Thompson, Carrie A.

6539 Background: The impact of insurance status on survival in diffuse large B‐cell lymphoma (DLBCL), the most common aggressive lymphoma, has not been evaluated after the implementation of the Affordable Care Act (ACA). The aim of this study is to compare overall survival (OS) in patients across insurance status groups and in the periods before and after the ACA. Methods: Adult patients with newly diagnosed DLBCL were identified from the National Cancer Database. The analysis was restricted to patients 64 years of age or younger as most patients 65 years or older are eligible for Medicare under the ACA. The 2004-2017 period was chosen to represent the immunochemotherapy era preceding and following the ACA. Logistic regression was used to explore associations between abstracted variables and insurance status groups. The Kaplan-Meier method and Cox proportional hazards model were used for survival analysis. Results: 93,692 adults (age < 64 years) with newly diagnosed DLBCL and known insurance status were identified (41.3% female, median age 54 years [range: 18 – 64], 81.8% White and 12.1% Black). 7,211 (7.7%) patients were uninsured, 64,744 (69.1%) had private insurance, 11,936 (12.7%) had Medicaid, and 9,801 (10.5%) had Medicare. When compared to insured patients (private insurance, Medicaid or Medicare), uninsured patients were more likely to have a median household outcome of < $38,000 [OR 1.93 (95% CI 1.79-2.07)], less likely to receive chemotherapy [OR 0.69 (0.64-0.77)], more likely to be male [OR 1.14 (1.07-1.21)], more likely to be non-White [OR 1.30 (1.20-1.40], and more likely to present with stage III or IV disease [OR 1.24 (1.16-1.32)]. Uninsured patients had an inferior OS [HR 1.21 (95% CI 1.15-1.27)] when compared to insured patients after adjustment for baseline comorbidity (Charlson-Deyo score ≥2), advanced stage, treatment with chemotherapy, and sociodemographic factors including sex, age, race, household income, facility type (academic/community), and location (urban/rural). With a median follow-up time of 14.8 years (95% CI 14.6-not reached), median OS was lower in uninsured patients [13.4 years (12.3-not reached) vs 14.8 years (14.7-not reached); p < 0.0001]. Despite the lack of major changes in DLBCL therapies, a diagnosis after the implementation of the ACA (in 2010 or later) was associated with a superior OS when compared with the outcomes of patients diagnosed in 2010 or earlier [HR 0.93 (95% CI 0.90-0.95)]. Similarly, five-year OS was superior in the insured group [HR 0.93 (95% CI 0.89-0.96)]. Conclusions: Uninsured patients with DLBCL and < 64 years old had inferior OS when compared with insured patients, and uninsured status emerged as an independent risk factor for inferior OS. Our data highlight the independent effect of insurance disparities - a potential indicator of variations in access to health care - on survival in DLBCL.

e13569 Background: Progress in understanding the molecular biology of DLBCL has led to development of complex molecular classifications that rely on sequencing methods. These molecular clusters are defined by activation of distinct pathways and may aid in selecting targeted therapy. In the molecular era, tissue requirements in clinical trials have increased to ensure sufficient tissue for molecular testing, potentially resulting in bias for enrollment of patients with larger excisional biopsies (EB). We examined the impact of tissue biopsy method on outcomes of DLBCL in a prospective observational study. Methods: Consecutive adult patients with DLBCL within 9 months from their initial diagnosis were enrolled into the Molecular Epidemiology Resource (MER) of the University of Iowa/Mayo Clinic Lymphoma Specialized Program of Research Excellence (SPORE). Demographics, clinical variables, type of tissue biopsy (EB vs. core needle biopsy (CNB)) for initial diagnosis and initial treatment were recorded at baseline. Pts were contacted every 6 months from the date of diagnosis for first 3 years and then annually thereafter. Study objectives were event free survival (EFS) and overall survival (OS) by tissue biopsy method. Results: A total of 1061 patients with newly diagnosed DLBCL, from 2002 to 2015, were included. The table lists baseline characteristics of the cohort. 