A Retrospective Analysis of Treatment Patterns in Elderly Patients with Chronic Myeloid Leukemia Receiving Dasatinib or Nilotinib As Second-Line Therapy after Imatinib

Abstract Introduction: Dasatinib and nilotinib are second-generation tyrosine kinase inhibitors (TKIs) originally approved as second-line treatment for patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase resistant or intolerant to imatinib. Despite the fact that one half of patients with CML are ≥65 years of age, elderly patients are often under-recruited in clinical trials and there are few studies that focus on these often medically complex patients. This study aimed to compare treatment patterns of elderly CML patients initiating dasatinib vs nilotinib as second-line TKI therapy after imatinib therapy in a real-world setting. Methods: Elderly Medicare beneficiaries (≥65 years old) with ≥2 CML diagnoses who initiated dasatinib or nilotinib following prior treatment with imatinib were identified in the Medicare Research Identifiable Files (RIF) from 2006 to 2012. Selected patients were continuously covered by Part A (i.e., institutional claims), Part B (i.e., non-institutional claims), and Part D (i.e., drug events) for ≥6 months before and ≥1 month after the second-line TKI therapy initiation date (i.e., index date). Patients were excluded from the study if they were enrolled in a clinical trial, had a stem-cell transplant, or received chemotherapy (except hydroxyurea) within the 6 months before the index date (i.e., baseline period). Patients were classified as dasatinib users or nilotinib users based on the second-line TKI therapy. Dose decreases and increases, defined as a dose change of ≥20mg for dasatinib and ≥100mg for nilotinib compared to the initial dose, were measured from the index date up to the end of follow-up or treatment discontinuation. Treatment adherence was measured using the proportion of days covered (PDC) during the 6- and 12-month periods following the index date and among patients with continuous insurance coverage during these periods. Treatment persistence, measured between the index date and the end of follow-up, included time to treatment discontinuation (i.e., a treatment gap of ≥30 consecutive days) or switch to another TKI. Multivariate regression analyses were used to test for statistical significance while adjusting for potential confounding factors. Results: Of the 659 patients that met the sample selection criteria, 379 were dasatinib users and 280 were nilotinib users. The average age was 76 years (inter-quartile range 70 – 81) and 62% were female. After the index date, 88% of selected patients were observed for ≥6 months and 73% for ≥12 months. The average patient follow-up was 24 months (median=22 months). Dasatinib users were more likely to start on the recommended dose compared to nilotinib users (74% vs 53%; p<.001); only 15% of dasatinib users started on a dose ≤70mg/day and 10% started on 140mg/day; also 18% of nilotinib users started on ≤400mg/day and 24% started on 600mg/day. Dose reductions were almost twice as common in dasatinib users (21% vs 11%; adjusted hazard ratio [HR]=1.94; p=.002) and dose increases were also more common in dasatinib users (9% vs 7%; adjusted HR=1.81; p=.048) compared with nilotinib users. During the 6- and 12-month periods following the index date, dasatinib and nilotinib users had similar adherence level (6-month period: average PDC=78% for dasatinib vs 76% for nilotinib, adjusted mean difference=1.19 percentage points, p=.520; 12-month period: average PDC=69% for dasatinib vs 70% for nilotinib, adjusted mean difference=-1.37 percentage points, p=.570). Nilotinib users were more persistent compared to dasatinib users as fewer patients discontinued (59% vs 67%; adjusted HR=0.79; p=.024) or switched to another TKI treatment (21% vs 29%; adjusted HR=0.72; p=.049). Conclusion: There are little data available on treatment patterns of elderly CML patients. This study suggests that it is hard to determine the right starting dose of drug in elderly patients receiving a second generation TKI following treatment with imatinib. Interestingly, those receiving nilotinib had fewer dose adjustments (decreases or increases) and were more persistent (fewer discontinuation and switching) compared to those receiving dasatinib despite having similar levels of adherence over the first 6- and 12-month periods following the treatment initiation. Studies which focus on patients with elderly CML may help to provide better treatment guidelines for this important population. Disclosures Liu: Jun Liu is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Latremouille-Viau:Dominick Latremouille-Viau is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Zhou:Zhou Zhou is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Guerin:Annie Guerin is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Fernandez:Daniel Fernandez is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Yi:Dingdong Yi is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Wang:Xufei Wang is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Wu:Eric Q. Wu is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Mhatre:Novartis Pharmaceuticals Corporation: Employment. Keir:Novartis: Employment, Equity Ownership. Chen:Novartis Pharmaceuticals Corporation: Employment; Novartis: stock options Other.

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Comparison of Survival Rates, Healthcare Resource Use and Costs of Elderly Patients with Chronic Myeloid Leukemia Receiving Dasatinib or Nilotinib As Second-Line Therapy

Blood ◽

10.1182/blood.v124.21.2618.2618 ◽

2014 ◽

Vol 124 (21) ◽

pp. 2618-2618

Author(s):

B. Douglas Smith ◽

Jun Liu ◽

Dominick Latremouille-Viau ◽

Zhou Zhou ◽

Annie Guerin ◽

...

Keyword(s):

