Effectiveness and safety of empegfilgrastim (Extimia®) in patients with solid tumors receiving cytotoxic therapy: final results of the DEFENDOR study
- Authors: Snegovoy A.V.1, Kononenko I.B.1, Radiukova I.M.2, Orlova S.A.3, Sultanbaev A.V.4, Dubovichenko D.M.5, Dergunov A.S.6, Saidullaeva A.F.6, Repina N.N.7, Gronskaia I.A.8, Rossokha E.I.9, Starostina T.V.10, Akimova O.V.11, Vasil'eva I.A.12, Godzhieva Z.A.13, Garanina O.I.14, Gorchkhanova K.I.15, Machekhina I.S.16, Gracheva A.S.6, Danilova A.E.17, Dmitrakova T.N.14, Dmitriev V.N.18, Dmitrochenko M.V.19, Dylinova O.V.20, El'kova V.O.10, Zhelezniak A.V.21, Zubova I.V.19, Ivanov A.N.3, Kaleikina L.P.22, Komoza I.V.14, Korolev D.N.23, Lebedeva L.N.5, Lebedinets A.A.24, Mamedguseinova N.N.25, Miagkova V.S.25, Matiushina E.I.26, Narovenkova K.V.14, Nikolaeva V.M.27, Novikov D.V.6, Polonskaia G.E.6, Rebrina O.V.19, Safronova M.A.19, Semenova A.S.27, Semenova I.A.14, Skotnikov R.A.7, Solov'eva E.P.5, Tat'ianenko A.N.6, Teterich A.A.18, Timin V.N.26, Tolmacheva I.A.14, Tiugina I.A.28, Khodkevich A.V.14, Tsarakhova F.V.29, Chapko I.S.5, Shegurova M.M.21, Shakurova N.R.30, Shalina A.I.20, Shumilkina E.A.3, Iakuba D.V.6, Ibragimova T.M.31, Feoktistova P.S.31, Sorokina I.V.31,32, Berezina A.M.33, Kiseleva P.V.32, Mironenko O.N.33, Prosianikova O.N.32
-
Affiliations:
- Lopatkin Scientific Research Institute of Urology – branch of the National Medical Research Radiological Centre
- Clinical Oncology Dispensary, Omsk
- Republican Clinical Oncology Dispensary, Cheboksary
- Republican Clinical Oncology Dispensary, Ufa
- Arkhangelsk Clinical Oncology Dispensary
- Tver Regional Clinical Oncology Dispensary
- Tula Regional Clinical Oncology Dispensary
- Saint Petersburg State University
- Altai Regional Oncology Dispensary
- Voronezh Regional Clinical Oncology Dispensary
- Ostoverkhov Kursk Oncology Scientific and Clinical Center
- Pskov Regional Clinical Oncology Dispensary
- Regional Oncology Dispensary, Vladikavkaz
- Briansk Regional Oncology Dispensary
- Republican Oncology Dispensary, Nazran
- Botkin Hospital
- City Clinic No. 106
- Belgorod Oncology Dispensary
- Smolensk Regional Oncology Clinical Dispensary
- Regional Clinical Oncology Hospital, Yaroslavl
- Nizhniy Novgorod Regional Clinical Oncology Dispensary
- Republican Oncology Dispensary, Saransk
- Primorsky Regional Oncology Dispensary
- Leningrad Regional Clinical Hospital
- Oncology Dispensary, Rostov-on-Don
- Komi Republican Oncology Dispensary
- Yakutsk Republican Oncology Dispensary
- Ivanovo Regional Oncology Dispensary
- Regional Oncology Dispensary
- Tomsk Regional Oncology Dispensary
- Loginov Moscow Clinical Scientific Center
- JSC "Biocad"
- Russian Academy of National Economy and Public Administration of the President of the Russian Federation
- Issue: Vol 26, No 2 (2024)
- Pages: 159-171
- Section: Articles
- URL: https://journals.rcsi.science/1815-1434/article/view/260598
- DOI: https://doi.org/10.26442/18151434.2024.2.202829
- ID: 260598
Cite item
Full Text
Abstract
Aim. To evaluate the effectiveness and safety of Extimia® (empegfilgrastim, JSC "BIOCAD") in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia (FN) and infections caused by FN in patients with solid tumors receiving myelosuppressive therapy.
