50.0%) or 1 (50.0%);37.5% had high risk cytogenetics; 25.0% had extramedullary disease.Pts received a median of 7.0 (2-11) prior lines of therapy, all pts were triple-class refractory and 8 pts (50.0%) were penta-drug refractory, and 15 pts (93.8%) were refractory to the last line of therapy.After a median follow-up of 11.1 mo (2.4-13.1),43.8% of pts remained on treatment; the most common reason for permanent treatment discontinuation was progressive disease (37.5%).The objective response rate by investigator was 50.0%(95% CI 24.7-75.3),although not yet mature at the time of analysis; 37.5% and 50.0%achieved complete response or better and very good partial response or better, respectively.Among responders, the median duration of response was not reached (95% CI 9.2, NE) and the probability of maintaining the response at 9 months was 100% (95% CI: 100, 100).Dose reduction or interruption due to AEs occurred in 87.5% of pts and 1 pt permanently discontinued due to AEs (neutropenia, thrombocytopenia).15 (93.8%) of pts reported G3/4 AEs.The most common TEAEs (≥50% of pts) were neutropenia (13 (81.3%) [G3/4, 13 (81.3%)])and CRS (11 (68.8%) [G3/4, 1 (6.3%)]).No pt had ICANS.Overall, 5 (31.3%) pts died; 4 (25%) due to disease progression, 1 (6.3%) unknown.Conclusions: Deep and durable responses to elranatamab monotherapy were observed in Japanese pts with heavily pre-treated refractory MM.The safety profile was manageable and no new safety signals were identified.These results support the continued development of elranatamab for the treatment of RRMM in Japanese pts.

Introduction: Multiple myeloma (MM) is a plasma cell malignancy with various clinical complications. Patients with relapsed and refractory multiple myeloma (RRMM) often suffer from disease progression and cycle through multiple treatments, including those from the same drug classes that they have failed before. Disease progression is usually associated with significant burden, including high health care resource utilization (HCRU) and costs. However, no current known literature quantifies HCRU and costs before and after disease progression in RRMM patients who have been exposed to multiple classes of therapies. This study aims to describe and compare hospitalization use and associated costs before and after disease progression in patients with RRMM who are triple-class exposed (TCE; defined as exposure to a proteosome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody). Methods: This retrospective cohort study used the Optum Clinformatics® Data Mart database from 1/1/2012 to 12/31/2021. Adults with ≥2 diagnosis codes for MM (ICD-10-CM: C90.0x) ≥30 days apart and who received a subsequent line of therapy (LOT) after becoming TCE were included. The start of a subsequent LOT after TCE was used as a surrogate to define disease progression, and the initiation date of the latest of such LOTs was defined as the index date if multiple eligible LOTs were observed for the same patient. Patients were also required to have ≥6-month continuous enrollment (CE) in medical and pharmacy plans before and after index. Patient characteristics were described at index and during the 6-month baseline period. A 2-month pre-post analysis was performed to compare all-cause inpatient admissions, intensive care unit (ICU) stays, hospitalization length of stay, and direct inpatient costs. Categorical variables were compared using McNemar's test, and counts and costs were compared using paired generalized linear models. Subgroup analyses were performed in patients with commercial insurance or Medicare Advantage. Results: A total of 523 patients met the study criteria. The mean age was 70.2 years, 63.1% were White, 51.2% were female, 72.5% had Medicare Advantage, the mean Quan-Charlson comorbidity index was 4.2, and 34.8% had ≥4 prior LOTs within the CE period containing the index date. The proportion of patients who had an all-cause inpatient admission (20.1% vs 12.8%, P = 0.0008) and an ICU stay (6.5% vs 1.9%, P = 0.0004) were significantly higher during the 2-month post- versus pre-index period. During the 2-month post-index period, patients on average had significantly more all-cause inpatient admissions (0.29 vs 0.16, P <0.0001). The mean inpatient length of stay for the cohort was numerically higher during the 2-month post- versus pre-index period (1.67 vs 1.07 days, P = 0.0751). The mean per-month cost of all-cause hospitalization was significantly higher during the 2-month post- versus pre-index period ($3,590.81 vs $1,267.18, P = 0.0008). The majority of the all-cause hospitalization use and costs (>90%) were MM-related. Similar trends were observed among commercial and Medicare Advantage patients. Conclusions: This study found a pronounced increase in hospitalization and costs in the 2 months immediately following disease progression in RRMM patients who are TCE. The data may support economic assessment and value framework for innovative treatments with significant prolonged progression-free survival. In addition, there is a need to focus on multifaceted efforts to improve overall well-being and the total cost of care for patients with RRMM.