Research Funding ◽

Index Date ◽

Survival Rates ◽

Baseline Period ◽

Harvard University ◽

Second Line ◽

Second Line Therapy ◽

Analysis Group ◽

Line Therapy

Abstract Introduction: Dasatinib and nilotinib are two second-generation tyrosine kinase inhibitors (TKIs) that are well established as treatment options for patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase resistant or intolerant to imatinib and the treatment guidelines do not differentiate based on patient age. Importantly, elderly patients (≥65 years old) account for about half of CML patients; yet there are little data reported focusing on outcomes in this distinct group of patients, often with multiple medical problems and different socio-economic profiles when compared to younger patients. This study aimed to compare survival rates, healthcare resource utilization (HRU), and medical service costs between elderly CML patients receiving dasatinib versus nilotinib as second-line therapy after imatinib. Methods: Patients aged ≥65 years with ≥2 CML diagnoses who received imatinib as first-line therapy followed by nilotinib or dasatinib as second-line therapy were identified using the Medicare Research Identifiable Files (RIF) from 2006 to 2012. Selected patients were continuously enrolled in the Part A (i.e., institutional claims), Part B (i.e., non-institutional claims), and Part D (i.e., drug events) for ≥6 months before and ≥1 month after the second-line TKI therapy initiation date (i.e., index date). Patients enrolled in a clinical trial, those with a stem-cell transplant, or receiving chemotherapy (except hydroxyurea) during the 6 months before the index date (i.e., baseline period) were excluded from the study. Based on the second-line TKI, patients were classified as nilotinib users or dasatinib users. Survival rates were estimated using Kaplan Meir analyses and compared between nilotinib and dasatinib users using Cox proportional-hazards models. HRU and healthcare costs (USD 2013; payer’s perspective) were observed from the index date up to the end of follow-up. Because the length of follow-up varied across patients, HRU and costs were reported per-patient-per-month (PPPM). Incidence rate ratios (IRR) were estimated using Poisson regression models and monthly cost differences were estimated using general linear models with a log link and a gamma distribution or two-part models. Multivariate regression analyses were used to adjust for potential confounding factors measured during the baseline period or at the index date. Results: After applying the sample selection criteria, 659 patients using a second-line TKI therapy were selected; 280 were nilotinib users and 379 were dasatinib users. On average, patients had a follow-up of 24 months (median=22 months) after the index date. The mean age was 76 years and most patients were female (62%). Nilotinib and dasatinib users were generally similar in terms of gender, region of residence, prior imatinib treatment duration, CML complexity, and comorbidity profile. However, nilotinib users were slightly older than dasatinib users; a greater proportion of nilotinib users were 80+ years old at the index date (35% of nilotinib users vs. 27% of dasatinib users; p=.039). In addition, the proportion of patients with cardiovascular disease (40% of nilotinib users vs. 31% of dasatinib users; p=0.015) or congestive heart failure (23% of nilotinib users vs. 14% of dasatinib users; p=0.002) during the baseline period was higher in nilotinib users when compared to dasatinib users. Despite these differences, the median survival time was >4.9 years for nilotinib users and 4.0 years for dasatinib users (log rank test p=.032). After adjusting for potential confounding factors, nilotinib users had a mortality risk that was 38% lower than that of dasatinib users (p=.006) and, nilotinib users had 21% fewer inpatient admissions, 17% fewer inpatient days, 31% fewer emergency room visits, and 12% fewer outpatient visits when compared to dasatinib users (PPPM; all p≤.001). The adjusted monthly medical cost was $378 lower in nilotinib users when compared to dasatinib users (PPPM; p=.045). Conclusion: This retrospective study of elderly Medicare beneficiaries with CML receiving second-line therapy with dasatinib or nilotinib suggested that those receiving nilotinib had longer survival, lower HRU, and lower medical costs than those receiving dasatinib. Further health outcome researches and longer term studies focusing on elderly CML are needed to better define the best practice patterns. Disclosures Liu: Jun Liu is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Latremouille-Viau:Dominick Latremouille-Viau is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Zhou:Zhou Zhou is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Guerin:Annie Guerin is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Fernandez:Daniel Fernandez is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Yi:Dingdong Yi is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Wang:Xufei Wang is an employee of Harvard University which has received research funding from Analysis Group, Inc.: Employment. Wu:Eric Q. Wu is an employee of Analysis Group, Inc. which has received consulting fees from Novartis Pharmaceuticals Corporation: Employment. Mhatre:Novartis Pharmaceuticals Corporation: Employment. Keir:Novartis: Employment, Equity Ownership. Chen:Novartis: stock options Other; Novartis Pharmaceuticals Corporation: Employment.

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Benefits of Early Switching From Imatinib to a Second-Generation Tyrosine Kinase Inhibitor Following 12 Month Complete Cytogenetic Response Failure: A Chart Review Analysis.

Blood ◽

10.1182/blood.v120.21.2792.2792 ◽

2012 ◽

Vol 120 (21) ◽

pp. 2792-2792

Author(s):

Daniel J. DeAngelo ◽

Lei Chen ◽

Annie Guerin ◽

Amy Styles ◽

Clemence Aberki ◽

...

Keyword(s):