Materials and methods. The paper presents the final results of a multicenter prospective observational post-marketing study of the safety and effectiveness of Extimia® (empegfilgrastim) in patients with solid tumors receiving cytotoxic therapy. For the primary prevention of FN, all patients received empegfilgrastim at 7.5 mg subcutaneously once per course of chemotherapy (CT) 24 hours after the end of CT administration. The primary endpoint included an assessment of the relative dose-intensity (RDI) of the CT courses administered. The endpoints of interest included the assessment of the RDI of CT courses by nosology and CT regimen, the frequency of dose-limiting neutropenia, and the incidence of all adverse events (AEs) in patients who received at least one dose of the study medication, including serious AEs.
Results. From February 2021 to December 2022, 3218 patients with various malignancies were included in 41 study centers of the Russian Fede- ration. Of these, 3217 (99.97%) patients received at least one dose of the study drug, and 2663 (82.8%) patients were included in the RDI evaluation population according to the study protocol. The mean age in this group was 56.9 (18–84) years. RDI ≥85% was achieved in 2,415 (90.7%) patients. The mean RDI was 96.2%, with a median of 100%. FN risk factors were present in 1216 (45.7%) patients, with age ≥65 years being the most common risk factor at 761/2663 (28.6%). It should be noted that in patients younger than 65 years, the RDI was 91.5%, and in elderly patients (≥65 years) 88.7%. Dose-limiting neutropenia was reported in 19 (0.7%) patients. There were 74 cases of grade 3–4 AEs (according to CTCAE v.5) in 59 (1.8%) patients. The most common were neutropenia, anemia, and diarrhea in 19 (0.7%), 7 (0.2%), and 6 (0.2%) patients, respectively. Serious AEs were reported in 17 patients (0.5%).
Conclusion. Primary prophylaxis of FN with long-acting granulocyte colony-stimulating factor empegfilgrastim effectively maintains RDI in various nosological and therapeutic groups of patients with different CT regimens in real-world clinical practice.
Full Text
##article.viewOnOriginalSite##About the authors
Anton V. Snegovoy
Lopatkin Scientific Research Institute of Urology – branch of the National Medical Research Radiological Centre
Author for correspondence.
Email: drsneg@gmail.com
ORCID iD: 0000-0002-0170-5681
D. Sci. (Med.), Prof.
Russian Federation, MoscowInessa B. Kononenko
Lopatkin Scientific Research Institute of Urology – branch of the National Medical Research Radiological Centre
Email: drsneg@gmail.com
ORCID iD: 0000-0002-7142-2986
Cand. Sci. (Med.)
Russian Federation, MoscowIrina M. Radiukova
Clinical Oncology Dispensary, Omsk
Email: drsneg@gmail.com
Cand. Sci. (Med.)
Russian Federation, OmskSvetlana A. Orlova
Republican Clinical Oncology Dispensary, Cheboksary
Email: drsneg@gmail.com
Head Department
Russian Federation, CheboksaryAlexander V. Sultanbaev
Republican Clinical Oncology Dispensary, Ufa
Email: drsneg@gmail.com
ORCID iD: 0000-0003-0996-5995
Cand. Sci. (Med.)
Russian Federation, UfaDaria M. Dubovichenko
Arkhangelsk Clinical Oncology Dispensary
Email: drsneg@gmail.com
Cand. Sci. (Med.)
Russian Federation, ArkhangelskAleksandr S. Dergunov
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
Head Department
Russian Federation, TverAleksandra F. Saidullaeva
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
Head Department
Russian Federation, TverNadezhda N. Repina
Tula Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
Head Department
Russian Federation, TulaIuliia A. Gronskaia
Saint Petersburg State University
Email: drsneg@gmail.com
ORCID iD: 0000-0002-1060-0806
oncologist
Russian Federation, Saint PetersburgElena I. Rossokha
Altai Regional Oncology Dispensary
Email: drsneg@gmail.com
ORCID iD: 0000-0002-5303-3012
Cand. Sci. (Med.)
