Crandall B

Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

Purpose: To determine the incidence and types of irAEs seen in the ED at VA San Diego Healthcare System (VASDHS).

Background: ICPIs activate T-cells against many tumor types, but they also cause irAEs, which can lead to organ dysfunction. With the increasing use of ICPIs, more patients are visiting the ED due to irAEs. ED providers should be familiar with irAEs to prevent misdiagnosis and further complications.

Methods: This was a retrospective study that included patients who received at least one dose of ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, or any ICPI combination. The primary outcome was the incidence/types of irAEs seen in the ED. Secondary outcomes included: percent of irAEs leading to hospital admission, percent of ED providers aware of ICPI therapy, and rate of ICPI discontinuation due to irAEs. Patients who experienced severe irAEs (irAEs that warranted an ED visit or ICPI discontinuation) were compared against those who didn’t to identify risk factors. Chi-square and Mann-Whitney U tests were used to compare categorical and continuous data, respectively.

Results: Out of 151 patients who received ICPIs, 22 experienced severe irAEs. Patient characteristics were similar except: more patients in the irAE group were diagnosed with melanoma and had received ipilimumab or >1 ICPI. A total of 246 ED visits were documented: 14 patients made 16 ED visits (6.5%) due to irAEs including colitis, hypophysitis, and hypothyroidism; 15 visits (93.8%) led to hospital admission, and 14 ED providers (87.5%) were aware of ICPI therapy. Ipilimumab and ipilimumab/nivolumab were the most recent ICPIs administered before an irAE. ICPIs were discontinued in 15 patients due to irAEs, 7 of which stopped after an ED visit.

Conclusion: The rate of irAE-related ED visits at VASDHS was lower than published literature (6.5% vs. 25%) which may have been due to small sample size. Most irAEs were associated with ipilimumab and combination ICPIs, similar to previous studies. Most ED providers were aware of ICPI therapy leading to appropriate diagnosis of irAEs. Risk factors for severe irAEs may include treatment with ipilimumab or >1 ICPI. Continuous education of ED staff regarding ICPIs and irAEs is recommended to ensure appropriate diagnosis and treatment.

Purpose: The purpose of this study was to characterize the incidence of cardiovascular events and time to first cardiovascular event due to tyrosine kinase inhibitors (TKIs) in patients with advanced RCC at VASDHS. Additional aims were to describe the current clinical practice management of cardiac monitoring via EKG or ECHO in this patient population.

Background: Over the past 12 years, the US Food and Drug Administration has approved six multitargeted TKIs for the treatment of RCC: axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib and sunitinib. Other than hypertension, most studies of these therapies did not report the incidence of cardiovascular events that occurred during early clinical trials.

Methodology: This was a retrospective study that evaluated the incidence of cardiovascular events in patients diagnosed with advanced RCC who received oral TKI therapy for at least 30 days. The incidence of cardiovascular events was collected in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) grading at predetermined time points from the start of each TKI therapy. Cardiovascular events were defined as hypertension, QT prolongation, congestive heart failure (CHF), stroke, myocardial infarction (MI) and pulmonary hypertension.

Results: Fifty-four patients were included in this study with a median age of 66 years. There were no cardiac events in patients without a history of cardiovascular disease. Eleven patients with a history of cardiovascular disease experienced an adverse cardiac event while taking pazopanib, sorafenib, or sunitinib. The most common adverse events were hypertension (n=6) and MI (n=2). The remaining three patients experienced a stroke, QT prolongation, or CHF. Seventy-three percent of events occurred within four months of starting therapy. Baseline EKG or ECHO were not available for most patients started on TKI therapy and obtained only when patients were symptomatic.

Conclusions: The results of this study indicate a need for baseline and routine monitoring in patients started on oral TKIs with a history of cardiovascular disease to align with the current recommendations as listed in the medication package inserts. Based on the results of this study, baseline and routine monitoring should be considered during the first four months of therapy in patients with a history of cardiovascular disease.

Purpose: The purpose of this study was to characterize the incidence of cardiovascular events and time to first cardiovascular event due to tyrosine kinase inhibitors (TKIs) in patients with advanced RCC at VASDHS. Additional aims were to describe the current clinical practice management of cardiac monitoring via EKG or ECHO in this patient population.

Background: Over the past 12 years, the US Food and Drug Administration has approved six multitargeted TKIs for the treatment of RCC: axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib and sunitinib. Other than hypertension, most studies of these therapies did not report the incidence of cardiovascular events that occurred during early clinical trials.

Methodology: This was a retrospective study that evaluated the incidence of cardiovascular events in patients diagnosed with advanced RCC who received oral TKI therapy for at least 30 days. The incidence of cardiovascular events was collected in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) grading at predetermined time points from the start of each TKI therapy. Cardiovascular events were defined as hypertension, QT prolongation, congestive heart failure (CHF), stroke, myocardial infarction (MI) and pulmonary hypertension.

Results: Fifty-four patients were included in this study with a median age of 66 years. There were no cardiac events in patients without a history of cardiovascular disease. Eleven patients with a history of cardiovascular disease experienced an adverse cardiac event while taking pazopanib, sorafenib, or sunitinib. The most common adverse events were hypertension (n=6) and MI (n=2). The remaining three patients experienced a stroke, QT prolongation, or CHF. Seventy-three percent of events occurred within four months of starting therapy. Baseline EKG or ECHO were not available for most patients started on TKI therapy and obtained only when patients were symptomatic.

Conclusions: The results of this study indicate a need for baseline and routine monitoring in patients started on oral TKIs with a history of cardiovascular disease to align with the current recommendations as listed in the medication package inserts. Based on the results of this study, baseline and routine monitoring should be considered during the first four months of therapy in patients with a history of cardiovascular disease.

Purpose: The purpose of this study was to characterize the incidence of cardiovascular events and time to first cardiovascular event due to tyrosine kinase inhibitors (TKIs) in patients with advanced RCC at VASDHS. Additional aims were to describe the current clinical practice management of cardiac monitoring via EKG or ECHO in this patient population.

Background: Over the past 12 years, the US Food and Drug Administration has approved six multitargeted TKIs for the treatment of RCC: axitinib, cabozantinib, lenvatinib, pazopanib, sorafenib and sunitinib. Other than hypertension, most studies of these therapies did not report the incidence of cardiovascular events that occurred during early clinical trials.

Methodology: This was a retrospective study that evaluated the incidence of cardiovascular events in patients diagnosed with advanced RCC who received oral TKI therapy for at least 30 days. The incidence of cardiovascular events was collected in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) grading at predetermined time points from the start of each TKI therapy. Cardiovascular events were defined as hypertension, QT prolongation, congestive heart failure (CHF), stroke, myocardial infarction (MI) and pulmonary hypertension.

Results: Fifty-four patients were included in this study with a median age of 66 years. There were no cardiac events in patients without a history of cardiovascular disease. Eleven patients with a history of cardiovascular disease experienced an adverse cardiac event while taking pazopanib, sorafenib, or sunitinib. The most common adverse events were hypertension (n=6) and MI (n=2). The remaining three patients experienced a stroke, QT prolongation, or CHF. Seventy-three percent of events occurred within four months of starting therapy. Baseline EKG or ECHO were not available for most patients started on TKI therapy and obtained only when patients were symptomatic.

Conclusions: The results of this study indicate a need for baseline and routine monitoring in patients started on oral TKIs with a history of cardiovascular disease to align with the current recommendations as listed in the medication package inserts. Based on the results of this study, baseline and routine monitoring should be considered during the first four months of therapy in patients with a history of cardiovascular disease.