593 (56%) pts underwent EB and 468 (44%) underwent CNB for initial diagnosis. A significantly higher proportion of patients receiving CNB had performance status >=2, advanced stage, high risk disease by international prognostic index (IPI), abnormal lactate dehydrogenase. Median time from diagnosis to treatment initiation (DTI) was significantly shorter in the CNB group (13 days) than EB group (19 days). 2-year EFS (60% vs 75%, HR 0.75 (0.6-0.9), p <0.01) was significantly lower in CNB than EB group. There was a trend towards lower OS (75% vs 80%, HR: 0.8 (0.6-0.95), p =0.049) in CNB than EB group. Conclusions: Patients undergoing CNB are more likely to have higher risk disease, shorter DTI and survival compared to those undergoing EB. A need for large amount of diagnostic tissue in biomarker driven clinical trials may result in disproportional exclusion of high risk DLBCL pts who have inferior outcomes after standard treatment and could potentially benefit from novel agents, resulting in overperformance of the control arm. The need for tissue must be carefully balanced against resulting selection bias.[Table: see text]

e19527 Background: While extra nodal involvement by MCL is relatively common, involvement of the central nervous system (CNS) is a rare ( < 5% of cases) complication with limited treatment options. We report the outcomes of a large cohort of patients (pts) with CNS MCL. Methods: MCL pts with CNS involvement seen at Mayo Clinic between 1/1/1995-9/16/2020 were identified. CNS involvement was defined by histologically confirmed CNS MCL, CSF analysis demonstrating lymphoma cells, and/or neuroimaging findings compatible with CNS lymphoma. Medical records were reviewed for baseline characteristics, treatment, and outcome. Kaplan-Meier method was used for time to event analysis. Results: Out of 1,753 pts with MCL, 36 (2%) had CNS involvement by MCL. Median age at MCL diagnosis was 64 years (range 36-83) and 26 were male (72%). At MCL diagnosis, non-CNS extranodal involvement was seen in 30 pts, 24 with 1 site and 6 with ≥ 2 sites; 24 had bone marrow involvement. 11 (31%) pts had blastoid variant. Median Ki-67 was 40% (range 15-100%). MIPI score was available in 17 pts [low risk (n = 5, 29%), intermediate risk (n = 9, 53%), high risk (n = 3, 18%)]. The most common frontline regimen for MCL was R-CHOP and 14 (39%) pts underwent autologous stem cell transplant in CR1. The incidence of CNS involvement was overall similar over the study period. Median time from MCL diagnosis to CNS involvement was 25 months (m) (range 0-167). 4 (11%) pts presented with CNS involvement at initial diagnosis and 32 presented at relapse (12 isolated CNS relapse and 20 concurrent CNS and systemic relapse. Abnormal CSF was noted in 27 (87%) pts [consistent with MCL diagnosis (n = 26), atypical lymphocytes (n = 1)]. Abnormal CNS imaging was reported in 27 (75%) pts [leptomeningeal (n = 18), leptomeningeal and parenchymal (n = 5), parenchymal (n = 2), ocular (n = 2)]. First line CNS-directed therapy data was available in 33 (92%) pts. 12 (34%) received intrathecal (IT) therapy alone, 19 (54%) received systemic +/- IT therapy, 2 (6%) received radiation alone, and 2 (6%) pts received no treatment (hospice). The overall CNS response to therapy was CR in 13 (42%) pts, PR in 3 (10%), SD in 8 (26%), and PD in 7 (22%) pts. Three pts received BTK inhibitors [ibrutinib (n = 2) or acalabrutinib (n = 1)] as the first CNS-directed therapy. One patient achieved a CR with a response lasting 4 m, another patient achieved a PR with response lasting 10 m. CNS response data was not available in the remaining pts. Median follow up from CNS involvement was 72 m (95% CI: 41-NR). Median EFS for the 1 st CNS-directed therapy was 3.7 m (95% CI: 1.6-6.1). At last follow up, 30 pts were deceased. The cause of death was CNS lymphoma in 10 (33%) pts and systemic lymphoma in 9 (30%) pts. Median OS from CNS involvement was 4.7 m (95% CI: 2.3-6.7). Conclusions: CNS involvement by MCL has dismal outcomes as evident by a median OS of approximately 5 m. BTK inhibitors may have a role in treatment of this rare complication, but further prospective investigation is needed.

