Incidence and clinical pattern of immune related adverse effects (irAE) due to immune checkpoint inhibitors (ICI).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e14151-e14151 ◽  
Author(s):  
Bicky Thapa ◽  
Joanna Roopkumar ◽  
Ann S Kim ◽  
Lorenzo Gervaso ◽  
Pradnya Dinkar Patil ◽  
...  

e14151 Background: ICIs have revolutionized outcomes in many advanced malignancies, however their use is associated with irAEs. Methods: An IRB-approved, retrospective chart review was done using the Cleveland Clinic pharmacy database. Patients were included who received six FDA approved (nivolumab, ipilimumab, pembrolizumab, atezolizumab, avelumab, or durvalumab) ICIs from July 2015 to December 2017. irAEs were identified from review of electronic medical records. Descriptive analysis was done to evaluate the incidence, pattern, and severity of irAEs. Results: A total of 1091 patients received ICI therapy, 651 (59.7%) were male, 958 (87.4%) white, 95 (8.7%) black. Lung cancer (540, 49.5%) comprised the majority of the cohort, followed by melanoma (152, 13.9%), and renal cell carcinoma (121, 11.1%). About 996 (91.3%) received treatment with only one ICI, 85 (7.8%) with 2 ICIs, and only 10 patients received 3 ICIs. A total of 487 (44.63%) patients encountered irAEs, 128 (11.73%) resulting in treatment cessation. Fatigue (152, 13.9%) was the most common, followed by dermatologic irAEs (131, 12%). Endocrine irAEs occurred in 108 (9.89%), GI toxicities, namely diarrhea and colitis, were seen in 92 (8.4%) and hepatotoxicity in 54 (4.94%). Other irAEs including rheumatologic, pneumonitis, renal, and neurological adverse effects were documented in 6.5%, 5.1%, 2.56%, and 2.01% respectively. Rare irAEs such as ocular toxicity, cardiac toxicity, and vasculitis were seen in 0.8%, 0.73%, and 0.54%, respectively. Compared with a pooled analysis from clinical trials (De Velasco G et al. Comprehensive Meta-analysis of Key irAEs from CTLA-4 and PD-1/PD-L1 Inhibitors in Cancer Patients) dermatologic irAEs and fatigue were less frequent; diarrhea/colitis, pneumonitis and rheumatologic irAEs were more frequent. Conclusions: irAEs on ICI therapy are very common. Awareness of the relative frequencies of various irAEs, particularly severe and rare irAEs, in a real-world setting can help improve quality of care for cancer patients receiving ICI. [Table: see text]

2020 ◽  
Author(s):  
Brian Gonzalez ◽  
Sarah Eisel ◽  
Kristine Bowles ◽  
Aasha Hoogland ◽  
Brian James ◽  
...  

2020 ◽  
Vol 31 ◽  
pp. S956
Author(s):  
B.D. Gonzalez ◽  
S.L. Eisel ◽  
K.E. Bowles ◽  
A.I. Hoogland ◽  
B.W. James ◽  
...  

Author(s):  
Brian D Gonzalez ◽  
Sarah L Eisel ◽  
Kristina E Bowles ◽  
Aasha I Hoogland ◽  
Brian W James ◽  
...  

