Incidence of hypertension and proteinuria in patients treated with bevacizumab versus bevacizumab biosimilar

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 83-83
Author(s):  
Yun Man ◽  
Han Yu ◽  
Sarbajit Mukherjee ◽  
Olivia Zalewski
Keyword(s):  
Reference Product ◽  
Group Versus ◽  
Composite Endpoint ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Event Analysis ◽  
Time To Event ◽  
Related Risk ◽  
Increased Risk ◽  
History Of

83 Background: Biosimilar products are proven to have no clinically meaningful differences in terms of safety and effectiveness with the reference product, however, to our knowledge, there is limited comparative analysis regarding adverse events for the bevacizumab biosimilars and the reference product. The purpose of this study was to evaluate the incidence of hypertension and proteinuria in patients treated with reference versus biosimilar bevacizumab to potentially streamline clinical management. Methods: A retrospective study was conducted with data consisting of gastrointestinal cancer patients who initiated either reference bevacizumab or biosimilar bevacizumab between January 2019 and July 2020 at Roswell Park Comprehensive Cancer Center. For the primary composite endpoint, Electronic Health Records were searched for the presence or absence of hypertension and proteinuria, as well as time to event analysis. In patients treated with bevacizumab biosimilar, demographics, hypertension and proteinuria related risk factors, bevacizumab containing chemotherapy regimen, and bevacizumab dosing were also identified to assess the risk association with hypertension and proteinuria. Results: 75 patients were included with 42 patients received bevacizumab and 33 patients received bevacizumab biosimilar. Hypertension occurred in 52.4% of reference bevacizumab group versus 36.4% of bevacizumab biosimilar group. Median time to hypertension is 84 days (bevacizumab) versus 24.5 days (bevacizumab biosimilar) following the first treatment (p= 0.0064). Proteinuria developed in 35.7% of reference bevacizumab patients compared to 30% of bevacizumab biosimilar patients. Median onset of proteinuria was 213 days (bevacizumab) versus 53.5 days (bevacizumab biosimilar) (p= 0.0022). In patients with a history of hypertension or underlying renal dysfunction, there was an increased risk of further hypertension and proteinuria, respectively. Conclusions: Higher risk of hypertension and proteinuria was associated with the bevacizumab reference product group, although not statistically significant. A shorter onset of hypertension and proteinuria was associated with the bevacizumab biosimilar group. Our results need further validation in larger cohorts, especially due to the more recent implementation of bevacizumab biosimilar products. [Table: see text]

Real-world outcomes of genetic testing in a GU genetics clinic and evaluation of current guidelines.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 668-668
Author(s):  
Annelise Pace ◽  
Ashley Henriksen Woodson ◽  
Rebecca Slack-Tidwell ◽  
Molly S. Daniels ◽  
Patrick Glen Pilie ◽  
...  
Keyword(s):  
At Risk ◽  
Genetic Testing ◽  
Retrospective Chart Review ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Clinical Criteria ◽  
Increased Risk ◽  
Genetic Test Results ◽  
History Of ◽  
Cancer Syndromes

668 Background: Several known hereditary cancer syndromes confer an increased risk for genitourinary (GU)-related malignancies. Various guidelines indicate when to refer patients to genetic counseling for GU cancers, but there are limited data on the performance of these guidelines in clinical practice, and the association between testing outcome and clinical and familial features that may delineate a heritable syndrome. The purpose of this study is to determine the most common indications for ordering genetic testing in a GU Genetics Clinic and evaluate the relationship between the indication for germline testing and outcome. Methods: An IRB-approved retrospective chart review was performed for 350 patients seen in a GU Genetics Clinic at a single comprehensive cancer center from 2014-2018. Subgroups of patients were formed based on their indication for genetic testing. Exact binomial tests were used to compare the proportion of patients with a positive (pathogenic or likely pathogenic) germline variant for those with vs. without each indication. Results: All patients had a genetic evaluation due to a personal or family history of GU cancer. The majority (324 of 350, 92.5%) were evaluated for either renal cell carcinoma (RCC) or prostate cancer (PrCa). Among patients seen for RCC-related evaluation (n = 159), 23 patients (14.5%) tested positive. Meeting published clinical criteria for a hereditary RCC syndrome significantly predicted positive testing ( P< 0.001). No other indication for testing, including RCC diagnosis ≤ 46 years, predicted for positive germline genetic test results. No positive patients were identified by age of RCC onset alone. Among patients seen for PrCa-related evaluation (n = 173), 13 (7.5%) individuals tested positive; all positive variants were in ATM or BRCA2. A single patient (1/13) was identified by metastatic PrCa status alone. Conclusions: Our data suggest current algorithms lack specificity for selecting individuals with RCC or PrCa at risk for germline mutations, and need to be revised. Evaluation of pedigrees and identifying presence of syndromic features are essential and increase the probability of identifying individuals at risk for harboring a germline mutation.

