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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 36, No. 5_suppl ( 2018-02-10), p. 127-127
    Abstract: 127 Background: Disruption of the immune system with immune checkpoint inhibitors can result in a multitude of immune-related adverse effects (irAE). While irAEs have been well-reported in clinical trials, the impact and magnitude of irAE’s in the real-world, particularly inpatient is unclear. Methods: Data was collected on patients with advanced malignancy who experienced a suspected irAE needing admission to an academic hospital (Feb 2011 to June 2017). Each case was reviewed comprehensively by minimum of two reviewers, including one sub-specialist. In addition, oncologists at our institution were surveyed regarding their confidence about managing patients with irAEs. Results: Over a span of 6 years, there were 343 hospitalizations for suspected irAEs and the majority (65%; N = 223) were confirmed irAEs that required treatment with immunosuppression or therapy stopped as result. The mean length of stay was 6.3 days (range 1 to 31 days), readmission rate for another irAE event 25%, total readmission rate 61.7%, and inpatient mortality 8%. The most common irAEs were enterocolitis (43.9%), pulmonary (16%), hepatic (15%), neurological (8.9%), endocrinopathies (7.1%), rheumatological (4%), dermatological (3%), cardiovascular (3%), renal (1.8%), and allergy (1.3%). Over the past 5 years, there was a significant increase in admissions due to irAEs (admissions in 2016 vs 2011, odds ratio = 3.07; p 〈 0.01). The Cancer Center survey (N = 26) revealed majority of oncologists do not feel very comfortable managing irAEs, and 48% felt that irAE complications should be managed on a different service. Conclusions: irAEs from immune checkpoint inhibitors can result in prolonged hospitalizations, high rate of readmissions, and mortality. The number of patients admitted due to irAEs has significantly increased by more than three-fold in the recent years, but majority of oncologists do not feel very comfortable managing irAEs. Consequently, there is a critical need for coordinated multidisciplinary approach, comprehensive provider education, and translational research program for early detection and intervention.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2018
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 28_suppl ( 2021-10-01), p. 26-26
    Abstract: 26 Background: EP-CTs investigate novel therapeutic approaches for patients with cancer, but little is known about the use of supportive care services and timing of goals of care (GOC) discussions in EP-CTs. Methods: We conducted a retrospective review of consecutive patients with cancer enrolled on EP-CTs at Massachusetts General Hospital from 2017-2019. We collected information about patients’ demographic/clinical characteristics, use of supportive care services (palliative care [PC], social work [SW] , physical therapy [PT], and nutrition), as well as documentation of GOC discussions and code status (before/during EP-CT vs after/never) via chart review. We examined patient characteristics associated with earlier receipt of supportive care services (before/during EP-CT vs after/never) and compared differences in the timing of GOC discussions and code status documented based on the receipt of supportive care services. Results: Among 425 patients enrolled on EP-CTs (median age 63.0; 56.0% female; 97.4% metastatic cancer; 22.1% gastrointestinal cancer), under half received supportive care services before/during trial (PC: 33.2% before/during, 66.8% post/never; SW: 41.9% before/during, 58.1% post/never; PT: 38.4% before/during, 61.6% post/never; and Nutrition: 33.2% before/during, 62.1% post/never). We identified the most common reasons for consulting each of the supportive care services (PC: 82.4% symptom management and 12.4% GOC; SW: 65.3% adjustment to illness and 23.8% referral for resources; PT: 44.8% safety/discharge planning and 24.6% mobility concerns; Nutrition: 73.2% for symptoms of anorexia/poor appetite and 21.5% nutrition assessment). Patients with GI cancer were more likely than those with other cancers to receive PC and SW before/during EP-CT (PC: 29.8% v 18.3%, p =.009; SW: 27.5% v 18.2%, p =.025). Earlier PC was associated with earlier hospice referral (HR = 1.95, p =.014) and shorter survival (HR = 1.54, p 〈 .001). Patients receiving earlier supportive care services were more likely to have GOC discussions documented earlier (PC: 65.2% v 13.0%, p 〈 .001; SW: 41.0% v 22.7%, p 〈 .001; PT: 38.7% v 25.2%, p =.005; Nutrition: 39.1% v 25.0%, p =.002). Patients with earlier PC were more likely to have earlier documented code status (46.8% v 24.3%, p 〈 .001), but not for any other service. Conclusions: In this cohort of patients with advanced cancer, under half received supportive care services before/during their participation in EP-CTs. We found that symptom management represented a common reason for referral to supportive care, highlighting the needs of this population. Patients who received earlier supportive care services were more likely to have earlier documentation of GOC discussions, with those receiving earlier PC having code status documented earlier and also experiencing earlier hospice use and shorter survival. These findings underscore the utility of supportive care services in EP-CTs.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 3