Tyrosine Kinase ◽

Tyrosine Kinase Inhibitor ◽

Disease Progression ◽

Research Funding ◽

Index Date ◽

Second Generation ◽

Kinase Inhibitor ◽

Cytogenetic Response ◽

Analysis Group

Abstract Abstract 2792 Background: The National Comprehensive Cancer Network (NCCN) guidelines (version 1.2013) recommend that patients with chronic myelogenous leukemia in chronic phase (CML-CP) should be tested for cytogenetic response 12 months following imatinib initiation. Failure to achieve complete cytogenetic response (CCyR) at 12 months should result in either an increased dose of imatinib (up to 800mg) or a change to a second-generation tyrosine kinase inhibitor (TKI). This study observed patients who failed to achieve CCyR at 12 months following the initiation of imatinib and compared treatment response rates and disease progression between patients who switched to a second-generation TKI early versus patients who did not. Methods: An online chart abstraction form was used to survey US oncologists and hematologists. Physicians submitted de-identified information on up to 10 adult patients with CML-CP who initiated imatinib as first line therapy (between 01/01/2007 and 26/07/2010) and failed to achieve CCyR at 12 months (between 10–14 months). Patients either switched to a second-generation TKI within 3 months following CCyR failure (early-switchers), or remained on imatinib for ≥3 months following CCyR failure (non-switchers). Non-switchers may have later switched to a second-generation TKI. The index date was defined as the date of the 12-month CCyR failure. Detailed patient information was collected, including demographics, comorbidities, imatinib dosage, and hematologic and cytogenetic response prior to the index date. Cytogenetic response and disease progression was also collected after the index date. CCyR was defined as 0% Philadelphia chromosome positive (Ph+) cells on cytogenetic testing. The proportion of patients achieving CCyR by 6, 12, and 24 months was reported among patients who had ≥1 cytogenetic test during these periods. Documented CCyR was defined as CCyR achievement analyzed among all patients, if patients were not tested for CCyR following the index date they were considered not to have achieved CCyR. Time to first documented CCyR achievement and time to disease progression were both estimated using multivariate Cox proportional hazard ratios (HR), where exposure was calculated from the index date to the first documented CCyR achievement, or to the date of progression, respectively. Multivariate regression analyses controlled for age, sex, race, index year, Charlson comorbidity index, imatinib dose and hematological response prior to index date, percentage of Ph+ cells and CML disease duration at index date, number of days between CML diagnosis and imatinib initiation, and rise in transcript level and chromosome abnormalities in Ph+ cells reported prior to the index date. Results: The majority of the 108 surveyed physicians were from a private practice (72.2%) and a small/intermediate practice size (61.1%). Physicians provided information on 593 patients who failed to achieve CCyR at 12 months; 306 were early-switchers and 287 were non-switchers. Among the non-switchers, 78 later switched to a second-generation TKI, and 104 increased imatinib dose after the index date. Patient demographics and comorbidities were similar among early-switchers and non-switchers, however, results of the 12-month cytogenetic test revealed that early-switchers had a greater number of Ph+ positive cells (51. 5 ± 16.6) compared to non-switchers (47.2 ± 13.1, p=.002). The median follow-up time was 612.5 days (range = 91–1625) and 591 days (range = 365–1623), respectively. Among patients tested for cytogenetic response during the follow-up period (274 early-switchers and 252 non-switchers), 35% of early-switchers subsequently achieved CCyR, compared to 24 % of non-switchers (p=.006). Within 6 months after the index date, 4.7% of the early-switchers achieved CCyR vs. 0.4% of non-switchers; by 12 months, 20.1% vs. 12.3% achieved CCyR; and by 24 months, 33.6% vs. 21.8% achieved CCyR, respectively (all p<.016). After adjusting for confounding factors, early-switchers had an 80% greater documented CCyR achievement rate compared to that of non-switchers (HR=1.80; p=.002) and a progression rate that was 81% lower (3.8% vs.1.5%, HR=0.19, p=.034). Conclusion: Early switching from imatinib to a second-generation TKI following 12-month CCyR failure was associated with better cytogenetic response and a lower risk of progression. Disclosures: DeAngelo: Novartis: Consultancy. Off Label Use: Everolimus in AML. Chen:Novartis Oncology: Employment, Own stock in Novartis Other. Guerin:Analysis Group, Inc.: Consultancy, Employment, I am an employee of Analysis Group, Inc, which has received consulting fees from Novartis Pharmaceuticals Other, Research Funding. Styles:Analysis Group, Inc.: Consultancy, Employment, Research Funding. Aberki:Analysis Group, Inc.: Consultancy, Employment, Research Funding. Giguere-Duval:Analysis Group, Inc.: Consultancy, Employment, Research Funding. Wu:Analysis Group, Inc.: Consultancy, Employment, I am an employee of Analysis Group, Inc, which has received consulting fees from Novartis Pharmaceuticals Other, Research Funding.

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Treatment Patterns and Outcomes of Patients with Double-Class Refractory or Triple-Class Refractory Multiple Myeloma: A Retrospective US Electronic Health Record Database Study

Blood ◽

10.1182/blood-2021-152301 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 2705-2705

Author(s):

Feng Wang ◽

Boris Gorsh ◽

Maral DerSarkissian ◽

Prani Paka ◽

Rachel Bhak ◽

...

Keyword(s):

Research Funding ◽

Performance Status ◽

Treatment Patterns ◽

Multiple Drug ◽

Publicly Traded ◽

Analysis Group ◽

Refractory Status ◽

Drug Classes ◽

Immunomodulatory Drug

Abstract Introduction: Patients with relapsed/refractory multiple myeloma (RRMM) resistant to multiple drug classes remain a high unmet need population, despite advances in MM patient care. The objective of this study was to assess real-world treatment patterns and outcomes in patients with RRMM who had failed multiple prior lines of therapy (LOT) and were refractory to multiple drug classes to identify gaps in their treatment pathways. Methods: This longitudinal retrospective cohort study utilized the COTA de-identified real-world database derived from US electronic health records of partnered healthcare providers from Q3 1988 through Q1 2020. Adults with active RRMM previously exposed to a proteasome inhibitor (PI) and an immunomodulatory drug and who received ≥3 prior LOTs were identified. Patients were further categorized as refractory to a PI and an immunomodulatory drug (double-class refractory [DCR]) or additionally to an anti-CD38 monoclonal antibody (i.e. daratumumab; triple-class refractory [TCR]). Determining refractory status was based on International Myeloma Working Group criteria. Index LOT was a new LOT after evidence of DCR or TCR status following ≥3 (DCR) or ≥4 (TCR) prior LOTs. Patient characteristics described included Eastern Cooperative Oncology Group (ECOG) performance status, International Staging System (ISS) stage, cytogenetic risk, age, index date, sex, and follow up time. Treatment pattern assessments included treatments received before/during/after index LOT, reasons for discontinuation, refractory status, and retreatment characteristics. Patient outcomes (overall survival [OS], duration of treatment [DOT], and time to next therapy [TTNT]) were analyzed using Kaplan-Meier survival analysis methods. Results: After excluding patients who were aged <18 years at start of index LOT with no evidence of clinical activity and who participated in a clinical trial during index LOT, 381 (DCR) and 173 (TCR) patients were available for analysis. Median follow-up from index LOT initiation through end of data availability/death was 14 (DCR) and 8 (TCR) months. Demographic characteristics were consistent between DCR and TCR patients. Approximately half were aged ≥65 years (49% DCR; 53% TCR), majority had high-risk cytogenetics (56% DCR; 66% TCR) or prior autologous stem cell transplantation (>62%), and 14-16% had ISS stage III. Patients had a median of 3 (DCR) and 6 (TCR) prior LOTs. Prior to index LOT, bortezomib and lenalidomide were the most commonly received PI and immunomodulatory drug (received by >98% of DCR or TCR patients) and the most common PI and immunomodulatory drugs to which patients were refractory (71% and 84% DCR; 76% and 83% TCR, respectively). At index LOT, PI/immunomodulatory drug-based and daratumumab-based therapies remained the most common therapies. Bortezomib and lenalidomide had the longest time to refractory status and highest retreatment rates among DCR or TCR patients. Approximately 40% of TCR patients were retreated with daratumumab-based therapies after becoming refractory (Table). After index LOT, 70% of DCR and 58% of TCR patients continued to a subsequent LOT. Patients most frequently discontinued index LOT due to disease progression (59% DCR; 60% TCR), toxicity (23% DCR; 25% TCR), or doctor preference (14% DCR; 10% TCR). Median duration of gaps between LOTs generally were shorter than 1 month (Table). Median OS was 22.3 (DCR) and 11.6 (TCR) months. Median DOT was 3.3 (DCR) and 2.8 (TCR) months, and median TTNT was 4.1 (DCR) and 3.2 (TCR) months. In multivariate statistical analyses, inferior baseline ECOG performance scores, and high-risk cytogenetic abnormalities were associated with worse prognosis (higher risk of death, shorter DOT, and shorter TTNT) in DCR and TCR patients. Age was not a significant factor after adjusting for other baseline factors. Conclusions: Treatment options are limited for US patients with DCR and TCR RRMM. DCR and TCR patients were frequently retreated with a PI, an immunomodulatory drug, or daratumumab, despite refractoriness to these agents. Many DCR and TCR MM patients stopped active MM treatment after discontinuing index treatment. Patients with DCR and TCR MM have poor prognosis, especially among high cytogenetic risk and poor performance status patients. This study provides the benchmark for new therapies, like BCMA-targeted agents, to be tested in this population. Funding: GSK (Study 217353). Figure 1 Figure 1. Disclosures Wang: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Gorsh: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. DerSarkissian: Analysis Group, Inc.: Current Employment. Paka: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Bhak: Analysis Group, Inc.: Current Employment; GlaxoSmithKline: Research Funding. Boytsov: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Zichlin: GlaxoSmithKline: Research Funding; Analysis Group, Inc.: Consultancy, Current Employment. Sansbury: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Yee: Analysis Group, Inc.: Current Employment; GlaxoSmithKline: Research Funding. Ferrante: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Khanal: GlaxoSmithKline: Research Funding; Analysis Group, Inc.: Current Employment. Noman: Analysis Group, Inc.: Current Employment; GlaxoSmithKline: Research Funding. Duh: Novartis: Other: I am an employee of Analysis Group, a consulting company that received funding from Novartis for this research study..