scholarly journals Early Probiotic Supplementation and the Risk of Celiac Disease in Children at Genetic Risk

Nutrients ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1790 ◽  
Author(s):  
Ulla Uusitalo ◽  
Carin Andren Aronsson ◽  
Xiang Liu ◽  
Kalle Kurppa ◽  
Jimin Yang ◽  
...  
Keyword(s):  
Celiac Disease ◽  
Dietary Supplements ◽  
Genetic Risk ◽  
First Year ◽  
Event Analysis ◽  
Time To Event ◽  
Probiotic Supplementation ◽  
Increased Risk ◽  
Regulatory Effects ◽  
First Year Of Life

Probiotics are linked to positive regulatory effects on the immune system. The aim of the study was to examine the association between the exposure of probiotics via dietary supplements or via infant formula by the age of 1 year and the development of celiac disease autoimmunity (CDA) and celiac disease among a cohort of 6520 genetically susceptible children. Use of probiotics during the first year of life was reported by 1460 children. Time-to-event analysis was used to examine the associations. Overall exposure of probiotics during the first year of life was not associated with either CDA (n = 1212) (HR 1.15; 95%CI 0.99, 1.35; p = 0.07) or celiac disease (n = 455) (HR 1.11; 95%CI 0.86, 1.43; p = 0.43) when adjusting for known risk factors. Intake of probiotic dietary supplements, however, was associated with a slightly increased risk of CDA (HR 1.18; 95%CI 1.00, 1.40; p = 0.043) compared to children who did not get probiotics. It was concluded that the overall exposure of probiotics during the first year of life was not associated with CDA or celiac disease in children at genetic risk.

Gemcitabine-related thrombocytosis: Does it increase the risk of thrombosis?

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6091-6091
Author(s):  
S. Ahmed ◽  
R. K. Shahid ◽  
A. Sami ◽  
S. Yadav ◽  
I. Ahmad ◽  
...  
Keyword(s):  
Platelet Count ◽  
Median Number ◽  
Vascular Event ◽  
Cancer Center ◽  
Platinum Compound ◽  
Advanced Malignancy ◽  
Exact Test ◽  
Patients With Cancer ◽  
Increased Risk ◽  
History Of

6091 Background: Gemcitabine is an antimetabolite agent that has demonstrated activity in various solid and hematological malignancies. Although thrombocytopenia is a known side effect, gemcitabine-related thrombocytosis has been uncommonly reported. Chemotherapy increases the risk of thrombo-embolism in patients with cancer. The study aimed to identify the incidence of gemcitabine-related thrombocytosis and to determine whether it has been associated with an increased risk of thrombo-embolism. Methods: Medical records of 175 consecutive adults patients with a malignant disease who received gemcitabine at Saskatoon Cancer Center were reviewed. Patients with history of prior thrombo-embolism or with baseline thrombocytosis were excluded. Fisher’s Exact test was done for statistical analysis. Results: 149 eligible patients with median age of 62 (26–83) and M:F of 1.01:1 were identified. 141 (95%) patients had advanced malignancy and 61 (41%) had received prior chemotherapy. 106 (71%) patients received combination of chemotherapy and 95% of those patients received gemcitabine in combination with a platinum compound. Median number of cycle was 3 (1–8). Median platelets count prior to commencement of gemcitabine was 285 × 109 (44–449). 83 (56%) patients experienced thrombocytopenia whereas 69 (46%) patients experienced thrombocytosis within 3 weeks of treatment with gemcitabine. Median post-gemcitabine platelet count in patients with thrombocytosis was 622 × 109 (457–1385). 15 (10%) patients experienced thrombocytosis with each cycle of gemcitabine. Median duration of thrombocytosis was 2 weeks (0.5−5). 13 (9%) of 149 patients experienced a vascular event (venous, n=9; arterial, n=4) within 6 weeks of treatment with gemcitabine. Median platelet count prior to the vascular event was 268 × 109 (79–669). All except one patient had advanced malignancy and 85% had received combination of chemotherapy. 5 of 69 (7%) patients with thrombocytosis experienced a vascular event compared with 8 of 80 (10%) patients without thrombocytosis (p=0.77). Conclusions: Gemcitabine has been associated with an increased incidence of thrombocytosis. However gemcitabine-related thrombocytosis is a transient phenomenon and has not been associated with an increased risk of a vascular event. No significant financial relationships to disclose.

