1358. A Real-World Study of the Burden of Illness and Treatment Patterns Among Patients with Uncomplicated Urogenital Gonorrhea in the United States

Abstract Background Gonorrhea (GC) is a major public health threat in the US. The Centers for Disease Control and Prevention (CDC) estimated direct healthcare costs of &271 million in 2018. CDC 2015 guidelines (applicable up to December 18, 2020) recommended cephalosporin plus azithromycin for GC. We used real-world data to assess patterns of inappropriate or suboptimal (IA/SO) or appropriate and optimal (AP&OP) antibiotic (AB) prescription (by CDC 2015 guidelines), and related healthcare costs, in US patients with uncomplicated urogenital GC (uUGG) diagnosed from July 1, 2013–June 30, 2018. Methods A retrospective cohort study of IBM MarketScan data (commercial/Medicare claims) in patients ≥ 12 years old with uUGG. Eligible patients had an AB prescription ±5 days of uUGG diagnosis (index date) and continuous health-plan enrollment with ≥ 6 months’ baseline/≥ 12 months’ follow-up data. Patients with complicated urogenital GC were excluded. Patients were stratified by AB prescription (IA/SO or AP&OP; defined in Table 1) during the first uUGG episode (ie, within 30 days of index). Generalized linear models were used for multivariate analysis. Table 1. Definitions of appropriateness of AB prescriptions Results Of 2847 patients with uUGG (58.5% male), 77.1% had an IA/SO prescription (mostly due to IA AB class [~82.0%] and duration [24.0%]), while only 22.9% had an AP&OP prescription; uUGG episodes were more frequent with IA/SO (n=2386) than AP&OP (n=714) prescriptions during follow-up. Patients with IA/SO prescriptions had higher GC-related total adjusted costs per patient (PP) per index episode (&196) vs those with AP&OP prescriptions (&124, p < 0.0001; Figure). Patients with IA/SO prescriptions also had higher GCrelated total adjusted costs PP during follow-up (&220) vs those with AP&OP prescriptions (&148, p < 0.0001), mostly driven by higher outpatient ambulatory and emergency room (ER) adjusted costs with IA/SO (&148 and &71, respectively) vs AP&OP prescriptions (&129 and &12, respectively, p ≤ 0.0152; Figure). ER visits PP at index and during follow-up were higher with IA/SO vs AP&OP prescriptions (p < 0.0001; Table 2). Figure. GC-related costs per patient with uUGG, stratified by appropriateness of AB prescription* Table 2. GC-related HRU per patient with uUGG, stratified by AB prescription Conclusion Most patients with uUGG were not prescribed treatments in accordance with CDC 2015 guidelines. High IA/SO AB prescriptions and associated healthcare costs suggest an unmet need for improved prescribing practices for uUGG in the US. Disclosures Madison T. Preib, MPH, STATinMED Research (Employee, Former employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Ziyu Lan, MSc, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Xiaoxi Sun, MA, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

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Abstract 307: Real-world Clinical Characteristics and Recurrence Burden of Patients Diagnosed With Recurrent Pericarditis in The United States

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.307 ◽

2020 ◽

Vol 13 (Suppl_1) ◽

Author(s):

David Lin ◽

Christine Majeski ◽

Maral DerSarkissian ◽

Matt Magestro ◽

Cristi Cavanaugh ◽

...

