Pegfilgrastim and Daily Granulocyte Colony-Stimulating Factor (G-CSF) Patterns of Use and Neutropenia-Related Outcomes in Cancer Patients in Spain: Results of the Learn Study.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4263-4263
Author(s):  
D. Almenar ◽  
J. Mayans ◽  
O. Juan ◽  
J.M. García Bueno ◽  
Ji Jalón ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Dose Reduction ◽  
Cancer Patients ◽  
Primary Prophylaxis ◽  
Antibiotic Consumption ◽  
Secondary Prophylaxis ◽  
Duration Of Treatment ◽  
Patterns Of Use ◽  
Treatment Use ◽  
Dose Delay

Abstract Background: Daily G-CSFs(Filgrastim, lenograstim) are widely used to reduce duration of chemotherapy-induced neutropenia(CIN) and incidence of febrile neutropenia(FN) in cancer patients(pts). Data on their patterns of use and effectiveness in routine clinical practice are however limited. The introduction of the once-per-cycle G-CSF pegfilgrastim(Neulasta®) in Spain in 2003 may have changed patterns of use of daily G-CSFs and CIN-related outcomes. Methods: Multicentre, retrospective, observational study of daily G-CSF and pegfilgrastim patterns of use and outcomes in adult subjects with non-myeloid malignancies receiving myelosuppressive chemotherapy(CT). Consecutive patient medical records with documented use of daily G-CSF or pegfilgrastim were abstracted from 10 Spanish centers during 2003. Endpoints: percentage of proactive(primary prophylaxis) vs reactive(secondary prophylaxis/treatment) use of G-CSFs, duration of treatment with G-CSF, and CIN-related outcomes(dose delay, dose reduction, incidence of FN, hospitalization and antibiotic consumption). Results: 248 charts documented pegfilgrastim or daily G-CSF use; 75 pts received pegfilgrastim only; 111 pts received daily G-CSF only(99 Filgrastim, 12 lenograstim); 62 pts received both daily G-CSF and pegfilgrastim during their CT(data not shown). Most common tumor types were lung(25%), breast(20%), malignant lymphomas(20%). Pattern of use (% pts on primary or secondary prophylaxis, or treatment at any time during CT) was:pegfilgrastim(39%,48%,17%, respectively) vs daily G-CSF(40%,48%,30%, respectively). Median number of injections/cycle in the daily G-CSF group was 6 (range 1–13) in primary prophylaxis, and 5 (range 1–11) in secondary prophylaxis and treatment. CIN-related outcomes are shown in the table below. Conclusions: Patterns of use of daily G-CSFs and pegfilgrastim were similar for primary and secondary prophylaxis, but a potential trend to less frequent treatment use in the pegfilgrastim group was observed. CIN-related complications, including incidence of FN, were observed to be lower in pts receiving pegfilgrastim. CT-related complications% pts (95% CI) Pegfilgrastim(n=75) Daily G-CSF(n=111) Dose Delay 44% (33; 55) 46% (36; 55) Dose Reduction 14.7% (8.2; 24.6) 20.7% (14.2; 29.2) Dose Reduction due to Neutropenia 6.7% (2.5; 15.0) 20.7% (14.1; 29.2) Febrile Neutropenia (FN) 10.7% (5.3; 19.9) 24.3% (17.2; 33.1) Hospitalization due to FN 9.3% (4.3; 18.3) 19.8% (13.4; 28.3) Antibiotic Consumption due to FN 8.0% (3.4; 16.7) 17.1% (11.2; 25.3)

Economic analysis of prophylactic granulocyte colony-stimulating factor (G-CSF) use based on a risk model for neutropenic complications in breast cancer patients receiving adjuvant chemotherapy

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6107-6107 ◽  
Author(s):  
D. C. Dale ◽  
L. E. Cosler ◽  
D. A. Wolff ◽  
E. Culakova ◽  
M. S. Poniewierski ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Febrile Neutropenia ◽  
Cancer Patients ◽  
Lower Cost ◽  
Risk Model ◽  
Primary Prophylaxis ◽  
Secondary Prophylaxis ◽  
Breast Cancer Patients ◽  
Expected Cost

