Persistent immune-related adverse events after cessation of checkpoint inhibitor therapy: Prevalence and impact on patients' health-related quality of life

Schulz, Thomas U.; Zierold, Sarah; Sachse, Michael Max; Pesch, Giulia; Tomsitz, Dirk; Schilbach, Katharina; Kähler, Katharina C.; French, Lars E.; Heinzerling, Lucie

doi:10.1016/j.ejca.2022.08.029

Cited by 26 publications

(12 citation statements)

References 33 publications

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“…This dataset was generated to investigate persistent irAEs in cancer patients ≥ 12 weeks after cessation of ICI therapy, to assess the prevalence of persistent irAEs, and to analyze the impact of persistent irAEs on HRQoL [1] . As persistent irAEs mimic non-ICI-induced autoimmune diseases, patients with autoimmune diseases were included in the study to identify commonalities and differences regarding autoimmune symptoms, related therapies, and implications on HRQoL.…”

Section: Objectivementioning

confidence: 99%

Health-related quality of life (EuroQol 5D-5L) in patients with autoimmunity in the context of immunotherapy: A large dataset comprising cancer patients after cessation of checkpoint inhibitor therapy and patients with autoimmune diseases

et al. 2022

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Section: Objectivementioning

confidence: 99%

Health-related quality of life (EuroQol 5D-5L) in patients with autoimmunity in the context of immunotherapy: A large dataset comprising cancer patients after cessation of checkpoint inhibitor therapy and patients with autoimmune diseases

et al. 2022

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“…By blocking the pathways that regulate the immune system, ICIs do not only stimulate T-cell mediated tumour lysis, but also increase the activity of the immune system against self-antigens, causing organ inflammation [ 5 ]. These immune-related adverse events (irAEs) can be severe, lifelong and often require immunosuppressive therapy [ 6 ]. Furthermore, the incidence of irAEs gradually increases with duration of treatment [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Safe Stop IPI-NIVO trial: early discontinuation of nivolumab upon achieving a complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab – study protocol

Janssen,

van Dijk,

de Joode

et al. 2024

BMC Cancer

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Background Patients with irresectable stage III or metastatic melanoma presenting with poor prognostic factors are usually treated with a combination of immune checkpoint inhibitors (ICIs), consisting of ipilimumab and nivolumab. This combination therapy is associated with severe immune related adverse events (irAEs) in about 60% of patients. In current clinical practice, patients are usually treated with ICIs for up to two years or until disease progression or the occurrence of unacceptable AEs. The incidence of irAEs gradually increases with duration of treatment. While durable tumour responses have been observed after early discontinuation of treatment, no consensus has been reached on optimal treatment duration. The objective of the Safe Stop IPI-NIVO trial is to evaluate whether early discontinuation of ICIs is safe in patients with irresectable stage III or metastatic melanoma who are treated with combination therapy. Methods The Safe Stop IPI-NIVO trial is a nationwide, multicentre, prospective, single-arm, interventional study in the Netherlands. A total of 80 patients with irresectable stage III or metastatic melanoma who are treated with combination therapy of ipilimumab-nivolumab and have a complete or partial response (CR/PR) according to RECIST v1.1 will be included to early discontinue maintenance therapy with anti-PD-1. The primary endpoint is the rate of ongoing response at 12 months after start of ICI. Secondary endpoints include ongoing response at 24 months, disease control at different time points, melanoma specific and overall survival, the incidence of irAEs and health-related quality of life. Discussion From a medical, healthcare and economic perspective, overtreatment should be prevented and shorter treatment duration of ICIs is preferred. If early discontinuation of ICIs is safe for patients who are treated with the combination of ipilimumab-nivolumab, the treatment duration of nivolumab could be shortened in patients with a favourable tumour response. Trial registration ClinicalTrials.gov ID NCT05652673, registration date: 08–12-2022.

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“…Figure 1 shows the dramatic increase in both FDA approvals (blue bars) and rise in prevalent ICI‐treated patients within our healthcare network (solid line) between 2011 and 2022. ICIs are being increasingly used in the adjuvant setting; thus, not only will the number of patients receiving ICI therapy increase, but ICI‐treated patients are also expected to live longer than before, and may be at risk for long‐term complications of ICI treatment 2–6 . Treatment‐induced immune‐mediated adverse events (irAEs) affect between 60% and 80% of patients who receive ICIs; in the kidney, irAEs manifest as acute tubulointerstitial nephritis (ICI‐AIN) in the majority of cases.…”

Section: Introductionmentioning

confidence: 99%

Immunological mechanisms underlying clinical phenotypes and noninvasive diagnosis of immune checkpoint inhibitor‐induced kidney disease

Seethapathy

Mistry

Sise

2023

Immunological Reviews

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SummaryImmune checkpoint inhibitors (ICIs) have become a mainstay of cancer therapy, with over 80 FDA‐approved indications. Used in a variety of settings and in combination with each other and with traditional chemotherapies, the hyperactive immune response induced by ICIs can often lead to immune‐related adverse events in bystander normal tissues such as the kidneys, lungs, and the heart. In the kidneys, this immune‐related adverse event manifests as acute interstitial nephritis (ICI‐AIN). In the era of widespread ICI use, it becomes vital to understand the clinical manifestations of ICI‐AIN and the importance of prompt diagnosis and management of these complications. In this review, we delve into the clinical phenotypes of ICI‐AIN and how they differ from traditional drug‐induced AIN. We also detail what is known about the mechanistic underpinnings of ICI‐AIN and the important diagnostic and therapeutic implications behind harnessing those mechanisms to further our understanding of these events and to formulate effective treatment plans to manage ICI‐AIN.

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Persistent immune-related adverse events after cessation of checkpoint inhibitor therapy: Prevalence and impact on patients' health-related quality of life

Cited by 26 publications

References 33 publications

Health-related quality of life (EuroQol 5D-5L) in patients with autoimmunity in the context of immunotherapy: A large dataset comprising cancer patients after cessation of checkpoint inhibitor therapy and patients with autoimmune diseases

Health-related quality of life (EuroQol 5D-5L) in patients with autoimmunity in the context of immunotherapy: A large dataset comprising cancer patients after cessation of checkpoint inhibitor therapy and patients with autoimmune diseases

Safe Stop IPI-NIVO trial: early discontinuation of nivolumab upon achieving a complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab – study protocol

Immunological mechanisms underlying clinical phenotypes and noninvasive diagnosis of immune checkpoint inhibitor‐induced kidney disease

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