Russian Federation, BarnaulTatiana V. Starostina
Voronezh Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, VoronezhOksana V. Akimova
Ostoverkhov Kursk Oncology Scientific and Clinical Center
Email: drsneg@gmail.com
oncologist
Russian Federation, KurskIuliia A. Vasil'eva
Pskov Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, PskovZarina A. Godzhieva
Regional Oncology Dispensary, Vladikavkaz
Email: drsneg@gmail.com
chemotherapist
Russian Federation, VladikavkazOl'ga Iu. Garanina
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, BrianskKhava I. Gorchkhanova
Republican Oncology Dispensary, Nazran
Email: drsneg@gmail.com
oncologist
Russian Federation, NazranIuliia S. Machekhina
Botkin Hospital
Email: drsneg@gmail.com
oncologist
Russian Federation, MoscowAleksandra S. Gracheva
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, TverAnastasiia E. Danilova
City Clinic No. 106
Email: drsneg@gmail.com
oncologist
Russian Federation, Saint PetersburgTat'iana N. Dmitrakova
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, BrianskVadim N. Dmitriev
Belgorod Oncology Dispensary
Email: drsneg@gmail.com
D. Sci. (Med.)
Russian Federation, BelgorodMarina V. Dmitrochenko
Smolensk Regional Oncology Clinical Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, SmolenskOlga V. Dylinova
Regional Clinical Oncology Hospital, Yaroslavl
Email: drsneg@gmail.com
oncologist
Russian Federation, YaroslavlViktoriia O. El'kova
Voronezh Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, VoronezhAlla V. Zhelezniak
Nizhniy Novgorod Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, Nizhniy NovgorodIrina V. Zubova
Smolensk Regional Oncology Clinical Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, SmolenskAleksandr N. Ivanov
Republican Clinical Oncology Dispensary, Cheboksary
Email: drsneg@gmail.com
oncologist
Russian Federation, CheboksaryLiliia P. Kaleikina
Republican Oncology Dispensary, Saransk
Email: drsneg@gmail.com
oncologist
Russian Federation, SaranskIuliia V. Komoza
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, BrianskDmitrii N. Korolev
Primorsky Regional Oncology Dispensary
Email: drsneg@gmail.com
Head Department
Russian Federation, VladivostokLiudmila N. Lebedeva
Arkhangelsk Clinical Oncology Dispensary
Email: drsneg@gmail.com
Cand. Sci. (Med.)
Russian Federation, ArkhangelskAndrei A. Lebedinets
Leningrad Regional Clinical Hospital
Email: drsneg@gmail.com
Cand. Sci. (Med.)
Russian Federation, Saint PetersburgNaira N. Mamedguseinova
Oncology Dispensary, Rostov-on-Don
Email: drsneg@gmail.com
oncologist
Russian Federation, Rostov-on-DonValeriia S. Miagkova
Oncology Dispensary, Rostov-on-Don
Email: drsneg@gmail.com
oncologist
Russian Federation, Rostov-on-DonElena I. Matiushina
Komi Republican Oncology Dispensary
Email: drsneg@gmail.com
Head Department
Russian Federation, SyktyvkarKristina V. Narovenkova
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, BrianskValentina M. Nikolaeva
Yakutsk Republican Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, YakutskDenis V. Novikov
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, TverGalina E. Polonskaia
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, TverOlesia V. Rebrina
Smolensk Regional Oncology Clinical Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, SmolenskMariia A. Safronova
Smolensk Regional Oncology Clinical Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, SmolenskAnna S. Semenova
Yakutsk Republican Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, YakutskInessa A. Semenova
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, BrianskRoman A. Skotnikov
Tula Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, TulaEkaterina P. Solov'eva
Arkhangelsk Clinical Oncology Dispensary
Email: drsneg@gmail.com
Cand. Sci. (Med.)
Russian Federation, ArkhangelskAnna N. Tat'ianenko
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, TverAntonina A. Teterich
Belgorod Oncology Dispensary
Email: drsneg@gmail.com
Head Department
Russian Federation, BelgorodVladimir N. Timin
Komi Republican Oncology Dispensary
Email: drsneg@gmail.com
Head Department
Russian Federation, SyktyvkarIrina A. Tolmacheva
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, BrianskIana A. Tiugina
Ivanovo Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, IvanovoAleksandra V. Khodkevich
Briansk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, BrianskFatima V. Tsarakhova
Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, VladikavkazIana S. Chapko
Arkhangelsk Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, ArkhangelskMargarita M. Shegurova
Nizhniy Novgorod Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, Nizhniy NovgorodNadezhda R. Shakurova
Tomsk Regional Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, TomskAnna I. Shalina
Regional Clinical Oncology Hospital, Yaroslavl
Email: drsneg@gmail.com
oncologist
Russian Federation, YaroslavlElena A. Shumilkina
Republican Clinical Oncology Dispensary, Cheboksary
Email: drsneg@gmail.com
oncologist
Russian Federation, CheboksaryDaria V. Iakuba
Tver Regional Clinical Oncology Dispensary
Email: drsneg@gmail.com
oncologist
Russian Federation, TverTansylu M. Ibragimova
Loginov Moscow Clinical Scientific Center
Email: drsneg@gmail.com
oncologist
Russian Federation, MoscowPolina S. Feoktistova
Loginov Moscow Clinical Scientific Center
Email: drsneg@gmail.com
ORCID iD: 0000-0002-0340-7119
Cand. Sci. (Med.)
