Management Of Adverse Events Research Articles

Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer

Use of individualized starting dose and niraparib hematologic adverse event management costs in ovarian cancer

Introducing vaccination services in prison settings: case study from Moldova

Abstract Introducing vaccination services within prison settings presents a multifaceted challenge and opportunity, particularly evident in the case of Moldova. This Eastern European nation grapples with various socio-economic and healthcare disparities, with its prison population often experiencing heightened health vulnerabilities. Amidst such complexities, the implementation of vaccination services emerges as a crucial strategy not only to safeguard the health of incarcerated individuals but also to contribute to broader public health goals. Moldova’s journey in this regard reflects a commitment to advancing preventive healthcare within its correctional facilities. The introduction of vaccination services in prisons necessitated a comprehensive approach, encompassing policy development, infrastructure enhancement, staff training, and community engagement. Infrastructure enhancement was imperative to ensure the provision of vaccination services in a safe, efficient, and dignified manner within prison settings. This involved the establishment of designated vaccination areas equipped with the necessary medical supplies and equipment. Staff training emerged as a cornerstone of the initiative, empowering healthcare professionals working within prisons with the knowledge, skills, and confidence to deliver vaccination services effectively. Training programs encompassed various aspects, including vaccine administration, adverse event management, and communication strategies tailored to the specific needs of incarcerated individuals. Collaboration with people living in prison facilitated the dissemination of accurate information, addressed concerns, and encouraged participation in vaccination programs. During the period 2021-2023 7454 doses of antiCOVID-19, 1298 doses of anti-Flu vaccine, 3083 doses of anti-HBV vaccines were administered.

Safety and Tolerability of Nintedanib in Patients with Fibrosing Interstitial Lung Diseases: Post-marketing Data.

Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis (IPF), other forms of progressive pulmonary fibrosis (PPF), and systemic sclerosis-associated interstitial lung disease (ILD). We present global post-marketing safety data for nintedanib in these fibrosing ILDs. Data on adverse events in patients with fibrosing ILDs who were treated with nintedanib were collected via spontaneous reporting and solicited reporting in various studies (excluding clinical trials).Data were collected from 15 October 2014 (first regulatory approval) to 15 October 2023. Adverse events were coded using the Medical Dictionary for Regulatory Activities. Cumulative exposure to nintedanib was estimated using sales data. Cumulative exposure to nintedanib was 380,557 patient-years. Diarrhoea was reported at a rate of 227.5 per 1000 patient-years. Only 2.6% of diarrhoea events were reported as serious. Of 39,788 (33.6%) diarrhoea events with a known time to onset, almost 60% occurred within the first 3months of treatment. The rate of serious liver enzyme and bilirubin elevations (including drug-induced liver injury) was 4.0 per 1000 patient-years. Bleeding was reported at a rate of 24.2 per 1000 patient-years. Most (81.3%) bleeding events were non-serious. The rates of myocardial infarction, ischaemic stroke, and venous thromboembolism were 3.3, 3.3, and 2.0 per 1000 patient-years, respectively. Gastrointestinal perforation was reported at a rate of 0.9 per 1000 patient-years. Post-marketing safety data on established and potential adverse events associated with nintedanib in patients with fibrosing ILDs, collected over 9years, demonstrated a safety profile that was similar to that established in clinical trials and provided in the product labels. Education of patients about the adverse events that may be associated with nintedanib, and the effective management of adverse events when they occur, is important to minimise the impact of adverse events and help patients remain on treatment.

Estimated cost of VEGFR TKI associated adverse events in metastatic renal cell carcinoma patients

IntroductionThe majority of metastatic renal cell carcinoma (mRCC) patients receive one or more VEGFR TKI agents, alone or in combination with an immune-oncology (IO) agent or an mTOR inhibitor. To date, the cost of adverse events (AEs) common to VEGFR TKIs has not been quantified. This study estimated the potential impact of differences in VEGFR TKI AE profiles on treatment cost efficiency in the relapsed/refractory (R/R) setting.MethodsPatients with documented mRCC who were treated with VEGFR TKI therapies between Jan 2015 and Mar 2021 were identified using EMR. ICD-10 diagnosis codes were used to identify the first occurrence of each class effect AE. Patients were matched to 3rd party insurance claims, and costs associated to TKI AEs within 90 days of index event were captured. Average per patient AE cost data was calculated and applied to published incidence data to estimate regimen-specific AE total cost burden within a hypothetical commercial plan for mRCC patients undergoing treatment in the R/R setting.ResultsThe highest total cost for AE management was attributed to lenvatinib and everolimus use at $13,303, followed closely by sunitinib at $13,092. Tivozanib treatment was associated with the lowest total cost of AE management at $7,523, driven by the relatively lower incidence of certain high-cost AEs.ConclusionsThe estimated costs of managing VEGFR TKI class-effect AEs were lowest with tivozanib, and highest with lenvatinib and everolimus, indicating potentially differential healthcare resource burden by TKI regimen. The use of tivozanib in the 3 L + mRCC setting suggests potential costs offsets when compared to other TKI regimens.

