Risk factors for myocarditis associated with immune checkpoint inhibitors using real-world clinical data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e15100-e15100 ◽  
Author(s):  
Prantesh Jain ◽  
Jahir Gutierrez Bugarin ◽  
Avirup Guha ◽  
Chhavi Jain ◽  
Tingke Shen ◽  
...  
Keyword(s):  
Risk Factors ◽  
Liver Disease ◽  
Cancer Patients ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Cox Proportional Hazards ◽  
Cancer Type ◽  
Real World Data

e15100 Background: Immune checkpoint inhibitors (ICIs) can cause unique, high-grade immune-related adverse events. Although rare, ICI related myocarditis has the highest fatality rate (~50%). Cardiovascular monitoring is not routinely performed in patients on ICI treatment, thus risk factors remain unknown. Characterizing rare but fatal cardiac toxicities requires integration of real-world data. Methods: U.S claims data (IBM MarketScan) of over 30 million commercially insured individuals was leveraged to identify 2,687,301 cancer patients between 2011-2018. Patients ≥18 years of age treated with ICIs (targeting CTLA4 (ipilimumab) and/or the PD1 (nivolumab, pembrolizumab)/PDL1 (atezolizumab, avelumab, durvalumab) alone or in combination with ICI and/or chemotherapy were identified and followed until disenrollment. Myocarditis, comorbidities, and treatment details were identified using diagnosis and billing codes. Analyses included descriptive statistics and Cox proportional hazards regression. Results: 16,541 ICI treated cancer patients were included (median age 60; 58% male). Myocarditis was identified in 252 (1.5%) patients, majority (90%) ≥50 years old (median 63) with 12,040 person-years of follow up. 62% received anti-PD1 monotherapy, 12% anti-CTLA4, and 15% received combination treatment with other ICIs and/or chemotherapy. Most common cancer types were lung (48%), melanoma (25%), and renal cancer (14%). Cumulative incidence of myocarditis at 1 year was 2.06%; 95% CI (1.78-2.37), median onset of 80.5 days, 42% occurring within 60 days of treatment. By univariate analyses, age, cancer type, diabetes (DM), hypertension (HTN), kidney, liver disease, atrial fibrillation (AF) were related to myocarditis. Risk was lower in patients who received anti-CTLA4 monotherapy (HR: 0.490; 95% CI: 0.26-0.92; p = 0.0251). On multivariable regression analyses only age, cancer type (renal, lung cancer), comorbidities DM and liver disease were significantly associated with myocarditis (Table). Conclusions: This is the largest real-world longitudinal study for ICI associated myocarditis showing higher than reported incidence and identifiable risk factors. [Table: see text]

scholarly journals A real‐world data of Immune checkpoint inhibitors in solid tumors from India

2021 ◽  
Author(s):  
Vanita Noronha ◽  
George Abraham ◽  
Vijay Patil ◽  
Amit Joshi ◽  
Nandini Menon ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Real World Data ◽  
World Data

284 Real World Data of Sequencing Immune Checkpoint Inhibitors (ICI) after Initial ICI

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A310-A310
Author(s):  
Krishna Gunturu ◽  
Muhammad Awidi ◽  
Rojer Ranjit ◽  
Brendan Connell ◽  
Rachel Carrasquillo ◽  
...  
Keyword(s):  
Cell Death ◽  
Programmed Cell Death ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Medical Center ◽  
Clear Understanding ◽  
Real World Data ◽  
World Data

BackgroundICI revolutionized modern Oncology landscape and being utilized in metastatic to adjuvant and neo-adjuvant settings. As Oncologists, we are treating cancer patients with ICI every day, yet there is still a lot that is unknown about these drugs. We don’t have clear understanding of the efficacy and toxicity when sequencing one ICI for another. We conducted a retrospective review of real world data at Lahey Hospital and Medical Center to understand further and to pave path for prospective studies to understand this issue further to improve patient care.MethodsWe retrospectively reviewed Oncology patient charts who received ICI between January1, 2014 to December 18, 2018. Total 483 patients received ICI during this time frame and 22 of these patients received a second ICI either as monotherapy or in combination with other ICI or chemotherapy.ResultsA total of 22 patients received subsequent ICI after the initial ICI as showed in table 1. 15 of the 22 (68%) patients were transitioned from one ICI to another monotherapy. 11 of these patients were transitioned secondary to disease progression (73%), three had immune related adverse events and one was switched per standard of care. One patient had ICI re-challenge. Three patients had a transition from ICI monotherapy to combination ICI therapy. One patient went onto chemo-immunotherapy and 2 patients transitioned from combination ICI to chemo-immunotherapy.Abstract 284 Table 1Real world data of sequencing immune checkpoint inhibitors (ICI) after initial ICIConclusionsICI therapy is evolving and patients are being treated with multiple lines of ICI. In current practices, ICI is frequently being transitioned from cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death 1 (PD-1) or its ligand, programmed cell death ligand 1 (PD-L1) classes or combined with chemotherapy or targeted therapy. It would be prudent to explore the effects of sequencing these medications either as a monotherapy or in combination with other therapies to better serve our patients and to prevent financial toxicity.