Keyword(s):

Real World ◽

The United States ◽

Recurrent Pericarditis ◽

Real World Data ◽

Acute Pericarditis ◽

The Us ◽

History Of ◽

Artery Disease ◽

First Recurrence

Introduction: Real-world data describing acute pericarditis (AP) etiology in the US are limited. Data on the characteristics of recurrent pericarditis (RP) patients (pts) are also sparse. To fill this gap, our study assesses longitudinal data from a nationwide privately-insured population. Methods: OptumHealth Reporting and Insights employer claims data (1/2007-3/2017) were used. AP pts were identified and categorized as idiopathic or non-idiopathic etiology based on presence or absence of attributable conditions. Among idiopathic AP pts, a subgroup of RP pts was identified. Recurrence was defined as ≥2 AP events separated by >4 weeks. First recurrence date marked the index date. Pts aged ≥18 years with ≥12 months of continuous enrollment pre-index (baseline) were included. Results: Of 17,168 AP pts, 4,175 (24.3%) had non-idiopathic and 12,993 (75.7%) had idiopathic etiology (Table 1). Application of inclusion criteria left 8,822 idiopathic AP pts, of whom 1,604 (18.2%) had ≥1 recurrence during a mean observation period of 29 months. On average, idiopathic RP pts were aged 50.7 years, 51.6% female, and 42.3% had baseline history of hypertension, 23.8% of coronary artery disease, 11.7% of hypercholesterolemia, and 7.3% of myocardial infarction. Mean (±SD) time from initial AP diagnosis to first recurrence was 8.7 (±12.1) months and mean (±SD) number of recurrences was 1.7 (±1.3) per pt. In idiopathic RP pts with ≥4 years of follow-up after the initial AP diagnosis (N=512), 35.9% had ≥2, 18.2% had ≥3, and 9.8% had ≥4 recurrences within 4 years. Conclusions: The etiologic distribution and proportion of pts with RP are consistent with previous reports. About 36% of RP pts experience ≥2 recurrences after AP diagnosis over 4 years. RP represents a significant clinical burden for affected pts.

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Bone Targeting Agent Treatment Patterns Among Patients with Multiple Myeloma Treated at Oncology Clinics Across the United States: Observations from Real-World Data

Blood ◽

10.1182/blood.v128.22.2364.2364 ◽

2016 ◽

Vol 128 (22) ◽

pp. 2364-2364

Author(s):

Christopher Kim ◽

Rohini K. Hernandez ◽

Paul C Cheng ◽

Jeremy Smith ◽

Lori Cyprien ◽

...

Keyword(s):

Zoledronic Acid ◽

Real World ◽

The United States ◽

Treatment Patterns ◽

First Year ◽

Real World Data ◽

Employment Equity ◽

The Us ◽

Equity Ownership

Abstract Introduction: Multiple myeloma (MM) is a hematologic malignancy with 30,330 estimated new cases in the US in 2016. The International Myeloma Working Group recommended that intravenous (IV) bisphosphonates be initiated in all patients with active MM administered at 3 to 4-week intervals. However, there are limited data to date on the real-world use of bone target agents (BTA; zoledronic acid and pamidronate disodium) in MM. The primary goal of this study is to describe current real-world BTA treatment patterns. Methods: A database of electronic medical records from >1 million patients treated at approximately 220 cancer centers across the United States, OSCER (Oncology Services Comprehensive Electronic Records, generated by Flatiron Health), was used to identify individuals 18 years or older diagnosed with MM (ICD-9 203.00; ICD-10 C90.00) with at least 1 clinic visit within 1 month of diagnosis date between January 1, 2009 and March 31, 2016. Timing of BTA administrations, frequency, schedule, and changes/discontinuation were calculated, renal function, and BTA treatment relative to anti-MM therapy regimens was also determined. Results: During the study period, 11,099 patients were diagnosed with MM; most were male (55%), white (59%), and 65 and older at diagnosis (66%). Through the end of the follow-up period (median follow-up: 687 days), 64% of patients received ≥1 administration of a BTA (% consistent across study period) and zoledronic acid was the predominant BTA (93% of patients received ≥1 administration). The mean time from MM diagnosis until first BTA was 105.7 days (median: 29, IQR: 11-78). In more recent years, the time to BTA initiation decreased. Initial BTA treatment occurred in first year after MM diagnosis in 58.7% of patients. By calendar year of diagnosis, the percentage of patients that ever received BTA treatment had decreased over time (2009-2010: 72.3%; 2011-2012: 68.0%; 2013-2014: 63.6%). Most BTA administrations were dosed on a Q4W schedule (77%), particularly in the first year of MM diagnosis (84%). A total of 2,350 patients (33.2%) either discontinued or changed BTA dosing scheduling through the end of follow-up. Approximately 54% of patients that received a first line anti-MM therapy received BTA concomitantly; in second line, concomitant BTA was 59%, and in third line, 55%. Conclusions: Real-world data from oncology practices across the US indicate that approximately two-thirds of MM patients received BTA treatment, and the treatment rate did not increase in more recent years. Additionally, few patients continued BTA beyond 2 years. Among BTA treated patients, BTA initiation occurred at approximately 3.5 months after diagnosis, and the majority of administrations followed a Q4W schedule with zoledronic acid. Further work will explore reasons for non-treatment and treatment discontinuation with particular attention given to potential contraindications such as renal impairment, and the added burden of IV therapy in MM. Disclosures Kim: Amgen Inc.: Employment, Equity Ownership. Hernandez:Amgen: Employment, Equity Ownership. Cheng:Amgen: Employment, Equity Ownership. Smith:Amgen: Consultancy. Cyprien:Amgen: Consultancy. Liede:Amgen: Employment, Equity Ownership.