Abstract Background Trials of immune checkpoint inhibitors (ICIs) have published patient-reported quality of life (QOL), but the size and heterogeneity of this literature can make patient education difficult. This meta-analysis aimed to describe change in QOL and symptomatology in patients receiving ICIs for cancer. Methods Following PRISMA guidelines, databases were searched through November 2019 for articles or abstracts of prospective, original studies reporting longitudinal QOL in adult cancer patients treated with ICIs. The prespecified primary outcomes were change in global QOL among patients treated with ICIs and difference in change since baseline in global QOL between patients treated with ICI vs. non-ICI active treatment. Secondary outcomes included physical functioning and symptomatology. All statistical tests were 2-sided. Results Twenty-six of 20,323 publications met inclusion criteria. Global QOL did not change over time in patients treated with ICIs (k = 26, n = 6,974, P = .19). Larger improvements in global QOL was observed in patients receiving ICI vs. non-ICI regimens (k = 16, ICI n = 3,588, non-ICI n = 2,948, P < .001). Physical functioning did not change in patients treated with ICIs (k = 14, n = 3,169, P=.47); there were no differences in mean change between ICI vs. non-ICI regimens (k = 11, n = 4,630, P=.94. Regarding symptoms, appetite loss, insomnia, and pain severity decreased but dyspnea severity increased in patients treated with ICIs (k = 14, n = 3,243–3,499) (Ps < 0.001). Insomnia severity was higher in patients treated with ICIs than non-ICI regimens (k = 11, n = 4,791) (P < .001). Conclusions This study is among the first to quantitatively summarize QOL in patients treated with ICIs. Findings suggest ICI recipients report no change in global QOL and higher QOL than patients treated with non-ICI regimens.


2021 ◽  
Vol 18 ◽  
pp. 147997312110022
Author(s):  
Kevin Cares-Marambio ◽  
Yessenia Montenegro-Jiménez ◽  
Rodrigo Torres-Castro ◽  
Roberto Vera-Uribe ◽  
Yolanda Torralba ◽  
...  

Knowledge on the sequelae of Coronavirus Disease 2019 (COVID-19) remains limited due to the relatively recent onset of this pathology. However, the literature on other types of coronavirus infections prior to COVID-19 reports that patients may experience persistent symptoms after discharge. To determine the prevalence of respiratory symptoms in survivors of hospital admission after COVID-19 infection. A living systematic review of five databases was performed in order to identify studies which reported the persistence of respiratory symptoms in COVID-19 patients after discharge. Two independent researchers reviewed and analysed the available literature, and then extracted and assessed the quality of those articles. Of the 1,154 reports returned by the initial search nine articles were found, in which 1,816 patients were included in the data synthesis. In the pooled analysis, we found a prevalence of 0.52 (CI 0.38–0.66, p < 0.01, I 2 = 97%), 0.37 (CI 0.28–0.48, p < 0.01, I 2 = 93%), 0.16 (CI 0.10–0.23, p < 0.01, I 2 = 90%) and 0.14 (CI 0.06–0.24, p < 0.01, I 2 = 96%) for fatigue, dyspnoea, chest pain, and cough, respectively. Fatigue, dyspnoea, chest pain, and cough were the most prevalent respiratory symptoms found in 52%, 37%, 16% and 14% of patients between 3 weeks and 3 months, after discharge in survivors of hospital admission by COVID-19, respectively.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ali Baradaran ◽  
Hojat Dehghanbanadaki ◽  
Sara Naderpour ◽  
Leila Mohammadi Pirkashani ◽  
Abdolhalim Rajabi ◽  
...  

Abstract Introduction The relationship between H. pylori infection and obesity development has remained controversial among various studies. The aim of this study was to clarify the pooled effect of H. pylori infection on the development of obesity and vice versa. Methods We searched international databases including Medline (PubMed), Web of sciences, Scopus, EMBASE, Cochrane, Ovid, and CINHAL to retrieve all case–control studies reporting the effect of H. pylori on obesity and vice versa, which had been published in English between January 1990 and June 2019. The quality of included studies was assessed by the Modified Newcastle–Ottawa Scale for Case–Control studies. The logarithm of the odds ratio (OR) and its standard error was used for the meta-analysis. Results Eight case–control studies with 25,519 participants were included for qualitative and quantitative analyses. The pooled analysis showed that obese participants had a higher risk of H. pylori infection than lean participants with an odds ratio of 1.46 (95%CI: 1.26, 1.68). Also, the pooled analysis revealed that participants infected by H. pylori had a higher risk of obesity than non-infected participants with an odds ratio of 1.01 (95%CI: 1.01, 1.02). Conclusion The results of this meta-analysis showed that there was a positive correlation between the risk of H. pylori infection and the prevalence of obesity development. Thus, H. pylori positive patients were more likely to be obese, and obese individuals had higher risks of H. pylori infection.


