Background
Diffuse large B‐cell lymphoma (DLBCL) represents the most common subtype of non‐Hodgkin lymphoma in the U.S., but current real‐world data are limited. This study was conducted to describe ...real‐world characteristics, treatment patterns, health care resource utilization (HRU), and health care costs of patients with treated DLBCL in the U.S.
Materials and Methods
A retrospective study was conducted using the Optum Clinformatics Data Mart database (January 2013 to March 2018). Patients with an International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis for DLBCL after October 2015 and no prior International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis for unspecified DLBCL or primary mediastinal large B‐cell lymphoma were classified as incident; those with such codes were classified as prevalent. An adapted algorithm identified lines of therapy (e.g., first line 1L). All‐cause HRU and costs were calculated per‐patient‐per‐year (PPPY) among patients with a ≥1L.
Results
Among 1,877 incident and 651 prevalent patients with ≥1L, median age was 72 years and 46% were female. Among incident patients, 22.6% had at least two lines (2L), whereas 38.4% of prevalent patients had ≥2L. The most frequent 1L therapy was rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R‐CHOP). Incident patients had 1.3 inpatient and 42.0 outpatient (OP) visits PPPY, whereas prevalent patients had 0.8 and 31.3 visits PPPY, respectively. Total costs were $137,156 and $81,669 PPPY for incident and prevalent patients, respectively. OP costs were the main driver of total costs at $88,202 PPPY, which were higher within the first year.
Conclusion
This study showed that a large portion of patients require additional therapy after 1L treatment to manage DLBCL and highlighted the substantial economic burden of patients with DLBCL, particularly within the first year following diagnosis.
Implications for Practice
Patients diagnosed with diffuse large B‐cell lymphoma (DLBCL) carry a substantial clinical and economic burden. A large portion of these patients require additional therapy beyond first‐line treatment. There is significant unmet need among patients with DLBCL who require additional therapy beyond first‐line treatment. Patients who do not respond to first‐line therapy and are not eligible for transplants have very high health care resource utilization and costs, especially in the first 12 months following initiation of treatment.
This article describes the real‐world demographic and clinical characteristics, as well as current treatment patterns, among patients diagnosed with diffuse large B‐cell lymphoma (DLBCL) and treated in the United States. Health care resource use and associated costs are assessed.
Limited real-world data exist on treatment patterns and clinical outcomes for patients with relapsed/refractory (R/R) classical Hodgkin's lymphoma (cHL).
This study used the ConcertAI Oncology ...Dataset to assess treatment patterns, real-world progression-free survival (rwPFS), and real-world overall survival (rwOS) in adults with R/R cHL diagnosed from 2000 to 2019.
Among 226 (79%) treated patients, there was substantial treatment heterogeneity. Median rwPFS was 21.0 months in the second line (2L) of therapy. Median rwOS was 146.7 months in 2L and decreased to 40.6 months in the fifth line.
Patients were exposed to a myriad of treatments in the R/R setting. These data support a relation between rwPFS and rwOS and highlight the need for effective therapeutic options.
Background: Patients with classical Hodgkin lymphoma (cHL) relapsed or refractory (R/R) disease who relapse after or are ineligible for autologous stem cell transplantation have a poor prognosis. ...Recently, the anti-PD1 monoclonal antibodies nivolumab and pembrolizumab were approved by the FDA (May 2016 and March 2017, respectively) as treatment options for R/R cHL patients. In the absence of head-to-head clinical trials, observational data may provide hypothesis-generating insight into the real-world outcomes of patients receiving these PD-1 inhibitors. This study aims to evaluate healthcare resource utilization (HRU) among patients with cHL initiated on pembrolizumab compared to nivolumab in the United States.
Methods: A retrospective database analysis was conducted using Symphony Health's Patient Integrated Dataverse® (07/2014-06/2018). The date of the first dispensing or administration of pembrolizumab or nivolumab was assigned as the index date. Patients who received both treatments and who initiated nivolumab prior to pembrolizumab approval, or in the first months after, were classified in the pembrolizumab cohort. Included patients were required to meet the following criteria: ≥12 months of continuous clinical activity prior to the index date, ≥1 inpatient or ≥2 outpatient visits with a cHL diagnosis prior to the index date, no diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma, and ≥18 years of age at the index date. Baseline patient characteristics were assessed in the 12-month baseline prior to the index date. Inverse probability of treatment weighting (IPTW) based on the propensity score was used to adjust for observed differences in baseline covariates between cohorts. Rates per person-year (PPY) of all-cause and cHL-related (i.e., visits with a primary or secondary diagnosis of cHL) HRU were calculated for weighted cohorts during the follow-up period, which spanned from the index date to the end of clinical activity or data availability. Rates of HRU were compared using rate ratios (RRs) from Poisson regression models.
