fisher’s exact test was employed for categorical variables and t-tests were employed for pseudo normally distributed continuous variables. Results Of the 53 participants, the median age was 59 years (26-89). 41.5% were women. The median time on dialysis was 1.6 years. According to the CFS, 6 patients were categorised as non-frail, 30 patients as intermediately frail and 17 as frail. Among frail participants, 41% were correctly perceived as frail by their nephrologist. Among non-frail participants, 100% were correctly perceived as non-frail by their nephrologist. Among those who were frail according to the CFS, those misclassified as intermediately frail or non-frail, were younger (median age of those misclassified 49 years vs 62 years of those not mis-classified, P=0.03) but did not differ by sex (P=1), time on dialysis (P=0.39), presence of diabetes (P=0.30) or presence of vascular disease (P=1). Conclusion In this study of adult patients undergoing chronic haemodialysis, perceived frailty correlated with measured frailty using the CFS less than 50% of the time. This suggests that clinical perception is not an accurate surrogate for frailty status in this population group. Additionally, this study suggests that younger patients with ESRD are less likely to be correctly perceived as frail. Such misclassification could influence clinical decisions for treatment, including candidacy for kidney transplantation.

Predictors of immune-related adverse events associated with checkpoint inhibitors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15159-e15159
Author(s):  
Alhareth Alsayed ◽  
Ashish Manne ◽  
Daisy E Escobar ◽  
Gaurav Sharma ◽  
Pranitha Prodduturvar ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Lymphocyte Count ◽  
Checkpoint Inhibitors ◽  
Hematological Parameters ◽  
White Blood Count ◽  
Categorical Variables ◽  
Fisher Exact Test ◽  
Continuous Variables ◽  
Grade 3

e15159 Background: Immune-related adverse events (irAE) remain a significant challenge with the expansion of checkpoint inhibitors (ICI) indications. Unlike previous studies published, we investigated risk factors for irAE development, including lymphocytes and neutrophils counts in lung cancer and melanoma treated with all available ICIs in current clinical practice. Methods: This is a retrospective study conducted at the University of South Alabama Mitchell Cancer Institute. Between 2015-2019. A total of 160 patients with a diagnosis of melanoma (N = 54) or lung cancer (N = 106) who received at least two doses of ICI including ipilimumab (15%), nivolumab (32%), pembrolizumab (35%), dual nivolumab/ipilimumab (5%), durvalumab (9%) and atezolizumab (4%). The patient's baseline characteristics were extracted with irAE (grade 3/4) details and survival outcomes. Descriptive statistics were used, Fisher exact test to compare categorical variables, and Wilcoxon rank sum test for continuous variables using JMP software. Results: The median age at diagnosis was 64 years (range 17-93), with 51% females. Race distribution with 76% Caucasians and 26% African Americans. Around 30% of the cohort was treated for recurrence, and 39% did receive prior systemic chemotherapy. Median overall survival (OS) was 13.5 months (m) for melanoma and 16 m for lung cancer with CI 95% [16-24] and [15-23], respectively. Twenty-nine (29%) percent of the cohort (N = 46) had grade 3/4 irAEs. Median of baseline hematological parameters including total white blood count (WBC), absolute neutrophil count (ANC), absolute lymphocyte count (ALC), ANC to ALC ratio, and platelet to ALC ratio of these patients were not statistically different from the cohort without grade 3/4 irAEs. Interestingly, if a patient has baseline ALC < 1K/μL, the risk of irAE recurrence is low when ICI is re-initiated, p = .0143 (after symptomatic recovery from irAEs). Conclusions: Irrespective of ICI used, baseline lymphocyte count, and its relation to other blood counts have no clear impact on irAE. Larger cohorts or prospective studies are needed to make stronger conclusions about the relationship between the immune system and the occurrence of irAEs

