scholarly journals Real-World Bruton Tyrosine Kinase Inhibitor Treatment Patterns, Compliance, Costs, and Hospitalizations in Patients with Mantle Cell Lymphoma in the United States

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3046-3046
Author(s):  
Bijal D. Shah ◽  
Keri Yang ◽  
Sizhu Liu ◽  
Jai Sivanantham ◽  
Yasser Ali ◽  
...  
Keyword(s):  
Real World ◽  
Research Funding ◽  
Index Date ◽  
Kinase Inhibitor ◽  
Cell Lymphoma ◽  
The United States ◽  
Treatment Patterns ◽  
Sociodemographic Characteristics ◽  
Mantle Cell ◽  
Bruton Tyrosine Kinase

Abstract Introduction: Mantle cell lymphoma (MCL) is a rare, aggressive, and incurable B-cell malignancy. MCL patients may initially respond well to frontline treatments; however, most will relapse or become refractory (r/r) to treatment. While there are real-world data available on the use of ibrutinib, the first Bruton tyrosine kinase inhibitor (BTKi) approved in 2013 for the treatment of r/r MCL, there is limited data on the more recently approved BTKis, acalabrutinib (approved in 2017) and zanubrutinib (approved in late 2019), primarily due to disease rarity and time lag of claims dataset. This study aimed to examine (1) clinical and sociodemographic characteristics of patients receiving BTKi, (2) treatment patterns and compliance by each BTKi, and (3) costs and hospitalizations associated with each BTKi use in the real-world setting in the United States. Methods: A retrospective observational study was conducted using the patient longitudinal data between July 2017 and May 2021 from the Symphony Health's IDV® (Integrated Dataverse), a de-identified, open-source claims database. IDV captures and aggregates data from different data vendors and assigns a unique patient identifier to each claim through a proprietary patient matching process. Patients were considered to be active in the open-source database and eligible for the study if they have ≥ 1 MCL diagnosis and ≥ 1 BTKi prescription claim for two consecutive semesters (1 semester = 6 months) pre- and post- index date. The index date was defined as the use of one of the BTKis of interest: ibrutinib, acalabrutinib, or zanubrutinib. The BTKi groups were not mutually exclusive to capture the potential switching between groups. Descriptive analysis was conducted to examine patient sociodemographic characteristics, comorbidities, concomitant medications, treatment patterns, costs, and hospitalizations in overall BTKi users, and by each BTKi. Treatment patterns were evaluated by frequency and duration of each BTKi use. Days of supplies and medication possession ratio were used to calculate persistency and compliance rates. Results: Among 30,199 patients with MCL identified from the database, 3,821 MCL patients were on BTKi therapy, and the final study population consisted