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

Blood ◽

10.1182/blood-2018-99-112532 ◽

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.

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Comparison of Adherence Between Nilotinib and Dasatinib As Second-Line Therapies in Chronic Myeloid Leukemia

Blood ◽

10.1182/blood.v118.21.2754.2754 ◽

2011 ◽

Vol 118 (21) ◽

pp. 2754-2754

Author(s):

Annie Guerin ◽

Vamsi K Bollu ◽

Amy Guo ◽

Michael Stepner ◽

James D Griffin ◽

...

Keyword(s):

Sensitivity Analysis ◽

Chronic Myeloid Leukemia ◽

Myeloid Leukemia ◽

Regression Models ◽

Index Date ◽

Confounding Factors ◽

Second Line ◽

Treatment Gap ◽

Pharmaceutical Corporation ◽

Analysis Group

Abstract Abstract 2754 Background: According to the NCCN guidelines, the recommended treatment option for patients diagnosed with Philadelphia-positive (Ph+) chronic myeloid leukemia (CML) in chronic or accelerated phases who are resistant or develop intolerance to first-line imatinib is to switch to one of the two second-generation BCR-ABL tyrosine kinase inhibitors, nilotinib or dasatinib. There is limited information on their comparative adherence. Analysis of adherence may reveal whether these two drugs are being used as intended and how adherence issues may potentially affect clinical outcomes. Nonadherence to imatinib has been associated with loss of cytogenetic response, imatinib failure, and higher rates of inpatient visits. A prior study covering the period up to 6/2009 has revealed a better adherence profile for nilotinib versus dasatinib. Since dasatinib was approved for once daily use in addition to twice daily use in 05/2009, this study replicated the analysis using more recent data to compare adherence between nilotinib and dasatinib as second-line therapies in CML. Methods: Medical and pharmacy records from two databases from January 1997 to April 2010 were combined to identify adult patients diagnosed with CML (ICD-9 code 205.1x) with ≥1 prescription for either nilotinib or dasatinib. Patients were required to have continuous enrollment ≥1 month prior to and after the index date, defined as the first prescription for nilotinib or dasatinib, and to continue their treatment ≥1 month before discontinuing or switching to another TKI. Adherence over an up-to 180-day period was evaluated based on the proportion of days covered (PDC; sum of days of medication on hand for nilotinib or dasatinib divided by the number of calendar days in the study period). Medication possession ratio (MPR) was also evaluated in a sensitivity analysis. PDC and MPR were compared between cohorts using linear regression models. Discontinuation was defined as a treatment gap ≥30 days, and rates were compared between cohorts using Kaplan-Meier survival analyses and Cox proportional hazard regression models. In a sensitivity analysis, discontinuation was defined as a treatment gap ≥90 days. All multivariate regression models were controlled for age, gender, CML complexity, adverse events at baseline, number of inpatient days, emergency room (ER) visits and outpatient visits during baseline, medical costs during baseline, CML year of diagnosis, Charlson Comorbidity Index, and bone marrow or stem cell transplant before the index date. Results: Adherence and discontinuation were analyzed for a total of 558 CML patients receiving a second-line TKI (473 dasatinib and 85 nilotinib). Patient characteristics were generally similar. Patients in the dasatinib cohort had a longer mean follow-up period compared with those in the nilotinib cohort (162 days vs. 146 days; P = 0.0007) and greater utilization and costs associated with inpatient and ER services. The mean PDC over the study period for nilotinib was higher compared with dasatinib (0.81 vs 0.68). After adjusting for confounding factors, the nilotinib group had a 0.115 higher PDC (approximately 17% higher) compared to the dasatinib group (P = 0.0004). Additionally, patients in the nilotinib group had a significantly higher MPR compared to patients in the dasatinib group (0.90 vs. 0.77 P = 0.0043). Discontinuation rates (gap ≥30 days) were significantly higher for dasatinib users than for nilotinib users, with an adjusted hazard ratio of 2.15 (P = 0.0013). Dasatinib-treated patients had higher discontinuation rates than nilotinib-treated patients after 3 months (40% vs 22%) and 6 months (50% vs 28%). These unadjusted differences were robust in the sensitivity analysis with discontinuation defined as a treatment gap ≥90 days, but the difference between the cohorts was no longer significant after adjusting for confounding factors (HR 1.76, P = 0.1328). Conclusions: This retrospective study showed that CML patients treated with nilotinib for second-line treatment were significantly more adherent to therapy, based on PDC and MPR, and had a lower discontinuation rate than did patients receiving dasatinib in this analysis. Further studies are needed to better understand treatment-specific factors affecting adherence and persistence (e.g., treatment cost, tolerability profile, dosing convenience). Disclosures: Guerin: Novartis Pharmaceutical Corporation: Annie Guerin is an employee of Analysis Group, Inc, which has received research funds from Novartis Pharmaceuticals. Bollu:Novartis Pharmaceutical Corporation: Employment, Vamsi K. Bollu worked for the Novartis Pharmaceuticals Corporation while performing this analysis but is currently employed by Sunovion Pharmaceuticals Inc. Sunovion Pharmaceuticals Inc. was not in any way associated with this study. Guo:Novartis Pharmaceutical Corporation: Employment. Stepner:Novartis Pharmaceutical Corporation: Michael Stepner is an employee of Analysis Group, Inc, which has received research funds from Novartis Pharmaceuticals. Griffin:Novartis Pharmaceutical Corporation: James D. Griffin is an employee of the Dana Farber Institute which has received consultancy fees from Analysis Group, Inc, which has received research funds from Novartis Pharmaceuticals Corporation. Wu:Novartis Pharmaceutical Corporation: Eric Q. Wu is an employee of Analysis Group, Inc, which has received consultancy funds from Novartis Pharmaceutical Corporation.