The treatment of multiple myeloma (MM) remains a challenge as patients eventually progress through several lines of therapy (LOTs), requiring use of multiple MM drug classes. In this retrospective US claims-database study, we examined the healthcare costs of patients with MM who received ≥ 4 prior LOTs, including triple-class exposure (TCE). Adult patients with MM were selected from the IBM MarketScan Commercial and Medicare claims databases (1 January 2012–30 June 2021). Eligible patients were required to have received at least four prior LOTs, and TCE (i.e., received a proteasome inhibitor, immunomodulatory drug, and anti–CD38-targeted monoclonal antibody) after the first-observed diagnosis of MM. The index date was defined as the initiation date of the first subsequent LOT after meeting the eligibility criteria for the study, and this date had to be after 1 January 2017 to capture contemporary cost estimates. The primary outcome measurements were all-cause and MM-related healthcare costs after the index date. The study population included 68 patients with MM (63

Background: Daratumumab (DARA) is an anti-CD38 monoclonal antibody approved for treatment of patients with newly diagnosed and previously treated multiple myeloma (MM). Hence, it is possible that patients initiating DARA may continue to use it as backbone of their treatment even if their line of therapy (LOT) or treatment regimen changes, sometimes with interruptions. Aims: This study examines the continuous duration of DARA treatment and dosing frequency across all LOTs using real-world data from MM patients in the U.S. Methods: This is a retrospective observational study conducted using Optum Clinformatics Data Mart database consisting of some Medicare and commercially insured MM patients utilizing DARA, between 11/1/2015-3/31/2021. Duration of DARA use was defined as the time interval between first initiation and discontinuation of DARA spanning multiple LOTs as a time-to-event outcome using Kaplan-Meier method. A gap of >60 days between two consequent DARA claim dates was defined as DARA discontinuation. Dosing frequency was calculated as the average number of DARA doses during defined time periods. Compliance ratios were calculated as observed dosing frequency divided by the dosing frequency for FDA approved regimens (DARA-Lenalidomide-Dexamethasone [DRd] and DARA-Pomalidomide-Dexamethasone [DPd]). All results were calculated for patients using DARA across multiple LOTs regardless of treatment regimen. Results: A total of 2125 patients initiating DARA therapy were included in this analysis with mean age (SD) of 70.9 (9.8) years, 51.3% males, and 64.8% white. The median length of DARA use spanning multiple LOTs, was 16.6 months. During the first year of DARA use, 90.5%, 83.2%, 72.6% and 63.5% of the patients continued DARA at 3, 6, 9, and 12 months, respectively. At years 2 and 3 of DARA use, 33.1% and 14.5% of the patients, respectively, continued DARA treatment (Figure 1). The mean dosing frequency in real world was similar to the dosing frequency on the approved label (Table 1). The compliance ratio was 0.98 over the period of 36 months. Table 1. - Real-world dosing frequency of daratumumab over 36 months of follow-up (N=2125) Follow-up Period (in months) % of original sample remaining Number of Daratumumab doses from RWDMean (SD) Number of Daratumumab doses based on PI Compliance ratio 0-3 90.5% 9.6 (2.4) 11 0.87 0-6 83.2% 15.0 (3.1) 17 0.88 0-9 72.6% 18.5 (3.4) 20 0.92 0-12 63.5% 22.0 (3.8) 23 0.96 0-18 46.5% 28.8 (4.6) 30 0.96 0-24 33.1% 35.4 (6.0) 36 0.98 0-36 14.5% 48.1 (8.6) 49 0.98 Abbreviations: RWD, real world data; SD, standard deviation; PI, prescribing information for DRd and DPd as approved label Image:Summary/Conclusion: Patients initiating DARA remain on the therapy for a median of 16.6 months with one-sixth continuing DARA beyond 3 years. The dosing frequency observed in the real-world was consistent with the approved label.

