Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis
Abstract
:Simple Summary
Abstract
1. Introduction
2. Methods
2.1. Search Strategy
2.2. Inclusion and Exclusion Criteria
2.3. Outcome Measures
2.4. Data Abstraction and Analysis
3. Results
3.1. Description of Studies
3.2. Outcome of FIL versus PCT/NT by Indication
3.2.1. CIN Indication
3.2.2. AML Indication
3.2.3. SCN Indication
3.2.4. BMT Indication
3.3. Outcome of FIL versus PEG-F by Indication
3.3.1. CIN Indication
3.3.2. AML Indication
3.4. Outcome of FIL versus Bio-F
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Study | Tumor Type | Filgrastim Intervention and Patient Number | FN Incidence | Grade 3 or 4 Neutropenia Incidence | Definition of FN |
---|---|---|---|---|---|
FIL vs. PCT/NT | |||||
Crawford et al., 2005 [33] | SCLC | N = 231 Filgrastim = 111 Placebo = 120 | Incidence of FN 38% vs. 74% p = 0.001 | Grade 4 neutropenia incidence in cycle 1 82% vs. 97% | ≥38.2 °C |
Timmer-Bonte et al., 2005 [36] | SCLC | N = 175 Filgrastim = 90 Placebo = 85 | Incidence of FN in cycle 1:10% vs. 24% Incidence of FN 2 to 5 cycles: 11% vs. 17% p = 0.001 | NR | ≥38.2 °C |
Doorduijun et al., 2003 [34] | NHL | N = 389 Filgrastim = 197 Placebo = 192 | Incidence of FN 36.5% vs. 44.8% p = 0.04 | NR | ≥38.2 °C |
Obsy et al., 2003 [35] | NHL | N = 455 Filgrastim = 226 Placebo = 229 | Granulocytopenic fever (<0.5 × 109/L) CHOP arms 34% vs. 50% p = not reported | Granulocytopenia (<0.5 × 109/L) CHOP arms 55% vs. 89% | >38.5 °C once or >38.0 °C twice in 4 h |
Obsy et al., 2003 [35] | NHL | N = 455 Filgrastim = 226 Placebo = 229 | Granulocytopenic fever (<0.5 × 109/L) CNOP arms 32% vs. 50% p = not reported | Granulocytopenia (<0.5 × 109/L) CNOP arms 64% vs. 86% | >38.5 °C once or >38.0 °C twice in 4 h |
Papaldo et al., 2003 [39] | Breast Cancer | N = 503 Filgrastim = 254 No Filgrastim = 249 | Incidence of FN 1.2% vs. 6.6% p = 0.004 | Grade 3/4 neutropenia: 28.6 vs. 81.6% p < 0.00001 | NR |
Fossa et al., 1998 [37] | Germ Cell | N = 259 Filgrastim = 129 No Filgrastim = 130 | Incidence of FN 20% vs. 30% p < 0.052 | NR | NR |
Geissler et al., 1997 [40] | ALL | N = 51 Filgrastim = 25 Placebo = 26 | Incidence of FN 12% vs. 42% p = not reported | NR | >38.0 °C |
Ottmann et al., 1995 [52] | ALL | N = 76 Filgrastim = 37 No filgrastim = 39 | Duration of prolonged neutropenia incidence 22% vs. 42% p = not reported | NR | >38.0 °C |
Zinzani et al., 1997 [42] | NHL | N = 149 Filgrastim = 77 No filgrastim = 72 | NR | Grade 4 neutropenia incidence 23.0% vs. 55.5% p = 0.00005 | NR |
Gebbia et al., 1993 [51] | Breast cancer | N = 86 Filgrastim = 43 Placebo = 43 | Incidence of FN 12% vs. 32% p < 0.05 | Grade 3 and 4 neutropenia 18% vs. 42% p < 0.05 | >38.0 °C |
Trillet-Lenoir et al., 1993 [45] | SCLC | N = 129 Filgrastim = 65 Placebo = 64 | Incidence of FN 26% vs. 53% p = 0.002 | NR | ≥38.2 °C |
Crawford et al., 1991 [7] | SCLC | N = 199 Filgrastim = 95 Placebo = 104 | Incidence of FN in cycle 1 28% vs. 57% p < 0.001 FN incidence across 6 cycles 40% vs. 77% p < 0.001 | Grade 4 neutropenia incidence in cycle 1 84% vs. 98% p = 0.001 | ≥38.2 °C |
FIL vs. PEG-F | |||||