AbstractThe development of cardiovascular disease (CVD) in long‐term survivors of lymphoma is of increasing importance. Here, we characterize the cumulative incidence and risk factors for CVD in lymphoma patients diagnosed in the current treatment era. From 2002–2015, newly diagnosed lymphoma patients (>18 years) were enrollment into a prospective cohort study that captured incident CVD, consisting of congestive heart failure (CHF), acute coronary syndrome (ACS), valvular heart disease (VHD), and arrhythmia. The cumulative incidence of CVD was calculated with death modeled as a competing risk. We estimated the association of treatment with anthracyclines or radiotherapy and traditional CVD risk factors with incidence of CVD using hazard ratios (HR) and 95% confidence intervals (CI) estimated from Cox regression. After excluding prevalent CVD at lymphoma diagnosis, the study consisted of 3063 patients with a median age of 59 years (range 18–95). The cumulative incidence of CVD at 10‐years was 10.7% (95% CI, 9.5%–12.1%). In multivariable analysis, increasing age (HR = 1.05 per year, p < 0.001), male sex (HR = 1.36, p = 0.02), current smoker (HR = 2.10, p < 0.001), BMI > 30 kg/m2 (HR = 1.45, p = 0.01), and any anthracycline treatment (HR = 1.57, p < 0.001) were all significantly associated with risk of CVD. Anthracyclines were associated with increased risk of CHF (HR = 2.71, p < 0.001) and arrhythmia (HR = 1.61, p < 0.01), but not VHD (HR = 0.84, p = 0.58) or ACS (HR = 1.32, p = 0.24) after adjustment for CVD risk factors. Even in the modern treatment era, CVD remains common in lymphoma survivors and preventive efforts are required that address both treatment and CVD risk factors.

Abstract Comparative data guiding initial therapy for Waldenström macroglobulinemia (WM), an infrequently encountered non‐Hodgkin lymphoma, are sparse. We evaluated three commonly used rituximab‐based frontline regimens: rituximab‐bendamustine (R‐Benda); dexamethasone, rituximab, cyclophosphamide (DRC); and bortezomib, dexamethasone, rituximab (BDR) in 220 treatment‐naïve patients with WM, seen at Mayo Clinic between November 1, 2000 and October 31, 2019. The median follow‐up was 4.5 (95%CI: 4–5) years. The R‐Benda cohort (n = 83) demonstrated superior overall response rate (ORR: 98%), in comparison to DRC (n = 92, ORR: 78%) or BDR (n = 45, ORR: 84%) cohorts, p = 0.003. Similarly, longer progression‐free survival (PFS) was evident with R‐Benda use [median 5.2 vs. 4.3 (DRC) and 1.8 years (BDR), p < 0.001]. The time‐to‐next therapy (TTNT) favored R‐Benda [median, not‐reached, 4.4 (DRC) and 2.6 years (BDR), p < 0.001). These endpoints were comparable between the DRC and BDR cohorts. Overall survival (OS) was similar across the three cohorts, p = 0.77. In a subset analysis of 142 patients genotyped for MYD88 L265P mutation, the ORR, PFS and TTNT were unaffected by the patients' MYD88 signature within each cohort. In conclusion, ORR, PFS and TTNT with R‐Benda are superior compared to DRC or BDR in treatment‐naïve patients with active WM. The patient outcomes with any one of these three regimens are unaffected by the MYD88 L265P mutation status.

