Filgrastim Versus Pegfilgrastim for Neutropenia Prevention in Children with Solid Tumors: A Randomized Trial
الموضوعات :
Aziz Eghbali
1
(Aliasghar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran)
Maryam Behtash
2
(Department of Pediatrics, Arak University of Medical Sciences, Arak, Iran)
Roghayyeh Rahimi Afzal
3
(Department of Pediatrics, Arak University of Medical Sciences, Arak, Iran)
Aygin Eghbali
4
(Aliasghar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran)
Bahar Taherkhanchi
5
(Department of Pediatrics, Erfan Niyayesh Hospital, Tehran, Iran)
Bahador Bagheri
6
(Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran|Department of Pharmacology, Semnan University of Medical Sciences, Semnan, Iran)
الکلمات المفتاحية: Chemotherapy, Malignancy, Pegfilgrastim, Filgrastim,
ملخص المقالة :
Prophylaxis of chemotherapy-induced neutropenia by granulocyte stimulatory factors (GCSFs) has a significant effect on reducing the complications of chemotherapy. The aim of this study was to compare effects of filgrastim and pegfilgrastim (two types of GCSFs) for neutropenia prevention in children with malignancies. This crossover study was carried out in children who were admitted to oncology ward of Amir Kabir Hospital, Arak, Iran. Patients were randomly divided into 3 groups each with 30 participants. Filgrastim (group A), pegfilgrastim (group B) were injected subcutaneously 10 µg/kg/day and 100 µg/kg as a single dose, respectively and patients in group C had no medical treatment. Washout period was 30 days. Cell blood were checked at beginning and at 3, 7, 14 days of the treatment. The mean age in group A was 6.4 ±3.5 years, the group B was 6.4 ± 3.5 and the group C was 6.2 ± 1.8. The mean Absolute Neutrophil Count (ANC) was similar in all three groups prior to chemotherapy. After receiving the last dose of chemotherapy, the mean ANC was not significantly different in 3 groups (p = 0.217), and only 2 cases of mild neutropenia were seen in group B. On the 14th day, the ratio of neutropenia was different in 3 groups, and this difference was significant (p = 0.000) but there was no significant difference between the ratio of neutropenia in group A and group B. (p = 0.524). 20% of cases in group C and then 16.7% in group B were treated due to delayed neutropenia and this difference was significant (p = 0.026). Pegfligrastim was associated with better clinical response and fewer side effects as compared to filgrastim in children with solid tumors. Due to efficacy and acceptable safety profile, pegfligrastim can be a better choice. There was no significant difference between the costs of the three groups (0.064)
1. Kline N.E., Sevier N., 2003. Solid tumors in children. Journal of Pediatric Nursing. 18(2), 96-102.
2. Nasr R., Hasanzadeh H., Khaleghian A., Moshtaghian A., Emadi A., Moshfegh S., 2018. Induction of apoptosis and inhibition of invasion in gastric cancer cells by titanium dioxide nanoparticles. Oman Medical Journal. 33(2), 111-117.
3. Jayedi A., Emadi A., Khan T.A., Abdolshahi A., Shab-Bidar S., 2020. Dietary Fiber and Survival in Women with Breast Cancer: A Dose-Response Meta-Analysis of Prospective Cohort Studies. Nutrition and Cancer. 1-11.
4. Seystahl K., Hentschel B., Loew S., Gramatzki D., Felsberg J., Herrlinger U., Westphal M., Schackert G., Thon N., Tatagiba M., 2020. Bevacizumab versus alkylating chemotherapy in recurrent glioblastoma. Journal of Cancer Research and Clinical Oncology. 146(3), 659-670.
5. Reson M., 2008. Wilms, tumor and other pediatric renal masses: Magnetic Resonance Imaging Clinics of North America. 16(3), 479-497.
6. Noripour S., Molaei A., Bandari R., Emadi A., Far S.M.F., Forozeshfard M., 2017. Comparison of the results of simultaneous surfactant administration and nasal continuous positive airway pressure (INSURE) and Non-administration of surfactant for the treatment of infants with respiratory distress syndrome. Journal of Comprehensive Pediatrics. 8(1), e37462.
7. Behrman R.E., Kliegman R.M., Jenson H., 2003. Nelson Textbook of Pediatrics: 17th Edition: Hardback. United States of America: Hal B. Jenson. 903-927. ISBN10 0721695566.
8. Gaviria J.M., Liles W.C., Dale D.C., 1999. The Influence of Colony-Stimulating Factors on Neutrophil Production, Distribution, and Function Clinical Applications of Cytokines and Growth Factors. Clinical Applications of Cytokines and Growth Factors. 118-136.
9. Kutluk T., Kurne O., Akyüz C., Ceyhan M., Kanra G., 2004. Cefepime vs. Meropenem as empirical therapy for neutropenic fever in children with lymphoma and solid tumours. Pediatric Blood & Cancer. 42(3), 284-286.