VEGF and VEGF receptor-2 (VEGFR2) gene polymorphisms predict tumor recurrence in stage II and III colon cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4004-4004 ◽  
Author(s):  
G. Lurje ◽  
A. M. Schultheis ◽  
A. E. Hendifar ◽  
S. Ashouri ◽  
W. Zhang ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cancer Patients ◽  
Tumor Recurrence ◽  
Stage Ii ◽  
Stage Iii ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Vegf Receptor ◽  
Stage Iii Colon Cancer ◽  
Increased Risk

4004 Background: Despite recent advances in the treatment of metastatic colorectal cancer, tailoring adjuvant treatment of stage II and III colon cancer patients remains controversial. Identifying a reliable panel of prognostic and predictive markers for tumor recurrence is critical in selecting an individualized and tailored chemotherapy. Tumor angiogenesis plays an important role in tumor development, progression and metastasis. In this retrospective study, we tested whether a specific pattern of 40 functionally significant polymorphisms in 37 genes involved in angiogenesis and tumor microenvironment will predict the risk of tumor recurrence in stage II and III colon cancer patients treated with adjuvant chemotherapy. Methods: Between 1999 and 2006 blood specimens from 140 patients (69 females and 71 males with a median age of 59 years; range=28–86) were obtained at the University of Southern California/Norris Comprehensive Cancer Center (USC/NCCC). Sixty-three patients had stage II and 77 had stage III colon cancer. The median follow-up was 5.4 years (range=2.0–16.8). 51 of 140 patients (36.4%) developed tumor recurrence with a 5-year probability of 0.28 ± 0.06 for stage II and 0.40 ± 0.06 for stage III colon cancer patients. Genomic DNA was extracted from peripheral blood and genotypes were determined using PCR based RFLP. Results: Polymorphisms in VEGF (C936T; p=0.009, log-rank) and VEGFR2 (+4422 AC- repeat; p=0.04, log-rank and +1416 T/A; p=0.0009, log-rank) were associated with risk of tumor recurrence in stage III colon cancer patients (n=77). VEGFR2 AC-repeat polymorphisms were additionally associated with risk of recurrence in Stage II colon cancer patients (n=63, p=0.02, log-rank). Conclusion: VEGF C936T and VEGFR2 (+4422 AC-repeat and +1416 T/A) polymorphisms may help to identify Stage II and III colon cancer patients who are at increased risk for developing tumor recurrence. Angiogenesis seems to play a crucial role in tumor recurrence, thus targeting VEGF and VEGFR2 may be of clinical benefit for stage II and stage III colon cancer patients. Large prospective trials are needed to validate these preliminary data. No significant financial relationships to disclose.

An interdisciplinary model for predicting patients at high risk for readmission amongst solid tumor oncology patients in a comprehensive cancer center.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 190-190
Author(s):  
Arvind Shinde ◽  
Ruth Nolen ◽  
Marjorie Jen Hein ◽  
Eduardo Siccion ◽  
Laura E. Crocitto ◽  
...  
Keyword(s):  
High Risk ◽  
Cancer Progression ◽  
Primary Care Physicians ◽  
Hospice Care ◽  
Interdisciplinary Team ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Targeted Interventions ◽  
Care Plans ◽  
Increased Risk

