First Case of Cytokine Release Syndrome after Nivolumab for Gastric Cancer

Oda, Hiroyasu; Ishihara, Mikiya; Miyahara, Yoshihiro; Nakamura, Junko; Kikuchi, Yuji; Iwasa, Motoh; Tsunoda, Akira; Yamashita, Yoshiki; Saito, Kanako; Mizuno, Toshiro; Shiku, Hiroshi; Katayama, Naoyuki

doi:10.1159/000496933

Cited by 26 publications

(15 citation statements)

References 14 publications

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“…Regardless of cancer type, ICI-related CRS safety reports were more numerous on anti-PD-1/PD-L1 antibodies, in line with the single case reports of CRS developed on either nivolumab or pembrolizumab (Foran et al, 2017;Rassy et al, 2017;Rotz et al, 2017;Zhao et al, 2018;Dimitriou et al, 2019;Honjo et al, 2019;Kogure et al, 2019;Oda et al, 2019). Moreover, a recent review of the largest clinical trials of ICIs (Michot et al, 2019), found that the frequency of hematological irAEs of all grades (including CRS), was higher with anti-PD-1 (4.1%) and anti-PD-L1 (4.7%) than with anti-CTLA-4 agents (0.5%, P < 0.0001).…”

Section: Discussionsupporting

confidence: 55%

“…ICI-related CRS reporting peaked in 2019 suggesting that, albeit likely depending on the progressively increasing use of ICIs for a variety of cancer types, CRS is progressively more easily recognized and diagnosed as associated to ICIs. Accordingly, among the limited isolated case reports published so far on CRS onset during treatment with ICIs, the majority deals with very recent cases, on either pembrolizumab or nivolumab used to treat different cancer types (Dimitriou et al, 2019;Honjo et al, 2019;Kogure et al, 2019;Oda et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

“…Despite the strict parallelism between ICI mechanism of action and CRS pathophysiologic mechanism, to date, only a few case reports have documented the association of ICIs as pharmacological triggers of CRS in cancer patients (Foran et al, 2017;Rassy et al, 2017;Rotz et al, 2017;Zhao et al, 2018;Dimitriou et al, 2019;Honjo et al, 2019;Kogure et al, 2019;Oda et al, 2019).…”

Section: Introductionmentioning

confidence: 99%

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Immune Checkpoint Inhibitor-Related Cytokine Release Syndrome: Analysis of WHO Global Pharmacovigilance Database

et al. 2020

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Immune checkpoint inhibitors (ICIs) have proven effective in the treatment of numerous cancers; however, they have been associated with immune-related adverse events (irAEs), among which cytokine release syndrome (CRS) has been reported in a few case reports. To describe the burden of ICI-related CRS and raise awareness of CRS as irAE, we queried VigiBase, the World Health Organization global database of spontaneously reported suspected adverse drug reactions (ADRs), and retrieved safety reports of suspected CRS associated with ICIs, gathered in the database through January 12 th 2020. We assessed ICI-related CRS safety reports in terms of geographical and temporal patterns of reporting, patient demographics and clinical features, treatment characteristics, CRS clinical presentation, timing, seriousness, and outcome. We retrieved 58 cases of whom 43 (74%) reported CRS with anti-programmed death-1/antiprogrammed death-ligand 1 agents. Melanoma (n=17, 29%) and hematologic malignancies (n=16, 28%) were the most common underlying cancers. ICIs were the solely suspected drugs in 37 (64%) cases. Typical signs and symptoms of CRS were reported in 25 (43%) patients. ICI-related CRS developed a median of 4 weeks after ICI initiation (IQR 1-18 weeks, n=9, 16%). Besides two fatal cases, CRS recovered/was recovering at the time of reporting in 35 (60%) cases. We observed differences in the geographical pattern of ICI-related CRS reporting, with a high proportion of ICI-related CRS cases in Australia and North America (0.14 and 0.10% respectively). Due to ICI expanding indications, clinicians should be aware that ICIs could contribute to CRS onset in cancer patients as pharmacological triggers.

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Section: Discussionsupporting

confidence: 55%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Immune Checkpoint Inhibitor-Related Cytokine Release Syndrome: Analysis of WHO Global Pharmacovigilance Database

et al. 2020

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“…CRS has been observed to be triggered by several monoclonal antibodies, systemic interleukin-2, and more recently, the CD19-CD3 chimeric antigen receptor Tcell therapy (35). A few case reports have detailed lifethreatening CRS in patients after the administration of ICIs, with occurrences ranging from cycles 1 to 17 (36)(37)(38)(39). The culprit medications were anti-PD-1 and anti-LAG-3.…”

Section: Discussionmentioning

confidence: 99%

Safety and Efficacy of Immune Checkpoint Inhibitors for Patients With Metastatic Urothelial Carcinoma and End-Stage Renal Disease: Experiences From Real-World Practice

Kuo

Huang

et al. 2020

Front. Oncol.