Russian Federation, MoscowIrina V. Sorokina
Loginov Moscow Clinical Scientific Center; JSC "Biocad"
Email: drsneg@gmail.com
Cand. Sci. (Biol.), Loginov Moscow Clinical Scientific Center, JSC "Biocad"
Russian Federation, Moscow; Saint PetersburgAnna M. Berezina
Russian Academy of National Economy and Public Administration of the President of the Russian Federation
Email: drsneg@gmail.com
independent expert of research projects
Russian Federation, MoscowPolina V. Kiseleva
JSC "Biocad"
Email: drsneg@gmail.com
technical support specialist
Russian Federation, Saint PetersburgOlga N. Mironenko
Russian Academy of National Economy and Public Administration of the President of the Russian Federation
Email: drsneg@gmail.com
ORCID iD: 0000-0001-8952-8386
Cand. Sci. (Econ.)
Russian Federation, MoscowOxana N. Prosianikova
JSC "Biocad"
Email: drsneg@gmail.com
ORCID iD: 0009-0005-3684-6301
Cand. Sci. (Med.)
Russian Federation, Saint PetersburgReferences
- Lyman GH. Impact of chemotherapy dose intensity on cancer patient outcomes. J Natl Compr Canc Netw. 2009;7:99-108.
- Bonadonna G, Valagussa P, Moliterni A, et al. Adjuvant cyclophosphamide, metho- trexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995;332:901-6.
- Bosly A, Bron D, Van Hoof A, et al. Achievement of optimal average relative dose intensity and correlation with survival in diffuse large B-cell lymphoma patients treated with CHOP. Ann Hematol. 2008;87:277-83.
- Budman DR, Berry DA, Cirrincione CT, et al. Dose and dose intensity as determinants of outcome in the adjuvant treatment of breast cancer. Cancer and Leukemia Group B. J Natl Cancer Inst. 1998;90:1205-11.
- Chirivella I, Bermejo B, Insa A, et al. Optimal delivery of anthracycline-based chemotherapy in the adjuvant setting improves outcome of breast cancer patients. Breast Cancer Res Treat. 2009;114:479-84.
- Wildiers H, Reiser M. Relative dose intensity of chemotherapy and its impact on outcomes in patients with early breast cancer or aggressive lymphoma. Crit Rev Oncol Hematol. 2011;77:221-40.
- Кононенко И.Б., Снеговой А.В., Ларионова В.Б. Нейтропения, лимитирующая проведение химиотерапии. Нужна ли профилактика? Онкогематология. 2022;17(1):135-42 [Kononenko IB, Snegovoy AV, Larionova VB. Chemotherapy limiting neutropenia. Is prevention required? Oncohematology. 2022;17(1):135-42 (in Russian)]. doi: 10.17650/1818-8346-2022-17-1-135-142
- Hanna RK, Poniewierski MS, Laskey RA, et al. Predictors of reduced relative dose intensity and its relationship to mortality in women receiving multi-agent chemotherapy for epithelial ovarian cancer. Gynecol Oncol. 2013;129:74-80.
- Loibl S, Skacel T, Nekljudova V, et al. Evaluating the impact of relative total dose intensity (RTDI) on patients’ short and long-term outcome in taxane- and anthracycline-based chemotherapy of metastatic breast cancer – a pooled analysis. BMC Cancer. 2011;11:131.