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Real-World Treatment Patterns and Outcomes Among Patients with Hairy Cell Leukemia

Blood ◽

10.1182/blood.v126.23.2125.2125 ◽

2015 ◽

Vol 126 (23) ◽

pp. 2125-2125

Author(s):

Sudeep Karve ◽

Victoria Divino ◽

Andrew Gaughan ◽

Mitch DeKoven ◽

Guozhi Gao ◽

...

Keyword(s):

Health Plan ◽

Real World ◽

Index Date ◽

Treatment Patterns ◽

Second Line ◽

First Line ◽

Second Line Therapy ◽

First Line Therapy ◽

Line Therapy

Abstract Background and Objective : Hairy cell leukemia (HCL) is a rare condition and accounts for ~2% of all leukemia cases in the US. NCCN guidelines recommend first-line agents including pentostatin and cladribine among patients with HCL. However, a paucity of data exists with regard to real-world treatment patterns among patients with HCL. Current study evaluates treatment patterns and associated clinical outcomes among patients with HCL using a large US administrative claims database. Methods : This retrospective observational study was conducted using the IMS Health PharMetrics Plus Health Plan Claims Database (2006-2014), which includes over 150 million unique health plan members across the US and is nationally representative of the commercially-insured US population. Data includes date stamped medical and pharmacy records along with information on health plan enrollment. Individuals with at least 2 medical claims with a diagnosis for HCL (identified using ICD-9-CM cod: 202.4x) were selected and the first observed claim defined the "index date." Patients <18 years of age at index date or with other malignancies during 6 months (the "pre-index period") prior to index date were excluded. Patients were required at least 90 days of continuous enrollment (the variable "follow-up period") in the health plan post index date with exception of patients who died within 3 months of diagnosis. Patients were followed until death (recorded on inpatient discharge disposition), end of enrollment or end of database, whichever occurred earlier. Study measures including patient demographic and baseline clinical characteristics, line of therapy (LOT), treatment patterns, relapse (receipt of same or new regimen in subsequent LOT following a gap of 365 days) and refractory disease (receipt of same or new regimen where the gap of two adjacent LOTs was <365 days) and post-treatment complications were assessed during the follow-up period. All analyses were descriptive in nature. Results : The study cohort included 749 patients after applying the selection criteria (mean follow-up from diagnosis 32 months). At diagnosis, the mean age (standard deviation) of the study cohort was 56 (10) years and majority of patients were male (77%). Mean baseline comorbidity burden (assessed using Charlson Comorbidity Index score) was 0.8 (1.1) with hypertension (24%) and aplastic anemia (22%) being the two most common co-morbidities. Only 38% (n=282) of patients received first-line chemotherapy post diagnosis. Majority initiated first-line cladribine (76%) as a single agent, while 9% had evidence of single agent pentostatin. Mean time to initiation of first-line therapy from diagnosis was 132 (294) days and average time on first-line therapy was 34 (104) days. Among patients with first-line therapy 14% received second-line therapy and rituximab (53%) and cladribine (21%) were frequently observed second-line agents. Post first-line therapy, mean time to initiation of second-line therapy was 303 (406) days. Among second-line initiators, 76% had refractory disease and 24% had relapsed following first-line. Neutropenia and fever were frequently reported complications while on chemotherapy. Conclusion : The real-world chemotherapy utilization patterns observed in this study are consistent with the NCCN guidelines with cladribine and pentostatin being the agents of choice for first-line therapy. Following diagnosis, more than one-third of patients initiated chemotherapy and only a small proportion of these received second-line chemotherapy suggesting durable response with first-line therapy. Limited follow-up post first-line therapy may have impacted the proportion of patients initiating second-line therapy as well as categorization of refractory and relapse disease. Disclosures Karve: AstraZeneca: Employment. Divino:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gaughan:AstraZeneca: Employment. DeKoven:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gao:MedImmune: Employment. Lanasa:MedImmune: Employment.