of 1,653 active patients with MCL and BTKi treatment. Patients in the zanubrutinib group were older (n=67, median age=78, 67.2% male) than those in either the acalabrutinib group (n=485, median age=74, 74.9% male) and ibrutinib group (n=1,242, median age=70, 73.8% male). Among zanubrutinib users, 22% were switched from ibrutinib and 7% switched from acalabrutinib, while 21% of acalabrutinib users were switched from ibrutinib. Over half of the ibrutinib use was in the frontline setting (68.4%) while the use of acalabrutinib and zanubrutinib was more in the r/r setting (68.9% and 80.6%, respectively). The most common comorbidities at BTKi treatment initiation were hypertension (41.1%), followed by dyslipidemia (28.6%), diabetes (17.5%), cardiac arrhythmia (15.6%), and gastroesophageal reflux disease (14.5%). However, 28.5% of acalabrutinib users were concurrently on proton pump inhibitors even though such concomitant use should be avoided. The compliance rate was higher in zanubrutinib group (65%) than acalabrutinib (62%) and ibrutinib (59%) groups. Overall, the average length of stay (LOS) is 5.9 days among MCL patients who used BTKi and had at least 1 hospitalization. Patients in the zanubrutinib group had a shorter LOS (4.0 days) than those in the ibrutinib (5.9 days) and acalabrutinib (5.8 days) groups (Figure 1A). On average, the total submitted inpatient charge per stay is lower for patients in the zanubrutinib group ($51,051) than patients in the ibrutinib ($79,482) and acalabrutinib ($74,546) groups (Figure 1B). Conclusions: This study provides the first real-world evidence on patients with MCL treated with all currently available BTKis, zanubrutinib, ibrutinib and acalabrutinib. BTKis are largely being used in second-line plus settings. Future studies are needed to understand the long-term outcomes of BTKi treatment as data matures. Figure 1 Figure 1. Disclosures Shah: Novartis: Consultancy, Other: Expenses; Pfizer: Consultancy, Other: Expenses; Amgen: Consultancy; Precision Biosciences: Consultancy; Kite, a Gilead Company: Consultancy, Honoraria, Other: Expenses, Research Funding; Servier Genetics: Other; Jazz Pharmaceuticals: Research Funding; Incyte: Research Funding; BeiGene: Consultancy, Honoraria; Acrotech/Spectrum: Honoraria; Pharmacyclics/Janssen: Honoraria, Other: Expenses; Bristol-Myers Squibb/Celgene: Consultancy, Other: Expenses; Adaptive Biotechnologies: Consultancy. Yang: BeiGene, Ltd.: Current Employment. Liu: BeiGene, Ltd.: Current Employment. Sivanantham: PRA Symphony Health Solutions: Consultancy; BeiGene, Ltd.: Consultancy. Ali: BeiGene, Ltd.: Current Employment. Casten: PRA Symphony Health Solutions: Consultancy; BeiGene, Ltd.: Consultancy. Satya: PRA Symphony Health Solutions: Consultancy; BeiGene, Ltd.: Consultancy. Tang: BeiGene, Ltd.: Current Employment.