Pharmacotherapy of acute ST-elevation myocardial infarction and the pharmacist's role, part 1: Patient presentation through revascularization.

In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Key pharmacotherapeutic modalities and considerations for the patient with ST-elevation myocardial infarction (STEMI) across the critical initial phases of care are reviewed. Despite established value in the emergency department (ED), cardiac care, and intensive care settings, there is currently little published literature describing or supporting clinical pharmacist roles in the acute management of STEMI. The high-risk period from hospital presentation through revascularization and stabilization involves complex pharmacotherapeutic decision points, many operational medication needs, and multiple layers of quality oversight. While rife with opportunities for pharmacists to optimize care, this timeframe appears inconsistently targeted by clinical pharmacy services, which may halt after ED evaluation and then resume upon postcatheterization cardiac unit admission. Herein we review the key pharmacotherapeutic modalities and considerations for the patient with STEMI across the critical initial phases of care. These include supportive therapies prior to revascularization, the host of antithrombotics involved in revascularization by percutaneous coronary intervention and/or fibrinolysis, and other periprocedural medications. Important practice guidelines and clinical resources are summarized from the clinical pharmacist perspective, and roles and responsibilities of the responding pharmacist are suggested. A companion article will extend the review to periprocedural adverse event management, key early decision-making regarding long-term risk reduction, and pharmacist involvement in institutional quality improvement efforts. We aim to support inpatient pharmacy departments in advancing clinical services for this critical patient population, and we call for further research delineating pharmacist impact on patient and institutional STEMI outcomes. Patients presenting with STEMI rapidly traverse multiple phases of care and receive a host of antithrombotic and supportive medications during acute management, presenting many important pharmacotherapeutic decision points and roles for pharmacists.

Ventilation strategies in cardiogenic shock: insights from the FRENSHOCK observational registry.

Despite scarce data, invasive mechanical ventilation(MV) is widely suggested as first-line ventilatory support incardiogenic shock(CS) patients. We assessed the real-life use of different ventilation strategies in CS and their influence on short and mid-term prognosis. FRENSHOCK was a prospective registry including 772 CS patients from 49 centers in France. Patients were categorized into three groups according to the ventilatory supports during hospitalization: no mechanical ventilation group (NV), non-invasive ventilation alone group (NIV), and invasive mechanical ventilation group (MV). We compared clinical characteristics, management, and occurrence of death and major adverse event (MAE) (death, heart transplantation or ventricular assist device) at 30days and 1year between the three groups. Seven hundred sixty-eight patients were included in this analysis. Mean age was 66years and 71% were men. Among them, 359 did not receive any ventilatory support (46.7%), 118 only NIV (15.4%), and 291 MV (37.9%). MV patients presented more severe CS with more skin mottling, higher lactate levels, and higher use ofvasoactive drugs and mechanical circulatory support. MV was associated with higher mortality and MAE at 30days (HR 1.41 [1.05-1.90] and 1.52 [1.16-1.99] vs NV). No difference in mortality (HR 0.79 [0.49-1.26]) or MAE (HR 0.83 [0.54-1.27]) was found between NIV patients and NV patients. Similar results were found at 1-year follow-up. Our study suggests that using NIV is safe in selected patients with less profound CS and no other MV indication. NCT02703038.

Managing Select Immune-Related Adverse Events in Patients Treated with Immune Checkpoint Inhibitors.

The increased use of immune checkpoint inhibitors (ICIs) across cancer programs has created the need for standardized monitoring and management of immune-related adverse events (irAEs). Delayed recognition without appropriate treatment can have serious and life-threatening consequences. The management of irAEs presents a unique set of challenges that must be addressed at a multidisciplinary level. Although various national and international guidelines and working groups provide high-level recommendations for the management of irAEs, practical guidance is lacking. Furthermore, timely collaboration between specialists requires institutional protocols that enable the early recognition, assessment, and treatment of irAEs. Such protocols should be developed by institution specialists and include algorithms for all healthcare providers involved in the care of patients treated with ICIs. At William Osler Health System in Brampton, Ontario, practical step-by-step multidisciplinary treatment approaches with recommendations for the management of irAEs were developed in collaboration with experts across Canada. Here, we provide an in-depth description of the approaches, outlining baseline investigations prior to the initiation of ICIs, as well as the monitoring and management of irAEs based on symptoms, severity, and involved organ systems. We encourage other centres to adapt and modify our approaches according to their specific needs and requirements.