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Health Economic Burden and Treatment-Based Survival for Current Follicular Lymphoma Treatment Practice in Japan Using a Nationwide Retrospective Claims Database

Blood ◽

10.1182/blood-2019-122639 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 2129-2129

Author(s):

Saaya Tsutsue ◽

Kensei Tobinai ◽

Jingbo Yi ◽

Bruce Crawford

Keyword(s):

Treatment Group ◽

Research Funding ◽

Index Date ◽

Survival Rates ◽

Treatment Patterns ◽

High Survival ◽

Inclusion Criteria ◽

Treatment Regimens ◽

Index Treatment

ABSTRACT Introduction: Follicular lymphoma (FL) is an indolent form of non-Hodgkin lymphoma (NHL), which accounts for 20-30% of all NHL cases. In most patients, FL is diagnosed in advance stages, mild disease progression and long treatment period that may incur a great burden to patients and healthcare system. However, to our knowledge there is no comprehensive analysis which have been done in the real world setting in Japan. Therefore, we conducted a retrospective claim database study to elucidate the lines of treatment patterns as well as the associated healthcare resource utilization (HCRU), and 3- and 5-year overall survival (OS) among 3,593 Japanese patients with a median age of 65.0 years. Methods: This retrospective study analyzed data from the Medical Data Vision (MDV) database for patients diagnosed with FL (ICD-10: C82). The MDV database is an electronic health records-based database comprised of anonymized inpatient and outpatient data covering over 25 million patients and over 374 Japanese hospitals, approximately 22% of acute phase hospitals, including 187 cancer therapeutic facilities. Patients who received treatment during the identification period from 1 October 2008 to 31 December 2017 were selected. Patients were required to have data for at least 6 months before the first treatment date (ie, patient index date) and at least 12 months after the index date (unless they died). Costs were converted from Japanese yen to US dollars using the exchange rate based on January of each year of service. For 3- and 5-year OS, patients who had a record of death in their hospital discharge were counted as an event, otherwise they were censored at the latest of: end of patient record, end of data availability, or end of the 3- or 5- year period. Results: A total of 3,593 patients with FL met the inclusion criteria of which 51.2% was female patients. Of these 3,593 patients who met the inclusion criteria, 3,004 patients (83.6%) received rituximab-based (R) therapy as index treatment, of which 1309 (36.4%) of patients received R-CHOP. During the subsequent lines of therapies, patients received heterogeneous treatment regimens (fig 1). Overall, the average healthcare cost during follow-up period was $67,557.40 for all FL patients, ranging from $39,340 (immunotherapy, targeted therapy, or hormone therapy without R) to $ 95,095 (other R-based chemotherapy). The average number of outpatient visits during follow-up for all FL patients was 51, ranging from 44.6 to 55.1 for each treatment group. There were 3,394 (94.5%) patients who had at least one hospitalization during follow up period. Among those who had at least one hospitalization, the average number of hospitalizations was 3.8 for all FL patients, ranging from 2.5 to 4.6 for each treatment group. The average number of days of hospitalization during follow-up was 74.5 for all FL patients, ranging from 31 to 110.4 for each treatment group. 85 (2.4%) FL patients received a stem cell transplant (SCT) during follow-up at the age under 79 years, with other R-based therapies having the highest percentage (7.6%). There were 346 (9.7%) FL patients receiving radiation therapy, ranging from 8.1% (other treatment groups) to 24.1% (immunotherapy, targeted therapy, or hormone therapy without R). There were 337 deaths (9.4%) recorded within 3 years and 400 (11.1%) within 5 years of index treatment. The median Kaplan-Meier OS was not reached for most analysis groups due to the overall high survival rates. When comparing overall survival by index regimen group, chemotherapy without R consistently had worse survival, especially compared to R-based regimens (fig. 2). Conclusions: Patients with FL in Japan received diverse treatment regimens and multiple lines of therapy with relatively high survival rates. Majority of patients have received R-based therapies and have shown longer survival rates compared to those who have received chemotherapy without R. This is the first study to clarify lines of treatment patterns using retrospective claims database and treatment group-based OS in FL patients in Japan, which will give clinical insights of the landscape of daily practices and the associated real world health economic burden for patients, clinicians and healthcare providers to support their better decision makings. Disclosures Tsutsue: Celgene: Employment. Tobinai:Solasia: Honoraria; Mundi Pharma: Consultancy, Honoraria, Research Funding; Takeda Pharmaceutical: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Honoraria, Research Funding; Ono Pharmaceutical: Consultancy, Honoraria, Research Funding; Yakult: Honoraria; AbbVie: Research Funding; Meiji Seika: Honoraria; Janssen Pharmaceutical: Honoraria, Research Funding; Bristol-Myers Squibb: Honoraria; HUYA Bioscience: Consultancy, Honoraria; Zenyaku Kogyo: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Eisai: Honoraria, Research Funding; Chugai Pharmaceutical: Honoraria, Research Funding; Verastem: Honoraria; Kyowa Kirin: Honoraria, Research Funding. Yi:Celgene: Consultancy. Crawford:Celgene: Consultancy.

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Treatment Patterns and Outcomes in Patients with Relapsed/Refractory Follicular Lymphoma Who Received Third Line Therapy at the Christie NHS Foundation Trust in the UK

Blood ◽

10.1182/blood-2021-148490 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 5011-5011

Author(s):

Kim Linton ◽

Cristina Julian ◽

Adam Gibb ◽

Ellie White ◽

Emma-Frances Armstrong ◽

...

Keyword(s):