Inflammatory bowel disease (IBD) is a chronic disease with the potential for significant morbidity in case of suboptimal treatment (e.g. low treatment adherence). In spite of immense research in IBD, literature on association of IBD with race/ethnicity is fragmented. In this study, we aimed to evaluate the association between race/ethnicity and treatment adherence and persistence among patients with Crohn’s disease (CD) or ulcerative colitis (UC) initiated with biologic therapies. This observational, retrospective study utilized the Optum Clinformatics (Optum) Extended Data Mart Socioeconomic Status (SES) database. Adult patients with ≥ 2 medical claims for CD or UC diagnosis, ≥ 1 medical or pharmacy claim for corresponding FDA-approved biologic therapy, and a ≥ 12-month pre-index (index date: date of the first biologic medical/pharmacy claim) continuous health plan enrollment were included. Treatment adherence was measured as the proportion of days covered of ≥ 80

Introduction: In the US, bortezomib, lenalidomide, and dexamethasone (VRd) is one of the preferred treatment regimens in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM) based on the results from the phase 3 Southwest Oncology Group (SWOG) S0777 study. Although the efficacy of VRd in transplant-ineligible or -deferred NDMM patients was demonstrated in SWOG S0777, clinical trials have strict eligibility criteria that may not translate to the real-world. There is limited real-world data on the characteristics and outcomes of non-transplanted patients with NDMM treated with VRd, especially in older, frail patients with comorbidities. This study aimed to address these knowledge gaps by evaluating the characteristics and outcomes of patients with NDMM who received VRd as first-line of therapy (LOT) in US oncology practice.

Introduction: Daratumumab, a CD38 monoclonal antibody, was approved for the treatment of heavily pretreated relapsed or refractory multiple myeloma (MM) in 2015 and for newly diagnosed MM (NDMM) in 2018. The phase 3 MAIA study demonstrated that daratumumab plus lenalidomide/dexamethasone (D-Rd) improved clinical outcomes, including overall survival, versus lenalidomide/dexamethasone (Rd) in transplant-ineligible NDMM (Facon T, et al. EHA Library. 2021). However, limited real-world data are available regarding patients with MM treated with daratumumab in the US. We evaluated patient characteristics and treatment outcomes among transplant-ineligible NDMM patients who received D-Rd as first-line therapy in US oncology practices.

Introduction: Daratumumab (DARA) is a human IgGk monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action. Since its approval for relapsed or refractory multiple myeloma (MM) in 2015 and newly diagnosed MM (NDMM) in 2018, DARA has become the foundation of treatment for MM. However, there is limited real-world evidence describing patients (pts) with MM treated with DARA-containing regimens in the US, especially for NDMM pts. Thus, using a large US claims database, we evaluated pt and treatment characteristics among MM pts who received DARA-containing regimens as first-line (1L) or second-line (2L) therapy, and separately for the subset who received DARA plus lenalidomide/dexamethasone (D-Rd) given its more recent approval in NDMM.

157 Background: This study describes health-related quality of life (HRQoL) and its predictors including the role of O6-methylguanine DNA methyltransferase promoter (MGMT) testing in first-line (1L) patients (pts) with newly diagnosed glioblastoma multiforme (GBM). Methods: Real-world data were drawn from the GBM Disease-Specific Programme – a cross-sectional study administered to medical and neuro-oncologists who provided information on demographic/clinical status and treatment (tx) patterns for their next 4 consulting 1L GBM pts from May to July 2016 in EU5 countries. Pts voluntarily completed self-completion forms (PSCs), comprising the EORTC QLQ-C30, BN20, and EQ-5D-3L. Linear regressions were conducted using QLQ-C30 global health status (GHS), EQ-5D-3L utility, and EQ-5D visual analogue scale (VAS) scores as dependent variables. Demographic and clinical factors were included as independent variables. Statistically significant results with P<0.05 are presented. Results: 279 1L GBM pts completed a PSC, with a mean age 58.7 years old, 63% were male. 68% (n=189) were MGMT-tested with known results, of which 58% (n=110) were methylated and 42% (n=79) unmethylated. Mean GHS was 45.6 (SD=19.4), utility was 0.57 (SD=0.35), and VAS was 53.5 (SD=18.3). All functional domain scores of the QLQ-C30 were below reference values for general brain cancer population, with differences larger than published thresholds for clinical importance. Age >75 years and ECOG score of 2+ were associated with decreased HRQoL. Longer 1L tx duration, stable/responding disease, and receiving care in Germany, Italy, Spain, or UK (vs France) were associated with increased HRQoL. Results were similar for the subset of pts that was MGMT-tested; however, a greater Charlson index score and not receiving steroids (or RT) were associated with increased HRQoL. MGMT status did not appear to be an independent predictor of HRQoL. Conclusions: HRQoL in pts with GBM receiving 1L treatment is poor. Functional domain scores indicate clinically meaningful problems for these patients. Important predictors of HRQoL include age, performance status, time since tx initiation, country of care, comorbidities, and steroid use alongside RT. Results suggest there remains an unmet need in the tx management of GBM.

