scholarly journals Cost Simulation for Febrile Neutropenia Hospitalization in the US Due to Pegfilgrastim on-Body Injector Failure Compared to Single-Injection Pegfilgrastim and Daily Injections with Reference and Biosimilar Filgrastim in Non-Hodgkin Lymphoma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2251-2251
Author(s):  
Ali McBride ◽  
Andriy Krendyukov ◽  
Nicola Mathieson ◽  
Kim Campbell ◽  
Sanjeev Balu ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Hodgkin Lymphoma ◽  
Failure Rate ◽  
Real World ◽  
Single Injection ◽  
Daily Injection ◽  
Failure Rates ◽  
Device Failure ◽  
Non Hodgkin Lymphoma ◽  
Number Of Patients

Abstract Introduction: Failure rates ranging from 1.7-3.8% of the pegfilgrastim on-body injector (PEG-OBI) device have been reported (Joshi, Curr Med Res Opin 2017; Stuessy, J Clin Onc 2017; Mahler, Clin J Onc Nurs 2017). Failures may increase the risk of chemotherapy-induced febrile neutropenia (FN) and FN-related hospitalizations (FN-HOSP) beyond the FN and FN-HOSP rates for prophylaxis with single-injection pegfilgrastim (PEG) or daily injections of reference (REF-FIL) or Sandoz filgrastim biosimilar (BIOSIM-FIL). We aimed to estimate for a US panel of 10,000 patients with non-Hodgkin lymphoma (NHL) the total incremental costs of PEG-OBI prophylaxis and incremental FN-HOSP costs at different PEG-OBI failure rates versus (vs) assured prophylaxis administration with PEG, REF-FIL, or BIOSIM-FIL. Methods: Simulation analysis from a US payer perspective of the total incremental prophylaxis costs associated with PEG-OBI failure rates of 1-5% compared to assured prophylaxis administration with PEG, REF-FIL, and BIOSIM-FIL in chemotherapy cycle 1 for a panel of 10,000 NHL patients. Filgrastim daily injection regimens included real-world durations of 5 (Gascón, Support Care Cancer 2016) and 6.5 days (Weycker, Ann Pharmacother 2006) and standard 11 days, all clinician-administered. Differential base rates of FN-HOSP (rate of FN-HOSP without colony-stimulating factor [CSF] minus rate with CSF) in NHL patients was computed for two chemotherapy regimens: 1) cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) (Chrischilles, Cancer Control 2002; 13.25% with CSF, 23.28% without), and 2) CHOP or cyclophosphamide, mitoxantrone, vincristine and prednisone (CNOP) (Osby, Blood 2003; 33.0% with CSF, 50.0% without). Costs (US$) were based on 1Q2018 average selling price for drugs and 2018 Current Procedural Terminology reimbursement for administration. FN-HOSP costs in 2012 of $25,676 per episode for NHL patients (Tai, J Oncol Pract 2017) were adjusted per the Consumer Price Index for Medical Care to $29,938.63 for 2018. Results: Table 1 (Chrischilles; CHOP) and Table 2 (Osby; CHOP/CNOP) present, for PEG-OBI failures rates of 0.01-0.05, the incremental number of patients at risk for FN-HOSP and associated incremental costs; and total incremental costs of PEG-OBI prophylaxis over the costs of assured prophylaxis administration with other CSFs in CTX cycle 1 for a panel of 10,000 NHL patients. Except for one scenario (savings of $72,916 at 0.1 failure rate due to the lower PEG-OBI administration costs), all scenarios showed incremental costs associated with PEG-OBI prophylaxis and failures of the PEG-OBI device (Tables 1 and 2). Per Chrischilles rates, in a panel of 10,000 NHL patients, incremental FN-HOSP costs due to PEG-OBI device failure ranged from $300,284 (at 0.01 failure rate) to $1,501,422 (at 0.05 failure rate). Total incremental costs of PEG-OBI over PEG ranged from $227,369 to $1,128,222. Total incremental costs of PEG-OBI over REF-FIL ranged from $6,794,984 to $28,859,922; and over BIOSIM-FIL from $19,004,984 to $34,409,922. Per the Osby rates, in a panel of 10,000 NHL patients, incremental FN-HOSP costs due to PEG-OBI device failure ranged from $508,957 to $2,544,784. Total incremental costs of PEG-OBI over PEG ranged from $135,757 to $2,171,584; over REF-FIL from $7,003,657 to $29,903,284; and over BIOSIM-FIL from $19,213,657 to $35,453,284. Conclusions: In this simulation of NHL patients treated with CHOP or CNOP, the total incremental costs of PEG-OBI prophylaxis vs assured prophylaxis administration with other CSFs vary as a function of PEG-OBI failure rates, baseline and failure-associated FN-HOSP risk, and the alternative CSF prophylaxis option. Incremental costs of PEG-OBI prophylaxis and failure are lowest vs PEG and highest vs BIOSIM-FIL at real-world duration of 5 days. Disclosures Krendyukov: Sandoz: Employment. Mathieson:Sandoz: Employment. Campbell:Sandoz Inc.: Employment. Balu:Sandoz Inc.: Employment. MacDonald:Sandoz: Consultancy. Abraham:Sandoz: Consultancy.