Follicular Lymphoma ◽

Board Of Directors ◽

Research Funding ◽

Index Date ◽

Treatment Patterns ◽

Advisory Committees ◽

Time Period ◽

Third Line ◽

Privately Held

Abstract Background: There are limited data on real-world treatment patterns and outcomes for follicular lymphoma (FL) in the relapsed/refractory (r/r) setting, with shorter response durations reported after each relapse (Link et al, 2019; Rivas-Delgado et al, 2019 and Batlevi et al, 2020). We examined treatment patterns for patients with FL initiating third line (3L) therapy at a single institution by time period in the post-rituximab era (2004-2010 and 2011-2020), and clinical outcomes for the overall cohort receiving therapy between 2004 and 2020. Methods: This is a retrospective, observational study of patients with FL who initiated 3L therapy between 2004 and 2020 in routine clinical practice at The Christie NHS Foundation Trust, UK. We selected patients aged ≥18 years at 3L initiation, with histologically documented FL Grade 1−3a treated with two prior lines of systemic therapy including an anti-CD20 monoclonal antibody and an alkylating agent, and at least one year of follow-up after initiating 3L therapy; follow-up ended June 2021. We excluded patients with grade 3b FL or transformation to high grade lymphoma any time before 3L treatment. Overall response rate (ORR) and complete response (CR) to 3L therapy was calculated, and overall survival (OS), progression free survival (PFS) and time to next treatment (TTNT) were estimated using the Kaplan-Meier (KM) method with 3L therapy initiation date as the index date. Results: Overall, 41 patients met all eligibility criteria; 11 and 30 patients received 3L therapy between 2004-2010 and 2011-2020, respectively. Median age at index date was 59 years and 53.7% were male; 73.2% had grade 1 or 2 FL; 78.1% had advanced stage (III/IV) FL at diagnosis. Median follow-up was 33.9 (IQR: 14.5, 63.0) months, and median time from diagnosis to 3L treatment was 60.2 (IQR: 29.4, 89.1) months. The most common regimen in 3L was rituximab plus bendamustine (R-benda) followed by rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and rituximab used as a single agent (R-mono). Treatment patterns differed by time period (Table 1). R-benda was more commonly used between 2011 and 2020. The most common sequence was rituximab plus cyclophosphamide, vincristine and prednisone (R-CVP) followed by R-CHOP and R-benda (Figure 1). ORR to 3L treatment was 61.0%, CR 29.3%. Median OS, PFS and TTNT with 95% confidence interval (CI) were 70.0 (30.2-NR), 19.2 (9.5-34.7) and 11.8 (9.0-27.6) months after 3L initiation, respectively. Two- and five-year OS rates were 79% and 50%, and two-year PFS rate was 37%. Conclusions: Patients with r/r FL treated in the routine 3L setting have highly variable treatment patterns and unfavorable outcomes, representing a continued unmet medical need. This study is limited by its small size and evolving treatments, warranting a larger study of more recently treated 3L patients to evaluate the impact of modern treatment pathways and novel therapies on clinical outcomes for r/r FL. Figure 1 Figure 1. Disclosures Linton: University of Manchester: Current Employment; BeiGene: Research Funding; Hartley Taylor: Honoraria; Genmab: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Aptitude Health: Honoraria; Celgene: Research Funding; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Julian: Genentech, Inc.: Current Employment, Current holder of stock options in a privately-held company. Gibb: The Christie NHS Foundation Trust: Current Employment; Takeda: Honoraria, Research Funding, Speakers Bureau. Li: Genesis Research: Current Employment. Liu: Genesis Research: Current Employment. Shewade: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Radford: BMS: Honoraria; Takeda: Consultancy, Honoraria, Research Funding, Speakers Bureau; ADC Therapeutics: Consultancy, Current holder of individual stocks in a privately-held company, Honoraria, Speakers Bureau; AstraZeneca: Current holder of individual stocks in a privately-held company.

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Treatment Patterns and Economic Burden Among Elderly Patients with Acute Myeloid Leukemia Treated with Hypomethylating Agents: A SEER-Medicare Analysis

Blood ◽

10.1182/blood-2021-145593 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4975-4975

Author(s):

Andrew M. Brunner ◽

David Huggar ◽

Ronda Copher ◽

Zheng-Yi Zhou ◽

Miriam L. Zichlin ◽

...

Keyword(s):

Induction Therapy ◽

Economic Burden ◽

Research Funding ◽

Index Date ◽

Baseline Period ◽

Publicly Traded ◽

Patient Costs ◽

Analysis Group ◽

Remission Phase

Abstract Introduction: Previously, we assessed the economic burden of newly diagnosed acute myeloid leukemia (AML) among Medicare patients and found that the economic burden of relapse is high, at approximately 1.2 and 1.6 times the monthly per-patient costs associated with early and late post-remission therapy, respectively (Tabah A, et al. Blood 2020:136(suppl 1):45). A notably high proportion of patients (55%) received ≥ 1 cycle of a hypomethylating agent (HMA). Therefore, the objective of this study was to assess the economic burden of AML among a subgroup of elderly patients who received only HMA monotherapy during induction and then achieved disease remission. Healthcare resource utilization (HCRU) and costs associated with various phases (ie, induction, post-remission therapy, and post-relapse) were assessed. Methods: A retrospective analysis was conducted using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, which comprised Medicare claims (parts A, B, and D from 2007 through 2016) and the US National Cancer Institute's SEER database (cancer diagnoses from 2007 to 2015). Included patients had an AML diagnosis in the SEER registry, were ≥ 65 years of age at the AML diagnosis date, had initiated HMA (and no other active treatment) in the outpatient (OP) setting during the first induction cycle post-AML diagnosis, and had an International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) diagnosis code for AML remission following the initiation of induction therapy. Patients were excluded if they had another blood malignancy (including a history of myelodysplastic syndromes), had received hematopoietic stem cell transplantation, or were enrolled in a clinical trial. The induction therapy period was defined as the first initiation of HMA post diagnosis (index date) to the end of the cycle during which a patient had a code for AML remission. The 6-month period prior to the index date was defined as the baseline period. The post-remission phase ended at the earliest of relapse or end of follow-up (ie, death, end of eligibility, or end of available data [December 31, 2016]). The post-relapse phase was from the date of first AML relapse ICD-9/10 code after remission to the end of follow-up. Patient characteristics during the baseline period were summarized descriptively. HCRU and costs (adjusted to 2019 US dollars) associated with induction and post-remission therapy were assessed during days that were part of a treatment cycle. The average per-patient monthly HCRU and costs were reported for the induction, post-remission, and post-relapse phases. Results: A total of 71 patients with newly diagnosed AML (azacitidine: n = 31; decitabine: n = 40) received HMA induction therapy and achieved remission. The median age at AML diagnosis was 78.8 years, 50.7% of patients were male, and 85.9% were White. The mean ± standard deviation (median) time from index date to the end of follow-up was 16.0 ± 12.3 (14.0) months. A total of 63.4% of patients (n = 45) received post-remission therapy. Among all patients, 43.7% relapsed and 85.9% died by the end of follow-up. OP visits were the most common type of visit across all phases with 95.6% of patients having ≥ 1 OP visit during post-remission therapy and 83.9% during the post-relapse phase. Inpatient (IP) visits were highest in the post-relapse phase with 77.4% of patients having ≥ 1 IP visit. The monthly mean per-patient healthcare costs were highest for the post-relapse phase, followed by post-remission therapy, and induction (Table). Costs associated with the OP setting were the greatest contributor to the induction costs (48.9%) while costs associated with the IP setting were the drivers of the costs in the post-remission therapy (56.2%) and post-relapse (72.8%) phases. Conclusions: The economic burden of AML treated with HMA induction therapy was highest in the post-relapse phase, at approximately 1.7 and 1.6 times the monthly per-patient costs during the induction and post-remission therapy phases, respectively. In addition, IP costs made up nearly two-thirds of total monthly per-patient costs in the post-relapse phase, up from approximately 44% and 56% of the induction and post-remission therapy phases, respectively. Treatment options that extend the post-remission phase would reduce the high economic burden associated with AML relapse. Figure 1 Figure 1. Disclosures Brunner: Celgene, Forty Seven Inc, Jazz: Other: Advisory Board; Novartis, Celgene, Takeda, AstraZeneca: Research Funding. Huggar: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Copher: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Zhou: Sanofi: Research Funding; Analysis Group: Current Employment, Other: Employee of Analysis Group which received consulting fees for this project . Zichlin: Analysis Group, Inc.: Consultancy, Current Employment; GlaxoSmithKline: Research Funding. Anderson: Analysis Group, which received consultancy fees from GSK: Consultancy, Current Employment. Downes: nalysis Group (employment), Bristol Myers Squibb (consultancy): Consultancy, Current Employment. McBride: BMS: Current Employment.