The TNT protocol: A phase II study using talimogene laherparepvec (TVEC), nivolumab (N) and trabectedin (T) as first, second/third line therapy for advanced sarcoma, including desmoid tumor and chordoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS11572-TPS11572 ◽  
Author(s):  
Sant P. Chawla ◽  
Victoria S. Chua ◽  
Katherine Kim ◽  
Paul Stendahl Dy ◽  
Micaela Kristina Paz ◽  
...  
Keyword(s):  
Survival Rate ◽  
Adverse Events ◽  
Desmoid Tumor ◽  
Locally Advanced ◽  
Categorical Variables ◽  
System Organ Class ◽  
Continuous Variables ◽  
Talimogene Laherparepvec ◽  
Combination Methods ◽  
Advanced Sarcoma

TPS11572 Background: Talimogene laherparepvec (TVEC), an oncolytic HSV expressing huGMCSF, may be synergistic with trabectedin (T) and nivolumab (N) in treating advanced sarcoma. Objectives: (1) To evaluate the best overall response by RECIST v1.1, progression-free survival rate (PFS), and overall survival rate, (2) To determine the incidence of conversion of an unresectable tumor to a resectable one, and (3) To evaluate the incidence of adverse events related to the drug combination. Methods: This is an open label phase 2 study. A total of 40 patients will receive T (1.2 mg/m2 CIV over 24 hours q3 weeks), N (240 mg IV over 30 min q 2 weeks) and TVEC (intratumorally q 2 weeks according to tumor size). Eligible patients are those with histopathologically confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma including desmoid tumor and chordoma, previously untreated or treated, with measurable disease by RECIST v1.1, and at least, one accessible tumor for intratumoral injection of TVEC. Currently, 31 of the 40 patients have been enrolled. Statistical Considerations: Continuous variables will be summarized by the sample size (n), mean, standard deviation, first and third quartiles, minimum and maximum. Categorical variables will be summarized by the n and percent in each category. Point estimates for efficacy endpoint incidences will be accompanied by a 2-sided 95% exact binomial CI. Time to event endpoints will be summarized descriptively using the KM method. Safety (incidence and severity of adverse events and significant laboratory abnormalities) will be performed on all patients (ITT population). Patient incidence of all treatment emergent AEs will be tabulated by system organ class and preferred term. Clinical trial information: 03886311 .

Racial and insurance disparities in multiple myeloma management in a referral center.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18140-e18140
Author(s):  
Anne Renteria ◽  
Sundar Jagannath ◽  
Kezhen Fei ◽  
Sylvia Lin ◽  
Radhi Yagnik ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Racial Differences ◽  
Private Insurance ◽  
Insurance Coverage ◽  
Autologous Stem Cell Transplant ◽  
Categorical Variables ◽  
Cell Transplant ◽  
Continuous Variables ◽  
Logistic Regression Models ◽  
Referral Center

e18140 Background: Multiple Myeloma (MM) management has significantly improved disease-free and overall (OS) survival but disparities among racial groups still exist. After the Affordable Care Act, the extent to which induction, autologous stem cell transplant (ASCT), and maintenance therapies are used are uncertain. We sought to describe underuse of induction, ASCT and maintenance in a large referral center. Methods: Between 2010 and 2014, 3101 patients were diagnosed with MM via ICD-9 code from the Data Warehouse and certified hospital tumor registry. NCCN 2014 and CMS guidelines were used to define the categories of treatment underuse, and define transplant eligibility. Demographics including insurance, Charlson Comorbidity Index and treatments received were determined via chart abstraction. To date, 393 confirmed MM from 697 charts were abstracted. Comparison by groups used Chi-square for categorical variables, t-test and ANOVA for continuous variables. Multivariate logistic regression models were applied to predict underuse of induction, harvest, ASCT, and maintenance. Results: Patients were 62 ±11.3 years-old, with no racial differences in age and insurance coverage. More minorities had Medicaid (Black [B] 13%, White [W] 7%, Hispanic [H] 25%; p = 0.001). Almost all patients (97%) received induction (B 99%, W 96%, H 100%; p = 0.3), with no difference by insurance. Among transplant eligible patients, 93% underwent harvest, 87% underwent ASCT, with no racial differences. Patients with Medicare or self-pay were less likely to undergo harvest compared to patients with Medicaid or private insurance (p = 0.01). No difference in ASCT rates by insurance were noted. B patients were less likely to receive maintenance than non-B (73% vs 86%; p = 0.03), with no difference by insurance. OS was 73%, with no racial differences. In multivariate model, older age predicted induction underuse (aOR = 1.15, 95% CI: 1.06-1.25) (c = 0.9, p = 0.005), and B patients experienced more maintenance underuse (aOR = 2.22, 95% CI: 1.09-4.54) (c = 0.61, p = 0.1), controlling for age and comorbidity. Conclusions: While there were no racial or insurance differences in access to induction therapy, fewer Black patients received maintenance therapy. Interviews are underway to understand reasons for observed differences.