Usefulness of urine dipstick test in the management of adverse events associated with immune checkpoint inhibitors.

The usefulness of urine dipstick tests (UDTs) in patients with diabetes has been reported. The aim of the present study was to investigate the utility of self-performed UDTs and patient diaries in the management of impaired glucose tolerance, one of the adverse events of immune checkpoint inhibitors (ICIs). Patients receiving ICIs underwent self-checks with UDTs twice a week for up to 6months. Pharmacists checked the results at every patient visit, and by phone every 3months. The primary endpoint was to prospectively assess whether symptoms recorded in patient diaries and UDTs could reduce unscheduled hospital admissions due to impaired glucose tolerance. The secondary endpoint was the correlation between the symptoms in the patient diaries and UDT results. A total of 112 patients were enrolled in the study. Out of the 3197 planned self-UDTs, 3128 (97.8%) were performed. Forty-four patients (39.3%) were admitted to the hospital, two (1.8%) of whom were admitted due to abnormal glucose tolerance, with one having a positive UDT. There were 46 unscheduled outpatient visits (41.1%), of which five (4.5%) were due to abnormal glucose tolerance symptoms and four were due to a positive UDT. The correlation between descriptions of fatigue or dry mouth in the patient diaries and positive glucose UDTs was 52.4% in sensitivity and 62.4% in specificity. Self-monitoring of symptoms and self-performing of UDTs could not reduce the emergency hospitalization rate. However, this approach could be effective in the objective monitoring of patient status, especially regarding glucose intolerance occurrences.

Management of immune-related adverse events in oncology settings

Management of immune-related adverse events in oncology settings

Adverse events associated with azithromycin and clarithromycin in adults aged ≥65: a disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database

ABSTRACT Background Azithromycin and clarithromycin are commonly used to treat community-acquired pneumonia in adults aged ≥ 65, such as mycoplasma pneumonia. This study aims to evaluate adverse events (AEs) associated with azithromycin and clarithromycin in this age group by analyzing the FDA Adverse Event Reporting System (FAERS), providing insights for clinical use and management of AEs in this population. Research design and methods We retrieved reports of AEs related to azithromycin and clarithromycin from the FAERS database. Disproportionality analysis was conducted using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Gamma Poisson Shrinkage (MGPS) to identify AEs associated with azithromycin and clarithromycin in adults aged ≥ 65. Results A total of 2,019 adverse event reports were retrieved for azithromycin, and 2,392 for clarithromycin. Off-label use (n = 349) and drug interactions (n = 487) were the most reported AEs in adults aged ≥ 65 for azithromycin and clarithromycin, respectively. Prolonged QT interval showed the strongest signal among AEs for azithromycin in this age group. Drug interaction-related medication errors had the strongest signal for clarithromycin. Seven signals not explicitly included in the azithromycin package insert were identified in adults aged ≥ 65. Fourteen signals not explicitly included in the clarithromycin package insert were identified. Conclusions Among adults aged ≥ 65, cardiac-related adverse events are more closely associated with azithromycin than with clarithromycin. Conversely, AEs related to drug interactions and psychiatric symptoms are more associated with clarithromycin. Additionally, clinicians should be vigilant regarding AEs not specified in the package inserts. The findings of this study may help optimize the selection of azithromycin and clarithromycin based on patient circumstances and assist clinicians in focusing on relevant AEs for early intervention.

Impact of systemic steroids on the efficacy of first line imatinib treatment of patients with advanced gastrointestinal stromal tumors (GISTs).