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Economic Burden of Newly Diagnosed Acute Myeloid Leukemia: A Retrospective Study Using the SEER-Medicare Database

Blood ◽

10.1182/blood-2020-136768 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 45-45

Author(s):

Ashley Tabah ◽

David Huggar ◽

Krystal Huey ◽

Ronda Copher ◽

Zheng-Yi Zhou ◽

...

Keyword(s):

Board Of Directors ◽

Economic Burden ◽

Research Funding ◽

Index Date ◽

Publicly Traded ◽

Advisory Committees ◽

Analysis Group ◽

Remission Period ◽

Medicare Database

Introduction: Acute myeloid leukemia (AML) poses significant economic burden on the healthcare system, particularly during induction therapy and at disease relapse. The burden associated with ongoing post-remission therapy is less clear. In patients diagnosed with AML enrolled in Medicare who received an induction therapy and achieved disease remission, we assessed the healthcare resource utilization (HCRU) and costs associated with each disease period (induction, early/late post-remission, and post-relapse). Methods: A retrospective analysis was conducted using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, comprising Medicare claims (parts A, B, and D from 2007 to 2016) and the US National Cancer Institute's SEER database (cancer diagnoses from 2007 to 2015). Identified patients had a diagnosis of AML in the SEER registry, were ≥ 65 years at the AML diagnosis date, initiated chemotherapy post-AML diagnosis (i.e. induction), and had an International Classification of Diseases, Ninth/Tenth Revision (ICD-9/10) diagnosis code for AML remission following the start of therapy. Patients were excluded if they had another blood malignancy, had received a prior hematopoietic stem cell transplant, or were enrolled in a clinical trial. Induction was defined as any therapy received from the date of first post-diagnosis chemotherapy initiation (index date) to the end of the cycle during which a patient had an ICD-9/10 code for AML remission. The 6 months prior to the index date was defined as the baseline period. Post-remission therapy was divided into an early post-remission period, which included any therapy initiated within the first 60 days (≤ 60 d) after end of induction, and a late post-remission period, which included therapy initiated more than 60 days (> 60 d) after end of induction. If specific treatment information was available, late post-remission therapy was defined by a treatment switch occurring > 60 d after end of induction. Post-remission therapy ended at the earliest of relapse or end of follow-up (i.e., death, end of eligibility, or end of available data [December 31, 2016]). The post-relapse period was from the date of first AML relapse ICD-9/10 code after remission to the end of follow-up. Baseline patient characteristics, as well as HCRU and costs (adjusted to 2019 US dollars) during the baseline, induction, post-remission, and post-relapse periods, were summarized descriptively. HCRU and costs associated with induction and post-remission therapy periods were assessed during days that were part of a treatment cycle. The average per patient per month (PPPM) HCRU and costs were reported. Duration of response (DoR) from the first remission to the earliest of relapse or death was estimated using Kaplan-Meier analysis. Results: A total of 530 patients were identified. The median age at AML diagnosis was 73 years, 53.6% of patients were male, and 80.6% were white. The median time from index date to the end of follow-up was 13.5 months. Most patients received therapy with hypomethylating agents during the AML treatment. A total of 31.9% of patients who achieved remission did not receive post-remission therapy during follow-up; for these patients, mean (median) time from end of induction to relapse or end of follow-up was 125 (23) days. A total of 63.2% of patients received chemotherapy in the early post-remission period, and 43.0% of all patients went on to receive chemotherapy in the late post-remission period. The median DoR was 5.8 months; a total of 48.9% of patients had relapsed and 80.2% had died by the end of follow-up. The mean PPPM healthcare costs were highest for induction, followed by post-relapse, early post-remission, and late post-remission periods (Table). Costs associated with the inpatient (IP) setting were the greatest contributor to PPPM costs across all periods. IP visits were most common during induction with 92.1% of patients having ≥ 1 IP visit, relative to 53.8% during baseline, 65.7% during early post-remission, 71.5% during late post-remission, and 91.1% post-relapse. Conclusions: The economic burden of relapse is approximately 1.2 and 1.6 times higher than the mean PPPM healthcare costs during early and late post-remission periods, respectively. There exists a large unmet need for therapies that will extend the duration of the post-remission period and reduce the overall economic burden of AML. Disclosures Tabah: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Huggar:Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company; Karyopharm Therapeutics: Current equity holder in publicly-traded company; FibroGen: Current equity holder in publicly-traded company. Huey:Bristol Myers Squibb: Current Employment. Copher:Bristol Myers Squibb: Current Employment. Zhou:BMS: Other: Employee of Analysis Group Inc., which received consulting fees. Zichlin:BMS: Other: Employee of Analysis Group Inc., which received consulting fees. Koenigsberg:BMS: Other: Employee of Analysis Group Inc., which received consulting fees. Brunner:Novartis: Research Funding; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Research Funding; AstraZeneca: Research Funding; Forty-Seven Inc: Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees.

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