scholarly journals Real-World Treatment Patterns Among a Contemporary Cohort of Commercially Insured Mantle Cell Lymphoma Patients in the United States

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4845-4845
Author(s):  
Lindsey E. Roeker ◽  
Shaum Kabadi ◽  
Chakkarin Burudpakdee ◽  
Aimee Near ◽  
Keiko Wada ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Research Funding ◽  
Index Date ◽  
Treatment Patterns ◽  
Treatment Regimens ◽  
Oral Medications ◽  
Mantle Cell ◽  
Insured Patients

Abstract Introduction Mantle cell lymphoma (MCL) is a rare, aggressive non-Hodgkin lymphoma associated with a poor prognosis. The approval of ibrutinib in November 2013 has changed the treatment paradigm for patients with relapsed or refractory MCL. There remains a lack of information on the current treatment patterns used in clinical practice in a contemporary cohort of commercially insured patients. We aimed to identify the treatment patterns for MCL overall and by line of therapy (LOT) and to describe patient demographics and clinical characteristics in a large cohort of commercially insured MCL patients. Methods A retrospective cohort study was conducted with the IQVIA Real-World Data Adjudicated Claims-US database. Adult patients (≥18 years old) with ≥1 claim for a NCCN-recommended MCL treatment between November 1, 2013 and December 31, 2017 were identified. Index date was the first treatment claim. Patients were also required to have ≥1 diagnosis of MCL during the study period (November 1, 2012 to January 31, 2018), ≥12 months of continuous enrollment prior to index date (pre-index period) and ≥30 days after index date (follow-up period). Patients were excluded if they were ≥65 years at index and not enrolled in Medicare Risk or Medicare Cost, enrolled in a clinical trial during the study period, had evidence of MCL treatment in the pre-index period (except for patients indexed on ibrutinib as it is indicated for MCL patients with ≥1 prior treatment), or had evidence of stem cell transplant (SCT) before index date. The most commonly observed MCL treatment regimens were identified, and demographic and clinical characteristics of patients and treatment durations by regimen were described. Treatment regimen was defined as the combination of all agents observed in the 35-day period after the first MCL treatment claim; treatment duration was defined as the start of treatment until a gap of ≥90 days between end date and next date of treatment or treatment modification. Treatment end date occurred 90 days after the end of the supply for oral medications or 30 days after the last administration for non-oral medications. Results There were 1,785 patients treated with the most commonly observed MCL treatment regimens. The most common regimens, irrespective of LOT, were rituximab monotherapy (including maintenance therapy; n=773, 43.3%), R-CHOP (n=723, 40.5%), B-R (n=436, 24.4%), and ibrutinib monotherapy (n=199, 11.1%). Overall, patients had a median (IQR) age of 57 (52-62) years, and 59.4% were male. Most patients were commercially or self- insured (57.5% and 33.6%, respectively). Patients had a median Charlson Comorbidity Index (CCI) of 0 (IQR 0-1; mean [SD] 0.9 [1.4]), with the most common CCI components being diabetes (15.7%), chronic pulmonary disease (12.8%), and congestive heart failure (9.5%). During the follow-up period (median [IQR] 22.5 [10.5-35.3] months), in addition to the MCL regimen(s), patients received radiation therapy (17.4%), SCT (10.0%), and/or immunotherapy (0.2%). The use of targeted therapies (i.e. lenalidomide, bortezomib) other than ibrutinib was infrequent. When considering treatment lines, R-CHOP was the most commonly observed first regimen, followed by rituximab, B-R, and ibrutinib; for the second and third observed regimens, rituximab was the most common, followed by ibrutinib (Figure 1). The median (IQR) duration for the first observed regimen was 8.1 (3.9-18.0) months for ibrutinib, 5.0 (3.3-5.6) months for B-R, 4.0 (2.5-4.4) months for R-CHOP, and 1.9 (1.7-4.4) months for rituximab; ibrutinib also had the longest duration in the second and third line (median [IQR] 5.5 [2.4-13.5] months and 8.3 [3.9-12.4] months, respectively). Conclusion This is the largest study of MCL patients describing treatment patterns in current clinical practice among commercially insured patients. MCL patients were most commonly treated with chemoimmunotherapy for all treatment lines while ibrutinib was the second most common LOT2 and LOT3 regimen. As the treatment landscape and clinical practice continues to change with the use of novel agents, future studies are warranted to further study toxicities and outcomes in the real-world setting. Disclosures Kabadi: AstraZeneca: Employment. Burudpakdee:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Near:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Wada:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Mato:TG Therapeutics: Research Funding; Sunesis: Honoraria, Research Funding; Acerta: Research Funding; Janssen: Consultancy, Honoraria; AstraZeneca: Consultancy; Pharmacyclics: Consultancy, Honoraria, Research Funding; Regeneron: Research Funding; Celgene: Consultancy; Prime Oncology: Speakers Bureau; Abbvie: Consultancy.

scholarly journals 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 ◽  
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.

Real-world treatment patterns and sequencing for metastatic renal cell carcinoma (mRCC): Results from the Flatiron database.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 286-286
Author(s):  
Saby George ◽  
Jillian Faccone ◽  
Stephen Huo ◽  
Ying Zhang ◽  
Brian Stwalley ◽  
...  
Keyword(s):  
Real World ◽  
Index Date ◽  
Kinase Inhibitor ◽  
Clear Cell ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
Study Cohort ◽  
Similar Treatment