Nonattendance of adult otolaryngology patients for scheduled appointments

2006 ◽  
Vol 121 (3) ◽  
pp. 258-261 ◽  
Author(s):  
A D Cohen ◽  
D M Kaplan ◽  
M Kraus ◽  
E Rubinshtein ◽  
D A Vardy
Keyword(s):  
Logistic Regression ◽  
Waiting Time ◽  
Female Gender ◽  
Categorical Variables ◽  
Multivariate Logistic Regression Model ◽  
Patient Scheduling ◽  
Continuous Variables ◽  
Chi Square ◽  
Related Factors ◽  
Chi Square Test

Background: Nonattendance for appointments is an impediment to otolaryngology patient care worldwide. In a previous study of children attending an otolaryngology clinic, we observed that attendance was determined by the waiting time for an appointment and the timing of the appointment within the day. However, the factors that affect nonattendance in adults have not been well studied.Objective: We aimed to investigate factors associated with nonattendance in adults visiting an otolaryngology clinic.Methods: Nonattendance was observed for a period of one year in adult patients visiting an ambulatory otolaryngology clinic. The following parameters were also noted: age, gender, treating physician, waiting time and timing of the appointment. The chi-square test was used to analyse differences between categorical variables. The t-test was used to analyse differences between continuous variables. Logistic regression was used for multivariate analyses.Results: The study assessed 8071 visits to the otolaryngology clinic. The overall proportion of nonattendance was 27.7 per cent. A multivariate logistic regression model demonstrated that nonattendance was significantly associated with the following factors: female gender, younger age, long waiting time for an appointment, timing of the appointment within the day and the treating physician.Conclusion: In adult otolaryngology patients, nonattendance was associated with patient-related factors and healthcare systems related factors alike. It is suggested that managed overbooking could be carefully introduced into otolaryngology patient scheduling.

scholarly journals AB0210 COMPARISON OF EFFICACY AND SAFETY OF BIOSIMILAR RITUXIMAB AND ORIGINATOR RITUXIMAB IN REAL CLINICAL PRACTICE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1131.2-1131
Author(s):  
D. Kusevich ◽  
Y. Olyunin ◽  
E. Nasonov
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Normal Distribution ◽  
Group Treatment ◽  
Repeated Administration ◽  
Continuous Variables ◽  
Efficacy And Safety ◽  
The Third ◽  
Baseline Examination ◽  
Real Clinical Practice