Objective: To examine the effect of robotic-assisted surgery implementation for treatment of endometrial cancer in the United States on 30-day clinical outcomes and costs. Methods: We retrospectively reviewed data of adult patients who underwent total hysterectomy for endometrial cancer in the US hospitals in Premier Healthcare Database between January 1, 2008 and September 30, 2015. We conducted trend analyses comparing the proportions of surgical approaches with the associated clinical outcomes and costs over the study period using Mann-Kendall tests. Clinical outcomes and costs of robotic-assisted surgery, laparoscopic and open surgery have been compared after propensity score 1:1 matching in the most recent 3 years (January 1, 2013-September 30, 2015). Results: Of a total of 35,224 patients, use of robotic-assisted surgery increased from 9.48% to 56.82% while open surgery decreased from 70.4% to 28.1% over the study period. A 2.5% decrease in major complications (P < .001), a 2.9% decrease in minor complications (P = .001), and a 2.0% decrease 30-day readmissions (P = .001) was observed across all surgical approaches. Perioperative 30-day total cost slightly decreased from US $11,048 to US $10,322 (P = .08). Among propensity-score matched patients, robotic-assisted surgery was associated with shorter hospitalization than open surgery (median [interquartile range], 2.0 [2.0-3.0] vs 4.0 [3.0-6.0] days) and laparoscopic surgery (2.0 [2.0-3.0] vs 3.0 [2.0 -4.0] days), fewer 30-day complications (20.1% vs 33.7%) (all P < .001), and comparable perioperative 30day total costs (median [interquartile range], US $12,200 [US $9,509-US $16,341] vs US $12,018 [US $8,996-US $17,162]; P = .34) with open surgery. Conclusion: Robotic-assisted surgery facilitated the widespread diffusion of a minimally invasive approach nationally for endometrial cancer, with reduction of perioperative morbidity and no increase in overall treatment-related 30-day costs at national level. (C) 2019 Elsevier Inc. All rights reserved.

AIM:To determine the costs of adverse events (AEs) associated with current metastatic melanoma (MM) therapies.MATERIALS & METHODS:Two retrospective cohort studies were independently conducted using the PharMetrics and MarketScan databases. Included patients were aged ≥18 years, and had ≥1 MM diagnosis and ≥1 claim for systemic therapy from 2004 to 2015.RESULTS:A total of 1654 and 1329 patients were identified in PharMetrics and MarketScan, respectively. The corresponding adjusted 30-day incremental costs of AEs by category were highest for CNS/psychiatric (US$21,277 and $18,739), gastrointestinal ($18,534 and $15,648), respiratory ($17,338 and $17,064), cardiovascular ($16,083 and $15,430), hematological/lymphatic ($14,997 and $15,538) and metabolic/nutritional AEs ($12,340 and $17,251).CONCLUSION:The costs of AEs associated with systemic therapies for MM are substantial.

Introduction The past decade has witnessed adoption of conservative gynecologic treatments, including minimally invasive surgery (MIS), alongside steady declines in inpatient hysterectomies. It remains unclear what factors have contributed to trends in outpatient benign hysterectomy (BH), as well as whether these trends exacerbate disparities. Materials and methods Retrospective cohort of 527,964 women ≥18 years old who underwent BH from 2008 to 2014. BH surgical approaches included: open/abdominal hysterectomy (AH), vaginal hysterectomy (VH), laparoscopic hysterectomy (LH), and robotic-assisted hysterectomy (RH). Quarterly frequencies were calculated by care setting and surgical approach. We used multilevel logistic regression (MLR) using the most recent year of data (2014) to examine the influence of patient-, physician-, and hospital-level preoperative factors and surgical approaches on outpatient migration. Results From 2008–2014, surgical approaches for LH and RH increased, which coincided with decreases in VH and AH. Overall, a 44.2% shift was observed from inpatient to outpatient settings (P<0.0001). Among all outpatient visits MIS increased, particularly for RH (3.6% to 41.07%). We observed increases in the proportion of non-Hispanic Black and Medicaid patients who obtained MIS in 2014 vs. 2008 (P<0.001). Surgical approach (51.8%) and physician outpatient MIS experience (19.9%) had the greatest influence on predicting outpatient BH. Compared with LH, RH was associated with statistically significantly higher likelihood of outpatient BH overall (OR 1.23; 95% CI, 1.16–1.31), as well as in sub-analyses of more complex cases and hospitals that performed ≥1 RH (P<0.05). Conclusion From 2008–2014, rates of LH and RH significantly increased. A significant shift from inpatient to outpatient setting was observed. These findings suggest that RH may facilitate the shift to outpatient BH, particularly for patients with complexities. The adoption of MIS in outpatient settings may improve access to disadvantaged patient groups.