286 Background: RCC accounts for ~80%‒90% of all kidney cancers worldwide. The mRCC treatment landscape is rapidly changing with the approval of new therapies; data describing real-world (RW) treatment patterns and sequencing are limited. This study investigates the characteristics, treatment patterns, and sequencing for mRCC patients in the RW (December 2015‒May 2020) and post-dual immuno-oncology therapy (IO-IO) approval in the United States (April 2018‒May 2020). Methods: Adults diagnosed with mRCC between December 2015 and May 2020 were selected from the Flatiron electronic medical record database for this retrospective study. The study cohort was required to have ≥ 1 month of medical data from the initial mRCC diagnosis date (index date). We used descriptive statistics to analyze baseline patient characteristics, treatment patterns, and sequencing. Results: Of 3,524 patients with mRCC (overall cohort, December 2015–May 2020), most were male (68.5%) and had clear cell histology (68.2%). The median age at metastatic diagnosis was 68 years (range, 23–85) and the median follow-up from index date was 328 days. Based on IMDC risk score, 75.8% of patients were categorized as intermediate/poor risk and 23.2% as favorable risk (1% missing). Systemic therapy for RCC was initiated in 79.1% (N = 2788) of patients. The most common treatments for first-line (1L) therapy were tyrosine kinase inhibitor (TKI) monotherapy (mono; 56.4%), IO-IO (19.1%), IO-TKI (9.5%), IO mono (6.9%), and others (8.1%). Second-line (2L) therapy was received by 1303 patients; treatment sequences are presented in the table below. Among patients who received IO-based therapy in the 1L (N = 990), 11% were retreated with IO on any subsequent line. When stratified by clear cell and non-clear cell histology, similar treatment patterns and sequences were observed. Among patients who initiated 1L treatment post-April 2018 (N = 1395), the most common treatments for 1L therapy were IO-IO (36.9%) and TKI mono (32.7%). Among patients who received 2L treatment after initiating 1L post-April 2018 (N = 486), TKI mono followed by IO mono, and IO-IO followed by TKI mono were the most prescribed sequences (Table). Conclusions: Following approval of IO-based therapies for 1L, RW treatment patterns for mRCC are evolving; IO-IO has become the most common 1L therapy received by all patients initiating treatment for mRCC. [Table: see text]

Real-world treatment patterns among patients (pts) diagnosed with primary mediastinal large B-cell lymphoma (PMBCL) in the United States (US).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19050-e19050
Author(s):  
Xiaoqin Yang ◽  
François Laliberté ◽  
Guillaume Germain ◽  
Monika Kumar Raut ◽  
Mei Sheng Duh ◽  
...  
Keyword(s):  
B Cell ◽  
Real World ◽  
Index Date ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Treatment Patterns ◽  
Duration Of Therapy ◽  
Large B Cell Lymphoma ◽  
Icd 10 ◽  
Large B Cell

e19050 Background: PMBCL is a rare mature B-cell neoplasm (2-4% of non-Hodgkin lymphomas) for which there is only limited data on treatment patterns in clinical practice. In October 2015, PMBCL was differentiated from diffuse large B-cell lymphoma (DLBCL) with the advent of ICD-10-CM PMBCL-specific codes. This study aims to describe real-world treatment patterns among pts diagnosed with PMBCL in the US. Methods: A retrospective database analysis was conducted using the Optum Clinformatics DataMart database (01/2013-03/2018). Pts with a first PMBCL ICD-10-CM diagnosis (with or without an antecedent ICD-10-CM diagnosis of DLBCL/other lymphoma, which may have been assigned before PMBCL confirmation) after October 1st, 2015 (index date) and no ICD-9-CM diagnosis code for unspecified PMBCL/DLBCL, were identified as incident pts. Those with PMBCL ICD-10-CM and unspecified ICD-9-CM diagnosis for PMBCL/DLBCL before October 2015 (index date) were identified as prevalent pts. PMBCL diagnoses on ≥2 medical visits and ≥12 months of continuous enrollment pre-index date were required. An adapted algorithm developed from previously published studies was used to identify lines of therapy (LOT). Duration of therapy spanned from LOT initiation up to discontinuation of all agents in the LOT, a switch to another LOT, or the addition of a new agent. Results: Among 148 PMBCL pts (118 incident; 30 prevalent), median (interquartile range) age was 66 (42-77) years. In incident pts, 48.3% were treated with ≥1 LOT (mean ± standard deviation [SD] duration of therapy: 86.0 ± 69.8 days) and 14.4% were treated with ≥2 LOT. The most frequently used first-line (1L) therapy (54.4% of pts) was R-CHOP (rituximab, cyclophosphamide, doxorubicin and vincristine). In prevalent pts, 63.3% were treated with ≥1 LOT (mean ± SD duration of therapy: 88.3 ± 44.6 days) and 20.0% were treated with ≥2 LOT. The most frequently used 1L therapy was R-CHOP (68.4%). Conclusions: This study demonstrated that a large portion of pts require additional therapy after 1L treatment to manage PMBCL, underscoring the significant unmet need in this population.

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