scholarly journals Modeling the Epidemiology of Indolent Non-Hodgkin Lymphoma (iNHL) in France

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5371-5371
Author(s):  
Xavier Troussard ◽  
Alain Herrera ◽  
Edouard Cornet ◽  
Philippe Solal-Céligny
Keyword(s):  
Hodgkin Lymphoma ◽  
Real World ◽  
Economic Model ◽  
Disease Incidence ◽  
Newly Diagnosed ◽  
Need For Treatment ◽  
Modeling Approach ◽  
Non Hodgkin Lymphoma ◽  
Therapeutic Algorithms ◽  
Number Of Patients

Abstract As of 2014, there were few reliable publication sources of epidemiology data for Non-Hodgkin Lymphoma (NHL) in France, particularly with regard to indolent forms such as Follicular Lymphoma (FL), Waldenström Macroglobulinemia (WM) and Marginal Zone Lymphoma (MZL). In addition, epidemiology registries provide useful data on disease incidence but no information can be directly obtained on the number of relapsed patients, especially in the rare iNHL subtypes. At the same time, many new and effective drugs will be made available to the Hematologist/Oncologist community. As a consequence, there will be an increase in the complexity of therapeutic algorithms. We undertook an innovative modeling approach to address the need for a greater understanding of the number of relapsed patients available to these new therapies. The objective of the model was to determine the yearly incidence of first line and later lines of therapy patients from 2014 to 2018 and in consequence, provide relevant data to determine precisely which population might be in need for the new compounds and bring accurate data that could be implemented into a prospective economic model. First, we used the “Registre Régional des Hémopathies Malignes de Basse-Normandie” (RRHMBN) to collect real world patient characteristics, such as patient subgroups and tumor staging. The RRHMBN is dedicated to Hematological malignancies and supported by official Health Authorities: “Institut National du Cancer“(INCA) and “Institut National de Veille Sanitaire” (INVS). Then, we applied these data to the French National Network of Registers “FRANCIM” incidence and survival data (table 1 below). Table 1 Yearly number of patients newly diagnosed Table 1. Yearly number of patients newly diagnosed Finally, we applied the results from medical literature to progression free survival for each standard of care treatment in our epidemiological model. The table below shows yearly the number of patients in need for treatment in first and subsequent lines of therapy as produced by our model. Table 2 Yearly number of patients in need for treatment in first and subsequent lines Table 2. Yearly number of patients in need for treatment in first and subsequent lines Our modeling approach compensates for a lack of real world information on relapsed iNHL. We have shown that there is a significant number of relapsed patients who are in need of new treatments in France. The model is able to answer the question of how many patients are in need of novel therapies in later lines through 2018 and provide for iNHL investigators efficient prospective data that can be integrated into medico-economic model development. Furthermore, these data address a current medical need for the development of a new iNHL algorithm, necessitated by the expected arrival of new treatment options for patients in the relapsed setting. Disclosures No relevant conflicts of interest to declare.