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Real-world utilization and costs with biosimilar and reference filgrastim in patients with breast cancer receiving myelosuppressive chemotherapy in a community oncology setting from 2015 to 2017.

Journal of Clinical Oncology ◽

10.1200/jco.2020.39.28_suppl.57 ◽

2021 ◽

Vol 39 (28_suppl) ◽

pp. 57-57

Author(s):

Robert M. Rifkin ◽

Lisa Herms ◽

Chuck Wentworth ◽

Anupama Vasudevan ◽

Kimberley Campbell ◽

...

Keyword(s):

Breast Cancer ◽

Real World ◽

Initial Period ◽

The United States ◽

Time Frame ◽

Real World Data ◽

Electronic Health Record Data ◽

Myelosuppressive Chemotherapy ◽

Community Oncology ◽

The Us

57 Background: Biosimilars have potential to reduce healthcare costs and increase access in the United States, but lack of uptake has contributed to lost savings. Filgrastim-sndz was the first FDA-approved biosimilar, and much can be learned by evaluating its uptake. In February 2016, the US Oncology Network converted to filgrastim-sndz as its short-acting granulocyte colony-stimulating factor (GCSF) of choice for prevention of febrile neutropenia (FN) following myelosuppressive chemotherapy (MCT). To understand utilization and cost patterns, this study analyzes real-world data of GCSFs within a community oncology network during the initial period of conversion to the first biosimilar available in the US. Methods: This descriptive retrospective observational study used electronic health record data for female breast cancer (BC) patients receiving GCSF and MCT at high risk of FN. Patient cohorts were defined by first receipt of either filgrastim or filgrastim-sndz during the 410 days before and after biosimilar conversion. Healthcare resource utilization (HCRU) and costs for GCSF and complete blood counts (CBC) were collected at GCSF initiation through the earliest of 30 days following end of MCT, loss to follow up, death, or data cutoff. Results: 146 patients were identified: 81 (55.5%) filgrastim and 65 (44.5%) filgrastim-sndz. No directional differences existed in baseline characteristics between the cohorts. Higher proportions of filgrastim-sndz patients received dose-dense MCT (33.8% vs 22.2%). Time trends show an initial spike in HCRU and cost for filgrastim-sndz patients after formulary conversion, which subsequently decreased and converged to that of the filgrastim cohort after 12 months. When aggregated, the overall median total administration counts, per patient per month (PPPM) and dosage, were marginally higher for filgrastim-sndz (5 vs 3; 2.9 vs 1.4; 1920 vs 1440 mcg, respectively). Median PPPM costs were higher for filgrastim-sndz ($803 vs $545). Median CBC utilization and costs were higher for filgrastim-sndz (2.8 vs 2.5; $28 vs $23, respectively). Conclusions: This study provides insight into real-world HCRU and cost patterns after formulary conversion to a biosimilar for BC patients receiving MCT and GCSF. As a descriptive study, causal inferences cannot be made and an underlying effect from index chemotherapy cannot be excluded. Convergence of HCRU and costs after 12 months suggests that overall results may be driven by behavior at initial formulary switch. Since filgrastim-sndz was the first US biosimilar approved, the uptake may be indicative of an experience with biosimilar acceptance in general. Future real-world studies of biosimilars must consider inconsistent utilization and practice trends during the time frame directly following formulary conversion.