Park et al., 2017 [66] | Breast Cancer | N = 74 Filgrastim = 38 DA 3031 = 36 | Incidence of FN 7.9% vs. 17.1% | NR | NR |
Kubo et al., 2016 [70] | NHL | N = 111 Filgrastim = 56 Pegfilgrastim = 55 | Incidence of FN 55.6% vs. 56.6% p = not reported | NR | <37.5 °C |
Zhang et al., 2015 [68] | Breast Cancer | N = 171 Filgrastim = 43 PEG 60 μg/kg = 43 PEG 100 μg/kg = 43 PEG 120 μg/kg = 42 | Incidence of FN 11.63% vs. 6.98% vs. 4.65% vs. 11.90% | NR | ≥38.2 °C |
Park et al., 2013 [67] | Breast Cancer | N = 61 Filgrastim = 21 DA-3031 3.6 mg = 20 DA-3031 6 mg = 20 | Incidence of FN9.5% vs. 15% vs. 5% | NR | NR |
Green et al., 2003 [8] | Breast Cancer | N = 152 Filgrastim: 75 Pegfilgrastim: 77 | Incidence of FN 15% vs. 9% | NR | ≥38.2 °C |
Grigg et al., 2003 [73] | NHL | N = 50 Filgrastim: 22 Pegfilgrastim: 27 | Incidence of FN in cycle 1 was 0% vs. 15% | NR | ≥38.2 °C |
Vose et al., 2003 [74] | NHL | N = 60 Filgrastim: 31 Pegfilgrastim: 29 | Incidence of FN 19% vs. 21% | Incidence of grade 4 neutropenia 68% vs. 69% | ≥38.2 °C |
Holmes et al., 2002 [9] | Breast Cancer | N = 296 Filgrastim: 147 Pegfilgrastim: 149 | Incidence of FN 18% vs. 9% | Incidence of grade 4 neutropenia in cycle 1 79% vs. 77% | ≥38.2 °C |
Holmes et al., 2002 [19] | Breast Cancer | N = 125 Filgrastim = 25 PEG 30 μg/kg = 19 PEG 60 μg/kg = 60 PEG 100 μg/kg = 46 | Incidence of FN 4% vs. 21% vs. 8% vs. 7% | Incidence of grade 4 neutropenia 76% vs. 95% vs. 90% vs. 74% | ≥38.2 °C |
FIL vs. Bio-F | |||||
Blackwell et al., 2018 [76] | Breast Cancer | N = 213 Filgrastim: 51 Switched biosimilar: 109 EP2006: 53 | Incidence of FN across cycles 2–6 0% vs. 3.4% | NR | ≥38.3 °C |
Hegg et al., 2016 [80] | Breast Cancer | N = 217 Filgrastim: 108 Biosimilar filgrastim: 109 | NR | NR | ≥38.2 °C |
Blackwell et al., 2015 [77] | Breast Cancer | N = 214 Filgrastim: 107 EP 2006: 107 | NR | NR | ≥38.3 °C |
Waller et al., 2010 [81] | Breast Cancer | N = 278 Filgrastim: 95 Biosimilar filgrastim: 183 | Incidence of FN in cycle 1–3 2.4% vs. 2.4% | NR | ≥38.5 °C |
del Giglio et al., 2008 [78] | Breast Cancer | N = 348 Filgrastim: n = 136 XM02: n = 140 Placebo/XM02: n = 72 | FN incidence 20.7% vs. 22.1% vs. 41.7% | NR | >38.5 °C |
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Rastogi, S.; Kalaiselvan, V.; Ali, S.; Ahmad, A.; Guru, S.A.; Sarwat, M. Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis. Biology 2021, 10, 1069. https://doi.org/10.3390/biology10101069
Rastogi S, Kalaiselvan V, Ali S, Ahmad A, Guru SA, Sarwat M. Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis. Biology. 2021; 10(10):1069. https://doi.org/10.3390/biology10101069
Chicago/Turabian StyleRastogi, Shruti, Vivekananda Kalaiselvan, Sher Ali, Ajaz Ahmad, Sameer Ahmad Guru, and Maryam Sarwat. 2021. "Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis" Biology 10, no. 10: 1069. https://doi.org/10.3390/biology10101069
APA StyleRastogi, S., Kalaiselvan, V., Ali, S., Ahmad, A., Guru, S. A., & Sarwat, M. (2021). Efficacy and Safety of Filgrastim and Its Biosimilars to Prevent Febrile Neutropenia in Cancer Patients: A Prospective Study and Meta-Analysis. Biology, 10(10), 1069. https://doi.org/10.3390/biology10101069