Effective management of adverse events is required to maintain sufficient imatinib dosing when treating patients with gastrointestinal stromal tumors (GISTs). Skin rash is a common adverse event of imatinib, which can be effectively controlled by systemic steroid treatment without imatinib dose modification or interruption. However, the impact of the use of systemic steroids on the efficacy of imatinib treatment remains unclear. Between October 2014 and February 2022, 277 consecutive patients from a prospective registry of GIST patients were included as the study population. Patients who started systemic steroids due to grade ≥ 3 skin rash or grade 2 skin rash with grade 2 pruritis were classified as the steroid group, whereas patients who did not develop a skin rash or those who did not require steroids for a mild skin rash were classified as the control group. Efficacy outcomes were compared between the two groups. Among the 277 patients, 30 (10.8%) were treated with systemic steroids for skin rash. There was no significant difference in progression free survival (PFS) or overall survival (OS) between the steroid and control groups (3-year PFS, 67.7% vs. 65.1%, p = 0.53; 3-year OS, 91% vs. 89.9%, p = 0.67, respectively). The use of systemic steroids was not an independent factor associated with PFS (hazard ratio 0.73, 95% confidence interval 0.36-1.49, p = 0.39) and OS (hazard ratio 0.37, 95% confidence interval 0.12-1.18, p = 0.09). In the steroid group, patients who successfully maintained the imatinib dosage showed a trend toward more favorable survival outcomes than those who did not (3-year PFS, 73.3% vs. 44.4%, p = 0.34; 3-year OS, 95.8% vs. 75.0%, p = 0.15, respectively). The use of systemic steroids for the control of imatinib induced severe skin rash did not adversely affect the efficacy outcomes of imatinib in patients with advanced GIST.

Managing Adverse Events in Clinical Trials with R and Shiny

Adverse events (AEs) are critical occurrences that can significantly impact patient safety and the overall success of clinical trials. Effective management of AEs is essential for ensuring regulatory compliance and safeguarding participants' well-being. This paper explores the integration of R and Shiny as innovative tools for the real-time monitoring, visualization, and analysis of AEs in clinical trials. By leveraging R’s robust statistical capabilities and Shiny’s interactive interface, researchers can enhance data management processes, facilitate informed decision- making, and foster collaboration among stakeholders. A case study is presented to illustrate the practical application of R Shiny in tracking AEs, demonstrating its effectiveness in improving trial outcomes and ensuring patient safety. The findings emphasize the need for adopting dynamic data analysis tools to optimize adverse event management in the evolving landscape of clinical research. KEYWORDS Adverse Events, Clinical Trials, R, Shiny, Data Management, Visualization, Real-Time Monitoring, Patient Safety.

12265 Isolated Adrenocorticotropic Hormone Deficiency In The Setting Of Anti-PD1 Immunotherapy

Abstract Disclosure: J. Poncelet: None. Q. Wang: None. A.J. Montero: Advisory Board Member; Self; AstraZeneca, Gilead. Other; Self; Medical Advisor for Paragon Infusion Services. L. Tranchito: None. Isolated Adrenocorticotropic Hormone Deficiency in the Setting of Anti-PD1 Immunotherapy Introduction: Immune checkpoint inhibitors have been associated with endocrine immune-related adverse events, such as secondary adrenal insufficiency with isolated ACTH deficiency in rare instances. Case Presentations: We present two different cases of isolated ACTH deficiency (IAD) while on anti-PD1 therapy with pembrolizumab. Patient A is a 66-year-old woman with history of tobacco use, hypertension, and COPD diagnosed with stage IV lung adenocarcinoma. After completing 15 cycles of pembrolizumab, she reported symptoms of fatigue, weakness, lightheadedness, and was subsequently admitted to the hospital for symptomatic hyponatremia. Lab workup revealed a morning cortisol level of 0.6 ug/dL (n2.5-20 ug/dL) and ACTH <1.5 pg/mL (n7.2-63.3 pg/mL), both of which had previously been normal. Her TSH was mildly elevated with a normal free T4. Her FSH, LH, prolactin, and IGF levels were normal as was MRI of the pituitary. She therefore was diagnosed with IAD and started physiologic steroid replacement therapy with hydrocortisone with subsequent symptomatic improvement and normalization of her serum sodium. Patient B is a 60-year-old woman with a history of osteoporosis, aortic stenosis, and stage II triple negative breast cancer treated with neoadjuvant chemotherapy and pembrolizumab. Two months after starting immunotherapy, she presented to her oncology office with symptoms of fatigue, poor appetite, body aches, and dizziness. Her labs revealed mild hyponatremia, cortisol of 0.9 ug/dL (n2.5-20 ug/dL) and ACTH <1.5 pg/mL (n7.2-63.3 pg/mL). TSH, LH, FSH, and prolactin levels were normal. She started physiologic steroid replacement therapy with hydrocortisone for IAD, which led to improvement in her symptoms. Both patients continue pembrolizumab. Conclusions: Immune-related adverse events affecting endocrine pathways have been reported with immune checkpoint inhibitors. There is no method to predict which patients may be affected, and no guidelines exist on when or how often to monitor hormone levels in these patients. Importantly, patients can continue immune checkpoint inhibitors despite IAD if controlled by hormone replacement, though ACTH recovery should not be expected[1]. Recognition of symptoms can prompt earlier evaluation for secondary adrenal insufficiency and provide greater benefit to patients. 1.Schneider BJ, Naidoo J, Santomasso BD, et al. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: ASCO Guideline Update [published correction appears in J Clin Oncol. 2022 Jan 20;40(3):315]. J Clin Oncol. 2021;39(36):4073-4126. doi:10.1200/JCO.21.01440 Presentation: 6/1/2024