10. Ishiguro H., Fung M.C., Sakata T., Morizane T., Adachi S., 2003. Evidence-based management of neutropenia and fever. Gan to kagaku ryoho. Cancer & Chemotherapy. 30(9), 1365-1371.
11. Vardakas K.Z., Michalopoulos A., Falagas M.E., 2005. Fluconazole versus itraconazole for antifungal prophylaxis in neutropenic patients with haematological malignancies: a meta‐analysis of randomised‐controlled trials. British Journal of Haematology. 131(1), 22-28.
12. Rogers Z., Aquino V., Buchanan G., 2002. Hematologic supportive care and hematopoietic cytokines. Principles and Practice of Pediatric Oncology. 4th ed. Philadelphia: Lippincott Williams and Wilkins. 1205-1238.
13. Glaspy J.A., 2003. Hematopoietic management in oncology practice. Part 2. Erythropoietic factors. Oncology (Williston Park, NY), 17(12), 1724-1730.
14. Lord B., Bronchud M., Owens S., Chang J., Howell A., Souza L., Dexter T., 1989. The kinetics of human granulopoiesis following treatment with granulocyte colony-stimulating factor in vivo. Proceedings of the National Academy of Sciences. 86(23), 9499-9503.
15. Welte K., Gabrilove J., Bronchud M.H., Platzer E., Morstyn G., 1996. Filgrastim (r-metHuG-CSF): the first 10 years. Blood, 88(6), 17-29.
16. Smith T.J., Khatcheressian J., Lyman G.H., Ozer H., Armitage J.O., Balducci L., Bennett C.L., Cantor S.B., Crawford J., Cross S.J., 2006. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. Journal of Clinical Oncology. 24(19), 3187-3205.
17. Milano-Bausset E., Gaudart J., Rome A., Coze C., Gentet J.C., Padovani L., Lacarelle B., André N., 2009. Retrospective comparison of neutropenia in children with Ewing sarcoma treated with chemotherapy and granulocyte colony-stimulating factor (G-CSF) or pegylated G-CSF. Clinical Therapeutics. 31, 2388-2395.
18. Molineux G., 2002. Pegylation: engineering improved pharmaceuticals for enhanced therapy. Cancer Treatment Reviews. 28, 13-16.
19. Willis F., Pettengell R., 2002. Pegfilgrastim. Expert Opinion on Biological Therapy. 2(8), 985-992.
20. Blackwell K., Donskih R., Jones C.M., Nixon A., Vidal M.J., Nakov R., Singh P., Schaffar G., Gascón P., Harbeck N., 2016. A comparison of proposed biosimilar LA-EP2006 and reference pegfilgrastim for the prevention of neutropenia in patients with early-stage breast cancer receiving myelosuppressive adjuvant or neoadjuvant chemotherapy: pegfilgrastim randomized oncology (supportive care) trial to evaluate comparative treatment (PROTECT-2), a phase III, randomized, double-blind trial. The Oncologist. 21(7), 789-794.
21. Kourlaba G., Dimopoulos M.A., Pectasides D., Skarlos D.V., Gogas H., Pentheroudakis G., Koutras A., Fountzilas G., Maniadakis N., 2015. Comparison of filgrastim and pegfilgrastim to prevent neutropenia and maintain dose intensity of adjuvant chemotherapy in patients with breast cancer. Supportive Care in Cancer. 23 (7), 2045-2051.
22. Ehsani M., Ordouee M., Salamati P., Shahgholi E., Sotoudeh K., Hatami S., Ajami H., Abolghasemi H., 2006. Evaluation of efficacy and side effects of FILGRASTIM versus PD-Grastim in prevention of neutropenia in patients with neuroblastoma under treatment with OPEC chemotherapy protocol – A Comparative Study. Iranian Journal of Pediatrics. 16(3), 319-324.
23. Chan A., Leng X.Z., Chiang J.Y., Tao M., Quek R., Tay K., Lim S.T., 2011. Comparison of daily filgrastim and pegfilgrastim to prevent febrile neutropenia in Asian lymphoma patients. Asia‐Pacific Journal of Clinical Oncology. 7(1), 75-81.
24. Tan H., Tomic K., Hurley D., Daniel G., Barron R., Malin J., 2011. Comparative effectiveness of colony-stimulating factors for febrile neutropenia: a retrospective study. Current Medical Research and Opinion. 27(1), 79-86.
25. Weycker D., Malin J., Barron R., Edelsberg J., Kartashov A., Oster G., 2012. Comparative effectiveness of filgrastim, pegfilgrastim, and sargramostim as prophylaxis against hospitalization for neutropenic complications in patients with cancer receiving chemotherapy. American Journal of Clinical Oncology. 35(3), 267-274.
