scholarly journals PCN151 IMPACT OF ADVERSE EVENTS (AES) ON HEALTHCARE RESOURCE UTILIZATION (HRU) AND TOTAL COSTS OF CARE (TCOC) AMONG PATIENTS WITH LARGE B-CELL LYMPHOMA (LBCL)

2020 ◽  
Vol 23 ◽  
pp. S49
Author(s):  
A. McBride ◽  
M. Tian ◽  
M.P. Jun ◽  
C. Pelletier ◽  
A. Powers
Keyword(s):  
Adverse Events ◽  
B Cell ◽  
Resource Utilization ◽  
Healthcare Resource ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Healthcare Resource Utilization ◽  
Costs Of Care ◽  
Large B Cell Lymphoma ◽  
Large B Cell

scholarly journals Burden of illness and outcomes in second-line large B-cell lymphoma treatment: real-world analysis of Medicare beneficiaries

2021 ◽  
Author(s):  
Karl M Kilgore ◽  
Iman Mohammadi ◽  
Anny C Wong ◽  
Julia T Snider ◽  
Paul Cheng ◽  
...  
Keyword(s):  
B Cell ◽  
Stem Cell Transplant ◽  
Healthcare Resource ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Healthcare Resource Utilization ◽  
Cell Transplant ◽  
Second Line ◽  
Large B Cell Lymphoma ◽  
Large B Cell

Aims: To characterize elderly large B-cell lymphoma patients who progress to second-line treatment to identify potential unmet treatment needs. Patients & methods: Retrospective USA cohort study, patients receiving second-line autologous stem cell transplant (SCT) preparative regimen (‘ASCT-intended’) versus those who did not; stratified further into those who received a stem cell transplant and those who did not. Primary outcomes were: healthcare resource utilization, costs and adverse events. Results: 1045 patients (22.0%) were included in the ASCT-intended group, 23.3% of whom received SCT (5.1% of entire second-line population). Non-SCT patients were older and had more comorbidities and generally higher rates of healthcare resource utilization and costs. Conclusion: Elderly second-line large B-cell lymphoma patients incurred substantial costs and a minority received potentially curative SCT, suggesting significant unmet need.

Weekly Four Times Rituximab Consolidation Following Reduced Cycles Of R-CHOP Induction Chemotherapy In Extremely Elderly Patients With Diffuse Large B Cell Lymphoma

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3031-3031
Author(s):  
Deok-Hwan Yang ◽  
Won Seog Kim ◽  
Young-Rok Do ◽  
Sung Yong Oh ◽  
Min Kyoung Kim ◽  
...  
Keyword(s):  
Partial Response ◽  
Adverse Events ◽  
Elderly Patients ◽  
B Cell ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Concomitant Disease ◽  
Chop Regimen ◽  
Large B Cell Lymphoma ◽  
Large B Cell

Abstract Purpose Poor outcome of patients with elderly diffuse large B-cell lymphoma (DLBCL) has been linked to their decreased ability to receive full course of R-CHOP, dose-reduction of chemotherapy due to toxicities and their concomitant disease to interrupt the treatment. Recently, several studies suggested that attenuated R-CHOP regimen or reduced cycles of R-CHOP showed the survival benefit along with good tolerability and safety for very elderly patients. The study is aimed to determine objective response, toxicitiy and clinical outcome of weekly four times rituximab augmentation after reduced cycles of R-CHOP in extremely elderly patients with DLBCL. Patients and Methods Prospective, multi-institutional phase II trial was conducted for patients with previously untreated CD20+ diffuse large B cell lymphoma who aged more than 70 years and achieved complete or partial response after 4th R-CHOP chemotherapy (NCT01181999). R-CHOP was infused every 21 days, with initial dose-intensity of CHOP regimen was modulated according to Charlson Comorbidity Index (CCI). If patients were with CCI <1, patients were treated with standard dose of CHOP, however, if patients with CCI °Ã1, patients were with 75% of conventional dose initially. Rituximab consolidation (375mg/m2) was treated weekly four times, at the time of full recovery after 4th R-CHOP. Trimethoprim/sulfamethoxasole (160mg/800mg, 1T orally) was given daily during rituximab consolidation. Response assessment based on Revised International Workshop Criteria was evaluated at the completion of the fourth R-CHOP, after rituximab consolidation and whenever disease progression is suspected. Results 51 DLBCL patients were enrolled from 14 institutes between June 2010 and April 2013. Median age was 76 years (range: 70-89) and 35.3% patients had more than 2 concomitant chronic disease. 36 out of 51 patients could be proceeded toward weekly four times rituximab consolidation. High treatment-related mortality (13.7%) during R-CHOP was huddle to proceeding to consolidation treatment. 35 patients (68.6%) presented with high-intermediate or high risk based on IPI and 12 patients (23.5%) were classified with a score of 2 by Glasgow prognostic score (GPS). After a median follow-up of 18.6 months, overall response rate was 70.6% with 66.7% of complete response and 3.9% of partial response. 31 patients (60.8%) were started with decreased dose of CHOP with median 75% reduction of CHOP (range; 50-100%). 2-year probability of progression-free survival (PFS) was 71.5 ±7.9% with 10 relapses. GPS based on systemic inflammatory indicators was a useful prognostic indicator for PFS compared to IPI. The adverse events were mainly related with hematologic toxicities and neutropenic infections during R-CHOP. However, no toxicities were reported associated with rituximab weekly infusion and no adverse events related with delayed infection after rituximab consolidation. Conclusions Rituximab consolidation after reduced cycles of R-CHOP resulted in a favorable response with high tolerability. Debulking R-CHOP and followed by weekly rituximab consolidation could be a good compromise between efficacy and tolerability for extremely elderly DLBCL Disclosures: No relevant conflicts of interest to declare.