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 2654-2654
    Abstract: 2654 Background: The exponential increase in FDA-approved indications for immune checkpoint inhibitors (ICI) in cancer care has resulted in therapeutic success but also in the occurrence of immune-related adverse effects (irAEs) that can represent a significant clinical challenge. On October 3 2017, the Massachusetts General Hospital (MGH) implemented the Severe Immunotherapy Complications (SIC) Service, a multi-disciplinary care team for patients hospitalized with irAEs. The objectives of this study were to evaluate the impact of SIC Service on 1) healthcare utilization and 2) patients outcomes. Methods: Using pharmacy and hospital admission databases, a list of patients was identified that both received ICI for a malignancy and were hospitalized with severe irAEs in the period prior to initiation of the SIC service and after SIC initiation. The pre-SIC period was defined as an admission between 4/2/2016 through 10/3/2017, and the post-SIC period as an admission from 10/3/2017 through 10/24/2018. The rate of readmission after the index hospitalization was the primary outcome. Secondary outcomes included lengths of stay (LOS) for both initial irAE admissions and readmissions, use of corticosteroids and non-steroidal second-line immunosuppression, ICI discontinuation, and inpatient mortality in the pre- and post-SIC periods. Results: Among 1169 patients treated in the pre-SIC service intervention period; 127 were hospitalized for irAE. Among 1159 patients treated in the post-SIC intervention 122 were hospitalized for irAE. SIC Service implementation was associated with a significant reduction in irAE readmission rates (post-SIC 14.8% vs. pre-SIC 25.9%; odds ratio [OR], 0.46; 95% CI, 0.22-0.95; p=0.036). The length of stay, rates of corticosteroid use, second-line immunosuppression, and ICI discontinuation for irAE, as well as inpatient mortality rates were not significantly different before and after SIC Service implementation. Conclusions: This is the first study to report that establishing a highly subspecialized care team focused on irAEs can be associated with improved clinical outcomes for patients receiving ICI therapy. Such care teams may play an essential part in optimizing irAE care.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e18609-e18609
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e18609-e18609
    Abstract: e18609 Background: EP-CTs are increasingly important options for patients with cancer and often involve intensive monitoring. Characterizing the time burden and logistical intensity of EP-CT protocols could help patients and clinicians make informed decisions about trial participation. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs at Massachusetts General Hospital from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), EP-CT investigational agent (immunomodulatory [IM], targeted inhibitor [TI] , antibody drug conjugate [ADC]/chemotherapy prodrug), and logistical intensity (visit frequency required per protocol and presence of extended visits). We defined visit frequency as the number of visits required per protocol within the first 28 days on trial. We defined an extended visit as six or more hours required in clinic on at least one day during the first 28 days on study. We evaluated associations among patient characteristics, investigational agents, logistical intensity, and time spent on trial. Results: Among 421 patients (median age = 63.0 years, 56.9% female, 97.6% metastatic disease), 43.2% were enrolled in IM EP-CTs, 43.0% TI, and 13.8% ADC/chemotherapy prodrug investigational agents. Patients enrolled on ADC/prodrug trials had the highest burden of metastatic disease (mean sites: 2.8 [ADC] vs 2.4 [TI] vs 2.3 [IM] , p = 0.007) and oldest age (mean years: 64.0 [ADC] vs 61.7 [IM] vs 58.5 [TI], p = 0.003). However, those on ADC trials had the most days spent on trial (mean days: 78.3 [TI] vs 102.2 [IM] vs 131.8 [ADC] , p = 0.003). Patients enrolled on TI trials had the highest required visit frequency compared with those enrolled on other trials (mean visits: 5.5 [TI] vs 5.3 [ADC] vs 5.0 [IM], p = 0.027). Additionally, those on TI trials were most likely to have an extended visit (82.3% [TI] vs 58.2% [IM] vs 29.3% [ADC] , p 〈 0.001) and least likely to receive first in human therapy (38.1% [TI] vs 74.1% [ADC] vs 74.2% [IM], p 〈 0.001). Conclusions: In this cohort of patients participating in EP-CTs, we found that those enrolled on TI trials had the highest per protocol visit frequency and greatest likelihood of required extended visits. Those on ADC trials spent the most days on trial despite having the highest average age and burden of metastatic disease. These data highlight the time burden and logistical intensity of EP-CTs, underscoring certain trials as especially time intensive, which may help inform trial selection and participation.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 5