190 Background: Increasing emphasis is being placed on reducing hospital readmission (readm) rates. Reduction of hospital readm remains a challenge, especially among the oncology population. Identifying patients (pts) at increased risk can assist with developing targeted interventions. Methods: From 1/1/11 to 12/31/12, an interdisciplinary team consisting of medical oncologists, hospitalist physician and NP, QI specialist, and case manager prospectively reviewed the medical oncology inpatient census on a biweekly basis to identify pts at risk for readm. Pts with any of the following conditions were considered at high risk for readm: significant pain, wounds, intestinal obstruction, refractory neutropenia despite GCSF, elderly/frail, unstable housing, patient/family non-compliance, rapid cancer progression, refusal of appropriate hospice care, and stalled care plans. These criteria were based upon previous years’ anecdotal experience. Interdisciplinary interventions to address these conditions were identified and initiated. Results: 272 pts were assessed during these sessions. Each session took on average 60 minutes. 69 pts (25%) were deemed to have at least one high risk factor. Chart review revealed that 6 died in the hospital and 13 were discharged to hospice. No pts on hospice were readmitted. Of the remaining 50 high risk pts, 14 (28%) and 25 (50%) pts were readmitted within 14 days and 30 days, respectively. Conclusions: This interdisciplinary team model seems to have a fair predictive value in identifying pts at higher risk for readmission. However, it is time and labor intensive. Enrollment of appropriate high risk pts in hospice mitigates this risk. Given the current emphasis on decreasing readm and the increased cost/penalties associated with readm, the next step will be to pilot cost-effective interventions for pts with these high risk factors. Potential interventions which we have instituted include follow-up calls, social service referrals, intensive family/pt education, clinic appointments within 3 days of discharge, greater coordination with primary care physicians, and more effective hospice discussions. Supported by CA 62505.

Fractures and health care resource use in cancer patients with chemotherapy-associated peripheral neuropathy (CAPN).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e13038-e13038
Author(s):  
Arijit Ganguli ◽  
Patrick J Reilly ◽  
Saurabh Ray
Keyword(s):  
Peripheral Neuropathy ◽  
Cancer Patients ◽  
Resource Use ◽  
Index Date ◽  
Event Analysis ◽  
Office Visits ◽  
Inclusion Criteria ◽  
Time To Event ◽  
Kaplan Meier ◽  
Increased Risk

e13038 Background: Chemotherapy has been associated with increased risk of fractures1. This study examines the real-world incidence of fractures and healthcare resource use (HRU) that may be associated with CAPN in cancer patients. Methods: A retrospective analysis utilized a national health insurer claims -database (2001-2009), to identify patients ≥18 yrs with a cancer ICD-9-code (140-239) and a chemotherapy drug code (J9xxx). The 1st chemotherapy date was the "index date." Patients with a record of peripheral neuropathy (PN) in the pre-index date were excluded. Patients with a PN post-index were matched with no-PN post-index (non-PN) based on gender, age and index date. Both groups were compared for number of fractures, HRU (hospital outpatient (OP), office, and emergency-room [ER] visits) and all-cause costs in their 365-days post-index period. Time to 1st fracture post-index was compared using Kaplan Meier time to event analysis. Results: Of 34,625 patient meeting the inclusion criteria, 1675 patients (4.3%) formed the PN group and were matched to non-PN group. At baseline, mean age was 54.9 yrs, 62.5% were females, and no difference in % of bone metastasis (p=0.12) between the groups. In PN group, 5.3% (n=87) had a fracture 365-days post-index compared to 3.5% (n=58) in non-PN group (p<0.05). Mean days to fracture from index date in PN group was shorter than the non-PN group (150.9 vs. 153.4, p<0.05). In PN group, annual mean number of OP visit (14.6 vs. 12.0, p<0.0001), ER visit (0.47 vs. 0.30, p<0.001), and office visits (30.4 vs. 23.3, p<0.0001), were higher compared to non-PN group. Annual healthcare cost of PN patients was 21% higher than non-PN patients ($64,578 vs. $53,221) and CAPN-related cost in PN group was estimated to be $5,580 annually. Conclusions: Patients with CAPN were associated with higher incidence of fractures, HRU and cost.

Characterization of unplanned 30-day medical oncology readmissions after discharge at an academic medical center with a comprehensive cancer center.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 269-269 ◽  
Author(s):  
Inga Tolin Lennes ◽  
Justin Eusebio ◽  
Nie Bohlen ◽  
Margaret Ruddy ◽  
David P. Ryan
Keyword(s):  
Readmission Rate ◽  
Medical Center ◽  
Academic Medical Center ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Unplanned Readmission ◽  
Oncology Patient ◽  
Hematopoietic Stem ◽  
Medical Oncologists ◽  
Increased Risk