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Disability burden in patients with tenosynovial giant cell tumors in the United States from employer perspective.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.30_suppl.92 ◽

2018 ◽

Vol 36 (30_suppl) ◽

pp. 92-92

Author(s):

Feng Lin ◽

Raluca Ionescu-Ittu ◽

Irina Pivneva ◽

Willy Wynant ◽

Sherry Shi ◽

...

Keyword(s):

Giant Cell ◽

Linear Models ◽

Joint Destruction ◽

Unmet Need ◽

The United States ◽

Work Loss ◽

Giant Cell Tumors ◽

Limited Mobility ◽

Comorbidity Burden

92 Background: Tenosynovial giant cell tumor (TGCT) is a rare locally aggressive tumor causing pain, swelling, joint destruction, and limited mobility. This study assessed the disability burden and the associated costs in TGCT patients from an employer’s perspective. Methods: A retrospective analysis was performed using medical and disability claims from the OptumHealth database. Incident patients 18-64 years old with a diagnosis of TGCT (as identified by ICD-9: 727.02, 719.2x; ICD-10: D48.1, D21.x, M12.2) were matched 1:10 to controls without TGCT based on age, gender, index year, and follow-up duration. Patients without earning and disability data were excluded. Days of work loss due to disability claims and absenteeism associated with medical visits were compared using Poisson regression models. Costs were compared using generalized linear models. Results: A total of 1,395 eligible TGCT patients were matched with 13,950 controls without TGCT. Despite similar demographics (36% female, mean age 45-47) and only slightly higher comorbidity burden (mean Charlson Comorbidity Index (CCI): 0.3 versus 0.2), TGCT patients had increased usage of analgesic drugs (44% versus 20%) and MRI tests (37% versus 3%), prior to their diagnosis, compared with controls. During follow-up, TGCT patients were more likely to have disability claims (15.1% vs. 5.6%; p < 0.001), had more disability claim days (9.5 versus 2.0; p < 0.001), medically related absenteeism days (9.9 versus 4.3; p < 0.001), and total days of work loss (19.4 versus 6.3; p < 0.001) per person-year compared with their matched controls. After adjusting for age, gender, index year and CCI score, the average annual indirect cost per person was greater for patients with TGCT than controls ($4,653 versus $1,902; p < 0.001). Conclusions: In addition to the known problems of pain, limitation of mobility, and eventual joint destruction, TGCT patients had substantial indirect costs associated with increased work absenteeism and disability. These findings highlight the unmet need for more effective treatments to reduce not only the medical, but also the economic burden of TGCT.