INTRODUCTION: To assess the impact of patients, physicians, hospital factors and the choice of surgical routes on the likelihood of benign hysterectomy (BH) in outpatient (vs. inpatient) setting. METHODS: We reviewed the Premier Hospital Perspective Databases for women ≥18 years old who underwent BH from 2008-2014. Patient-, surgeon-, and hospital-level factors, and surgical routes, were included in the analysis .The impacts of preoperative factors and surgical routes were analyzed via a logistic regression model. RESULTS: A total of 527,964 patients who underwent BH were identified. Patient factors contributed 43.3% to the likelihood of outpatient BH, surgeon factors 22.7% and hospital factors 4.4%; surgical routes and surgeon experience of MIS in outpatient setting were the top 2 individual factors that contributed 38.0% and 20.4%, respectively. Subtotal hysterectomy (OR 1.25, 95%CI 1.23-1.28) was more likely in outpatient; older, non-white, higher CCI, obese, and insured by Medicare were less likely for outpatient BH. Surgeons with experience of outpatient minimally-invasive surgery (OR 2.90, 95%CI 2.85-2.96), obstetrics & gynecology surgeons (OR 1.71, 95%CI 1.62-1.80) and hospitals in the South region (OR 2.17, 95%CI 2.13-2.22) were more likely to perform outpatient BH. Compared to laparoscopic, robotic-assisted BH (OR 1.05, 95%C I 1.03-1.07) were more likely, whereas abdominal BH(OR 0.017, 95%CI 0.016-0.018) and vaginal BH(OR 0.45, 95%CI 0.44-0.46) were less likely to be performed in outpatient. (All P values < 0.05). CONCLUSION: Surgical routes and surgeon’s previous experience of MIS in outpatient setting were more impactful factors. Choice of robotic-assisted surgical route was associated with increased likelihood of outpatient BH.

Background: The majority of patients with myelodysplastic syndromes (MDS) develop anemia, and may require red blood cell (RBC) transfusions and become transfusion-dependent. Transfusion-dependency places patients at significant risk of developing iron overload. Iron chelation therapy (ICT) has been associated with improved overall and leukemia-free survival among MDS patients with iron overload. This study aims to assess the real-world treatment patterns of ICT among MDS patients, and its associated survival outcomes.

Background: Patients with myelodysplastic syndrome (MDS) may present with anemia and become red blood cell (RBC) transfusion dependent (TD), which increases the risk of iron overload (IO). Iron chelation therapy (ICT) treats IO and has been shown to be associated with improved survival and quality of life among TD MDS patients. Deferasirox (DFX) is an oral ICT used to reduce IO in TD MDS patients. This study aims to assess real-world treatment patterns and adherence among MDS patients on Medicare receiving DFX as ICT.

