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 Long-acting granulocyte colony-stimulating factor in primary prophylaxis of early infection in patients with newly diagnosed multiple myeloma

2021 ◽  
Author(s):  
Xinjing Ding ◽  
Jianghua Ding ◽  
Hong Gu ◽  
Chuanxiang Zhong
Keyword(s):  
Multiple Myeloma ◽  
Treatment Group ◽  
Febrile Neutropenia ◽  
Primary Prophylaxis ◽  
Treatment Delay ◽  
Early Infection ◽  
Control Group ◽  
Newly Diagnosed ◽  
Long Acting ◽  
Stimulating Factor

Abstract Purpose This study sought to compare the efficacy of prophylactic long-acting and standard granulocyte colony-stimulating factor (G-CSF) on febrile neutropenia, early infections, and treatment delay in patients with newly diagnosed multiple myeloma receiving the therapeutic regimen of bortezomib, lenalidomide, and dexamethasone (BLD). Methods A prospective study with 68 consecutive patients with multiple myeloma was conducted in three regional hospitals. Participants were randomly treated with the BLD regimen in combination with prophylactic long-acting G-CSF (treatment group) or standard G-CSF (control group). The primary endpoints were the incidence rates of febrile neutropenia, early infection, and treatment delays. The secondary endpoint was clinical outcomes. Results Thirty-three patients were assigned to the treatment group and thirty-five patients were assigned to the control group. The incidence of febrile neutropenia was 6.1% and 17.1% in the treatment and control groups, respectively (p = 0.297). However, the rates of early infection and treatment delay were markedly lower in the treatment group than in the control group (6.1% vs. 25.7% and 9.1% vs. 31.4%; p < 0.05). Notably, all early infections occurred during the first four cycles of BLD therapy, and the most common type of infection was pneumonia. No significant difference in clinical efficacy was found between the two groups. All participants achieved at least partial remission. Conclusions Prophylactic administration of domestic long-acting G-CSF markedly reduced the rates of early infection and treatment delay as compared with standard G-CSF in patients newly diagnosed with multiple myeloma. Notably, all early infections occurred during the first four cycles of BLD therapy. As such, it seems appropriate to administer long-acting G-CSF with the aim of primary prophylaxis of early infection, particularly within the first four courses of chemotherapy in the setting of newly diagnosed multiple myeloma.

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)

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.

Biosimilar medicines in oncology: Single-center experience with biosimilar G-CSF.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19501-e19501
Author(s):  
Nello Salesi ◽  
Barbara Di Cocco ◽  
Enzo Veltri
Keyword(s):  
Febrile Neutropenia ◽  
Locally Advanced ◽  
Cost Savings ◽  
Living Organism ◽  
Primary Prophylaxis ◽  
Prostate Adenocarcinoma ◽  
Secondary Prophylaxis ◽  
Prophylaxis Group ◽  
Single Center Experience ◽  
Platinum Based Chemotherapy

e19501 Background: A biosimilar medicine is one with proven similarity to a reference biological product for which the patent has expired and whose active ingredient is produced or derived from a living organism. Recombinant granulocyte colony-stimulating growth factors (G-CSF) are used for the prophylaxis of febrile neutropenia. Methods: In this observational study a total of 48 patients with solid tumours were treated with biosimilar Zarzio, a new biosimilar G-CSF for 4−14 days from the day following the end of chemotherapy. The primary prophylaxis group was composed of 10 patients with breast carcinoma receiving adjuvant chemotherapy (CEF: 5-fluorouracil 600 mg/m2, epirubicin 100 mg/m2 G1, cyclophosphamide 600 mg/m2 G1, q 21 for 4 cycles à docetaxel 100 mg/m2 G1, q 21); 17 patients with locally advanced or metastatic lung carcinoma (66% adenocarcinoma, 34% squamous) receiving 4–6 cycles of platinum-based chemotherapy; 6 patients with metastatic gastric adenocarcinoma treated with TCF (Taxotere 75 mg/m2, cisplatin 75 mg/m2, 5-fluorouracil 300 mg/m2 by continuous 24 hour infusion for 5 days, q 21) for 4–6 cycles; 4 patients with prostate adenocarcinoma treated with Docetaxel 75 mg/m2 G1, q 21 in 6 cycles. The secondary prophylaxis group was composed of 11 patients with colorectal adenocarcinoma (54.5% treated with adjuvant XELOX therapy: Xeloda 2000 mg/m2 G1à14, oxaliplatin 130 mg/m2 G1, q 21, and the remainder treated with first-line metastatic FOLFOXIRI therapy [CPT-11 165mg/m2 G1, 5-FU 3200 mg/m2 continuous infusion for 48 hours, oxaliplatin 85 mg/m2 G1, q 14]). Results: Three cases of febrile neutropenia were reported: two in patients with prostate adenocarcinoma and one case in a patient with pulmonary squamous cell carcinoma and multiple secondary skeletal lesions. These patients were treated with antibiotics with resolution of the clinical picture without hospitalization after 24 hours. Conclusions: Our experience indicates that the use of biosimilar G-CSF is safe and effective at reducing neutropenic complications in patients with mixed tumors and is associated with cost savings.