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Incremental Healthcare Utilization and Cost Burden of Comorbid Insomnia in Alzheimer’s Disease Patients

Journal of Alzheimer s Disease ◽

10.3233/jad-210713 ◽

2021 ◽

pp. 1-12

Author(s):

Zaina P. Qureshi ◽

Ellen Thiel ◽

James Nelson ◽

Rezaul Khandker

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Healthcare Utilization ◽

Real World ◽

Healthcare Costs ◽

Real World Data ◽

Skilled Nursing ◽

Comorbid Insomnia ◽

Comorbidity Burden

Background: Insomnia is associated with worsened clinical outcomes among Alzheimer’s disease dementia (AD) patients, increased caregiver burden, and healthcare utilization. Objective: This study aimed to characterize the incremental healthcare burden of insomnia in AD using real-world data. Methods: A retrospective observational study was conducted on AD patients selected from the IBM® MarketScan Commercial and Medicare Supplemental Databases. AD patients with claims-based evidence of insomnia were direct matched to a non-insomnia cohort based on demographic factors. Healthcare utilization and associated costs were assessed for a 12-month follow-up period. Results: A total of 3,500 insomnia AD patients and 9,884 non-insomnia AD patients were analyzed. The insomnia cohort had a higher comorbidity burden at baseline (mean score on Charlson Comorbidity Index 2.5 versus 2.2, p < 0.001) and higher proportions of patients with baseline diagnoses for other conditions including depression: 40%, insomnia cohort versus 25%, non-insomnia (p < 0.001). AD patients with insomnia were more likely to have a claim for inpatient hospitalizations (39.8%versus 32.3%), emergency room services (56.4%versus 48.0%), and skilled-nursing services (42.6%versus 31.9%) (all p < 0.05). Mean total annual healthcare costs during the 12-month follow-up period were significantly higher among AD patients with insomnia as compared to those without. (Mean costs: $37,356 versus $27,990, p < 0.001). Conclusion: AD patients with comorbid insomnia are more likely to use higher-cost healthcare services such as inpatient hospitalization, and skilled nursing, and have higher total healthcare costs. This real-world analysis provides evidence that AD disease management should consider proper treatment of comorbid insomnia due to the incremental burden and cost implications.

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12-month uptake of PD-L1 testing and atezolizumab (atezo) + nab-paclitaxel (nab-pac) treatment in metastatic triple-negative breast cancer (mTNBC) following accelerated FDA-approval in the United States.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e13103 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e13103-e13103

Author(s):

Leisha A. Emens ◽

Christopher Craggs ◽

Marcio Debiasi ◽

Matthew Kent ◽

Patricia Luhn ◽

...

Keyword(s):

Real World ◽

Systemic Therapy ◽

Locally Advanced ◽

The United States ◽

Considerable Proportion ◽

Real World Data ◽

Fda Approval ◽

Third Line ◽

Line Of Therapy

e13103 Background: In March 2019, atezo + nab-pac received accelerated FDA-approval for the treatment (tx) of patients (pts) with unresectable locally advanced or metastatic TNBC who express PD-L1 in immune cells (IC), based on the results from the randomized IMpassion130 clinical trial. A companion diagnostic, the Ventana SP142 PD-L1 assay, was concurrently approved. This real-world data analysis describes the uptake of both PD-L1 testing and therapy with atezo + nab-pac from the time of approval. Methods: This is a retrospective study using the Flatiron Health electronic health record (EHR) derived de-identified database, representing > 2.4 million US cancer pts from > 280 cancer clinics. Pts diagnosed with mTNBC starting any line of systemic therapy between March 9, 2019 and December 31, 2019 (to be updated in April 2020 for 12-months follow-up) were included. Two cohorts were examined: pts receiving either atezo-based tx, or tx without atezo. Demographics were described in the pt group overall and by line of therapy (LOT). Steroid tx at baseline was classified as any order/administration of a steroid within the first three administrations of a systemic therapy in a given LOT. Any record of a PD-L1 test was reported. Results: 228 pts diagnosed with mTNBC were included; 65 pts (28%) received any atezo combination, the majority in combination with nab-pac: 57% (n = 37) in first-line (1L), 25% (n = 16) in second-line (2L), and 18% (n = 12) in third-line or later (3L+). Median age at metastatic diagnosis (mDx) for atezo-treated pts was: 1L, 65 y (IQR: 49, 72); 2L, 56 y (IQR: 48, 64); 3L+, 52 y (IQR: 42, 60). Median age at mDx for non-atezo-treated patients was: 1L, 63 y (IQR: 53, 74); 2L, 59 y (IQR: 51, 65); 3L+, 61 y (IQR: 53, 71). Of 228 pts, 158 (69%) had any PD-L1 test recorded. Among atezo-treated pts, 62 (95%) had a documented PD-L1 test; of those 40 (62%) were tested using the SP142 assay. Overall, 205 tests were recorded: SP142, n = 96 (46.8%); unknown/not documented, n = 44 (21.5%); 22C3, n = 36 (17.6%); lab-developed test, n = 26 (12.7%); SP263, n = 2 (1.0%); and 28-8, n = 1, (0.5%). 37 (57%) atezo-treated pts received a steroid at baseline. Conclusions: Atezo tx and testing with SP142 is being implemented following accelerated FDA-approval. A considerable proportion of pts received steroids at baseline and had nab-pac as chemotherapy backbone in clinical practice. Clinical outcomes of atezo-treated pts in the real-world setting remain to be further explored pending longer pt follow-up times.