6107 Background: Although recent economic analyses of prophylactic G-CSF provide cost saving febrile neutropenia (FN) risk estimates of approximately 20%, many regimens have reported rates <20%. A prospective nationwide cohort study was undertaken to develop risk models for neutropenic complications (NC) including severe and febrile neutropenia in patients receiving cancer chemotherapy (Lyman ASCO 2005). A cost-effectiveness model is presented to evaluate the economic impact of G-CSF prophylaxis based on the model. Methods: Data on 974 consecutive breast cancer patients receiving adjuvant chemotherapy at 115 randomly selected practice sites were analyzed. The clinical and cost impact of G-CSF prophylaxis in high-risk patients based on the model was compared with: 1) no G-CSF; 2) primary prophylaxis; and 3) secondary prophylaxis. Pegfilgrastim costs were based on Medicare pricing while hospitalization costs and mortality on national hospitalization data. Results: Independent predictors of first cycle NC included: type and schedule of chemotherapy, diabetes, elevated bilirubin, planned RDI >85%, low glomerular filtration rate and low neutrophil count. Prophylactic G-CSF was associated with a decreased risk. Model R2=0.327 and c-statistic=0.80 [95% CI: 0.78–0.83; P<.001]. At a baseline FN risk of 8.4% per cycle, the expected costs over four cycles of chemotherapy were: no pegfilgrastim: $1,285; primary prophylaxis: $2,573; secondary prophylaxis: $2,040 and model-targeted G-CSF: $1,527. Expected cost varied with FN risk and model performance. Primary prophylaxis was associated with lower cost than no prophylaxis at FN risk >18%, while the model outperformed both strategies at an FN risk >10%. At a baseline cycle risk of FN of 8.4%, model-guided G-CSF was associated with an expected cost of $44,980 per life saved. Cost savings increased as model discrimination increased. The model was consistently associated with lower cost compared to secondary prophylaxis. Conclusions: A risk model for NC has been developed in breast cancer patients receiving adjuvant chemotherapy. Use of the model to guide G-CSF support appears to be cost-effective at an overall FN risk of 10%. [Table: see text]

Prophylaxis in people with haemophilia

2009 ◽  
Vol 101 (04) ◽  
pp. 674-681 ◽  
Author(s):  
Massimo Franchini ◽  
Annarita Tagliaferri ◽  
Antonio Coppola
Keyword(s):  
Quality Of Life ◽  
Cost Benefit ◽  
Primary Prophylaxis ◽  
Secondary Prophylaxis ◽  
Severe Haemophilia ◽  
Duration Of Treatment ◽  
First Choice ◽  
Long Term Treatment

SummaryA four-decade clinical experience and recent evidence from randomised controlled studies definitively recognised primary prophylaxis, i.e. the regular infusion of factor concentrates started after the first haemarthrosis and/or before the age of two years, as the first-choice treatment in children with severe haemophilia. The available data clearly show that preventing bleeding since an early age enables to avoid or reduce the clinical impact of muscle-skeletal impairment from haemophilic arthropathy and the related consequences in psycho-social development and quality of life of these patients. In this respect, the aim of secondary prophylaxis, defined as regular long-term treatment started after the age of two years or after two or more joint bleeds, is to avoid (or delay) the progression of arthropathy. The clinical benefits of secondary prophylaxis have been less extensively studied, especially in adolescents and adults; also in the latter better outcomes and quality of life for earlier treatment have been reported. This review summarises evidence from literature and current clinical strategies for prophylactic treatment in patients with severe haemophilia, also focusing on challenges and open issues (optimal regimen and implementation, duration of treatment, long-term adherence and outcomes, cost-benefit ratios) in this setting.

scholarly journals Pegfilgrastim for primary prophylaxis of febrile neutropenia in multiple myeloma

2021 ◽  
Author(s):  
Claudio Cerchione ◽  
Davide Nappi ◽  
Giovanni Martinelli
Keyword(s):  
Multiple Myeloma ◽  
Febrile Neutropenia ◽  
Supportive Care ◽  
Survival Rates ◽  
Primary Prophylaxis ◽  
Secondary Prophylaxis ◽  
Novel Agents ◽  
Severe Side Effect ◽  
Maximum Benefit ◽  
Long Acting

AbstractMultiple myeloma (MM) survival rates have been substantially increased thanks to novel agents that have improved survival outcomes and shown better tolerability than treatments of earlier years. These new agents include immunomodulating imide drugs (IMiD) thalidomide and lenalidomide, the proteasome inhibitor bortezomib (PI), recently followed by new generation IMID pomalidomide, monoclonal antibodies daratumumab and elotuzumab, and next generation PI carfilzomib and ixazomib. However, even in this more promising scenario, febrile neutropenia remains a severe side effect of antineoplastic therapies and can lead to a delay and/or dose reduction in subsequent cycles. Supportive care has thus become key in helping patients to obtain the maximum benefit from novel agents. Filgrastim is a human recombinant subcutaneous preparation of G-CSF, largely adopted in hematological supportive care as “on demand” (or secondary) prophylaxis to recovery from neutropenia and its infectious consequences during anti-myeloma treatment. On the contrary, pegfilgrastim is a pegylated long-acting recombinant form of granulocyte colony-stimulating factor (G-CSF) that, given its extended half-life, can be particularly useful when adopted as “primary prophylaxis,” therefore before the onset of neutropenia, along chemotherapy treatment in multiple myeloma patients. There is no direct comparison between the two G-CSF delivery modalities. In this review, we compare data on the two administrations’ modality, highlighting the efficacy of the secondary prophylaxis over multiple myeloma treatment. Advantage of pegfilgrastim could be as follows: the fixed administration rather than multiple injections, reduction in neutropenia and febrile neutropenia rates, and, finally, a cost-effectiveness advantage.

scholarly journals A Phase IV Clinical Trial of Patients with Solid Tumors Receiving Lenograstim as Primary Prophylaxis for Chemotherapy-Induced Neutropenia, in a Docetaxel-Based Regimen