Abstract Background: Most indolent non-Hodgkin lymphomas (NHL) are considered incurable and are characterized by relapse and remission. Quality of life (QOL) can be affected by disease burden, side effects of treatment, and psychosocial effects of living with an incurable cancer. However, little is known about QOL in this population. We sought to describe QOL at diagnosis, change in QOL over time, and determinants of QOL in patients with indolent NHL. Methods: Newly diagnosed lymphoma patients were prospectively enrolled within 9 months of diagnosis in the University of Iowa/Mayo Clinic SPORE Molecular Epidemiology Resource. Eligibility criteria included age ≥18 years; exclusion criteria included HIV-positive, non-US residency, and inability to complete surveys in English. All pathology was reviewed by a hematopathologist. Patients with indolent B-cell NHL were included in this analysis. QOL was measured at baseline (BL) and 3 year follow-up (FU3) with the Functional Assessment of Cancer Therapy-General scale (FACT-G), which measures 4 QOL domains: physical, social/family, emotional, and functional well-being (WB), and a single item Linear Analogue Self-Assessment (LASA) for measuring overall QOL. Patients who did not complete ≥80% of FACT-G questions were excluded. Clinical data were abstracted according to a standard protocol and patients were systematically followed for events (progression, re-treatment, and death). CLL patients were excluded for event analysis due to differing definitions of outcome (progression/retreatment vs. time to first treatment). Treatment was defined as any systemic therapy (including chemotherapy, targeted agents, or antibody therapy) or radiation. QOL scores were transformed to a 0-100 scale with 100 representing the best WB or QOL for analysis. Change in QOL was assessed using the raw difference in QOL scores (i.e., FU3-BL) on the 0-100 scale with positive change scores representing improvements; minimally important difference was defined as 7 points on the transformed FACT-G subscales per previously established cutoffs (Yost and Eton, Eval & Health Prof. 2005 Jun;28:172-91). Changes in QOL from BL to FU3 were assessed using one-sample t-test of change scores vs zero. Results: 1050 patients with indolent NHL enrolled between 9/02-12/2012 and with both pre-treatment and 3 year QOL were included. QOL was collected after initiation of therapy in 215 patients (20%) and prior to therapy in 835 (80%). Subtype was 41% CLL/SLL, 32% grade 1-2 FL, 14% extranodal marginal zone, and 13% other (lymphoplasmacytic lymphoma and other). Median age was 62 years and 55% were male. At the FU3 assessment, 577 patients (55%) had received treatment, 42 (4%) transformed, and 53 (25%) had an event. Emotional WB significantly improved from BL to FU3 (mean +5.9, SD 13.3, p&lt;0.001) while social/family WB significantly decreased (mean -4.8, SD 20.5, p&lt;0.001). Functional WB, physical WB, overall FACT-G, and overall QOL LASA were not significantly different at FU3. These findings were similar in those who were treated vs. those who were observed. We also assessed the results stratified by non-CLL patients who had progression or retreatment between BL and FU3. In patients with an event in the first 3 years, emotional WB had a significant improvement from BL to FU3 (mean +3.6, SD 13.6, p=0.002) and overall QOL LASA decreased (mean -4.0, SD 20.0, p=0.01). In patients without an event, improvements were reported in functional WB (mean +2.1, SD 18.2, p=0.01), physical WB (mean +2.5, SD 13.9, p=0.001), emotional WB (mean +7.0, SD 15.0, p&lt;0.001), and overall QOL LASA (mean +1.1, SD 11.4, p=0.03), while social/family WB decreased (mean -6.2, SD 20.3, p&lt;0.001). Sensitivity analysis showed that results were consistent in the subset of patients who had BL QOL collected prior to initiating therapy. While many changes were statistically significant, they were small in magnitude; only the improvement in emotional WB in the entire cohort approached clinical significance and met that criterion in those without an event. Conclusions: In this large sample of patients with indolent lymphoma, QOL generally remained stable from diagnosis to FU3 while emotional WB showed improvement, suggesting psychosocial adaptation by the patient. Mean score changes in functional WB, physical WB, emotional WB, social/family WB, and overall QOL were more pronounced in patients without an event in the first 3 years since diagnosis. Disclosures Shanafelt: Hospira: Research Funding; AbbVie: Research Funding; Celgene: Research Funding; GlaxoSmithKline: Research Funding; Genentech: Research Funding; Jannsen: Research Funding; Pharmacyclics: Research Funding.