Results: A total of 92 patients initiated on pembrolizumab and 218 patients initiated on nivolumab met the selection criteria and were included in the analysis. Of the 92 pembrolizumab patients, 6 patients received nivolumab during the baseline period. After weighting, the mean age was similar at 55 years in both cohorts, while the proportion of female was lower in the pembrolizumab cohort (35.3%) compared to the nivolumab cohort (44.1%; standardized difference StD=17.9%). The mean (median) follow-up period was 295 (264) days for pembrolizumab users and 274 (208) days for nivolumab users (StD=9.4%). Mean Quan-Charlson Comorbidity Index score was well balanced after weighting in the pembrolizumab and nivolumab cohorts (4.2 and 4.3, respectively; StD=2.2%); 13.8% and 15.0% had depressive disorders (StD=3.7%), and 8.5% and 10.2% had substance-related and addictive disorders (StD=5.8%), respectively. The mean number of baseline hospitalizations (pembrolizumab=1.6, nivolumab=1.5; StD=3.1%) was also well balanced after weighting.
The total person-time of observation was 74.6 and 163.6 years for the weighted pembrolizumab and nivolumab cohorts, respectively. Over this period, patients in the pembrolizumab cohort had significantly lower rates of all-cause hospitalizations (0.46) PPY than those in the nivolumab cohort (1.39; RR 95% confidence interval, CI=0.33 0.09-0.80, P=0.014; Figure). Furthermore, the rate of cHL-related hospitalizations PPY was significantly lower in the pembrolizumab cohort (0.06) compared to the nivolumab cohort (0.42; RR 95% CI=0.14 0.02-0.37, P<0.001; Figure). A similar trend (i.e., ratio below 1) was observed for all-cause and cHL-related outpatient visits, but the difference was not statistically significant (all-cause RR 95% CI=0.84 0.56-1.11, P=0.200; cHL-related RR 95% CI=0.90 0.47-1.42, P=0.647).
Conclusion: In this real-world study, adult cHL patients treated with pembrolizumab had significantly lower rates of all-cause and cHL-related hospitalizations than those treated with nivolumab. Fewer all-cause and cHL-related outpatient visits were also observed among pembrolizumab users. Additional research is warranted to further investigate these early trends in real-world HRU observed among patients with cHL receiving anti-PD1 therapies.
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Laliberté:Janssen Scientific Affairs, LLC: Research Funding; Merck & Co., Inc.: Research Funding. Raut:Merck & Co., Inc.: Employment. Yang:Merck & Co.: Employment. Germain:Janssen Scientific Affairs, LLC: Research Funding; Merck & Co., Inc.: Research Funding. Sen:Merck & Co., Inc.: Employment. MacKnight:Merck & Co., Inc.: Research Funding; Janssen Scientific Affairs, LLC: Research Funding. Desai:Merck & Co., Inc.: Employment. Duh:Analysis Group, Inc., a consulting firm that has received research funding from Shire, a Takeda company, to conduct this study: Employment; Shire: Research Funding; Merck: Research Funding.
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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 1
st
, 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.
Background: Around a third of patients with diffuse large B-cell lymphoma (DLBCL) either relapse following first-line (1L) chemoimmunotherapy (CIT) or are refractory to 1L CIT. Among patients with ...relapsed or refractory (R/R) disease eligible for second-line (2L) therapy, fewer than half survive beyond 5 years. Refractory DLBCL entails a poorer prognosis than relapsed DLBCL; however, literature on healthcare resource use (HRU) for these two populations is sparse. This study sought to describe HRU and healthcare costs in U.S. patients with relapsed and refractory DLBCL.
Methods: A retrospective claims analysis was conducted using the Optum® ClinformaticsTM DataMartTM database (01/2013-03/2018). Adult patients with ≥1 hospitalizations or ≥2 outpatient (OP) visits with an ICD-10-CM diagnosis code for DLBCL after 10/01/2015 were included. Patients were defined as (1) incident if they had no prior ICD-9-CM diagnosis code for unspecified DLBCL or primary mediastinal large B-cell lymphoma (PMBCL), or as (2) prevalent if they had a prior ICD-9-CM code for unspecified DLBCL or PMBCL. For incident cases, the index date was defined as the date of the first ICD-10 code for DLBCL or other lymphoma (after 10/01/2015); for prevalent cases, the index date was the date of the first unspecified ICD-9 code for DLBCL or PMBCL. Patients with an ICD-10 code for PMBCL at any time, or an ICD-9/ICD-10 code for Hodgkin lymphoma, multiple myeloma, and other selected lymphomas during the 12 months before the index date were excluded.