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Samuel J. Fourie ◽  
Alicia McMaster ◽  
Rashem Mothilal ◽  
Keith I. Maart
Keyword(s):  
Febrile Neutropenia ◽  
Solid Tumors ◽  
Primary Prophylaxis ◽  
Duration Of Treatment ◽  
Open Label ◽  
Recurrence Rates ◽  
Optimal Dosing ◽  
Grade 3 ◽  
African Patients ◽  
Phase Iv

Docetaxel-based chemotherapy regimens have substantially improved survival and recurrence rates for cancer patients. Safety profile of docetaxel regimens includes toxicities, particularly a high risk of neutropenia and febrile neutropenia. Granotax was a prospective, open label, multicentre, national phase IV study that evaluated the incidence and severity of neutropenia in adult patients with solid tumors being treated with a docetaxel-based regimen while receiving the GCSF lenograstim. Among the 394 enrolled patients the incidence of grade 3-4 neutropenia was 16.2% and of febrile neutropenia was 1.5%, far lower than the reported 85–100% and 30–40% incidence without G-CSFs. A total of 68 patients (17.3%) were reported to have experienced at least one grade 3-4 adverse event during the study. Two (0.5%) patients and 32 (8.1%) patients had dose delayed due to febrile neutropenia and neutropenia, respectively. Four (1.0%) patients and 32 (8.1%) patients had a dose changed due to febrile neutropenia and neutropenia, respectively. The low incidence of adverse effects and chemotherapy dose changes, delays, and withdrawals supports the use of lenograstim as effective primary prophylaxis in South African patients being treated with a docetaxel-based regimen. Furthermore, lenograstim may increase the patient’s exposure to chemotherapy allowing patients to receive optimal dosing and duration of treatment, benefitting survival.

scholarly journals Outcomes of Primary and Secondary Prophylaxis of Chemotherapy Induced and Febrile Neutropenia (CIN/FN) in Bendamustine Plus Rituximab (BR) Regimens in Patients with Lymphoma and Chronic Lymphocytic Leukemia (CLL): Real-World, Single-Center Experience

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5353-5353
Author(s):  
Logan Moore ◽  
Trace Bartels ◽  
Daniel O. Persky ◽  
Abhijeet Kumar ◽  
Ivo Abraham ◽  
...  
Keyword(s):  
Febrile Neutropenia ◽  
Treatment Outcomes ◽  
Real World ◽  
Data Monitoring Committee ◽  
Primary Prophylaxis ◽  
Secondary Prophylaxis ◽  
Data Monitoring ◽  
Independent Data ◽  
Single Center ◽  
Monitoring Committee

Introduction: Granulocyte stimulating growth factors (G-CSF) such as filgrastim or pegfilgrastim are indicated as prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). BR regimen is considered an intermediate FN risk (10-20%) per National Comprehensive Cancer Network guidelines. Therefore, patients receiving BR need to be assessed using patient specific risk factors to evaluate the need for primary prophylaxis. This study evaluates real-world patterns and outcomes associated with primary and secondary G-CSF prophylaxis in patients with B-cell lymphoma and CLL treated with BR. Methods: Retrospective chart review of all lymphoma or CLL patients treated with BR from 11/2013 through 6/2019 at the University of Arizona Cancer Center was conducted. Baseline demographic and chemotherapy cycle data was analyzed through Chi-Squared test and Unpaired t-test with a-priori p-value of 0.05 being considered statistically significant. Results: Eighty-five patients met inclusion criteria. Of these, 48 received G-CSF during all chemotherapy cycles for primary prophylaxis while 37 received G-CSF only for secondary prophylaxis. Same-day pegfilgrastim compared to next-day pegfilgrastim or filgrastim was the most common G-CSF dosing utilized with primary and secondary prophylaxis patients receiving it (87.5%, 94.6%) respectively. As shown in Table, primary and secondary prophylaxis groups were similar on baseline characteristics (p>0.05); the primary outcome of FN (p>0.05); all secondary outcomes (p>0.05) except for a higher frequency of dose delays in secondary (37.8%) vs primary prophylaxis patients (14.6%; p=0.01); and mean absolute neutrophil counts (ANC) in all cycles (p>0.05) except for cycles 3 and 5. Higher ANC levels were found in primary prophylaxis patients (4.06+0.43) vs secondary prophylaxis (3.03+0.30; p=0.03) for cycle 3 and (3.57+0.25) vs (2.88+0.26; p=0.03) for cycle 5. Conclusion: In this single-center retrospective study, BR-treated lymphoma and CLL patients receiving primary vs secondary with G-CSF showed similar outcomes except, notably, for chemotherapy dose delays that may put secondary patients at risk for poor treatment outcomes. Further research is needed to evaluate the impact of primary vs secondary prophylaxis on chemotherapy treatment outcomes. Table Disclosures Persky: Sandoz: Consultancy; Debiopharm: Other: Member, Independent Data Monitoring Committee; Bayer: Consultancy; Morphosys: Other: Member, Independent Data Monitoring Committee. McBride:Sanofi Genzyme: Consultancy; Sandoz: Consultancy; teva: Consultancy.

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