Initial experience of TAS-102 chemotherapy in Australian patients with chemorefractory metastatic colorectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 71-71
Author(s):  
Azim Jalali ◽  
Hui-Li Wong ◽  
Rachel Wong ◽  
Margaret Lee ◽  
Lucy Gately ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Febrile Neutropenia ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Performance Status ◽  
Progression Free Survival ◽  
Median Number ◽  
Ecog Performance Status ◽  
Number Of Patients

71 Background: For patients with refractory metastatic colorectal cancer (mCRC) treatment with Trifluridine/Tipiracil, also known as TAS-102, improves overall survival. In Australia, TAS-102 was initially made available locally through patients self-funding, later via an industry sponsored Medicine Access Program (MAP) and then via the Pharmaceutical Benefits Scheme (PBS). This study aims to investigate the efficacy and safety of TAS-102 in real world Australian population. Methods: A retrospective analysis of prospectively collected data from the Treatment of Recurrent and Advanced Colorectal Cancer (TRACC) registry was undertaken. The characteristics and outcomes of patients receiving TAS-102 were assessed and compared to all TRACC patients and those enrolled in the registration study (RECOURSE). Results: Across 13 sites, 107 patients were treated with TAS-102 (non-PBS n = 27, PBS n = 80), The median number of patients per site was 7 (range: 1-17). The median age was 60 years (range: 31-83), compared to 67 for all TRACC patients and 63 for RECOURSE. Comparing registry TAS-102 and RECOURSE patients, 75% vs 100% were ECOG performance status 0-1, 74% vs 79% had initiated treatment more than 18 months from diagnosis of metastatic disease and 39% vs 49% were RAS wild type. Median time on treatment was 10.4 weeks (range: 1.7-32). Median clinician assessed progression-free survival was 3.3 compared to RECIST defined PFS of 2 months in RECOURSE study, while median overall survival was the same at 7.1 months. Two patients (2.3%) had febrile neutropenia and there were no treatment-related deaths in the real-world series, where TAS102 dose at treatment initiation was at clinician discretion. In the RECOURSE study there was a 4% febrile neutropenia rate and one treatment-related death. Conclusions: TRACC registry patients treated with TAS102 were younger than both TRACC patients overall and those from the RECOURSE trial. Less strict application of RECIST criteria and less frequent imaging may have contributed to an apparently longer PFS. However overall survival outcomes achieved with TAS102 in real world patients were comparable to findings from this pivotal trial with an acceptable rate of major adverse events.

scholarly journals A Randomized Controlled Clinical Study of Peg-Rhg-CSF for Preventing Chemotherapy-Induced Neutropenia in Patients with B-Cell Non-Hodgkin Lymphoma

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5323-5323
Author(s):  
Changqing Zhen ◽  
Mei Ding ◽  
Kang Lu ◽  
Xueling Ge ◽  
Na Chen ◽  
...  
Keyword(s):  
Clinical Study ◽  
Febrile Neutropenia ◽  
B Cell ◽  
Hodgkin Lymphoma ◽  
Cell Lymphoma ◽  
Study Group ◽  
Randomized Controlled ◽  
Non Hodgkin Lymphoma ◽  
Prophylactic Use ◽  
Controlled Clinical Study