Abstract Introduction: Although increased physical activity (PA) is associated with improved quality of life in cancer survivors, knowledge about the impact of PA on survival in lymphoma patients is limited. We studied the impact of usual adult PA and PA at 3 years after diagnosis on overall (OS) and lymphoma-specific (LSS) survival in lymphoma patients. Methods: Lymphoma patients were prospectively enrolled within 9 months of diagnosis into the Lymphoma SPORE Molecular Epidemiology Resource (MER) cohort. At baseline, patients reported their usual level of mild, moderate and strenuous PA during most of their adult life and (for survivors) again at the 3 year follow-up (FU3), which we used to calculate the Godin Leisure Score Index (LSI). At FU3, patients also self-reported change in PA since diagnosis as increase, decrease or no change. LSI was modeled as a continuous score (per 10-point change) and by tertile. Survival was measured as time from diagnosis (for baseline PA) and time from FU3 (for FU3 PA) until death due to any cause and due to lymphoma. We evaluated the association of PA with outcome using Kaplan-Meier curves as well as hazard ratios (HRs) and 95% confidence intervals (CI) from Cox models stratified by lymphoma subtype and adjusted for age and sex (and baseline PA for change models). Results: Of 4087 patients enrolled in the MER at the Mayo Clinic from 2002-2012, 3129 had baseline PA data (3060 evaluable for LSI), and 1845 (1395 evaluable for LSI) had FU3 PA data. In the baseline cohort, 57.6% of the patients were male. The median age at diagnosis was 62 years (range 18-92 years). The majority had ECOG performance status &lt;2 (95%), no B-symptoms (85.8%) and advanced disease (63% stage III-IV) at diagnosis. The subtypes included were CLL/small lymphocytic (25.9%), follicular (18.1%), diffuse large B-cell (16.8%), marginal zone (8.1%), Hodgkin (6.9%), mantle cell (4.8%), T-cell (5%) and other (14.3%) lymphomas. The median LSI was 28 (range 0-57) at baseline and 25 (range 0-67) at FU3 with a median change in LSI of -2 (range -57 to 61). At a median follow-up of 84 months from diagnosis (IQR 59-119 months) in the cohort with baseline PA, there were 806 total deaths (271 in pts with FU3 PA) and 423 lymphoma deaths (104 in pts with FU3 PA). When analyzed as a continuous variable, baseline LSI was associated with OS (HR 0.95, 95% CI 0.91-0.99) and LSS (HR 0.95, 95% CI 0.90-1.01). LSI by tertiles was associated with OS (p&lt;0.0001, Figure 1a), and patients in the high LSI compared to the low LSI tertile had superior OS (HR 0.81, 95% CI 0.68-0.97) and LSS (HR 0.81, 95% CI 0.63-1.04). For prognosis after 3 years, continuous LSI at FU3 was also associated with superior OS (HR 0.84, 95% CI 0.77-0.92) and LSS (HR 0.76, 95% CI 0.65-0.89). LSI at FU3 by tertiles was associated with OS (p&lt;0.0001, Figure 1b), and patients in the high LSI compared to the low LSI tertile had superior OS (HR 0.51, 95% CI 0.34-0.77) and LSS (HR 0.33, 95% CI 0.16-0.67). A change in LSI from baseline to FU3 PA was associated with superior OS (HR 0.84, 95% CI 0.76-0.92) and LSS (HR 0.74, 95% CI 0.64-0.87) after FU3. Change in LSI by tertiles was associated with OS (p=0.0007, Figure 1c). Compared to patients with stable LSI (change of LSI between -10 and 5 points from baseline, n=429), patients who increased LSI by &gt; 5 (n=464) had improved OS (HR 0.67, 95% CI 0.45-1.00) and LSS (HR 0.47, 95% CI 0.23, 0.94), while patients who decreased LSI by &gt;10 (n=477) had no association with OS or LSS. Self-reported change in PA from baseline to FU3 was associated with OS (p&lt;0.0001, Figure 1d); compared to no change, an increase in PA was not associated with OS (HR 0.79, 95% CI 0.42-1.48) or LSS (OR 0.73, 0.26-2.07), while a reduction in PA was associated with inferior OS (HR 1.94, 95% CI 1.49-2.53) and LSS (HR 2.51, 95% CI 1.62-3.88). After excluding patients with any events through FU3, the associations for the PA change and OS remained significant for change in LSI (HR 0.91, 95%CI 0.83-1.00) and self-reported decrease in PA (HR 1.83, 95%CI 1.32-2.53). Conclusions: Patients with a higher level of usual PA during adult life have significantly better OS and LSS after lymphoma diagnosis compared to those who are less physically active. Higher PA in 3-year survivors is also associated with improved survival, while a reduction in physical activity is associated with worse outcomes. These data support an important role for PA in lymphoma survivorship and also provide a strong rationale for a PA