Patients with DLBCL were classified as relapsed if they initiated 2L ≥90 days after the last dose of the 1L therapy and as refractory if they initiated 2L <90 days after the last dose of 1L therapy. The 12-month period prior to the index date was defined as the baseline period. HRU (including hospitalizations, OP, ER, and other visits) and associated costs, including pharmacy costs, were evaluated per patient per year (PPPY) from the initiation of 1L up until end of data availability or end of continuous health plan enrollment.
Results: A total of 139 and 68 incident DLBCL patients were identified as relapsed and refractory, respectively, with median (interquartile range IQR) age of 74 (68-81) and 72 (67-78), and mean Quan-Charlson comorbidity index score of 3.1 in both cohorts. The mean (SD) number of baseline all-cause hospitalizations was 0.35 (0.67) for relapsed and 0.40 (0.98) for refractory patients. Mean total baseline healthcare costs were $21,195 for relapse and $29,754 for refractory patients. R/R patients with prevalent DLBCL (153 relapsed; 21 refractory) had similar baseline characteristics.
In incident DLBCL patients, those with relapsed and refractory DLBCL were observed for 495 and 346 days, respectively. On average, 1.7 and 2.4 hospitalizations PPPY occurred in relapsed and refractory patients, respectively. The table shows the breakdown of HRU by type of visits. Although hospitalizations were qualitatively higher in refractory patient, mean ± SD total healthcare costs were in similar range (relapsed= $164,631 ± 115,503; refractory= $159,729 ± 102,442). Corresponding OP costs (relapsed= $99,748 ± 85,350; refractory= $86,505 ± 59,081) were mainly driven by DLBCL anti-cancer therapy costs and were qualitatively higher among relapse compared to refractory patients ($41,768 ± 46,135 and $29,454 ± 32,242, respectively).
In prevalent DLBCL, evaluation periods of relapsed and refractory patients lasted 964 and 786 days, respectively. Patients with relapsed DLBCL had 1.1 hospitalizations PPPY, and those with refractory DLBCL had 1.9 hospitalizations PPPY. Corresponding mean ± SD total healthcare costs were $112,653 ± 79,617 and $95,465 ± 50,167 PPPY, respectively. More pronounced results (i.e., higher rates of hospitalizations and corresponding healthcare costs for refractory compared to relapse patients) were observed in a sensitivity analysis when HRU and costs were assessed up to 6 months post-index date, which suggests that refractory patients are more likely to be hospitalized early on.
Conclusions: In this U.S. real-world study, patients with R/R DLBCL incurred substantial HRU and costs, thereby imposing a considerable burden on the healthcare system. There was a trend towards higher hospitalizations for refractory patients, suggesting a worse prognosis; however total healthcare costs were similar, offset by higher anti-cancer therapy costs among relapsed patients.
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Yang:Merck & Co.: Employment. Laliberté:Janssen Scientific Affairs, LLC: Research Funding; Merck & Co., Inc.: Research Funding. Germain:Janssen Scientific Affairs, LLC: Research Funding; Merck & Co., Inc.: Research Funding. Raut:Merck & Co., Inc.: Employment. Duh:Analysis Group, Inc., a consulting firm that has received research funding from Shire, a Takeda company, to conduct this study: Employment; Shire: Research Funding; Merck: Research Funding. Sen:Merck & Co., Inc.: Employment. Lejeune:Merck & Co., Inc.: Research Funding. Desai:Merck & Co., Inc.: Employment. Armand:Merck & Co.: Employment, Membership on an entity's Board of Directors or advisory committees, Other: Travel fees, gifts, and others, Research Funding; Pfizer Inc: Research Funding; Otsuka: Research Funding; Bristol Myers Squibb Pharmaceuticals: Employment, Membership on an entity's Board of Directors or advisory committees, Other: Travel fees, gifts, and others, Research Funding; Roche: Research Funding; Dana-Farber Cancer Institute: Employment; Sigma-Tau: Research Funding; Affimed: Research Funding; Serventa: Research Funding; Infinity Pharmaceuticals: Employment, Membership on an entity's Board of Directors or advisory committees.
Background: Left ventricular diastolic dysfunction (DD) has a central role in the pathophysiology of heart failure with preserved ejection fraction (HFpEF).