2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Guo-wei Qin ◽  
Tong-tong Xu ◽  
Xiang-wei Lv ◽  
Shi-min Jiang ◽  
Ke-jia Zhang ◽  
...  

Objective. To perform a systematic evaluation of the efficacy and safety of combined treatment of Shenmai injection and chemotherapy for lung cancer. Methods. A literature search for randomized controlled trials (RCTs) describing the treatment of lung cancer by Shenmai injection and chemotherapy or chemotherapy alone was performed using the PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Value In Paper (VIP), China BioMed, and Wanfang databases. The databases were searched for entries published before September 1, 2019. Results. Thirty-seven RCTs, comprising a total of 2808 cases, were included in the present meta-analysis. Of these, 1428 cases were treated by Shenmai injection plus chemotherapy, and 1380 cases were treated only by chemotherapy. The results of meta-analysis showed that the combined treatment (Shenmai injection plus chemotherapy) increased the short-term efficacy of treatment (relative risk [RR] = 1.183, 95% confidence interval [CI] = 1.043–1.343, P < 0.01 ) and improved patients’ quality of life (RR = 1.514, 95%CI = 1.211–1.891, P < 0.01 ) compared with chemotherapy alone. With regard to the adverse effects, the combined treatment markedly reduced the incidence of white blood cell (WBC) reduction (RR = 0.846, 95%CI = 0.760–0.941, P < 0.01 ), platelet reduction (RR = 0.462, 95% CI = 0.330–0.649, P < 0.01 ), and hemoglobin reduction (RR = 0.462, 95% CI = 0.330–0.649, P < 0.01 ) and alleviated drug-induced liver injury (RR = 0.677, 95%CI = 0.463–0.990, P < 0.05 ). However, it did not offer a significant protective effect (RR = 0.725, 95%CI = 0.358–1.468, P < 0.05 ). The effect of the combined treatment on the occurrence of vomiting was considerable (RR = 0.889, 95%CI = 0.794–0.996, P < 0.05 ), and the combined treatment markedly increased the immunity of patients with lung cancer. Conclusion. The combined treatment of Shenmai injection plus chemotherapy enhanced the short-term efficacy of chemotherapy, improved the patient quality of life, alleviated the adverse effects of chemotherapeutics, and increased the patient immunity. These results should be confirmed by large-scale, high-quality RCTs.


PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0255716
Author(s):  
Náthali Felícia Mineiro dos Santos Garrett ◽  
Ana Cristina Carvalho da Costa ◽  
Elaine Barros Ferreira ◽  
Giovanni Damiani ◽  
Paula Elaine Diniz dos Reis ◽  
...  

Background Checkpoint inhibitors have revolutionized advanced melanoma care; however, their cutaneous side effects have not been definitively elucidated. Objective To identify the prevalence of cutaneous toxicity in patients with melanoma treated with immune checkpoint inhibitors as monotherapy and/or in combination with chemotherapy and/or radiotherapy. Materials and methods We performed a systematic review and meta-analysis, which encompassed both clinical trials and observational studies describing the dermatological toxicities in patients treated with immune checkpoint inhibitors. The protocol was registered in the International Prospective Register of Systematic Review under the number CRD42018091915. The searches were performed using the CINAHL, Cochrane CENTRAL, LILACS, LIVIVO, PubMed, Scopus, and Web of Science databases. The methodological quality of the studies was evaluated with the JBI Critical Appraisal Checklist for Studies Reporting Prevalence Data Results A total of 9,802 articles were identified in the databases. The final sample comprised 39 studies. The evaluated drugs were ipilimumab, tremelimumab, pembrolizumab, and nivolumab. The results suggest that the most prevalent side effect was grade 1 and 2 pruritus (24%), followed by grade 1 and 2 rash (21%) and grade 1 and 2 vitiligo (10%). Conclusion The most prevalent side effects in patients treated with checkpoint inhibitors are pruritus, rash, and vitiligo, and they are rated mostly as grades 1 and 2 adverse events. Remarkably, vitiligo is most commonly found in patients treated with PD-1 inhibitors.


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