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Pharmacokinetic/pharmacodynamic differences between chemotherapy and immunotherapy. Reproduced with permission from [25]. Dotted blue line represents waning of the biological effects of immunotherapy over time, and solid blue line represents early or late toxic effects. Horizontal dotted blue arrow therefore represents duration of immunotherapy treatment benefit 

Pharmacokinetic/pharmacodynamic differences between chemotherapy and immunotherapy. Reproduced with permission from [25]. Dotted blue line represents waning of the biological effects of immunotherapy over time, and solid blue line represents early or late toxic effects. Horizontal dotted blue arrow therefore represents duration of immunotherapy treatment benefit 

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Cancer immunotherapy has transformed the treatment of cancer. However, increasing use of immune-based therapies, including the widely used class of agents known as immune checkpoint inhibitors, has exposed a discrete group of immune-related adverse events (irAEs). Many of these are driven by the same immunologic mechanisms responsible for the drugs...

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... increasing patient exposure to immunotherapy, the nature and range of irAEs is becoming more clearly defined, and several new but serious adverse events have been reported [22]. Skin, gut, endocrine, lung and muscu- loskeletal irAEs are relatively common, whereas, cardiovas- cular, hematologic, renal, neurologic and ophthalmologic irAEs are well-recognized but occur much less frequently (Fig. 1). Although the majority of irAEs are mild to moder- ate in severity, serious, occasionally life-threatening irAEs (e.g., severe colitis, pneumonitis, encephalitis, toxic epider- mal necrolysis, myocarditis, and autoimmune type I dia- betes mellitus [T1DM] presenting as diabetic ketoacidosis), are reported in the literature, and treatment-related deaths have been reported in up to 2% of patients in clinical trials [14,23,24]. As life-threatening irAEs are rare, and may mimic other better-known conditions, there is growing recognition of the need to educate both the oncology and general medical communities in recognizing and institut- ing urgent and appropriate treatment of these conditions. Immune-related AEs resulting from immunotherapy can have a delayed onset and prolonged duration compared to adverse events resulting from chemotherapy ( Fig. 2), in part due to pharmacodynamic differences. Moreover, the relationship between irAEs and dose/exposure remains to be fully established [25]. As such, clinicians must remain vigilant to the diverse clinical presentations of irAEs and the possibility that patients may present with irAEs late in the course of treatment, and -in some cases -months or even years after treatment discontinuation [26,27]. Nonetheless, since diagnostic tests may be invasive and potentially costly, investigations should be undertaken judiciously and reserved for situations when the results will guide patient management. Table 1 provides a list of recommended tests to consider in all patients prior to ini- tiating checkpoint inhibitor ...

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... 4 Without early identification and proper management, irAEs can develop into severe complications, resulting in treatment discontinuation or failure and even death, which poses a considerable challenge in daily clinical care. 5,6 Isolated RCTs and their meta-analyses present the highest quality of evidence and are the basis for guidelines issued by healthcare organisations. 7 However, the evaluation of entire profiles of rare irAEs derived from RCTs data is difficult owing to their stringent diagnostic standards and selection criteria, relatively small sample sizes, and limited follow-up duration. ...