Comparison of salvage therapies for relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Network meta-analysis.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19037-e19037 ◽  
Author(s):  
Venkata Vosuri ◽  
Ravi Kaisreddy ◽  
Somasekhar Bandi
Keyword(s):  
Adverse Events ◽  
B Cell ◽  
Cell Lymphoma ◽  
Meta Analysis ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
High Dose ◽  
Large B Cell Lymphoma ◽  
High Dose Cytarabine ◽  
Large B Cell

e19037 Background: Salvage chemotherapy followed by autologous stem cell transplantation(ASCT) is the standard second-line treatment for relapsed or refractory diffuse large b-cell lymphoma(DLBCL). Rituximab plus ifosfamide, carboplatin, and etoposide(R-ICE) and rituximab plus dexamethasone, high dose cytarabine, cisplatin(R-DHAP) are the two widely used regimens worldwide but quest for optimal regimen continues. Our objective is to compare currently available salvage therapies based on complete response and adverse events. Methods: Pubmed, EMBASE and Clinicaltrials.gov were queried for salvage therapies in relapsed or refractory DLBCL. Only randomized clinical trials including phase 2 and 3 trials involving salvage therapies for relapsed or refractory DLBCL were selected. Data was extracted based on meta-analysis guidelines by two independent reviewers. Network meta-analyses of treatment effects and adverse outcomes were calculated with a frequentist approach. Results: Overall, 5 studies(1480 patients) were included. The salvage therapies investigated were rituximab plus ifosfamide, carboplatin, and etoposide(R-ICE), rituximab plus dexamethasone, high dose cytarabine, cisplatin(R-DHAP), rituximab plus gemcitabine, dexamethasone, cisplatin(R-GDP), ofatumumab plus dexamethasone, cytarabine, and cisplatin(O-DHAP), ifosfamide plus ofatumunab, carboplatin, and etoposide(O-ICE), dacetuzumab plus rituximab, ifosfamide, carboplatin and etoposide(DR-ICE). Of the 6 regimens in the network, treatment with R-DHAP (OR:0.36,95%CI:0.24-0.54), R-GDP(OR:0.37,95%CI: 0.21-0.65), O-ICE(OR:0.16,95%CI: 0.05-0.53), O-DHAP(OR:0.30,95%CI:0.17-0.52), DR-ICE(OR:0.77,95%CI:0.40-1.49) were not superior against network placebo(R-ICE) in achieving complete response. Higher odds of occurring severe adverse events was observed in R-DHAP(OR:2.02,95%CI: 1.35-3.01) and O-DHAP(OR:2.15,95%CI: 1.24-3.72) salvage regimens when compared to R-ICE. Conclusions: R-DHAP, R-GDP, O-ICE and O-DHAP were found to have no difference in treatment effect in achieving complete response in comparison to R-ICE. R-DHAP and O-DHAP are associated with higher number of severe adverse events in comparison with R-ICE. Outcomes mentioned above should be interpreted in the context of drugs and other factors involved in the disease.

scholarly journals IPI, Comorbidity Index, Hospitalization for Treatment-Related Adverse Events Are Predictors for Outcome in Elderly Diffuse Large B Cell Lymphoma Patients