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COVID19 Real-World Data for the US and Lessons to Re-Open Business

10.1101/2020.06.02.20120618 ◽

2020 ◽

Author(s):

Pascal J. Goldschmidt-Clermont

Keyword(s):

Enterprise Resource Planning ◽

Real World ◽

Resource Planning ◽

The United States ◽

Lessons Learned ◽

Planning System ◽

Real World Data ◽

World Data ◽

The Us ◽

Contact Tracking

AbstractIn March of 2020, the COVID19 pandemic had expanded to the United States of America (US). Companies designated as “essential” for the US had to maintain productivity in spite of the growing threat created by the SARS-CoV-2 virus. With this report, we present the response of one such company, the Lennar Corporation, a major homebuilder in the US. Within days, Lennar had implemented a morning health check via its enterprise resource planning system, to identify associates (employees) who were sick, or not in their “usual state of health”. With this survey, Lennar was able to ensure that no one sick would show up to work, and instead, would self-quarantine at home. Furthermore, with thorough contact tracking, associates exposed to COVID19 patients (suspected or RT-PCR test-confirmed), were also asked to self-quarantine. This survey, in addition to other safety measures, such as an overhaul of the company with nearly 50% of the company working from home, prolific communication, and many more measures, Lennar was able to function safely for its associates and successfully as an enterprise. The data that we present here are “real world data” collected in the context of working throughout a dreadful pandemic, and the lessons learned could be helpful to other companies that are preparing to return to work.

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The lines of loco-regional therapies received and the healthcare economic burden of patients newly diagnosed with hepatocellular carcinoma in the United States.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.286 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 286-286

Author(s):

Brian Seal ◽

Abdulla M. Abdulhalim ◽

Melissa Lingohr-Smith ◽

Jay Lin

Keyword(s):