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 28_suppl ( 2021-10-01), p. 84-84
    Abstract: 84 Background: EP-CTs are increasingly important options for patients with cancer and often involve intensive monitoring. Thus, characterizing the time burden and logistical intensity of EP-CTs could help patients and clinicians make informed decisions regarding trial participation. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs at Massachusetts General Hospital from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), EP-CT investigational agent (immunomodulatory therapy [IM], targeted inhibitor(s) [TI] , antibody drug conjugate [ADC]/chemotherapy prodrug), and logistical intensity (trial visit frequency, presence of extended visits, distance traveled in one direction from home zip code to trial site). We defined visit frequency as the number of visits per protocol within the first 28 days on trial. We defined an extended visit as six or more hours in clinic on at least one day during the first 28 days on study. We investigated associations among patient characteristics, investigational agent, and logistical intensity. Results: Among 421 patients (median age=60.6 years, 55.8% female, 97.4% metastatic disease), most (73.6%) had two or more sites of metastatic disease. EP-CTs included 43.2% IM, 43.0% TI, and 13.8% ADC/chemotherapy prodrug. Patients enrolled in ADC/prodrug trials had the highest burden of metastatic disease (mean sites: 2.8 [ADC] vs 2.4 [TI] vs 2.3 [IM] , p = 0.007) and oldest age (mean years: 64.0 [ADC] vs 61.7 [IM] vs 58.5 [TI], p = 0.003). Patients enrolled on TI trials had the highest visit frequency compared with those enrolled on other trials (mean visits: 5.5 [TI] vs 5.3 [ADC] vs 5.0 [IM] , p = 0.027) and the fewest days spent on trial (mean days: 78.3 [TI] vs 102.2 [IM] vs 131.8 [ADC], p = 0.003). Patients enrolled on TI trials were also most likely to have an extended visit (82.3% [TI] vs 58.2% [IM] vs 29.3% [ADC] , p 〈 0.001) and least likely to receive first in human therapy (38.1% [TI] vs 74.1% [ADC] vs 74.2% [IM], p 〈 0.001). Distance traveled from home to clinic did not significantly differ across trial type (median miles traveled: 35.1 [TI] vs 34.1 [IM] vs 33.2 [ADC], p = 0.884). Conclusions: In this cohort of patients participating in EP-CTs, we found that a plurality enrolled in IM studies. Those receiving ADC/prodrug regimens were older and had a higher burden of disease. On average, patients participating in EP-CTs had over five visits in the first month, with those enrolled on TI trials having the highest visit frequency and greatest likelihood of extended visits. Patients on TI trials also spent the fewest total days on trial. Despite the lack of significant differences in distance traveled, most patients were still traveling over 30 miles to get to the trial site. These data highlight the time burden and logistical intensity of various EP-CTs, which may help inform patient-clinician discussions about trial participation.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 6
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 15_suppl ( 2019-05-20), p. e18234-e18234
    Abstract: e18234 Background: Infection with influenza in adults with cancer carries an increased risk of morbidity and mortality. Vaccination against seasonal influenza (Flu-V) can decrease the incidence of influenza, shorten its course, and reduce influenza-associated morbidity. Recent data has suggested that the administration of the Flu-V to patients on an ICI leads to an exaggerated inflammatory response and an increased risk of irAE. However, this trend was demonstrated in a small cohort of patients with lung cancer. Current recommendation for annual Flu-V in patients treated with ICI is unclear and literature about safety is limited. We compared rates of Flu-V for patients on ICI admitted with severe toxicity vs those patients on ICI who were admitted for reasons other than toxicity. We also evaluated rate of Flu-V among oncology patients who had received non-immunotherapy modalities. Methods: We retrospectively evaluated patients treated with ICI who were admitted to Massachusetts General Hospital from February 5, 2011- June 12, 2017. Patients received ipilimumab, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, or a combination in treatment of an advanced solid tumor malignancies including melanoma, NSCLC, SCCHN. Admissions due to irAE were confirmed by review of