269 Background: Hospital readmission rate is increasingly suggested as a quality care metric. Currently there are no standard criteria for an avoidable readmission in oncology. Although patients with cancer have been identified as being at increased risk of readmission, there has been little to examine the reasons for the oncology patient readmission. The aim was to examine the profiles of patients with an unplanned readmission within 30 days after discharge by an oncology provider and to measure the unplanned 30-day readmission rate. Methods: A retrospective review of oncology provider discharge encounters resulting in a 30-day unplanned readmission during the 2012 calendar year at a tertiary hospital with a comprehensive cancer center was conducted. Planned readmissions for chemotherapy, radiation therapy, hematopoietic stem cell transplantation, dialysis, and surgical procedures, as well as readmissions for rehabilitation, hospice, and psychiatry were excluded. Medical oncologists analyzed medical records for the primary reason of readmission and if the readmission was possibly preventable. Results: Of the 2,944 admissions, a final cohort of 441 unplanned readmissions from 321 unique patients for an unplanned 30-day readmission rate of 14.9% was observed. The average age at admission was 59 (SD 15.9). The cohort was mostly male (56.9%) and White/Caucasian (84.4%). Gastrointestinal (24.0%), lymphoma (18.6%), and leukemia (17.5%) were the most common cancer types. Of those with solid tumors types (n = 225), approximately 70% had metastatic disease. The median time to readmission was 10 days and 10.7% died within 30 days of readmission. Oncology reviewers most commonly assessed that readmission was primarily due to treatment-related effects (46.7%) and the progression of disease (42.2%). Approximately 20% of 30-day readmissions were determined to be possibly preventable, representing 3% of all admissions for the year. Conclusions: Oncology patients readmitted within 30-days frequently present with complicated, advanced disease. A review by medical oncologists suggests there is margin for intervention to reduce 30-day unplanned admissions.

Epidemiology, prevalence, and prognosis of multiple malignancies of a subpopulation of a large German cancer center.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13634-e13634
Author(s):  
Gina Rüter ◽  
Robin Schmidt ◽  
Yassen Abdelatif ◽  
Ulrich Keilholz ◽  
Susen Burock
Keyword(s):  
Breast Cancer ◽  
Urinary Tract ◽  
Patient Characteristics ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Primary Tumors ◽  
Increased Risk ◽  
Cancer Of The Bladder ◽  
Cancer Of The Prostate

e13634 Background: Cancer patients have an increased risk of developing secondary primary neoplasia (SPN) compared to the general population. These multiple primary malignancies (MMs) represent an increasing challenge for patients and physicians. So far, little is known about risk factors, patient characteristics, and survival. The study’s purpose was to obtain an overview of the occurrence and distribution of MMs and the outcome and prognosis of affected patients reporting to a large cancer center in Germany. Methods: The cancer registry data base of the Charité Comprehensive Cancer Center was queried for patients, which had their first cancer diagnosis between 01.01.2009 - 31.01.2010 and consecutively developed at least one more primary cancer within the follow-up period till 31.03.2019. For defining MM the rules from the Surveillance, Epidemiology, and End Results (SEER) Program were used. General tumor and patient characteristics as well as outcome were analyzed. Results: In total, 231 patients (155 male; 76 female) were included in the final analysis. Out of the 231 patients, 203 (87.9 %) presented with 2 primary tumors, 27 patients (11.7 %) with 3 and 1 patient (0.4%) with more than three. MMs occurred mostly in patients > 65 years (59.3%) and between 50-64 years (30.3%). According to the SEER definition 75.3% of the patients had metachronous and 24.7% had synchronous MMs. Most male patients presented initially with cancer of the bladder and the urinary tract (20.6%) and developed SPN in the prostate and the testicles (53.1%). The second most common initial cancer in this cohort was cancer of the prostate and testicles (18.1%) and the subsequent developed SPN was cancer of the bladder and the urinary tract (28.6%). For female patients the most common initial diagnosis was breast cancer (32.9%) followed by breast cancer as SPN in 60%. Overall, most frequent SPN were cancer of the prostate and testicles (13.4%), cancers of the lung and trachea (12.6%), and breast cancer (10.4%). Most patients (37.7%) developed the SPN within the 1st year and 28.6% after 5 years or later. Patients with synchronous MMs had a more than 40 months shorter OS than patients with the metachronous MM (79.00 ± 14.58 months vs. 122.00 ± 9.66 months). Conclusions: We could show that most MMs develop within the first year but that there is another peak after 5 years. However, it is still unclear how often SPN are misinterpreted as progressive disease. Therefore, further analyses and close follow-up are necessary.