intervention trial in lymphoma patients. Figure 1 Figure 1. Disclosures Cohen: LAM Therapeutics, Inc: Research Funding; Takada: Research Funding; Infinity: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bioinvent: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees. Flowers: Spectrum: Consultancy; OptumRx: Consultancy; Acerta: Research Funding; Onyx: Research Funding; Janssen Pharmaceutical: Research Funding; V Foundation: Research Funding; TG Therapeutics: Research Funding; National Cancer Institute: Research Funding; Burroughs Welcome Fund: Research Funding; Genentech/Roche: Consultancy, Research Funding; Gilead: Consultancy; Research to Practice: Research Funding; Millennium/Takeda: Research Funding; National Institutes Of Health: Research Funding; Prime Oncology: Research Funding; Educational Concepts: Research Funding; Abbvie: Consultancy, Research Funding; Pharmacyclics LLC, an AbbVie Company: Research Funding; Seattle Genetics: Consultancy; Eastern Cooperative Oncology Group: Research Funding; Celgene: Consultancy, Research Funding; Infinity: Research Funding; Bayer: Consultancy; Clinical Care Options: Research Funding. Cerhan: Janssen: Other: Scientific Advisory Board (REMICADELYM4001); Janssen: Other: Multiple Myeloma Registry Steering .

Abstract Abstract Importance: The benefit of routine screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in patients with cancer before cancer-directed therapies is unclear. Herein, we characterize the outcomes of a cohort of cancer patients diagnosed with Coronavirus Disease 2019 (COVID-19) by routine screening in comparison with those diagnosed based on clinical suspicion or exposure history (non-routine screening). Objective: To describe and compare the outcomes of cancer patients diagnosed with COVID-19 on routine screening vs. non-routine screening at a multi-site tertiary cancer center. To identify risk factors for COVID-19-related hospital admission. Design: A multi-site prospective observational study was conducted between March 18 and July 31, 2020. Setting: Three major and 5 satellite campuses of the Mayo Clinic Cancer Center. Participants: Adult patients diagnosed with active cancer within the past five years and confirmed SARS-CoV-2 infection were included. Primary Outcomes and Measures: Clinical and laboratory data were assessed as independent variables. The primary outcome was COVID-19-related hospital admission. Secondary outcomes included intensive care unit (ICU) admissions and all-cause mortality. Results: Between March 18 and July 31, 2020, 5452 patients underwent routine screening in the outpatient setting, 44 (0.81%) were diagnosed with COVID-19. Routine screening detected additional 19 patients from inpatient and pre-procedural settings; 161 patients were diagnosed with COVID-19 based on non-routine screening. The median age of the entire cohort at diagnosis was 54 years, and 95 patients (42.2%) were female. COVID-19 related-hospitalization rate (17.5% vs. 26.7%, p=0.14), ICU admission (1.6% vs. 5.6%, p=0.19), and mortality (4.8% vs. 3.7%, p=0.72) were not significantly different between routine screening and non-routine screening groups. In the multivariable analysis, age ≥ 60 years (odds ratio: 4.4, p=0.023) and an absolute lymphocyte count ≤1.4 × 109/L (odds ratio: 9.2, p=0.002) were independent predictors of COVID-19-related hospital admission. Conclusions and Relevance: The COVID-19 positivity rate was low based on routine screening. Comparing the outcome with the non-routine screening cohort, there was no significant difference. These results led to an important practice change at our cancer center. We currently follow a testing strategy based on symptoms, exposure, risk factors, and clinical judgment. Citation Format: Zhuoer Xie, Antoine N. Saliba, Jithma Abeykoon, Umair Majeed, Daniel Almquist, Julia Wiedmeier-Nutor, Evandro Bezerra, Xavier Andrade-Gonzalez, Ashley Hickman, Karl Sorenson, Sagar Rakshit, Christopher Wee, Sri Tella, Anuhya Kommalapati, Nadine Abdallah, Joshua Pritchett, Mariza De Andrade, Dipesh Uprety, Andrew Badley, Joleen Hubbard, Naseema Gangat, Carrie A. Thompson, Thomas Witzig, Robert R. McWilliams, Konstantinos Leventakos, Thorvardur R. Halfdanarson. Outcomes of COVID-19 in patients with cancer: Results of a prospective observational comparison of routine screening strategy versus testing based on clinical suspicion [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2021 Feb 3-5. Philadelphia (PA): AACR; Clin Cancer Res 2021;27(6_Suppl):Abstract nr S06-03.