Introduction: B-cell non-Hodgkin lymphoma is the most frequent type of non-Hodgkin's lymphoma. RCHOP regimen is established as the standard therapy for aggressive and indolent B-cell NHL, which has a 10%-20% rate of febrile neutropenia (FN). Recently, pegylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) is frequently used in clinical practice. This randomized controlled clinical study was conducted to investigate the efficacy and safety of prophylactic PEG-rhG-CSF in patients with B-cell non-Hodgkin lymphoma on RCHOP chemotherapy. Methods:We included 162 patients with pathological diagnosis of B-cell non-Hodgkin lymphoma including diffuse large B-cell lymphoma, follicular lymphoma and mantle cell lymphoma (MCL),from October 2016 to May 2019 at Shandong Provincial Hospital Affiliated to Shandong University. All patients gave written informed consent in accordance with the Declaration of Helsinki. The patients were randomized into PEG-rhG-CSF and rhG-CSF groups. Each patient received three cycles of chemotherapy with identical RCHOP regimens. In the study group, the patients received PEG-rhG-CSF 6mg(weight≥45Kg)or 3mg(weight≤45Kg)once 24 hours after the end of chemotherapy drugs of every chemotherapy cycle. In the control group, they weren't preventively administered rhG-CSF. If their neutrophil count (ANC)≤1.0×109/L, they were administered rhG-CSF:5ug/kg/day until their neutrophil count (ANC)≥2.0×109/L. The primary endpoint was the incidence of III/IV grade neutropenia and febrile neutropenia(FN) after each chemotherapy cycle. Meanwhile the rate of antibiotics application and safety were observed. Analyses were performed with SPSS Statistics 20.0 (IBM-SPSS, Chicago, Illinois). The numerical data was presented as mean ± SD. Statistical analysis was performed using one-way analysis of variance and chi-square test. A p-value<0.05 was considered statistically significant. Results: Clinical characteristics for PEG-rhG-CSF and rhG-CSF groups were shown in Table1. There were no significant differences in age, gender,height, body weight, body mass index, Ann Arbor and IPI staging. The incidence of IV grade neutropenia during cycle 1 in 81 evaluable study cycles and 81 evaluable control cycles were 7.41% and 35.80%( P<0.01), with durations of 2.85±0.62 days and 3.11±1.23 days (P>0.05). The differences in I/II/III grade neutropenia between study and control groups weren't statistically significant (Table2,Fig.1). After secondary prophylactic use of PEG-rhG-CSF In the study group, the incidences of III/IV grade neutropenia decreased from 77.78% to 14.81% (P<0.01).Statistically significant differences were observed in the incidences of FN (12.35% and 34.57% for the PEG-rhG-CSF and rhG-CSF groups, respectively; P<0.01) and in the proportion of patients who received antibiotic therapy (11.11% and 37.04%, respectively; P<0.01) during cycle 1(Table2,Fig .2). The safety profiles of PEG-rhG-CSF and rhG-CSF were similar. Bone pain occurred in 7.41% of the cases during the study cycles and 2.47% in the control cycles (P>0.05 ), which were mostly mild or moderate. Patients receiving PEG-rhG-CSF who developed III/IV grade neutropenia were significantly older than those without neutropenia (53.41±14.96 vs. 63.64±4.65;years; p=0.01) (Fig.3).The incidence of III/IV grade neutropenia in patients older than 60 years was significantly higher than that in patients younger than 60 years(24.44% vs. 6.38%; P =0.038). Conclusions: Prophylactic use of PEG-rhG-CSF could effectively reduce the incidences of grade III/IV neutropenia and FN, which ensures that patients with lymphoma receive standard-dose chemotherapy to improve prognosis. III/IV grade neutropenia after prophylactic use of PEG-rhG-CSF were more likely to occur in patients older than 60 years. After the use of PEG-rhG-CSF, the elderly patients should be pay more attention to them. Disclosures No relevant conflicts of interest to declare.

Trends in use of primary prophylactic colony stimulating factors and neutropenia-related hospitalization in commercially insured patients receiving myelosuppressive chemotherapy in the United States: 2005–2017

2020 ◽  
pp. 107815522091577 ◽  
Author(s):  
Jennifer R Schenfeld ◽  
Corina W Bennett ◽  
Shuling Li ◽  
Lucy J DeCosta ◽  
Renee R Jaramillo ◽  
...  
Keyword(s):  
Lung Cancer ◽  
High Risk ◽  
Febrile Neutropenia ◽  
Hodgkin Lymphoma ◽  
Colony Stimulating Factor ◽  
Myelosuppressive Chemotherapy ◽  
Colony Stimulating Factors ◽  
Non Hodgkin Lymphoma ◽  
Insured Patients ◽  
Stimulating Factor