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Background With the increased use of immune checkpoint inhibitors (ICIs) in advanced lung cancer, adverse events (AEs), particularly immune-related AEs (irAEs), have garnered considerable interest. We conducted a comprehensive assessment of the toxicity profile in advanced lung cancer using multi-source medical data. Methods First, we systematically searched the PubMed, Embase, and Cochrane Library databases (from inception to 10 August 2021) for relevant randomised controlled trials (RCTs) involving ICI-based treatments for advanced lung cancer. The primary outcomes were treatment-related AEs and irAEs, including events that were assigned grade 1–5 and 3–5. The secondary outcomes were grade 5 AEs and irAEs (grade 1–5 and grade 3–5) in specific organs. Network comparisons were conducted for 11 treatments, including chemotherapy (CT), ICI monotherapy (three regimens: programmed death-1 receptor [PD-1] inhibitors, programmed death ligand-1 [PD-L1] inhibitors, and cytotoxic T lymphocyte-associated antigen [CTLA-4] inhibitors), dual-ICI combination therapy (two regimens), and treatment using one or two ICI drugs administered in combination with CT (five regimens). We also conducted a disproportionality analysis by extracting reports of various irAEs associated with ICIs from the FDA Adverse Event Reporting System (FAERS) database. The reporting odds ratios and fatality proportions of different irAEs were calculated and compared. PROSPERO: CRD42021268650. Findings Overall, 41 RCTs involving 23,121 patients with advanced lung cancer were included. Treatments containing chemotherapy increased the risk of treatment-related AEs compared to ICI-based regimens without chemotherapy. Concerning irAEs, PD-L1 + CTLA-4 + CT was associated with the highest risk of grade 1–5 irAEs, followed by two regimens of dual ICI combination, three regimens of ICI monotherapy, and three regimens of one ICI combined with CT. For 3–5 irAEs, CTLA-4 accounted for most AEs. Detailed comparisons of ICI-based treatment options provided irAE profiles based on specific organs/systems and AE severity. Insights from the FAERS database revealed that signals corresponding to pneumonitis, colitis, thyroiditis, and hypophysitis were observed across all ICI regimens. Further analyses of the outcomes indicated that myocarditis (163 of 367, 44.4%), pneumonitis (1610 of 4497, 35.8%), and hepatitis (290 of 931, 31.1%) had high fatality rates. Interpretation Included RCTs showed heterogeneity in a few clinical factors, and reports derived from the FAERS database might have involved inaccurate data. Our results can be used as a basis for improving clinical treatment strategies and designing preventive methods for ICI treatment in advanced lung cancer. Funding This study was supported by the Research Project of Drug Clinical Comprehensive Evaluation and Drug Treatment Pathway (SHYXH-ZP-2021-001, SHYXH-ZP-2021-006), Clinical Research Innovation and Cultivation Fund of Ren Ji Hospital (RJPY-LX-008), Ren Ji Boost Project of National Natural Science Foundation of China (RJTJ–JX–001), and Shanghai “Rising Stars of Medical Talent” Youth Development Program – Youth Medical Talents – Clinical Pharmacist Program (SHWJRS (2019) 072).
... Collectively, these cases have prompted guidelines for diagnosis and management. 38,39 Patients with the more severe manifestations of ICI-related myocarditis have varying degrees of heart block upon EKG, reduced ejection fraction, elevated plasma troponin, CPK, AST and LDH. Endomyocardial biopsy and autopsy studies reveal massive infiltration of CD8+ lymphocytes in the hearts of most of these severe and fatal events. ...
Article
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Filip Stefanovic,1,2 Andres Gomez-Caminero,3 David M Jacobs,2,4 Poornima Subramanian,2 Igor Puzanov,5,6 Maya R Chilbert,4 Steven G Feuerstein,4 Yan Yatsynovich,6,7 Benjamin Switzer,5 Jerome J Schentag2,4,5 1Department of Biomedical Engineering, University at Buffalo School of Engineering and Applied Sciences, Buffalo, NY, USA; 2CPL Associates LLC, Buffalo, NY, USA; 3Worldwide Health Economic and Outcomes Research, Bristol Myers Squibb, Princeton, NJ, USA; 4Department of Pharmacy Practice, University at Buffalo School of Pharmacy and Pharmaceutical Sciences, Buffalo, NY, USA; 5Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA; 6Department of Medicine, University at Buffalo Jacobs School of Medicine, Buffalo, NY, USA; 7Kettering Medical Center, Kettering, OH, USACorrespondence: Jerome J Schentag, CPL Associates LLC, 73 High St. Suite 310, Buffalo, NY, 14203, USA, Tel +1 716-867-0550, Fax +1 716-633-3331, Email Jerome.schentag@live.comBackground: Serious but rare side effects associated with immunotherapy pose a difficult problem for regulators and practitioners. Immune checkpoint inhibitors (ICIs) have come into widespread use in oncology in recent years and are associated with rare cardiotoxicity, including potentially fatal myocarditis. To date, no comprehensive model of myocarditis progression and outcomes integrating time-series based laboratory and clinical signals has been constructed. In this paper, we describe a time-series neural net (NN) model of ICI-related myocarditis derived using supervised machine learning.Methods: We extracted and