Radiation Therapy ◽

Economic Burden ◽

Healthcare Costs ◽

Index Date ◽

The United States ◽

Newly Diagnosed ◽

Ablative Therapy ◽

Regional Therapy ◽

The Us

286 Background: Hepatocelluar carcinoma (HCC) is one of the fastest growing causes of cancer-related deaths in the US. The objectives of this study were to examine the lines of loco-regional therapies received and the healthcare economic burden of patients newly diagnosed with HCC in the US. Methods: Patients (≥18 years of age) diagnosed with HCC who received ≥1 loco-regional therapy (index date) after diagnosis were identified from the MarketScan Commercial and Medicare Supplemental databases (July 1, 2013-May 31, 2018). Patients were required to have ≥6 months of continuous insurance enrollment before the index date and ≥1 month after (follow-up period). The follow-up period was censored when patients received any systemic therapy. During the follow-up periods, the number of patients who received radiation therapy, ablative therapy, and embolization procedures (transarterial embolization/chemoembolization [TAE] and radioembolization [TARE]) were examined. All-cause and HCC-related healthcare costs (total and patient out-of-pocket [OOP] payments per patient per month [PPPM]) were also measured. Results: Among the 2,101 patients newly diagnosed with HCC who received ≥1 loco-regional therapy, median age was 64 years and 75.0% were male; the mean follow-up duration was 11.5 months. During the follow-up periods, 28.1% (n = 590) received radiation therapy, 27.3% (n = 574) ablative therapy, and 77.3% (n = 1,623) embolization therapy (TAE: 68.7% [n = 1,443]; TARE: 20.7% [n = 434]); 30.9% of patients received multiple loco-regional therapies. During the follow-up periods, total all-cause healthcare costs were a mean of $20,316 (OOP: $378) PPPM, of which 70.7% ($14,359; OOP: $227 PPPM) were HCC-related. The breakdown of healthcare costs is shown in the table. Conclusions: According to the findings of this large-scale real-world analysis of patients newly diagnosed with HCC in the US, a vast majority received at least one embolization procedure. The monthly healthcare economic burden of patients with HCC treated with local-regional therapies is relatively high. [Table: see text]

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Treatment duration and response of advanced renal cell carcinoma (aRCC) patients (pts) who have completed first-line (1L) treatment (tx): Results from a cross-sectional real-world study.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.643 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. 643-643

Author(s):

Giovanni Zanotti ◽

Ruth Kim ◽

Stan Krulewicz ◽

Jennifer P. Hall ◽

Andrea Leith ◽

...

Keyword(s):

Real World ◽

Kinase Inhibitor ◽

Unmet Need ◽

Stage Iv ◽

Complete Response ◽

Cross Sectional Survey ◽

Real World Data ◽

Cross Sectional ◽

Therapeutic Landscape ◽

The Us

643 Background: In 2019, there was an estimated 73,820 new cases of kidney cancers in the US. The tx landscape for aRCC is changing rapidly. Recently approved txs for 1L aRCC include new targeted agents and immuno-oncology (IO) therapies. We examine outcomes for pts who completed 1L tx. Methods: Real-world data were drawn from the RCC Disease Specific Programme; a cross-sectional survey administered to US oncologists, nephrologists and urologists. Physicians completed pt record forms (PRFs) for up to the next 8 consulting aRCC pts receiving drug tx, from February - September 2019, plus additional optional PRFs for pts receiving/who had received either 1L tx of nivolumab/ipilimumab combination or cabozantinib, where these pts were available. Results: Physicians (n=82) provided data on 687 pts; 230 had progressed from 1L tx and were on 2L tx at time of data collection. Of those receiving 2L tx, 61% male; mean age was 66.4 years (SD=11.0); 43% stage IV at diagnosis. At 1L, 72% (n=165) had received tyrosine kinase inhibitor (TKI) monotherapy; 16% (n=37) IO+IO, 3% (n=7) TKI+IO and 9% (n=20) other regimens. Mean 1L duration was 10.3 months (SD=9.4) and mean time to 2L initiation was 13.7 months (SD=21.1). 1L treatment responses were: 6% complete response, 21% partial response, 16% stable disease, and the remainder relapsed/progressed (44%) or unknown response (13%). Most common 2L regimens were TKI (37%) or IO (34%) monotherapy. 47% of 1L TKI monotherapy pts received 2L IO monotherapy. 86% of 1L IO+IO pts received 2L TKI monotherapy. Conclusions: Some pts with aRCC progress to 2L; many experience poor clinical outcomes with 1L txs, highlighting high unmet need in 1L for more efficacious txs. Optimal tx strategy (and sequencing) continues to evolve. Approval of IO+TKI therapies, approved during the fieldwork period, has broadened the therapeutic landscape for 1L aRCC. Whilst the proportion of 1L pts receiving IO+TKI therapies is still low, the adoption of these in 1L is likely to transform the management of aRCC. Further research is needed to determine the optimum tx sequence in these pts with high unmet need.