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BackgroundImmune checkpoint inhibitors (ICIs) are used widely for treating metastatic urothelial carcinoma (mUC). In practical settings, evidence is lacking on the efficacy of ICIs in some difficult-to-treat patients, such as those with end-stage renal disease (ESRD). Herein, we evaluate the safety and efficacy of ICIs for patients with mUC and ESRD.MethodsFor this retrospective study, patients with mUC who were given ICIs at Kaohsiung Chang Gang Memorial Hospital and Linkou Chang Gung Memorial Hospital between April 2016 and November 2019 were consecutively enrolled. All clinicopathologic data, treatment responses, and adverse events were recorded. The immune-related adverse events (AEs), objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were compared between ESRD and non-ESRD groups.ResultsIn total, 129 patients with mUC were enrolled, with 11 patients categorized as the ESRD group. Among these patients with ESRD receiving ICIs, 7 of 11 (63.6%) had high-grade (grade ≥3) AEs, chiefly hematologic toxicity. Some rarely encountered AEs were noted, including toxic epidermal necrolysis, tuberculosis reactivation, ascites, and cytokine release syndrome. Patients in the ESRD group had numerically higher ORR (54.5% vs. 28.8%, p = 0.09), PFS (7.1 vs. 3.5 months, p = 0.42), and OS (not reached vs. 15.4 months) than the non-ESRD group. A multivariate Cox regression model demonstrated that leukocytosis (hazard ratio [HR]: 2.63; 95% confidence interval [CI]: 1.23–5.63; p = 0.01) and neutrophil-to-lymphocyte ratio (HR 2.91; 95% CI: 1.30–6.53; p = 0.01) were independent prognostic factors.ConclusionAdministration of ICIs in patients with mUC and ESRD demonstrated a modest antitumor activity, and should be used with caution for increasing risk of hematologic toxicity.

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“…Allergic symptoms (eyelid angioedema, flushing, and hives on the neck and face) were reported in one patient during treatment with nivolumab [96]. However, a case with cytokine release syndrome has been reported [97]. In a recent case report, a patient who had recurrent infusion reactions despite premedication against nivolumab was successfully treated with pembrolizumab, another PD-L1/PD-L2inhibitor [98].…”

Section: Nivolumabmentioning

confidence: 99%

Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events*

Gülşen¹,

Wedi²,

Jappe³

2020

Allergo J

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Purpose: Biotechnological substances (BSs) are strongly relied upon to prevent rejection of transplanted organs, and to treat oncological, allergological, and other inflammatory diseases. Allergic reactions to partly foreign biologics can occur due to their potential immunogenicity. The severity of an immune response to a biological drug may range from no clinical significance to a severe, life-threatening anaphylactic reaction. Methods: Detailed searches were performed on Pubmed, Web of Science, and Google Scholar to include all available publications. In addition, the Food and Drug Administration, the European Medicines Agency, and British Columbia Cancer Agency Drug Manual databases were screened for hypersensitivity reaction (HSR), infusion reaction, injection site reaction, urticaria, and anaphylaxis for individual BSs. Results: Treatment with BSs can cause various types of HSR. These are mentioned in the literature with definitions such as allergic reactions, anaphylactoid reactions, anaphylaxis, HSR, infusion reactions, injection site reactions, cytokine release syndrome, and urticaria. Due to the overlap in signs and symptoms in the reported descriptions, it is not always possible to differentiate these reactions properly according to their pathomechanism. Similarly, many data reported as anaphylaxis actually describe severe anaphylactic reactions (grades III or IV). Conclusion: There is an urgent need for a simpler symptom-or system-based classification and scoring system to create an awareness for HSRs to BSs. A better understanding of the pathophysiology of HSRs and increased clinical experience in the treatment of side effects will provide timely control of unexpected reactions. As a result, immunotherapy with BSs will become safer in the future. Cite this as Gülsen A, Wedi B, Jappe U. Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events.

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First Case of Cytokine Release Syndrome after Nivolumab for Gastric Cancer

Cited by 26 publications

References 14 publications

Immune Checkpoint Inhibitor-Related Cytokine Release Syndrome: Analysis of WHO Global Pharmacovigilance Database

Immune Checkpoint Inhibitor-Related Cytokine Release Syndrome: Analysis of WHO Global Pharmacovigilance Database

Safety and Efficacy of Immune Checkpoint Inhibitors for Patients With Metastatic Urothelial Carcinoma and End-Stage Renal Disease: Experiences From Real-World Practice

Hypersensitivity reactions to biologics (part I): allergy as an important differential diagnosis in complex immune-derived adverse events*

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