Incidence and Economic Burden of Infections in Cancer Patients Receiving Immune Checkpoint Inhibitors: A Retrospective Cohort Study

2020 ◽  
Author(s):  
Swarna Nalluru ◽  
Paramrajan Piranavan ◽  
Anvesh Narimiti ◽  
Ahmad D. Siddiqui ◽  
George M. Abraham
Keyword(s):  
Risk Factors ◽  
Cancer Patients ◽  
Economic Burden ◽  
Immune Checkpoint ◽  
Average Cost ◽  
Immune Checkpoint Inhibitors ◽  
Multidisciplinary Approach ◽  
Checkpoint Inhibitors ◽  
Antitumor Effects ◽  
Cost Per Admission

Abstract BACKGROUNDAlong with antitumor effects, Immune Checkpoint Inhibitors (ICPI) have shown great potential in treating chronic infections such as HIV, Hepatitis B and malaria, in ex-vivo studies. However, several case reports and case series have suggested an increased infection risk in cancer patients. The purpose of our study was to assess the risk of infections in cancer patients receiving ICPI. We also attempted to evaluate the role of a multidisciplinary approach (Oncology and Infectious disease specialists) and the cost associated with treatment. METHODS:Records on all cancer patients over age ≥18 years old who had received at least one dose of ICPI between 2015 to 2018 at a major community teaching hospital in the central Massachusetts region were reviewed. Several risk factors associated with infection were identified. A two-tailed, unpaired t-test was used to analyze the association between risk factors and infection. We calculated the cumulative length of stay (LOS) and cost per admission with a multidisciplinary vs. non-multidisciplinary approach. The calculated total average cost per admission was compared to a matched population (without an oncologic diagnosis) admitted with infections similar to that in our study, to compare the economic burden. RESULTSRetrospective chart review of 169 cancer patients receiving ICPI showed sixty-two episodes of infection in thirty-seven (21.8%) patients and a mortality rate of 3.5% due to associated complications. Risk factors like COPD, prior chemotherapy and steroid use were significantly associated (P<0.05) with infections. Further sub-group analysis showed increase in cumulative LOS from 5.9 to 8.1 days but approximately similar average cost per admission ($52,047 vs. $54,510) with non-multidisciplinary vs. multidisciplinary approach. The calculated total cost per admission during an episode of infection in this cohort of patients was $35,484; three-fold higher when matched to similar infections in a general non-oncologic population ($11,527). CONCLUSIONSA significant incidence of infections and associated health care resource utilization continues to prevail in cancer patients despite the utility of ICPI. A multidisciplinary approach to manage the infections and associated complications in cancer patients receiving ICPI increased the cumulative LOS but not the average cost per admission.

scholarly journals Risk Factors, Incidence, and Prognosis of Thromboembolism in Cancer Patients Treated With Immune Checkpoint Inhibitors

2021 ◽  
Vol 12 ◽  
Author(s):  
Xue-lin Zou ◽  
Wei-yong Chen ◽  
Guang-yan Zhang ◽  
Hua Ke ◽  
Qiu-hong Yang ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cancer Patients ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Widespread Application ◽  
Atypical Symptoms ◽  
High Risk Factors ◽  
Treatment Measures ◽  
Underlying Mechanisms

In recent years, immune checkpoint inhibitors (ICIs) have become the standard treatment option for tumors. With the widespread application of ICIs, immune-related adverse events (irAEs) have gradually attracted the attention of researchers. Owing to the characteristics of ICIs, irAEs can affect each organ of the human body. Thromboembolism is uncommon in cancer patients receiving ICIs, but it may affect their survival. Most thromboembolic events do not cause serious effects after early prediction and treatment, but life-threatening toxic reactions are also observed. This condition should not be ignored because of vague and atypical symptoms, which make early diagnosis more challenging. This article focuses on the high-risk factors, underlying mechanisms, incidence, and prognosis of thromboembolism in patients using ICIs and briefly describes the intervention and treatment measures. This information would allow patients to effectively manage the side effects of thromboembolism during Immune checkpoint inhibitors treatment, ensuring the efficacy of ICIs and reducing mortality.