Background:Due to the expiration of many originator biologics patents, their biosimilars (BS) have appeared and were put into clinical practice. The introduction of such drugs reduces the cost of treatment and thereby increases its availability. BS rituximab (RTX) Acellbia was developed by the Russian company “BIOCAD”. Its effectiveness and safety have been proven in two clinical trials. It was licensed in Russia for the treatment of rheumatoid arthritis (RA) in 2017.Objectives:To compare efficacy and safety of BSRTX and originator RTX (ORTX) in real clinical practice.Methods:RA patients fulfilling the EULAR/ACR 2010 criteria and followed-up at the V. A. Nasonova Research Institute of Rheumatology were included. All of them had previously received methotrexate without effect. They were divided into 4 groups. The first and second groups included patients who had not previously received biologics. Treatment with BSRTX was started in the first group, ORTX was administered in the second group. The third and fourth groups included patients who received ORTX with significant improvement. Patients of the third group were switched to BSRTX, in the fourth group treatment with ORTX was continued. ORTX and BSRTX were administered twice 500 mg over 2 weeks. The indication for repeated administration of ORTX and BSRTX was an exacerbation of RA. Patients were examined before the first or regular administration of ORTX or BSRTX and before the planned repeat course of treatment with these drugs. RA activity was evaluated with the DAS28. Adverse events (AE) were recorded. Data were tested for normality using the Kolmogorov-Smirnov test. Continuous variables are presented as mean ±SD if they obey normal distribution, and as median [quartile interval] if they were not consistent with normal distribution. Mann–Whitney U test was used for comparison between groups.Results:127 patients with RA were included. 66 patients had not previously received biologics. BSRTX was started in 35 of them and ORTX – in 31. 61 patients already received ORTHX with clinical improvement. 31 of them were switched to BSRTX, and 30 continued therapy with ORTX. The median interval between the baseline examination and the assessment before the second treatment course in the BSRTX group was 6 [5; 13] months, in the ORTX group – 7 [7; 11] months. In group 1 median DAS28 during follow-up decreased from 5,8 [5,2; 6,9] to 3,9 [3,1; 4,5], in group 2 – from 5,7 [5,2; 6,0] to 4,1 [3,8; 4,6], respectively. These changes were comparable in both groups. The mean duration of the interval between infusion of BSRTX or ORTX and repeated examination – 11,3±8,2 and 10,1±4,8 months, respectively. These differences are not significant. In group 3 median DAS28 at the baseline examination was 5,1 [3,9; 5,9], at the second one – 4,3 [3,8; 5,3], in group 4 – 4,6 [3,7; 5,4] and 4,2 [3,5; 5,2] respectively. These values did not differ significantly. The frequency and nature of adverse events during treatment with ORTX and BSRTX did not significantly differ. We did not observe serious AE and unexpected AE.Conclusion:The results of the present study show that efficacy and safety of BSRTX and ORTX were comparable when they were used as the first biologics and when switching from ORTX to BSRTX. BSRTX can be used in routine clinical practice for the treatment of RA.Disclosure of Interests:None declared

The association between immune-related adverse events and efficacy outcomes with consolidation pembrolizumab after chemoradiation in patients with stage III NSCLC: an analysis from HCRN LUN 14-179.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 9032-9032
Author(s):  
Nikhil Shukla ◽  
Sandra K. Althouse ◽  
Ahad Ali Sadiq ◽  
Shadia Ibrahim Jalal ◽  
Salma K. Jabbour ◽  
...  
Keyword(s):  
Adverse Events ◽  
Stage Iv ◽  
Wilcoxon Test ◽  
Stage Iii ◽  
Categorical Variables ◽  
Rank Test ◽  
Continuous Variables ◽  
Current Standard ◽  
Group A ◽  
Stage Iii Nsclc