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Treatment Patterns and Outcomes of 159 Ibrutinib-Treated MCL Patients in the United States: A Retrospective Electronic Medical Record Database and Chart Review Study

Blood ◽

10.1182/blood-2018-99-118848 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 4163-4163

Author(s):

Jeff Sharman ◽

Shaum Kabadi ◽

Jamyia Clark ◽

E Susan Amirian ◽

David J. Andorsky

Keyword(s):

Real World ◽

Research Funding ◽

Chart Review ◽

Kinase Inhibitor ◽

Stage Iv ◽

The United States ◽

Treatment Patterns ◽

Discontinuation Rate ◽

Real World Data

Abstract Introduction Ibrutinib, a Bruton's tyrosine kinase inhibitor, was approved in the U.S. for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in November of 2013. However, real-world data on ibrutinib use for the treatment of MCL is limited. The purpose of this study was to examine ibrutinib use, dosages, and reasons for treatment discontinuation among MCL patients treated in a community oncology practice setting. Methods The study population consisted of adult (≥18 year old) MCL patients treated with ibrutinib between November 1, 2013 and October 31, 2016, who were not enrolled in a clinical trial and had at least 2 visits to a US Oncology Network (USON) clinic. Patients with other primary cancers were excluded. Patient data were sourced from the USON's electronic health records system, iKnowMed (iKM)™. The structured iKM database provided information on demographics and clinical and treatment characteristics. Manual chart review was used to confirm ibrutinib treatment patterns. Duration of ibrutinib therapy (DOT), overall survival (OS), and progression-free survival (PFS) from systemic treatment initiation were estimated using Kaplan-Meier methods. Events were defined as death in the OS analysis, and progression or death in the PFS analysis. Patients were censored if their treatment was ongoing for DOT. Censors for OS and PFS were patients lost to follow up or those who did not experience a failure event within the study period. Results 159 eligible MCL patients were identified through iKM. The majority of patients were Caucasian (n=141, 88.7%), male (n=121, 76.1%), and diagnosed with Stage IV disease (n=117, 73.6%). Median follow-up for the population was 16.1 months. Approximately 7.5% (n=12) of patients received ibrutinib as first-line therapy (1L), compared to 54.1% (n=86) in 2L and 38.4% (n=61) in 3L or beyond. Median ibrutinib dose at initiation was 560mg (range: 140-700). During ibrutinib treatment, 16.4% (n=26) of patients experienced a dose reduction. Dose holds occurred in 30.2% (n=48), 66.7% (n=32) due toxicities. The overall discontinuation rate was 83.6% The primary reason for discontinuation was disease progression (n=46, 34.6%) followed by toxicities (n=34, 25.6%). Median DOT was higher for patients initiating treatment in 3L+ (14.9: 95% CI 8.8-17.1) compared to other lines. Median PFS was 19.6 (95% CI: 16.5-24.3) for the overall population and median OS was 25.8 months (95% CI: 19.9-not reached). Conclusions Our real-world findings on survival are consistent with those from clinical trials on ibrutinib in relapsed/refractory MCL, although our observed discontinuation rate (~84%) was higher than that of the trial (~58%), which had a similar median follow-up time (16.1 months vs. 15.3 months, respectively). Our findings provide additional data on MCL treatment patterns and patient outcomes in clinical practice. Disclosures Sharman: Acerta: Consultancy, Research Funding; Pharmacyclics, an AbbVie Company: Consultancy, Research Funding. Kabadi:AstraZeneca: Employment. Clark:McKesson Specialty Health: Employment, Equity Ownership. Amirian:McKesson Specialty Health: Employment. Andorsky:Celgene: Research Funding; CTI BioPharma: Consultancy, Research Funding; AstraZeneca: Consultancy; Genentech: Consultancy.

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