Abstract Disease progression after frontline therapy for Diffuse large B‐cell lymphoma (DLBCL) is a clinically significant event. Patients who experience early progression or have refractory disease have especially poor outcomes. Simple, clinically applicable prognostic tools are needed for selecting patients for consideration for novel therapies and prognostication in the relapsed/refractory (R/R) setting. Model building was performed in patients from the Surrogate endpoints in aggressive lymphoma (SEAL) consortium with disease progression after frontline immunochemotherapy. The primary endpoint was overall survival (OS) measured from date of progression. Validation was performed in the University of Iowa/Mayo Clinic SPORE Molecular Epidemiology Resource (MER) and Danish National Lymphoma Register (LYFO) cohorts. Model performance was assessed using time‐dependent concordance indices (c‐statistic) and calibration with metrics evaluated at 2 years from progression. Note, 1234 of 5112 patients treated with frontline immunochemotherapy in the SEAL consortium developed progressive disease. Time to progression on immunochemotherapy and age at progression were strongly associated with post‐progression OS (both p < 0.001). A prognostic model was developed incorporating spline fit for both variables. The model had good concordance in the discovery (0.67) and validation sets (LYFO c = 0.64, MER c = 0.68) with generally good calibration. Time to progression on frontline therapy is strongly associated with post‐progression OS in DLBCL. We developed and validated a simple to apply clinical prognostic tool in the R/R setting. The useful prediction of expected outcomes in R/R DLBCL and can inform treatment decisions such as considerations for CAR‐T therapy as well as trial designs. The model is available in smartphone‐based point of care applications.

Abstract Study Objective To determine whether there is a drug‐drug interaction precluding the concomitant use of levetiracetam and high‐dose methotrexate (HDMTX). Design Retrospective analysis. Setting Large academic tertiary care medical center. Patients Adult lymphoma patients who received HDMTX as a 4‐h infusion with or without concomitant levetiracetam. Measurements and Main Results Generalized estimating equations clustered on patient were used to assess each outcome. The primary outcome was the incidence of delayed MTX elimination (MTX level >1 µmol/L at 48 h). Secondary outcomes included incidence of acute kidney injury (AKI) and hospital length of stay (LOS). The 430 included patients receiving 1993 doses of HDMTX had a median (IQR) age of 66 (57.5, 72.6) years, 88 (20.5%) received concomitant levetiracetam with at least one dose of MTX, 267 (62.1%) were male, and 397 (92.3%) were Caucasian. HDMTX doses ranged from 1 to 8 g/m 2 . The most common lymphoma diagnoses were systemic diffuse large B‐cell lymphoma (DLBCL; 58.5%) and systemic DLBCL with central nervous system (CNS) involvement (32.8%). Rates of delayed elimination with and without levetiracetam were 13.4% and 16.3%, respectively (OR = 0.80, 95% CI 0.47–1.34, p = 0.39). AKI occurred in 15.6% and 17.0% of patients with and without concomitant levetiracetam, respectively (OR = 0.83, 95% CI 0.52–1.33, p = 0.28). The median LOS with and without levetiracetam was 4.2 and 4.1 days, respectively ( p = 0.039). On multivariable analyses, only age, body surface area, diagnosis of systemic DLBCL with CNS involvement, serum creatinine, hemoglobin, total bilirubin, and dose of HDMTX were associated with delayed elimination. Conclusions High‐dose methotrexate administered with concomitant levetiracetam was not associated with increased risk for delayed MTX elimination or AKI. These results support that levetiracetam and HDMTX are safe for coadministration.