clinical, radiologic, and pathologic features. Flu-V status was determined by rigorous chart review. Nearest neighbor matching was used to create a control group of cancer patients treated with non-ICI modalities. Descriptive statistics compared rates and timing of Flu-V relative to admission. Statistical significance was determined using Fischer’s Exact Test, p 〈 0.05. Results: Of 540 patients on ICI, 28% were admitted for irAE, 72% had a non-irAE reason for admission. The rate of Flu-V in the flu season prior to admission for irAE group was lower than for non-irAE (18.5% vs 29.6%; p value = 0.01). There were no differences in vaccination rates within ≤30 days (2.7% vs 3.6%, p = 0.80), ≤90 days (4.0% vs 9.3%, p = 0.05), or ≤180 days of admission (11.9% vs 18.5%, p = 0.07). Flu-V rate overall in patients on ICI was 26.5%. In comparison, Flu-V rate in the nearest neighbor non-immunotherapy oncology patients was 67% (n = 101). Conclusions: Flu-V rates were much lower in patients treated with ICI compared to patients treated with non-ICI modalities. We did not see a higher rate of Flu-V in patients admitted with irAE compared to non-irAE which suggests that Flu-V and severe irAE may not be linked in clinical practice. Additional studies are needed, but Flu-V in patients on ICI holds potential to improve care.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2019
    detail.hit.zdb_id: 2005181-5
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  • 7
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2021
    In:  Translational Behavioral Medicine Vol. 11, No. 11 ( 2021-11-30), p. 2043-2054
    In: Translational Behavioral Medicine, Oxford University Press (OUP), Vol. 11, No. 11 ( 2021-11-30), p. 2043-2054
    Abstract: Financial toxicity describes the financial burden and distress that can arise for patients, and their family members, as a result of cancer treatment. It includes direct out-of-pocket costs for treatment and indirect costs such as travel, time, and changes to employment that can increase the burden of cancer. While high costs of cancer care have threatened the sustainability of access to care for decades, it is only in the past 10 years that the term “financial toxicity” has been popularized to recognize that the financial burdens of care can be just as important as the physical toxicities traditionally associated with cancer therapy. The past decade has seen a rapid growth in research identifying the prevalence and impact of financial toxicity. Research is now beginning to focus on innovations in screening and care delivery that can mitigate this risk. There is a need to determine the optimal strategy for clinicians and cancer centers to address costs of care in order to minimize financial toxicity, promote access to high value care, and reduce health disparities. We review the evolution of concerns over costs of cancer care, the impact of financial burdens on patients, methods to screen for financial toxicity, proposed solutions, and priorities for future research to identify and address costs that threaten the health and quality of life for many patients with cancer.
    Type of Medium: Online Resource
    ISSN: 1869-6716 , 1613-9860
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2586893-7
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  • 8
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 275-275
    Abstract: 275 Background: Early phase clinical trials (EP-CTs) investigate novel treatment options in oncology, with recent advances in personalized therapy leading to improved outcomes and offering hope to patients with cancer. However, little research has sought to understand associations of patient-reported hope with quality of life (QOL), symptom burden, coping, and financial toxicity in EP-CT participants. Methods: We prospectively enrolled consecutive adults with cancer participating in EP-CTs at Massachusetts General Hospital from 04/2021-05/2022. Participants completed baseline surveys prior to treatment initiation that assessed hope (Herth Hope Index [HHI] , higher scores indicate greater hope), QOL (Functional Assessment of Cancer Therapy-General), symptom burden (physical: Edmonton Symptom Assessment System [ESAS]; psychological: Patient Health Questionaire-4 [PHQ4] ), coping (Brief COPE: self-blame, acceptance, denial, emotional support, active, behavioral disengagement), and financial toxicity (COST tool, higher scores indicate greater financial wellbeing). We used regression models to determine associations of hope scores with patient-reported QOL, symptom burden, coping, and financial toxicity. Results: Of 157 eligible patients, we enrolled 129 (enrollment rate 82.2%, median age = 62.5 years [range 33.0-83.0], 53.9% female, and 96.0% metastatic cancer). Most common cancer types were gastrointestinal (37.5%), breast (20.3%), lung (8.6%), and head and neck (7.8%). Patients had an average HHI score of 27.5 (range 15.3 – 36.0), with 30.5% reporting