Abstract Introduction: In the United States, colorectal cancer (CRC) is the fourth most common cancer and the second leading cause of cancer-related deaths. Although incidence rates of CRC have been ...decreasing overall, recent studies suggest a shift in demographics, specifically an increase in the number of new CRC cases among younger individuals and a higher incidence among those who identify as non-Hispanic Native American/Alaska Native. To examine the latest trends in incidence and overall survival (OS) among adults with CRC in the United States, we conducted an observational study using the Surveillance, Epidemiology, and End Results (SEER) Program database. Methods: Patients aged ≥18 years with newly diagnosed CRC between January 1, 2009, and December 31, 2020 were identified in the SEER 17 database. Age-adjusted incidence rates for CRC were calculated by race/ethnicity and age groups (18-49, 50-64, and ≥65 years) from 2009 to 2020. Kaplan-Meier curves were generated to examine 5-year OS by race/ethnicity, stage, and age groups. Results: There were 429,218 CRC cases identified with a median age of 67 years. Most were male (52.4%) with stage 0-II CRC (51.4%). Most patients identified as non-Hispanic White (66.3%), followed by non-Hispanic Black (11.5%), non-Hispanic Asian/Pacific Islander (8.9%), non-Hispanic Native American/Alaska Native (0.7%), and Hispanic of any race (12.7%). The age-adjusted incidence rate between 2009 and 2020 was 51.9 per 100,000 persons; incidence decreased from 59.5 per 100,000 persons in 2009 to 44.2 per 100,000 persons in 2020, with male patients having a higher incidence rate than female patients. By 2020, non-Hispanic Native American/Alaska Native patients had the highest incidence rate (54.5 per 100,000 persons) followed by non-Hispanic Black patients (50.6 per 100,000 persons). CRC incidence rates increased slightly for age <50 years (10.5 to 12.9 per 100,000 persons) and decreased for ages 50-64 (74.6 to 63.9 per 100,000 persons) and ≥65 years (222.4 to 136.1 per 100,000 persons). Non-Hispanic Black patients (53%), age ≥65 years (47%), and those with stage III-IV CRC (41%) had a lower 5-year OS from 2015 to 2019 compared to patients who were non-Hispanic White (57%), aged 50-64 (68%) and <50 years (70%), and with stage 0-II CRC (77%). Conclusion: Our results confirm a slight increase in CRC incidence among younger (<50 years) individuals over the 2009-2020 time period. Patients who were non-Hispanic Native American/Alaska Native had the highest CRC incidence rate and patients who were non-Hispanic Black had the poorest OS. Targeted preventative efforts such as CRC screening programs in addition to improved access to care/treatment may be needed to reduce the number of new cases and improve outcomes among historically underserved groups. Citation Format: Alicia C. McDonald, Seongjung Joo, Jiemin Ma, Mayur M. Amonkar, Changxia Shao, Kaushal Desai, Anne C. Deitz. Colorectal cancer incidence and overall survival by race, stage, and age: A SEER database analysis, 2009-2020 abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4871.
Abstract Introduction: Given sparse RW evidence, we assessed biomarker characteristics & clinical outcomes in community oncology practices among pre-treated non-MSI-H/dMMR mCRC patients. Methods: ...This retrospective cohort study used structured & chart review data from iKnowMed, The US Oncology Network electronic health record data & included non-MSI-H/dMMR adult mCRC patients pre-treated with standard of care (SoC) chemo who initiated subsequent systemic anticancer treatment (SACT), best supportive care (BSC) or neither from 1/1/2016 - 12/31/2021. Index date for SACT users was the regimen start date post SoC chemo & for patients on BSC & no SACT/BSC, it was last chemo administration date. Patients were followed from index date until 8/31/2022 for overall survival (OS) & real-world progression-free survival (rwPFS). KM analyses assessed outcomes, overall & stratified by treatment, RAS status & metastasis sites. Results: Of mCRC patients with >2 visits, 70.9% received MSI/MMR testing. In 292 eligible chart review patients, 69.5% received SACT in pre-treated setting (regorafenib 14.8%, trifluridine/tipiracil (TAS-102) 12.3%, other 72.9%), 28.8% received BSC & 1.7% neither. 