Current Approaches in Familial Colorectal Cancer: A Clinical Perspective

2006 ◽  
Vol 4 (4) ◽  
pp. 421-430 ◽  
Author(s):  
Patrick M. Lynch
Keyword(s):  
Colorectal Cancer ◽  
Cancer Genetics ◽  
Human Cancer ◽  
Clinical Syndrome ◽  
Colorectal Adenomas ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Inherited Cancer ◽  
Risk Estimates ◽  
Increased Risk

Individuals with a family history of colorectal cancer or colorectal adenomas have an increased risk for colorectal cancer. When no hereditary syndrome is evident, screening is based on empiric risk estimates. The risk is greatest for individuals with specific inherited cancer-predisposing disorders. When conditions such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer are diagnosed, specific neoplasm risk estimates can usually be performed based on advances in molecular genetics. These estimates lead to more straightforward and cost-effective approaches to surveillance and management. The National Comprehensive Cancer Center Network (NCCN) and other groups have provided detailed guidelines for evaluating patients based on recognition of clinical syndrome characteristics, followed by appropriate genetic counseling, genetic testing, and optimal surveillance. The NCCN guidelines are used as a frame of reference for this discussion of selected recent advances in human cancer genetics as they apply to clinical practice.

658 Toxicities of single agent and combination immune checkpoint inhibitors in patients with pre-existing autoimmune diseases

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A695-A695
Author(s):  
Sabina Sandigursky ◽  
Safa Houssein ◽  
Xerxes Pundole ◽  
Elizaveta Efuni ◽  
Samuel Cytryn ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Adverse Events ◽  
Autoimmune Diseases ◽  
Immune Checkpoint ◽  
Single Agent ◽  
Group Versus ◽  
Cancer Center ◽  
Combination Group ◽  
Safety And Efficacy ◽  
Increased Risk

BackgroundAutoimmunity is associated with increased risk of malignancy. However, patients with pre-existing autoimmune diseases (AIDs) were excluded from immune checkpoint inhibitor (ICI) trials as these agents can cause immune-related adverse events (irAEs). Data are limited on the safety and efficacy of combination immunotherapy in this at-risk population.MethodsWe conducted a multi-center retrospective study to evaluate the safety and efficacy of ICI therapy in patients with pre-existing AID treated at NYU and at MD Anderson Cancer Center. Primary endpoints were occurrence of irAEs and AID flares. Secondary endpoints were time to treatment failure (TTF) and overall survival (OS).ResultsOf 121 patients identified from our institutional databases, 53% received single-agent anti-PD-1 therapy, and 47% received ICI combination. Over half of malignancies were lung cancer (34%) and melanoma (20%). Preexisting AIDs included: rheumatologic (58%), gastrointestinal (12%), endocrine (16%) and neurologic (4%). Overall, 94% had asymptomatic AID, and 21% were receiving systemic immunomodulatory drugs at ICI initiation. Median duration of follow up after ICI initiation was 9 (0.4–41.9) months in patients receiving ICI combination and 8 (0.2–47.3) months in patients receiving anti-PD-1 monotherapy. Combination therapy was associated with higher rates of irAEs compared with anti-PD-1 monotherapy (56% versus 28%). Grade 3/4 irAEs were equivalent in both groups: combination (38%) and anti-PD-1 group (39%). Treatment related deaths were not observed in any group. AID flares occurred in 36% of the anti-PD-1 group versus 29% of combination group. Adverse events (irAEs and/or flares) required systemic immunomodulatory therapies more frequently in the combination group (84%) versus the anti-PD-1 group (59%), and permanent ICI discontinuation was reported in 19% of patients in the combination group versus 11% in the anti-PD-1 group. Tumor progression was observed in 49% of patients on combination ICI and TTF was 14.5 months (95% CI 0.000–31.5), while progression was observed in 64% of patients on anti-PD-1 monotherapy and TTF was 6.4 months (95% CI 4.01–8.9) (p=0.019). Median OS in the combination therapy group was not reached whereas it was 27.3 months in the anti-PD-1 monotherapy group.ConclusionsOur novel findings suggest that high rates of adverse events were observed in patients with pre-existing AIDs treated with ICI combination therapy. However, they were manageable and rarely required permanent ICI discontinuation. Taken together, these data show that ICIs should be offered, albeit with caution in patients with AIDs, to achieve durable cancer remission. Prospective clinical data are needed to guide these complex decisions.Ethics ApprovalThe study was approved by NYU Langone’s Ethics Board, approval number i18-01657 and MD Anderson’s Ethics Board, approval number PA19-0089

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