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1860-1860
Author(s):  
Caner Saygin ◽  
Xuefei Jia ◽  
Brian T. Hill ◽  
Robert M. Dean ◽  
Bhumika Patel ◽  
...  
Keyword(s):  
Adverse Events ◽  
B Cell ◽  
Cell Lymphoma ◽  
Performance Status ◽  
Age Groups ◽  
B Cell Lymphoma ◽  
Large B Cell Lymphoma ◽  
Comorbidity Index ◽  
Dose Reductions ◽  
Large B Cell

Abstract Background: International Prognostic Index (IPI) has been used as the primary prognostic tool in diffuse large B cell lymphoma (DLBCL) for more than 20 years. Even though the disease is more common in older population, the impact of comorbidities, dose reductions, and treatment-related adverse events (AEs) on the outcome in elderly DLBCL patients has not been well established. In this study, we aimed to investigate the effect of IPI, clinicopathological features, Charlson Comorbidity Index (CCI), AEs and dose reductions on survival of DLBCL patients aged 60 years or above. Methods: We identified 910 DLBCL patients (pts) treated at Cleveland Clinic between 2004-2014 and this analysis includes 413 pts aged ≥60 years. Patient and disease characteristics and treatment data of pts who received at least one cycle of treatment were analyzed for prognostic significance. CCI was calculated, excluding lymphoma, and patients were divided into low CCI (CCI score of 0-2) or high CCI (≥3). For regression analysis, patients were grouped into good or poor risk based on IPI ≤ 2 vs 3-5. Results: Median age of our cohort was 69 years (range, 60-100), 55% were male, and 91% Caucasian. Pts were divided into 3 age groups; 60-69 yrs (N=217), 70-79 yrs (N=124) and >80 yrs (N=72). Most pts had advanced stage disease (59%), high IPI ≥3 (58%) good performance status (PS) ≤1 (74%), and no B symptoms (31%). 15% had high CCI (≥3) with a trend towards higher incidence in >80 yrs (p=0.05). Our cohort had predominantly germinal center (GC) DLBCL (60%) with low incidence of MYC translocation (28%) among the 89 pts tested. Only median BMI (28%, p=0.007) and performance status (≥2: 27%, p=<0.001) was statistically significant among the age grps. 85% were treated with R-CHOP, 2% received CHOP, and 3% received R-EPOCH. 70% experienced at least one clinically significant AE with infection (34%) and febrile neutropenia (31%) being common. 78% had dose reduced chemo with higher frequency seen in older pts (59% in >80 yrs) (p=<0.001). Overall response rate was 92% with 78% achieving CR and no difference among the groups. Median OS and PFS were 9.6 and 3.8 years respectively with an estimated 10 year OS and PFS of 50% and 30%. In the univariable analysis, IPI (OS: HR 1.7, p=<0.001; PFS: HR 1.39, p=<0.001), ECOG PS (OS: HR 2.94 p=<0.001; PFS: 2.29, p=<0.001), CCI (OS: HR 2.1, p=<0.001; PFS: HR 1.59, p=0.015), LDH ratio (OS:HR 1.53, p=0.008; PFS: HR 1.58, p=<0.001), chemotherapy dose reduction (OS: HR 1.64, p=0.016; PFS: HR 1.45, p=0.029), AE (OS: HR 1.78, p=0.17; PFS: 1.56 p=0.017), and hospitalization (OS: HR 4.01, p-=<0.001; PFS: HR 1.56, p=0.017) predicted inferior OS and PFS. On multivariable analysis, only IPI (HR 1.5, p<0.001), CCI (HR 2.1, p=<0.006) and hospitalization (HR 2.4, p=<0.004) were significant predictors of OS. In addition to CCI (HR 2.0 p=0.013) and hospitalization (HR 2.45 p=<0.001), B symptoms (HR 0.62, p=0.038) was also prognostic for PFS. Among the age groups, adverse risk factors for OS were IPI (HR 1.47, p=0.006) and CCI (HR 1.47, p=0.006) in 60-69 yrs, and hospitalization in 70-79 years (HR 3.42, p=0.009). None of these factors predicted survival in >80 yrs, although there was trend observed with IPI (p=0.058) and PS (0.052). Conclusion: In this single center large cohort of DLBCL pts, higher CCI and hospitalization for AE were significant predictors of decreased OS and PFS, especially in pts aged 60-69 years. Although IPI is predictive, a better prognostic model incorporating comorbidities and treatment toxicities may help to better risk stratify older DLBCL patients. Figure Figure. Disclosures Smith: Spectrum: Honoraria; Abbvie: Research Funding; Genentech: Honoraria; Celgene: Honoraria.