Budget impact analysis of pembrolizumab versus the novel PD-1 inhibitor toripalimab in locally advanced or metastatic nonsquamous non-small cell lung cancer

ABSTRACT Aim To estimate the budget impact of adding a toripalimab regimen to the existing treatment mix of pembrolizumab, both with pemetrexed and carboplatin, in patients with locally advanced or metastatic nonsquamous NSCLC within two price inputs (wholesale acquisition cost (WAC) and average sales price (ASP)). Methods Budget impact analysis comparing a treatment mix “without” versus “with” the toripalimab regimen in the annual US nonsquamous NSCLC population treated with a PD-1 inhibitor, a 3-year time horizon, toripalimab market share of 1% in 2024, increasing to 4% (2025) and 5% (2026), and medication use adjustments for discontinuation or progression to estimate fully-treated-patient-equivalents. Cost inputs included drugs, administration, and grade 3/4 adverse event (AE) management. The models were replicated in a 1-million-member plan to estimate costs per-member-per-month (PMPM) and per-member-per-year (PMPY). One-way (OWSA) and probabilistic sensitivity analyses (PSA) as well as two scenario analyses were performed. Results In the “without” scenario, the 3-year WAC costs for the pembrolizumab regimen total $40,750,234,637 ($39,024,548,745 for treatment and $1,725,685,894 for managing AEs). In the “with” scenario, these costs decline to $39,341,379,081. Corresponding “with” costs for toripalimab are $1,186,027,704 (treatment) and $99,454,471 (AE management) for a total of $1,285,482,175. This yields annual net savings of between $10,779,362 (at 1% market share) in 2024 and $64,858,298 (5% market share) in 2026, for 3-year savings of $123,373,381. The associated savings in a 1-million-member plan are $0.030 PMPM and $0.363 PMPY. The ASP model shows similar patterns. Savings were demonstrated in 68% of PSA simulations; OWSAs and scenario analyses reveal how parameter variability impacts results. Conclusion Significant savings are likely achievable from treating between 1% (year 1) to 5% (year 3) of nonsquamous NSCLC patients with the toripalimab regimen. Projected 3-year savings range from $122 million (ASP) to $123 million (WAC); corresponding to savings of $0.030 PMPM and $0.363 PMPY.

Best Patient Care Practices for Administering PSMA-Targeted Radiopharmaceutical Therapy.

Optimal patient management protocols for metastatic castration-resistant prostate cancer (mCRPC) are poorly defined and even further complexified with new therapy approvals, such as radiopharmaceuticals. The prostate-specific membrane antigen (PSMA)-targeted agent 177Lu vipivotide tetraxetan ([177Lu]Lu-PSMA-617), approved after the phase III VISION study, presents physicians with additional aspects of patient management, including specific adverse event (AE) monitoring and management, as well as radiation safety. Drawing on our experience as VISION study investigators, here we provide guidance on best practices for delivering PSMA-targeted radiopharmaceutical therapy (RPT) to patients with mCRPC. After a comprehensive review of published evidence and guidelines on RPT management in prostate cancer, we identified educational gaps in managing the radiation safety and AEs associated with [177Lu]Lu-PSMA-617. Our results showed that providing sufficient education on AEs (e.g., fatigue and dry mouth) and radiation safety principles is key to effective delivery and management of patient expectations. Patient counseling by health care professionals, across disciplines, is a cornerstone of optimal patient management during PSMA-targeted RPT. Multidisciplinary collaboration is crucial, and physicians must adhere to radiation safety protocols and counsel patients on radiation safety considerations. Treatment with [177Lu]Lu-PSMA-617 is generally well tolerated; however, additional interventions may be required, such as dosing modification, medications, or transfusions. Urinary incontinence can be challenging in the context of radiation safety. Multidisciplinary collaboration between medical oncologists and nuclear medicine teams ensures that patients are monitored and managed safely and efficiently. In clinical practice, the benefit-to-risk ratio should always be evaluated on a case-by-case basis.