9032 Background: Consolidation checkpoint inhibitor therapy (CPI) for up to 1 year following chemoradiation (CRT) is a current standard of care for pts with inoperable stage III NSCLC. However, some pts are not able to complete 1 year of CPI due to immune-related adverse events (irAES). In multiple retrospective studies, pts with stage IV NSCLC treated with CPI who experience irAEs generally receive fewer cycles of CPI without a significant detrimental effect on efficacy. The association between irAEs and outcomes with consolidation CPI after CRT has never been reported. Here we report the association between irAEs and efficacy outcomes from the HCRN LUN 14-179, a single-arm phase II trial of consolidation pembrolizumab following concurrent CRT in pts with unresectable stage III NSCLC. Methods: After completion of CRT eligible pts with stage III NSCLC without PD received pembrolizumab 200 mg IV q 3 wks for up to 1 yr. Demographics, disease characteristics, and number of cycles of pembrolizumab received were reported in pts who had any grade irAEs (except pneumonitis which included grade >2 only) [Group A] and those without irAEs (except grade 1 pneumonitis) [Group B]. Chi-square test (or Fisher's Exact test) were used for comparisons for categorical variables and Wilcoxon test for continuous variables. The Kaplan-Meier method was used to analyze time to metastatic disease (TMDD), PFS, and OS. A log-rank test was used to compare groups. Results: 92 eligible pts for efficacy analysis were enrolled from March 2015 to November 2016. 4 yr OS estimate for all pts is 46.2%. Any grade irAEs (except grade I pneumonitis) (n = 37 pts) included pneumonitis (18.5%), colitis (3.3%), increased creatinine (5.4%), elevated transaminases (3.3%), hyperthyroidism (7.6%), hypothyroidism (13.0%). Grade ≥ 2 irAEs (n = 32 pts) included pneumonitis (18.5%), hypothyroidism (10.8%), and colitis (3.3%). Group A/B: male (21/38), female (16/17), current or former smoker (35/52), stage IIIA (20/35), stage IIIB (17/20), non-squamous (21/30), squamous (16/25). Median number of pembrolizumab cycles received in Group A/B pts were 9 vs 15 (p = 0.0942) respectively. 4 yr efficacy endpoints in Groups A/B were TMDD 35.3% vs 41.3% (p = 0.83), PFS 27.8% vs 28.7% (p = 0.97), OS 43.5% vs 47.9% (p = 0.99), respectively. Conclusions: Despite receiving fewer cycles of consolidation pembrolizumab, pts who experienced any grade irAEs (excluding grade 1 pneumonitis) did not have significantly reduced efficacy outcomes. Clinical trial information: NCT02343952.

scholarly journals Use of Hepatitis C Positive Organs: Patient Attitudes in Urban Chicago

2018 ◽  
Vol 49 (1) ◽  
pp. 32-40 ◽  
Author(s):  
Thomas Couri ◽  
Thomas G. Cotter ◽  
Daniel Chen ◽  
Mary Hammes ◽  
Bharathi Reddy ◽  
...  
Keyword(s):  
Hepatitis C ◽  
Insurance Coverage ◽  
Descriptive Analysis ◽  
Organ Transplant ◽  
Categorical Variables ◽  
Solid Organ ◽  
Continuous Variables ◽  
Patient Attitudes ◽  
Donor Pool ◽  
Transplant Candidates

Background: Hepatitis C virus (HCV)-infected organs are being transplanted in patients with and without HCV in the direct-acting antiviral era. Little is known about patient attitudes towards receiving an HCV-positive organ. Objectives: The aim of this study is to determine transplant candidates’ attitudes towards receiving HCV-positive organs. Methods: Adult solid organ transplant candidates were identified during a clinic visit or during outpatient hemodialysis from May to December 2017. Willing participants completed a survey. Descriptive analysis including mean and median for continuous variables and frequencies for categorical variables were calculated by the appropriate statistical method and compared across willing, unsure, and unwilling patients and between willing and unsure/unwilling patients. Results: Fifty patients were surveyed with median age 54.5 years (range 32–77). Eighty-eight percent were awaiting kidney transplant, and 12% were awaiting other organs. Median waitlist time was 39.8 months (range 1.7–203 months). Most patients (90%) had prior knowledge of HCV, but only 60% knew it was curable. Forty-six percent were willing, 30% were unsure, and 24% were unwilling to receive an HCV-positive organ. Those willing to accept an HCV-positive organ were significantly older, Caucasian, had shorter waitlist times, and had greater physician trust than those that were unsure/unwilling. Similar worries, such as HCV incurability, insurance coverage, fears over the organ not working, and post-transplant death, were expressed in both the willing and unsure/unwilling patients. Conclusions: The availability of HCV-positive organs may expand the donor pool and decrease waitlist times and mortality. These data highlight the need for patient education towards use of these organs.

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