high levels of hope. We found associations of higher hope scores with better QOL (B = 0.24, p 〈 0.001) and lower symptom burden (ESAS-physical: B = -0.14, p 〈 0.001; PHQ4-depression: B = -2.07, p 〈 0.001; PHQ4-anxiety: B = -0.93, p = 0.001). We also found that hope scores were associated with patients’ coping (self-blame [B = -1.44, p 〈 0.001]; acceptance [B = 1.40, p 〈 0.001], denial [B = -1.12, p = 0.004] , emotional support [B = 0.99, p 〈 0.001], active [B = 1.02. p = 0.001] , behavioral disengagement [B = -2.52, p 〈 0.001]). Lastly, we found that higher hope scores were associated with greater financial wellbeing (B = 0.11, p = 0.026). Conclusions: In this prospective cohort study, we demonstrated a substantial proportion of EP-CT participants had high baseline hope and identified associations of hope scores with other important patient-reported outcomes. Specifically, we found novel associations of higher hope scores with better QOL, lower symptom burden, more adaptive coping mechanisms, and greater financial wellbeing, underscoring the importance of targeting these patient-reported outcomes when seeking to enhance the care experience of EP-CT participants.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
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  • 9
    In: European Journal of Cancer, Elsevier BV, Vol. 142 ( 2021-01), p. 143-146
    Type of Medium: Online Resource
    ISSN: 0959-8049
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    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
    detail.hit.zdb_id: 1120460-6
    detail.hit.zdb_id: 1468190-0
    detail.hit.zdb_id: 82061-1
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  • 10
    In: The Oncologist, Oxford University Press (OUP), Vol. 26, No. 6 ( 2021-06-01), p. 514-522
    Abstract: The aim of this study was to characterize severe immune-related adverse events (irAEs) seen among hospitalized patients and to examine risk factors for irAE admissions and clinically relevant outcomes, including length of stay, immune checkpoint inhibitor (ICI) discontinuation, readmission, and death. Methods Patients who received ICI therapy (ipilimumab, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, or any ICI combination) at Massachusetts General Hospital (MGH) and were hospitalized at MGH following ICI initiation between January 1, 2011, and October 24, 2018, were identified using pharmacy and hospital admission databases. Medical records of all irAE admissions were reviewed, and specialist review with defined criteria was performed. Demographic data, relevant clinical history (malignancy type and most recent ICI regimen), and key admission characteristics, including dates of admission and discharge, immunosuppressive management, ICI discontinuation, readmission, and death, were collected. Results In total, 450 admissions were classified as irAE admissions and represent the study's cohort. Alongside the increasing use of ICIs at our institution, the number of patients admitted to MGH for irAEs has gradually increased every year from 9 in 2011 to 92 in 2018. The hospitalization rate per ICI recipient has declined over that same time period (25.0% in 2011 to 8.5% in 2018). The most common toxicities leading to hospitalization in our cohort were gastrointestinal (30.7%; n = 138), pulmonary (15.8%; n = 71), hepatic (14.2%; n = 64), endocrine (12.2%; n = 55), neurologic (8.4%; n = 38), cardiac (6.7%; n = 30), and dermatologic (4.4%; n = 20). Multivariable logistic regression revealed statistically significant increases in irAE admission risk for CTLA-4 monotherapy recipients (odds ratio [OR], 2.02; p & lt; .001) and CTLA-4 plus PD-1 combination therapy recipients (OR, 1.88; p & lt; .001), relative to PD-1/PD-L1 monotherapy recipients, and patients with multiple toxicity had a 5-fold increase in inpatient mortality. Conclusion This study illustrates that cancer centers must be prepared to manage a wide variety of irAE types and that CTLA-4 and combination ICI regimens are more likely to cause irAE admissions, and earlier. In addition, admissions for patients with multi-organ involvement is common and those patients are at highest risk of inpatient mortality. Implications for Practice  The number of patients admitted to Massachusetts General Hospital for immune-related adverse events (irAEs) has gradually increased every year and the most common admissions are for gastrointestinal (30.7%), pulmonary (15/8%), and hepatic (14.2%) events. Readmission rates are high (29% at 30 days, 49% at 180 days) and 64.2% have to permanently discontinue immune checkpoint inhibitor therapy. Importantly, multiple concurrent toxicities were seen in 21.6% (97/450) of irAE admissions and these patients have a fivefold increased risk of inpatient death.
    Type of Medium: Online Resource
    ISSN: 1083-7159 , 1549-490X
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2023829-0
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