Purpose Describe temporal changes in use of myelosuppressive chemotherapy, primary prophylactic colony-stimulating factor, and neutropenia-related hospitalization, in commercially insured patients. Methods Using a large commercial administrative database, we identified annual cohorts of adult patients diagnosed with breast or lung cancer, or non-Hodgkin lymphoma and initiating myelosuppressive chemotherapy during 2005–2017. We described yearly changes in proportions of myelosuppressive chemotherapy by febrile neutropenia risk category (high, intermediate, unclassified) and proportion of prophylactic colony-stimulating factor use and unadjusted incidence of neutropenia-related hospitalization in the first cycle of myelosuppressive chemotherapy. Results Annual cohorts included 4383–5888 eligible patients during 2005–2017. The proportion of eligible patients aged ≥ 65 years increased from 26.0% in 2005 to 58.2% in 2017. Myelosuppressive chemotherapy use with regimens with high risk for febrile neutropenia increased from 15.1% in 2005 to 31.0% in 2017; and regimens with intermediate risk for febrile neutropenia decreased from 63.7% to 48.1% in 2017. Prophylactic colony-stimulating factor use increased from 41.6% in 2005 to 54.3% in 2017. Crude incidence of neutropenia-related hospitalization for all cancers increased from 2.0% to 3.1%, with a substantial increase in neutropenia-related hospitalization observed among non-Hodgkin lymphoma patients (2.8% to 8.5%) during 2005–2017. Conclusion Among adult patients with breast and lung cancer, and non-Hodgkin lymphoma receiving myelosuppressive chemotherapy, use of regimens with high risk for febrile neutropenia increased, as did the use of prophylactic colony-stimulating factors after 2005. Incidence of neutropenia-related hospitalization increased slightly, particularly among non-Hodgkin lymphoma patients. Further studies are required to understand this increasing trend of neutropenia-related hospitalization, changing patient-level risk factors, and febrile neutropenia management.

scholarly journals A Note on the Failure Rates in Finite Mixed Populations

2012 ◽  
Vol 49 (2) ◽  
pp. 405-415
Author(s):  
Ji Hwan Cha ◽  
Massimiliano Giorgio
Keyword(s):  
Failure Rate ◽  
Real World ◽  
Finite Population ◽  
Mixed Population ◽  
Failure Rates ◽  
Finite Populations ◽  
Modeling And Analysis ◽  
Mixed Populations ◽  
Survival Patterns ◽  
Almost All

Almost all populations existing in the real world are finite populations. Specifically, in the areas relevant to lifetime modeling and analysis, finite populations are frequently encountered. However, descriptions of failure/survival patterns of elements in the finite population have not yet been properly established. In particular, it is questionable whether the ordinary failure rate can be defined for finite populations in the same way and whether the corresponding interpretations are still valid. In this paper we consider two kinds of finite mixed population and provide new definitions for their failure rates. Then we clarify the notion of failure rate in finite populations.

Serum nm23-H1 protein as a prognostic factor in aggressive non-Hodgkin lymphoma

Blood ◽  
2001 ◽  
Vol 97 (5) ◽  
pp. 1202-1210 ◽  
Author(s):  
Nozomi Niitsu ◽  
Junko Okabe-Kado ◽  
Masataka Okamoto ◽  
Toshiyuki Takagi ◽  
Takashi Yoshida ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Hodgkin Lymphoma ◽  
Cell Lymphoma ◽  
Survival Rates ◽  
Interleukin 2 ◽  
Progression Free Survival ◽  
B Cell Lymphoma ◽  
Aggressive Lymphoma ◽  
Non Hodgkin Lymphoma ◽  
Number Of Patients

Advances in chemotherapy have led to a favorable long-term prognosis in approximately 50% of patients with aggressive non-Hodgkin lymphoma (NHL). However, the remaining patients do not enjoy such prolonged survival after standard treatment. New prognostic factors are needed to define this poor-prognosis group and to plan an appropriate treatment strategy. It has been reported that serum nm23-H1 protein may be a new prognostic factor for aggressive NHL. In the present study involving multiple institutions and a large number of patients, the level of nm23-H1 protein was compared among different types of lymphoma; it was lowest for indolent lymphoma, followed by aggressive lymphoma and then highly aggressive lymphoma. In addition, patients with aggressive NHL and higher nm23-H1 levels had worse overall and progression-free survival rates than those with lower nm23-H1 levels. The nm23-H1 level was also compared between patients with diffuse large B-cell lymphoma and patients with peripheral T-cell lymphoma. The results suggest that the level of nm23-H1 could serve as a prognostic factor in both groups. Moreover, the prognosis of lymphoma patients could be ascertained even more precisely by combining soluble interleukin-2 receptor or soluble CD44 and nm23-H1 levels. A multivariate analysis confirmed that the nm23-H1 level is an independent and important prognostic factor in aggressive NHL. Therefore, it may provide useful information for clinicians to determine the appropriate therapy for each type of lymphoma.

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