- Nielson CM, Bylsma LC, Fryzek JP, et al. Relative Dose Intensity of Chemotherapy and Survival in Patients with Advanced Stage Solid Tumor Cancer: A Systematic Review and Meta-Analysis. Oncologist. 2021;26(9):e1609-18. doi: 10.1002/onco.13822
- Seebacher V, Reinthaller A, Koelbl H, et al. The Impact of the Duration of Adjuvant Chemotherapy on Survival in Patients with Epithelial Ovarian Cancer – A Retrospective Study. PloS One. 2017;12(1):e0169272. doi: 10.1371/journal.pone.0169272
- Li L, Ma S, Wu M, et al. The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomized controlled study. BMJ Support Palliat Care. 2019;9(4):373-80. doi: 10.1136/bmjspcare-2019-001862
- Canton C, Boussari O, Boulin M, et al. Impact of G-CSF Prophylaxis on Chemotherapy Dose-Intensity, Link Between Dose-Intensity and Survival in Patients with Metastatic Pancreatic Adenocarcinoma. Oncologist. 2022;27(7):e571-9. doi: 10.1093/oncolo/oyac055
- Holmes FA, Jones SE, O’Shaughnessy J, et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002;13:903-9.
- Naeim A, Henk HJ, Becker L, et al. Pegfilgrastim prophylaxis is associated with a lower risk of hospitalization of cancer patients than filgrastim prophylaxis: a retrospective United States claims analysis of granulocyte colonystimulating factors (G-CSF). BMC Cancer. 2013;13:11.
- Снеговой А.В., Кононенко И.Б., Сорокина И.В., и др. Частота встречаемости схем с высоким риском развития фебрильной нейтропении и частота развития дозолимитирующей нейтропении среди пациентов, получающих цитотоксическую терапию по поводу злокачественных новообразований: результаты исследования FLAME. Современная Онкология. 2023;25(3):378-84 [Snegovoy AV, Kononenko IB, Sorokina IV, et al. The frequency of regimens associated with high risk of febrile neutropenia and the incidence of dose-limiting neutropenia among patients receiving cytotoxic therapy for malignancies: the FLAME study results. Journal of Modern Oncology. 2023;25(3):378-4 (in Russian)]. doi: 10.26442/18151434.2023.3.202452
- Cornes P, Gascon P, Chan S, et al. Systematic Review and Meta-analysis of Shortversus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia. Adv Ther. 2018;35(11):1816-29. doi: 10.1007/s12325-018-0798-6
- Wang Y, Chen L, Liu F, et al. Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis. Sci Rep. 2019;9(1):15374. doi: 10.1038/s41598-019-51982-4
- Криворотько П.В., Бурдаева О.Н., Ничаева М.Н., и др. Эффективность и без- опасность препарата ЭКСТИМИЯ® (эмпэгфилграстим) у пациентов с диагнозом «рак молочной железы», получающих миелосупрессивную химиотерапию: результаты двойного слепого сравнительного клинического исследования III фазы. Современная Онкология. 2015;17(2):45-5 [Krivorotko PV, Burdaeva ON, Nechaeva MN, et al. Efficacy and safety of Extimia® (empegfilgrastim): results of a double-blind controlled phase III study in patients with diagnosis «breast cancer» receiving myelosuppressive chemotherapy. Journal of Modern Oncology. 2015;17(2):45-52 (in Russian)].
- Chu E, DeVita VT Jr. Principles of Cancer Management. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: Principles and Practice of Oncology. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2005; pp. 295-306.
- Madry R, Poplawska L, Haslbauer F, et al. Results of a prospective dose intensity and neutropenia prophylaxis evaluation programme (DIEPP) in cancer patients at risk of febrile neutropenia due to myelosuppressive chemotherapy. Wien Klin Wochenschr. 2016;128:238-2.
- National Comprehensive Cancer Network. Practice Guidelines in Oncology (NCCN Guidelines®) V.3.2024. January 30, 2024.
- Green MD, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003;14:29-35.
- Holmes FA, Jones SE, O’Shaughnessy, et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002;13:903-9.
- Green MD, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003;14:29-35.
- Holmes FA, Jones SE, O’Shaughnessy J, et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002;13:903-9.
- Siena S, Piccart MJ, Holmes FA, et al. A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily filgrastim in patients with stage II–IV breast cancer. Oncol Rep. 2003;10:715-24.