scholarly journals Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer

2020 ◽  
Vol 87 ◽  
pp. 102031 ◽  
Author(s):  
Giulia Pasello ◽  
Alberto Pavan ◽  
Ilaria Attili ◽  
Alberto Bortolami ◽  
Laura Bonanno ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Real World Data ◽  
World Data

Incidence and economic burden of infections in cancer patients receiving immune checkpoint inhibitors.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19365-e19365
Author(s):  
swarna sri nalluru ◽  
Paramarajan Piranavan ◽  
Anvesh Narimiti ◽  
Shanil Shah ◽  
Ahmad Daniyal Siddiqui ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cancer Patients ◽  
Economic Burden ◽  
Immune Checkpoint ◽  
Average Cost ◽  
Immune Checkpoint Inhibitors ◽  
Multidisciplinary Approach ◽  
Checkpoint Inhibitors ◽  
Antitumor Effects ◽  
Cost Per Admission

e19365 Background: Along with antitumor effects, Immune Checkpoint Inhibitors (ICPI) have shown great potential in treating chronic infections such as HIV, Hepatitis B, and malaria, in ex-vivo studies. However, several case reports and case series suggested increased infection risk in cancer patients receiving ICPI. The purpose of our study is to assess the risk of infections in cancer patients receiving ICPI. We also attempted to evaluate the role of a multidisciplinary approach (Oncology and Infectious disease specialists) and the cost associated with treatment. Methods: Records on all cancer patients over age ≥18 years old who had received at least one dose of ICPI from 2015 to 2018 at two major community teaching hospitals in the Central Massachusetts region were reviewed. Several risk factors associated with infection were identified. Two-tailed unpaired t-test was used to analyze the association between risk factors and infection. We calculated the average length of stay (LOS) and cost per admission with a multidisciplinary vs. non-multidisciplinary approach. The calculated total average cost per admission was compared with a random set of non-oncologic population admitted with similar infections noted in our study to estimate the economic burden. Results: Thirty-seven (21.8%) patients developed sixty-two episodes of infection. Microbiological confirmation was available in 13 episodes. Risk factors like COPD (P = 0.01), prior chemotherapy (P = 0.03), and steroid use (P = 0.003) were significantly associated with infections. An infection-associated mortality rate was noted to be 2.3%. With the involvement of multidisciplinary team, the average LOS increased from 5.9 to 8.1 days. Yet, the average cost per admission approximately remained the same (52,047$ vs. 54,510$). Upon comparison with a non-oncologic patient, the average cost per admission for an infection in cancer patients receiving ICPI increased from 11,527$ to 35,484$. Conclusions: Surprisingly, a significant incidence of infections and associated health care resource utilization continue to prevail in cancer patients despite the utility of ICPI. Although the economic burden due to the infections in this set of patients is remarkably high when compared to the general population, the multidisciplinary approach did not increase the hospital costs.

Lessons learned from the reimbursement policy for immune checkpoint inhibitors and real-world data collection in Taiwan

2020 ◽  
pp. 1-5
Author(s):  
Li Ying Huang ◽  
Churn-Shiouh Gau
Keyword(s):  
Health Insurance ◽  
National Health Insurance ◽  
National Health ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Reimbursement Policy ◽  
Real World Data ◽  
World Data

Abstract This paper describes the reimbursement policy for immune checkpoint inhibitors in Taiwan and provides a perspective to improve the quality, consistency, and transparency of decision making. Global trends for cancer treatment have shifted from chemotherapies to targeted therapies and immuno-oncology (IO) medicine, leading to significant increases in treatment costs. To enhance the accessibility of advanced therapy, the Taiwan National Health Insurance Administration announced two pathways for high-cost medicine: the managed entry agreement and a set of general rules of reimbursement submission for high-cost drugs. To further manage the financial burden on Taiwan's national health insurance system, the policy makers introduced novel inhibitory drugs for cancer immune checkpoints, subject to a maximum annual budget of NT$800 million (≈US$26.7 million). In April 2019, a national registry was established for patients undergoing cancer immunotherapy. Clinical characteristics, treatment duration, toxicity, and the outcome of the postcheckpoint inhibitor treatments were recorded. By analyzing real-world data, we assess the therapeutic effect of IO treatment in Taiwanese patients, thereby enabling payers to adjust payment regulations and rules for reimbursement. The Health Technology Assessment Team plays an important role in drawing upon the evidence to support policy making. Under an implemented cost-management mechanism, Taiwan's high-cost drug policy has enabled patients to access new medicines and maximized patient benefits.

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