modeled data from electronic medical records of ICI-treated patients who had an elevation in their troponin. All data collection was performed using an electronic case report form, with approximately 300 variables collected on as many occasions as available, yielding 6000 data elements per patient over their clinical course. Key variables were scored 0– 5 and sequential assessments were used to construct the model. The NN model was developed in MatLab and applied to analyze the time course and outcomes of treatments.Results: We identified 23 patients who had troponin elevations related to their ICI therapy, 15 of whom had ICI-related myocarditis, while the remaining 8 patients on ICIs had other causes for troponin elevation, such as myocardial infarction. Our model showed that troponin was the most predictive biomarker of myocarditis, in line with prior studies. Our model also identified early and aggressive use of steroid treatment as a major determinant of survival for cases of grade 3 or 4 ICI-related myocarditis.Conclusion: Our study shows that a supervised learning NN can be used to model rare events such as ICI-related myocarditis and thus provide clinical insight into drivers of progression and treatment outcomes. These findings direct attention to early detection biomarkers and clinical symptoms as the best means of implementing early and potentially life-saving steroid treatment.Keywords: NN modeling, myocarditis, checkpoint inhibitor, steroid response, dose and timing
... In the treatment of lung cancer patients, they often face the use of corticosteroids, such as treatment of brain metastases to reduce and prevent brain edema and improve tumor-related complications, the treatment of moderate to severe irAEs, and pretreatment before ICIs combined with chemotherapy. Some relevant clinical studies have confirmed that the application of corticosteroids during ICI treatment may inhibit the antitumor efficacy of ICIs [14][15][16]. The retrospective study conducted by Kathryn et al. [17] included 640 patients treated with ICIs monotherapy in two cancer centers, of which 90 patients received corticosteroid therapy (≥10 mg/d prednisone). ...
Article
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Background: This study was designed to investigate the clinical application, efficacy, and safety of immune checkpoint inhibitors (ICIs) in the treatment of lung cancer in the real world. Methods: A retrospective, observational analysis was conducted on patients treated with ICIs in four tertiary hospitals in the region from January 2015 to March 2021, to evaluate the clinical efficacy of ICIs single-agent or combined chemotherapy and anti-vascular drugs in the first-line or second-line treatment of patients with lung cancer. Results: Three hundred and fifteen patients were enrolled in this study. In patients with stage III-IV adenocarcinoma and Squamous cell carcinoma, the objective response rate (ORR) and disease control rate (DCR) were 35.5% (87/245) and 93.5% (229/245), respectively, the median progression-free survival (PFS) was 10.8 months, and the median overall survival (OS) was not reached. A total of 132 patients received ICIs as the first-line treatment, the median treatment cycle was 8 cycles (2-20 cycles), the short-term efficacy ORR was 38.6%, DCR was 93.9%, and the median PFS was 11.4 months. One hundred thirteen patients received ICIs treatment as second-line treatment, the median treatment cycle was five cycles (2-10 cycles), the short-term efficacy ORR was 31.9%, DCR was 92.9%, and the median PFS was 10.0 months. There were no statistically significant differences in ORR, DCR, or median PFS with ICIs as the first-line treatment compared with the second-line treatment(P > 0.05). The results of subgroup analysis showed that Eastern Cooperative Oncology Group performance status (ECOG PS), epidermal growth factor receptor (EGFR) mutation status, pathological type and number of treatment lines were not correlated with median PFS(P > 0.05). However, there were statistically significant differences in programmed death-ligand 1(PD-L1) expression, corticosteroid interference, and antibiotic (Abx) treatment among all groups (P < 0.05). In terms of safety, the overall incidence of adverse reactions in 315 patients was 62.5%, and the incidence of immune-related adverse events (irAEs) was 13.7%. Grade 1-2 and 3-4 incidence of adverse events were 34.9 and 27.65%, respectively. There were four patients who experienced fatal irAEs, two cases were liver damage leading to liver failure, one case was immune related pneumonia, and one case was immune related myocarditis. Conclusion: In the real world, ICIs has a good effect on patients with lung cancer and significantly improves ORR and PFS.
... Le bilan biologique est non spécifique, un syndrome inflammatoire pouvant également être présent en cas de PI ou en raison de la pathologie tumorale. La fibroscopie bronchique permet de réaliser des prélèvements infectieux larges (aspiration bronchique et LBA avec analyse bactériologique, mycobactériologique, mycologique dont PCR Pneumocystis et virologique) [10,12,19,24,25]. L'analyse anatomopathologique du LBA apporte un argument supplémentaire pour ce diagnostic avec habituellement un profil d'alvéolite immune caractérisé par une hyperlymphocytose [12]. ...