- Kourlaba G, Dimopoulos MA, Pectasides D, et al. Comparison of filgrastim and pegfilgrastim to prevent neutropenia and maintain dose intensity of adjuvant chemotherapy in patients with breast cancer. Support Care Cancer. 2015;23:2045-51.
- Skarlos DV, Timotheadou E, Galani E, et al. Pegfilgrastim administered on the same day with dose-dense adjuvant chemotherapy for breast cancer is associated with a higher incidence of febrile neutropenia as compared to conventional growth factor support: matched case-control study of the Hellenic Cooperative Oncology Group. Oncology. 2009;77:107-12.
- Wang X, He Y, Wang T, et al. Efficacy of pegfilgrastim to support neoadjuvant dose-dense epirubicin and cyclophosphamide chemotherapy in breast cancer. Support Care Cancer. 2019;27(8):3019-25. doi: 10.1007/s00520-018-4572-8
- Morita S, Kikumori T, Tsunoda N, et al. Feasibility of dose-dense epirubicin and cyclophosphamide with subcutaneous pegfilgrastim 3.6 mg support: a single-center prospective study in Japan. Int J Clin Oncol. 2018;23(1):195-200.
- Mizuno Y, Fuchikami H, Takeda N, et al. Efficacy of reduced dose of pegfilgrastim in Japanese breast cancer patients receiving dose-dense doxorubicin and cyclophosphamide therapy. Jpn J Clin Oncol. 2017;47:12-7.
- Havrilesky LJ, Reiner M, Morrow PK, et al. A review of relative dose intensity and survival in patients with metastatic solid tumors. Crit Rev Oncol Hematol. 2015;93:203-10.
- Снеговой А.В., Кононенко И.Б., Клясова Г.А., и др. Протоколы клинических рекомендаций поддерживающей терапии в онкологии. Под ред. акад. РАН М.И. Давыдова. Протокол профилактики фебрильной нейтропении гранулоцитарными колониестимулирующими факторами. 2023–2024; с. 24-35 [Snegovoi AV, Kononenko IB, Kliasoava GA, et al. Protokoly klinicheskikh rekomendatsii podderzhivaiushchei terapii v onkologii. Pod red. akad. RAN MI Davydova. Protokol profilaktiki febril'noi neitropenii granulotsitarnymi koloniestimuliruiushchimi faktorami. 2023–2024; p. 24-35 (in Russian)].
- Nakayama G, Hayashi N, Tanaka C, et al. Addition of bevacizumab to compensate for the negative influence of attenuated relative dose intensity of cytotoxic agents on the outcome in patients with metastatic colorectal cancer. J Clin Oncol. 2013;31(Suppl. 15):e14614a.
- Aoyagi T, Morii T, Tajima T, et al. Analysis of the risk factors for febrile neutropenia in patients with bone and soft tissue sarcoma. Anticancer Res. 2015;35(4):2375-83.
- Reichardt P, Tilgner J, Hohenberger P, Dorken B. Dose-Intensive chemotherapy with ifosfamide, epirubicin, and filgrastim for adult patients with metastatic or locally advanced soft tissue sarcoma: a phase II study. J Clin Oncol. 1998;16(4):1438-43.
- Jung JH, Shin DW, Kim J, et al. Primary Granulocyte Colony-Stimulating Factor Prophylaxis in Metastatic Pancreatic Cancer Patients Treated with FOLFIRINOX as the First-Line Treatment. Cancers (Basel). 2020;12(11):3137. doi: 10.3390/cancers12113137
- Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the Use of WBC Growth Factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015;33(28):3199-212. doi: 10.1200/JCO.2015.62.3488
- Kjeldsted E, Gehl J, Sørensen DM, et al. Patient-Related Characteristics Associated with Treatment Modifications and Suboptimal Relative Dose Intensity of Neoadjuvant Chemotherapy in Patients with Breast Cancer – A Retrospective Study. Cancers (Basel). 2023;15(9):2483. doi: 10.3390/cancers15092483
- Von Minckwitz G, Schwenkglenks M, Skacel T, et al. Febrile neutropenia and related complications in breast cancer patients receiving pegfilgrastim primary prophylaxis versus current practice neutropaenia management: results from an integrated analysis. Eur J Cancer. 2009;45:608-17.
- Kuderer NM, Dale DC, Crawford J, et al. Mortality, morbidity, and cost associated with febrile neutropenia inadult cancer patients. Cancer. 2006;106:2258-66.