Use of Hematopoietic Colony-Stimulating Factors: Comparison of the 1994 and 1997 American Society of Clinical Oncology Surveys Regarding ASCO Clinical Practice Guidelines

1999 ◽  
Vol 17 (11) ◽  
pp. 3676-3681 ◽  
Author(s):  
Charles L. Bennett ◽  
Jane A. Weeks ◽  
Mark R. Somerfield ◽  
Joe Feinglass ◽  
Thomas J. Smith
Keyword(s):  
Febrile Neutropenia ◽  
Clinical Oncology ◽  
Practice Guidelines ◽  
Palliative Therapy ◽  
Lower Lobe ◽  
Primary Prophylaxis ◽  
Secondary Prophylaxis ◽  
Evidence Based ◽  
Clinical Scenarios ◽  
American Society

PURPOSE: The American Society of Clinical Oncology (ASCO) Health Services Research Committee sought to assess whether more appropriate patterns of colony-stimulating factor (CSF) use occurred after the publication of ASCO evidence-based practice guidelines in 1994 and 1996 for patients with solid tumors or lymphoma. METHODS: In 1994 and 1997, questionnaires describing clinical scenarios were mailed to ASCO members who practiced medical oncology. Physicians were asked the extent to which they preferred to use a CSF for primary prophylaxis, secondary prophylaxis, or treatment of neutropenic complications. Multiple regression analyses were used to determine predictors of overall propensity to use CSFs and, when using a CSF, propensity to support longer schedules of CSF use. RESULTS: Decreased use of CSFs was shown in the following situations: (1) treatment for febrile neutropenia without localizing signs (39% in 1994 v 29% in 1997) or with a right lower lobe infiltrate (54% v 46%); (2) primary prophylaxis with paclitaxel for ovarian cancer (20% v 11%) or cyclophosphamide, doxorubicin, and vincristine chemotherapy for small-cell lung cancer (8.4% v 4.6%); and (3) secondary prophylaxis after afebrile neutropenia following chemotherapy for germ cell tumors (44.5% v 36.0%). One third fewer physicians supported the extended use of CSFs until an absolute neutrophil count ≥ 10,000/mm3 or a WBC count ≥ 10,000/mm3 was reached, both counts serving as criteria for stopping CSF therapy. However, we observed high rates of CSF use despite ASCO guideline recommendations against use in the following clinical situations: (1) primary prophylaxis in patients at low risk of febrile neutropenia (6% v 16%); (2) secondary prophylaxis late in the course of curative and palliative therapy (80% v 53%); and (3) treatment of afebrile and uncomplicated febrile neutropenia (30% v 60%). In 1994 and 1997, fee-for-service physicians were more likely than other physicians to prefer use of CSF support while maintaining treatment dose and schedule instead of using dose-reduction strategies, and, when using a CSF, they were more likely to support longer CSF treatment schedules (P < .05 for both scenarios). CONCLUSION: Decreased use and more appropriate use of CSFs in accordance with ASCO guideline recommendations occurred from 1994 to 1997, but there remain many opportunities to reduce CSF use with no clinical harm. Many oncologists continue to support the use of CSFs in scenarios and with scheduling criteria that the guidelines and evidence do not support. ASCO's evidence-based guidelines should be linked with formal continuous quality improvement initiatives to substantially improve the quality of supportive oncology care.

Neutropenic fever and neoadjuvant intraperitoneal and systemic chemotherapy (DCF-like) in gastric cancer with peritoneal dissemination.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 144-144
Author(s):  
Andrés Jesús Muñoz Martin ◽  
Pilar Garcia Alfonso ◽  
Luis Gonzalez Bayon ◽  
Wenceslao Vasquez Jimenez ◽  
Ana Belen Ruperez Blanco ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Febrile Neutropenia ◽  
Treatment Modality ◽  
Systemic Chemotherapy ◽  
Japanese Patients ◽  
Primary Prophylaxis ◽  
Secondary Prophylaxis ◽  
Peritoneal Catheter ◽  
Phase Ii Studies ◽  
First Results

144 Background: Neoadjuvant intraperitoneal and systemic chemotherapy (NIPS) is a new treatment modality in gastric cancer with peritoneal seeding. Several phase I-II clinical trials with NIPS and cytoreductive surgery have shown an increase in overall survival in Japanese patients (pts) with acceptable toxicity. We report the toxicity related to neutropenia and granulocyte colony stimulating factor (G-CSF) use of the first experience in Spain with NIPS (DCF-like) in gastric cancer with peritoneal carcinomatosis. Methods: Ten consecutive pts have been enrolled in this protocol in a compassionate use program in our center from 2009 to 2011. Chemotherapy (DCF-like) was delivered through an implantable peritoneal catheter. Primary prophylaxis with GCS-F was not used as described in the phase II studies, except in one pt. Clinical characteristics (Table). Results: The incidence of grade 3–4 neutropenia was 70% and any grade neutropenia 80%. Febrile neutropenia was described in 50% of the pts. All pts received secondary prophylaxis according to ASCO guidelines. No treatment-related deaths were observed. One pt discontinued chemotherapy due to febrile neutropenia and diarrhoea. There were no complications due to the infection of peritoneal catheter. Late or unexpected toxicities have not been observed. Conclusions: The first results suggest febrile neutropenia rate of this treatment modality exceeds the 20% ASCO threshold. Primary prophylaxis with G-CSF should be considered in this setting. [Table: see text]

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]

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