Blinatumomab Monotherapy Shows Efficacy in Patients with Relapsed Diffuse Large B Cell Lymphoma

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1637-1637 ◽  
Author(s):  
Andreas Viardot ◽  
Mariele Goebeler ◽  
Richard Noppeney ◽  
Stefan W. Krause ◽  
Stefan Kallert ◽  
...  
Keyword(s):  
Adverse Events ◽  
B Cell ◽  
Phase Ii ◽  
Research Funding ◽  
Cell Lymphoma ◽  
B Cell Lymphoma ◽  
Employment Equity ◽  
Large B Cell Lymphoma ◽  
Equity Ownership ◽  
Large B Cell

Abstract Abstract 1637 Blinatumomab (MT103) is a single-chain bispecific antibody construct with specificity for CD19 and CD3 belonging to the class of bispecific T cell engager (BiTE®). A phase I trial with indolent and mantle cell lymphoma patients established a maximal tolerable dose (MTD) at 60 μg/m2/d. The trial was subsequently amended to evaluate blinatumomab in patients with diffuse large B cell lymphoma (DLBCL). Patients were treated by 4–8-week continuous i.v. administration with the following dosing regimen: first week at 5 μg/m2/d, second week at 15 μg/m2/d and for the remaining treatment period at 60 μg/m2/d. Two cohorts each with 6 DLBCL patients were enrolled. The two cohorts solely differed by the dose and schedule of corticosteroid medication administered at the beginning of blinatumomab infusion for mitigation of adverse events. In the first cohort 100 mg prednisolone was applied 1 hour prior to start; and in the second cohort patients received dexamethasone on days 1, 2, and 3. Three sequential patients received dexamethasone also 6–12 hours prior to start of infusion. Out of the twelve patients, 5 were male and 7 female. The median age was 57 years (range from 26 to 78 years). Patients had received a median of 4 prior regimens (range from 2–6). All patients had been exposed to rituximab. Eight of the 12 patients had undergone autologous stem cell transplantation (ASCT). International prognostic index (IPI) at screening ranged from 1 to 3 with a median of 2. The most common clinical adverse events (AEs) regardless of causality (>30%) were pyrexia (81.8%), fatigue (54.5%), constipation (36.4%), headache (36.4%), tremor (36.4%) and weight increase (36.4%). The most frequent laboratory AEs regardless of causality (>30%) were hyperglycemia (63.6%), lymphopenia (54.5%), C-reactive protein increase (45.5%), gamma-glutamyltransferase increase (45.5%) and thrombocytopenia (36.4%). Most AEs occurred early and were reversible. Four of 12 patients discontinued infusion due to fully reversible CNS events, 2 of which qualified as dose limiting toxicities (DLTs). Although just one DLT (reversible CNS event grade 3) occurred in the prednisolone cohort, a further cohort applying prophylactic dexamethasone was opened to optimize management of CNS events. A further refinement of the dexamethasone schedule, starting longer time prior to start of blinatumomab, was introduced after one early patient in the cohort receiving dexamethasone had experienced a reversible CNS event leading to discontinuation. All three patients treated in this manner completed the first blinatumomab cycle without discontinuations. Only one showed a grade 1 tremor, and no other CNS AEs were reported in these three patients. Two of 12 patients were not exposed to 60 μg/m2/d due to early discontinuations and 1 patient is too early in treatment for response evaluation. Five out of the remaining 9 evaluable patients (56%) showed objective clinical responses (4 CR/CRu; 1 PR). Three out of the 5 patients with CR/CRu or PR had prior ASCT. Two patients achieved objective responses (1 CR, 1 PR) despite of discontinuation at 60 μg/m2/d. The median response duration is +182 days (longest current duration +428 days), with 4 out of 5 responses still ongoing. Further evaluation of the last cohort will refine the recommended phase II dose, and the intensity and timing of dexamethasone comedication. The observation of lasting CRs after blinatumomab monotherapy in DLBCL patients is promising and warrants further exploration in a phase II study. Disclosures: Krause: Micromet: Research Funding. Mackensen:Micromet Inc.: Research Funding. Topp:Micromet: Consultancy, Honoraria. Scheele:Micromet Inc.: Employment, Equity Ownership, Patents & Royalties. Nagorsen:Micromet Inc.: Employment, Equity Ownership, Patents & Royalties. Zugmaier:Micromet: Employment. Degenhard:Micromet Inc: Employment. Schmidt:Micromet AG: Employment. Kufer:Micromet Inc: Employment, Equity Ownership. Libicher:Micromet Inc.: Consultancy, Honoraria. Bargou:Micromet: Consultancy, Honoraria.

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