... Après élimination des diagnostics différentiels, il est recommandé par les sociétés savantes de cancérologie (ASCO, ESMO, SITC) [19,30,31] d'initier une corticothérapie intraveineuse à dose élevée à la phase initiale en cas de toxicité sévère (grade 3 ou 4 CTACEv5) pendant 48-72 heures, puis de diminuer la posologie, si l'évolution clinique est favorable, selon un protocole de décroissance progressive sur au moins 8 semaines [19,24,32]. Dans l'attente du résultat de l'ensemble des prélèvements infectieux, une antibiothérapie probabiliste est généralement associée à ce traitement. ...
Article
Résumé Introduction : Les inhibiteurs de points de contrôle immunitaire ont révolutionné la prise en charge de nombreux cancers et ont permis d’obtenir une efficacité et une réponse durable pour certains patients. L’immunothérapie est associée à des effets secondaires en lien avec l'infiltration de cellules immunitaires dans les tissus normaux pouvant entraîner des réactions dysimmunitaires disproportionnées. Ces effets secondaires peuvent toucher n’importe quel organe dont le poumon, pouvant parfois engager le pronostic vital. Ils peuvent ressembler à des événements de nature infectieuse, dont la COVID-19. Observations : Nous rapportons le cas de 3 patients ayant présenté des toxicités pulmonaires sévères secondaires à l’immunothérapie entre mars et mai 2020 avec hypothèse initiale d’une pneumopathie à SARS-CoV-2. Après investigations approfondies, le diagnostic de toxicité pulmonaire à l’immunothérapie fut retenu, avec une évolution clinique et radiologique favorable suite à l’instauration d’une corticothérapie. Conclusion : La toxicité pulmonaire secondaire à l’immunothérapie reste un effet indésirable rare mais pouvant engager le pronostic vital. La démarche diagnostique impose d’éliminer plusieurs diagnostics différentiels. Le tableau clinique est réversible et l’évolution habituellement favorable après instauration d’une corticothérapie.
... ICIrelated toxicity management relies on the administration of immunosuppressors such as systemic corticosteroids. [85][86][87] Conversely, antiangiogenic agents related to toxicity result from various underlying mechanisms due to on-target effects and are mainly managed by dose reductions and treatment interruption. to a more complex management and recognition of treatment-related toxicity, as there is an overlap between some ICI related and VEGFR TKI related adverse events. ...
... TRAEs that required additional guidance based on overlapping toxicities were identified, and recommendations were set up focusing on adverse events requiring differential diagnosis of etiology, for which no published guidelines were yet available. 84,85,87,89,90 These events were identified as diarrhea, hepatitis, cardiovascular events, and fatigue and lead to specific recommendations. 88 As a general rule for low-grade adverse events, it is recommended to first assess the absence of severity symptoms that would require immediate intervention. ...
Article
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Manuela Tiako Meyo,1,2 Jeanne Chen,1,2 Francois Goldwasser,1,2 Laure Hirsch,1,2 Olivier Huillard1,2 1Department of Medical Oncology, Institut du Cancer Paris CARPEM, AP-HP, APHP.Centre, Hôpital Cochin, Paris, France; 2Immunomodulatory Therapies Multidisciplinary Study Group (CERTIM), AP-HP, APHP.Centre, Hôpital Cochin, Paris, FranceCorrespondence: Olivier Huillard, Department of Medical Oncology, Institut du Cancer Paris CARPEM, AP-HP, APHP.Centre, Hôpital Cochin, 123 Bd de Port Royal, Paris, 75014, France, Tel +33 1 58 41 14 39, Fax +33 1 58 41 14 34, Email olivier.huillard@aphp.frAbstract: Until recently, the approved first-line treatment for metastatic RCC (mRCC) consisted of tyrosine kinase inhibitors (TKI) targeting the vascular endothelial growth factor receptors (VEGFR) monotherapy. The landscape of first-line treatment has been transformed in the last few years with the advent of immune checkpoint inhibitors (ICI) or VEGFR TKI plus ICI combinations. This article focuses on the profile of one of these ICI plus VEGFR TKI combination, avelumab plus axitinib. We detail the characteristics of each drug separately, and then we explore the rationale for their association, its efficacy and the resulting toxicity. Finally, we examine the factors associated with avelumab plus axitinib outcomes, and their impact on therapeutic strategy.Keywords: renal cell carcinoma, vascular endothelial growth factor, immune checkpoint inhibitor, axitinib, avelumab, pharmacology
... The efficacy of ICI treatment has been confirmed, and real-world clinical experience with its application has been gained. However, a wide spectrum of accompanying immune-related adverse events (ir-AEs) have been reported, with caution advised by expert oncologists [1]. These irAEs are driven by the immunologic mechanisms responsible for the therapeutic effects of ICIs [2,3]. ...