9560 Background: Current systemic therapies of metastatic melanoma (MM) include immunotherapy, target therapy (if BRAF mutated), high-dose IL-2, and chemotherapy, all of which are associated with different toxicity and adverse events (AEs). A comprehensive understanding of the costs of AEs will enable more accurate comparisons among the treatments and better management of costs. Methods: Two retrospective cohort studies were independently conducted using IMS PharMetrics Plus databases and MarketScan commercial and Medicare supplemental databases. Patients included those aged ≥ 18 years who had ≥ 1 metastatic melanoma diagnosis and ≥ 1 claim for any systemic therapies from July 1, 2004 to June 30, 2015. AEs were identified based on ICD-9-CM diagnosis/procedure codes. Incremental cost per AE was determined by comparing the 30-day expenditures between patients with the AE event and patients without the event using a generalized linear model. Propensity score with inverse probability of treatment weighted method was used to adjust for baseline demographic and clinical differences. Results: 1,654 patients from PharMetrics were included. Mean age was 61.2 years (SD ± 11.4); mean baseline Charlson comorbidity index was 8.0 (SD ± 2.3); 59% were male. 1,329 patients included from MarketScan had similar characteristics. The adjusted 30-day incremental costs by AE category in 2015 US$ are summarized below in the table. Conclusions: Incremental AE costs associated with systemic therapies of mm are substantial. AE Category Incremental Costs PharMetrics MarketScan $ 95% CI $ 95% CI Cardiovascular 16,083 (15,640, 16,526) 15,430 (15,052, 15,809) CNS/ psychiatric 21,277 (20,748, 21,806) 18,739 (18,255, 19,222) Gastrointestinal 18,534 (18,061, 19,007) 15,648 (15,173, 16,122) Hematologic/lymphatic 14,997 (14,652, 15,342) 15,538 (15,134, 15,941) Metabolic /nutritional 12,340 (11,851, 12,829) 17,251 (16,825, 17,677) Pain 12,928 (12,553, 13,303) 16,104 (15,691, 16,518) Skin/subcutaneous tissue 11,016 (10,717, 11,315) 10,597 (10,319, 10,875) Respiratory 17,338 (16,850, 17,826) 17,064 (16,620, 17,508) General/administration site 14,227 (13,829, 14,625) 13,371 (13,018, 13,724) Other 15,065 (14,643, 15,487) 15,381 (14,950, 15,812)

AimsTo identify the time to and patient characteristics associated with treatment intensification in patients with type 2 diabetes (T2D) and poor glycaemic control.MethodsUsing a large US insurance claims database, we conducted a retrospective cohort study among adult patients with T2D and glycated haemoglobin (HbA1c) ≥8% (index date) after ≥3 months of therapy including metformin. Patients were required to have continuous enrolment for at least 12 months before (baseline) and after index date, and no injectable antidiabetes medications. We defined treatment intensification as prescription fill for injectable or additional oral antidiabetic drugs (OADs). Cox modelling was performed to identify factors associated with time to treatment intensification.ResultsFor the 11 525 patients meeting the inclusion criteria, the mean age at index date was 57 years, 40% were female and the mean index HbA1c was 9.1%. Overall, 37% of patients had their treatment intensified <6 months after, 11% had their treatment intensified 6–12 months after, and 52% did not have their treatment intensified <12 months after the index date. A higher index HbA1c was associated with early intensification [hazard ratio (HR) 1.18 for HbA1c ≥9 to <10% and HR 1.41 for HbA1c ≥10% compared with HbA1c ≥8 to <9%; p < 0.0001), and later line of therapy was associated with late intensification (HR 0.78 for metformin with one OAD and HR 0.68 for metformin with ≥2 OADs compared with metformin monotherapy; p < 0.0001).ConclusionsFewer than half of patients with T2D and treatment failure received intensification within 12 months in a real‐world US population. Factors associated with treatment inertia can be used to target clinical care for these patients.

4544 Background: Sunitinib and sorafenib are oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) approved for treatment of patients with renal cell carcinoma (RCC) in 2005-2006. We conducted a population-based observational cohort study on the cardiovascular effects of VEGFR TKI therapy in elderly RCC patients. Methods: We analyzed patients with RCC diagnosed from 2000-2009 ages 66 and older using data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. We examined the incidence of cardiovascular adverse events through December 2010 including congestive heart failure and cardiomyopathy (CHF/CM), acute myocardial infarction (AMI), stroke, and cardiovascular deaths. We performed Cox-proportional hazard model to estimate the risk of these events associated with sunitinib or sorafenib adjusting for age, sex, comorbidity, and use of other systemic therapy. Results: A total of 171 out of 670 patients who received either sunitinib or sorafenib had cardiovascular events. The incidence rates for CHF/CM, AMI, stroke, and cardiovascular death in those who received one of the two drugs were 0.87, 0.14, 0.14, and 0.05 per 1000 person-days, respectively. Sunitinib or sorafenib use was associated with an increased risk of stroke (adjusted HR = 2.72, 95% CI: 1.49 -4.97) compared with 788 patients diagnosed with advanced RCC from 2007-2009 eligible for Part D but did not receive either agent. There were no statistically significant increased risks of CHF/CM, AMI, or cardiovascular deaths. Conclusions: Sunitinib or sorafenib are significantly associated with an increased risk of stroke, and clinicians should be aware of these rare adverse events.