Understanding Treatment Decisions and Management for Patients with Advanced Renal Cell Carcinoma Using Hypothetical Case Studies: A Vodcast.

In recent years, the armamentarium of therapies for the management of advanced renal cell carcinoma (aRCC) has grown. Combination therapies, including immuno-oncology (IO) agents and tyrosine kinase inhibitors [TKIs (IO-TKI)], and IO-IO combinations, are now approved for first-line treatment of aRCC. Decisions regarding the use of these combinations, IO-IO versus IO-TKI, can be challenging, as they have not been compared in a randomized trial; each of these combinations have been compared with sunitinib alone. In addition, patient-, disease-, and treatment-based factors must be evaluated in the decision-making process. More important is the consideration of patient management during treatment and optimal detection and management of toxicities to ensure continued benefit. In this vodcast, two experts in the field of kidney cancer will present case studies that represent typical patients seen in practice. The faculty will discuss treatment approaches, adverse event management, and which factors to consider during the treatment decision-making process. Viewers of the vodcast will get a better understanding of clinical trial outcomes related to an IO-TKI combination, such as axitinib plus pembrolizumab, that they can apply to their practice immediately. In addition, they will gain real-world insight into how experts approach the treatment of patients with aRCC and, more importantly, therapy management.

EL6 Supportive care in cancer and adverse event management

EL6 Supportive care in cancer and adverse event management

Post-Vaccine Myocarditis: Clinical Insights and Epidemiological Trends

Myocarditis is a rare but key adverse event linked to mRNA COVID-19 vaccines, predominantly in young males. Epidemiological data indicate an incidence of approximately 12.6 cases per million doses administered to patients aged 12-39 years, mostly following the second dose of the vaccine. Most patients present with elevated levels of cardiac biomarkers, chest pain, and abnormal ECG findings within a few days of vaccination. Proposed mechanisms for the exact pathophysiology of this include molecular mimicry between the SARS-CoV-2 spike protein and cardiac antigens, activation of immune pathways, and dysregulated cytokine expression. Despite these findings, the overall benefit-risk balance for COVID-19 vaccination remains positive, as the majority of patients recover fully. In contrast, COVID-19-associated myocarditis is more common and more severe, with an estimated incidence of 1,000-1,400 cases per 100,000 infections. Clinical presentation of vaccine-associated myocarditis is usually mild and self-limiting, and most patients do recover without significant long-term effects. Treatment is usually supportive in nature and has an emphasis on ruling out acute coronary syndrome and symptomatic management for heart failure or arrhythmias if present. Given its low incidence and the generally good outcome, vaccination against COVID-19 is recommended from 12 years of age and above, with provision for ongoing surveillance for monitoring and management of rare adverse events like myocarditis.

Toxicity of Cancer Immunotherapies in Older Patients: Does Age Make a Difference?

The use of immunotherapy agents especially immune checkpoint inhibitors is growing, and toxicities known as immune-related adverse events affecting any organ system may develop as a consequence of the treatment. With an ageing population, a considerable number of patients who will receive these therapies will be older adults. However, older patients who have highly heterogenous clinical characteristics, age-related changes in the immune system, a higher prevalence of comorbidities and frailty have been poorly represented in clinical trials, leaving gaps in understanding the safety of immune checkpoint inhibitor agents in this subgroup. Therefore, the safety of immune checkpoint inhibitors is a primary point of consideration when treating older patients with cancer. The available evidence is conflicting, but it generally suggests that the incidence of immune-related adverse events is not necessarily higher in older patients, but it may have a different profile. It is important to also note that the management of immune-related adverse events can be a challenge in these patients, owing to the risks associated with the use of corticosteroids and a reduced physiological reserve. A comprehensive characterisation of immune ageing, potential biomarkers to predict immune-related adverse events, the use of measures for frailty, enrolling older patients with cancer to clinical trials and analysis of real-world data are necessary to improve the evidence-based decision making for immune checkpoint inhibitor treatment in a geriatric oncology population.

MA06.08 Kinetics and Management of Adverse Events Associated with Lorlatinib after 5 Years of Follow-Up in the CROWN Study

MA06.08 Kinetics and Management of Adverse Events Associated with Lorlatinib after 5 Years of Follow-Up in the CROWN Study