Article
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Background and study aims Recent advances in cancer treatment have involved the clinical application of immune checkpoint inhibitors (ICIs) for various type of cancers. The adverse events associated with ICIs are generally referred to as immune-related adverse events (irAEs). Gastrointestinal irAEs are a major disorder, but gastritis is not frequently observed. The aims of this study were to elucidate the clinical, endoscopic, and histological characteristics of irAE gastritis. Patients and methods Information on patients treated with ICIs were collected from a single institute over 3 years. IrAE gastritis was identified based on the clinical course and endoscopic and histopathological findings. Of the 359 patients treated with ICIs, four cases of irAE gastritis were identified in clinical records from the endoscopy unit. The endoscopic and histopathological findings were analyzed, and further immunohistochemical studies with immune subtype markers and programmed cell death ligand-1 (PD-L1) antibody were conducted. Results Among four patients with irAE gastritis, the remarkable endoscopic characteristics were network-pattern erosion, erythematous and edematous mucosa with thick purulent discharge, and fragile mucosa. Corresponding histological features were fibrinopurulent exudate, severe inflammatory cell infiltration, and epithalaxia, respectively. The PD-L1 expression rate was ≥ 1 % in the gastric tissue of all patients with gastritis. These patients were treated with prednisolone (PSL) and their symptoms improved within a few days to 2 weeks. Conclusions IrAE gastritis were characterized by specific endoscopic findings. The appropriate endoscopic diagnosis may lead to effective treatment with PSL.
... Immune checkpoint inhibitors (ICIs) enhance antitumor activity by blocking negative regulators of T-cell function: e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and programmed cell death protein 1 or its ligand (PD-[L]1) [1,2]. By upregulating the immune system, ICIs have revolutionized the treatment of various cancers in recent years; however, they are associated with immune-related adverse events (irAE). ...
Article
Background: Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment, but are associated with immune-mediated diarrhea and colitis (IMDC). Clostridioides difficile infection (CDI) can cause infectious diarrhea with overlapping symptoms. Thus, we sought to elucidate the characteristics of CDI in patients treated with ICI, in the context of IMDC. Methods: We conducted a retrospective, single-center study of adult cancer patients (N=421) with ICI exposure from 2015-2020 and a positive stool nucleic acid amplification test and/or enzyme immunoassay for CDI. Baseline characteristics, treatments, and outcomes were compared between patients with and without concurrent IMDC. Results: Forty-one eligible patients were included, 27 with concurrent IMDC and 14 without. Twenty-seven patients were taking programmed death-1 or its ligand inhibitors and 14 were taking cytotoxic T-lymphocyte-associated antigen 4 inhibitors. Patients with concurrent CDI and IMDC had a longer symptom duration (20 vs. 5 days, P=0.003) and a higher rate of grade 3-4 diarrhea (41% vs. 7%, P=0.033). Among patients with concurrent IMDC, preceding antibiotics (P=0.050) and proton pump inhibitors (PPI) (P=0.038) were used more frequently among individuals who developed CDI after immunosuppressant exposure. Thirty-eight patients received antibiotics for CDI, while 5 required fecal microbiota transplantation for concurrent CDI & IMDC. Conclusions: CDI is common in ICI-treated cancer patients, especially those with IMDC requiring immunosuppressants. Antibiotics did not alter the need for immunosuppressants in those with concurrent IMDC. Use of PPI and antibiotics while receiving immunosuppressants for IMDC was associated with a greater risk of CDI. Further large-scale studies are warranted to clarify the role of CDI, antibiotics and immunosuppression treatment in IMDC patients.
... In some reports, 13-32% of ED presentations are for confirmed irAEs in patients receiving ICIs [5,6]. Anti-PD-(L)1, and anti-CTLA-4 ICIs can result in a range of irAEs with the onset of irAEs ranging from days to years after initial therapy and can mimic other common conditions such as infectious, pulmonary, or cardiac conditions [5,7,8]. Thus, the diagnosis and management of complex irAEs often involve multi-disciplinary input from oncologists and subspecialist providers [9,10]. ...