76.7% reported KRAS/NRAS testing with 60.7% wild-type & 39.3% mutant. Common metastasis sites were liver-only (44.2%), liver & lung (10.3%) & lung-only (8.9%). Median (range) duration of follow-up was 5.2 (2.7, 10.0) months for regorafenib, 5.3 (2.5, 8.6) for TAS-102 & 10.7 (5.3, 18.0) for the other treatments group. Median OS was 7.4 (95% CI: 5.8, 8.8) months & median rwPFS was 3.5 (95% CI: 3.2, 4.3) months (outcomes data in Table). Conclusions: 29.1% pre-treated, mCRC patients did not receive guideline recommended MSI/MMR testing, highlighting the need to improve testing. Outcomes varied by treatment, RAS status, & metastatic sites. The modest RW clinical benefit for SoC regorafenib & TAS-102, was consistent with trials & other RW studies; all highlighting an unmet need. Cohorts Median (95% CI) OS (months) Median (95% CI) rwPFS1 (months) Overall 7.4 (5.8, 8.8) 3.5 (3.2, 4.3) Regorafenib 5.6 (3.1, 9.7) 2.4 (1.8, 3.0) TAS-102 5.9 (3.4, 8.6) 3.0 (2.1, 3.4) Other SACT2 12.8 (9.8, 17.2) 4.9 (3.7, 5.8) BSC 2.4 (1.8, 3.2) - RAS mutation Wild-type 8.6 (6.6, 11.5) 4.0 (3.3, 4.9) Mutant 5.4 (3.4, 9.5) 3.2 (2.1, 4.6) Metastatic sites Liver only 8.0 (5.7, 11.7) 3.9 (3.0, 4.9) Lung only 17.0 (7.8, 35.6) 7.9 (3.3, 10.5) Liver & lung only 5.4 (2.4, 7.2) 3.5 (2.1, 5.4) Other 6.7 (4.1, 9.4) 3.2 (2.7, 3.9) Abbreviation: CI: confidence interval, TAS-102: trifluridine/tipiracil, OS: overall survival, rwPFS: real-world progression-free survival, SACT: systemic anticancer treatment 1Overall rwPFS was calculated among patients receiving subsequent SACT only (n = 203) 2Top 2 “other SACT” included irinotecan- or oxaliplatin-based treatment Citation Format: Mayur M. Amonkar, Sneha Sura, Kaushal Desai, Rishi Jain, Zhimei Liu, Nicole Niehoff, Thomas W. Wilson, Gregory Patton, David Cosgrove. Real-world (RW) biomarker characteristics and clinical outcomes in pre-treated non-MSI-H/dMMR metastatic colorectal cancer (mCRC) patients abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 927.
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Background: DLBCL, the most common type of non-Hodgkin lymphoma in the US, is associated with significant morbidity and mortality. In October 2015, DLBCL was differentiated from ...other related lymphoma entities with the advent of ICD-10-CM DLBCL-specific codes. With limited real-world data on patients (pts) with DLBCL in the modern treatment era, this study was conducted to characterize these pts. Methods: A retrospective study was conducted using the Optum Clinformatics Data Mart database (01/2013–03/2018). Pts ≥ 18 years of age with ≥ 1 hospitalization or ≥ 2 outpatient visits with an ICD-10-CM diagnosis code for DLBCL (or an antecedent diagnosis of other lymphoma, which may have been assigned before confirmation of DLBCL) after October 1
st
, 2015 (index date) and no prior ICD-9-CM code for unspecified DLBCL were identified as incident. Pts with an ICD-9-CM code for unspecified DLBCL before October 2015 (index date) were classified as prevalent. At least 12 months of continuous enrollment pre-index date (baseline period) was required. Pts with ICD-10-CM code for primary mediastinal B-cell lymphoma (PMBCL), baseline diagnoses of other malignancies such as Hodgkin lymphoma and multiple myeloma were excluded. Characteristics, including baseline comorbidities, healthcare resource utilization, and costs were assessed. Results: Among 4,074 DLBCL pts (3,201 incident; 873 prevalent), mean age ± standard deviation (SD) was 71 ± 12 years; 46% were female. Incident and prevalent pts had mean Charlson comorbidity index scores of 2.7 and 2.3, respectively. Most common baseline Elixhauser comorbidities were hypertension (68.4%), diabetes (31.1%), and cardiac arrhythmia (25.3%) in incident pts and hypertension (62.5%), diabetes (28.3%), and chronic pulmonary disease (20.6%) in prevalent pts. Mean ± SD number of baseline hospitalizations was 0.32 ± 0.83 and 0.21 ± 0.49 in incident and prevalent pts, respectively. Total mean ± SD baseline healthcare costs (before diagnosis) were $24,621 ± 45,628 for incident pts and $19,137 ± 29,307 for prevalent pts. Conclusions: This study documents substantial co-morbid and economic burden of incident as well as prevalent pts with DLBCL.
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