Article
Introduction: With the increasing use of immune checkpoint inhibitors (ICI) for cancer, there is a growing burden on the healthcare system to provide care for the toxicities associated with these agents. Herein, we aim to identify and describe the distribution of encounters seen in an urgent care setting for immune-related adverse events (irAEs) and the clinical outcomes from irAE management. Methods: Patient demographics, disease characteristics, and treatment data were collected retrospectively from encounters at an oncology Urgent Care Clinic (UCC) from a single tertiary center for upper aerodigestive malignancies from 1 July 2018 to 30 June 2019. Data were summarized using descriptive statistics with odds ratios for associations between patient features and hospitalization after UCC evaluation. Results: We identified 494 encounters from 289 individual patients over the study period. A history of ICI therapy was noted in 34% (n = 170/494) of encounters and 29 encounters (29/170, 17%) were confirmed and treated as irAEs. For those treated for irAEs, the majority (n = 19/29; 66%) were discharged home. Having an irAE was associated with an increased risk of hospitalization compared to non-irAEs (OR 5.66; 95% CI 2.15-14.89; p < 0.001). Conclusion: In this single institution experience, the majority of UCC encounters for confirmed irAEs were safely managed within the UCC. In ICI-treated patients, having an irAE was associated with an increased risk of hospitalization versus non-irAEs.
... Pre-ICI therapies, in which steroids were given before the start of the ICI, were found to have little to no effect on the rates of irAEs in studies [157]. Anti-TNF-alpha drugs have shown success in treating uveitis, colitis, and hepatitis in steroid-resistant irAEs [158]. Additional research has found that cyclophosphamide and mycophenolate for pneumonitis, and methotrexate and hydroxychloroquine for arthritis, are effective for steroid-resistant irAEs [159]. ...
Article
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Immunotherapy, which stimulates the body’s immune system, has received a considera- ble amount of press in recent years because of its powerful benefits. Cancer immunotherapy has shown long-term results in patients with advanced disease that are not seen with traditional chem- otherapy. Immune checkpoint inhibitors, cytokines like interleukin 2 (IL-2) and interferon-alpha (IFN), and the cancer vaccine sipuleucel-T have all been licensed and approved by the FDA for the treatment of various cancers. These immunotherapy treatments boost anticancer responses by stim- ulating the immune system. As a result, they have the potential to cause serious, even fatal, inflam- matory and immune-related side effects in one or more organs. Immune checkpoint inhibitors (ICPIs) and chimeric antigen receptor (CAR) T-cell therapy are two immunotherapy treatments that are increasingly being used to treat cancer. Following their widespread usage in the clinic, a wave of immune-related adverse events (irAEs) impacting virtually every system has raised concerns about their unpredictability and randomness. Despite the fact that the majority of adverse effects are minimal and should be addressed with prudence, the risk of life-threatening complications ex- ists. Although most adverse events are small and should be treated with caution, the risk of life- threatening toxicities should not be underestimated, especially given the subtle and unusual indi- cations that make early detection even more difficult. Treatment for these issues is difficult and necessitates a multidisciplinary approach involving not only oncologists but also other internal medicine doctors to guarantee quick diagnosis and treatment. This study’s purpose is to give a fun- damental overview of immunotherapy and cancer-related side effect management strategies.
... Second, immune-mediated toxicity was considered. Colitis is the second most commonly reported AE with ICI administration, and the symptoms typically develop from 6 to 8 weeks from the start of treatment; median onset of transaminase elevation is approximately 6-14 weeks after starting ICIs [33]. The pathogenesis of ICI-induced hepatitis is not well understood. ...
Article
Patients with cancer have a higher risk of severe COVID-19, and expert consensus advocates for COVID-19 vaccination in this population. Some cases of autoimmune hepatitis have been described after the administration of COVID-19 vaccine in the people in apparently good health. Immune checkpoint inhibitors (ICIs) are responsible for a wide spectrum of immune-related adverse events (irAEs). This article reports a case of hepatitis and colitis in a 52-year-old woman who was undergoing immunotherapy and was HBV positive 10 days after receiving the first Pfizer-BioNTech COVID-19 vaccine dose. Because both ICIs and the COVID-19 vaccines stimulate the immune response, the authors hypothesize that these vaccines may increase the incidence of irAEs during ICI treatment. There is a complex interplay between the immune-mediated reaction triggered by the vaccination and PD-L1 co-administration.