Prophylaxis of Neutropenia with Lipegfilgrastim in Breast Cancer Patients with Dose-Dense Chemotherapy: Results of a Noninterventional Study on Therapeutic Routine in Germany (NADENS)

Kiechle M.a· Schem C.b· Lüftner D.c· Hipp J.d· Stetzer E.e· Köhler U.f

Author affiliations

aFrauen- und Poliklinik, Technische Universität München, Munich, Germany
bMammazentrum Hamburg am Krankenhaus Jerusalem, Hamburg, Germany
cKlinik für Hämatologie und Onkologie, Charité Universitätsmedizin Berlin, Berlin, Germany
dMedical Affairs, Teva GmbH, Ulm, Germany
eMediveritas, Munich, Germany
fKlinik für Gynäkologie und Geburtshilfe, Klinikum St. Georg, Leipzig, Germany

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Article / Publication Details

First-Page Preview

Abstract of Research Article

Received: May 28, 2021
Accepted: May 10, 2022
Published online: May 11, 2022

Number of Print Pages: 6
Number of Figures: 0
Number of Tables: 3

ISSN: 1661-3791 (Print)
eISSN: 1661-3805 (Online)

For additional information: https://www.karger.com/BRC

Abstract

Introduction: Noninterventional study (NIS) on application and effectiveness of primary G-CSF prophylaxis with lipegfilgrastim in primary breast cancer patients undergoing dose-dense (dd) or intense-dose-dense (idd) chemotherapy (CTx) regimen in daily clinical practice. Methods: Prospective, multicenter, single-arm, NIS in 41 private practices and 27 hospitals in Germany. Results: Data analysis of 282 patients with a mean age of 49 years (93.6% of patients <65 years) was performed. Hormone receptor status was triple negative in 29.8% of patients, and 81.9% of patients were HER2 negative. A total of 73.8% of patients received “EC dd → taxane CTx.” Patients received lipegfilgrastim prophylaxis in 97.5% of 1,121 documented dd/idd cycles. Overall, the study registered 275 events of SN (CTCAE grade 3 or 4) and 9 events of FN. During the first dd cycle, SN occurred in 33.3% and FN in 1.1% of patients. CTx delay or dose reduction due to neutropenia was required in 2.5% of patients during the 4 dd cycles with lipegfilgrastim support. Overall, 314 adverse events (AEs) were reported from 107 patients and 27 serious AEs from 21 patients. None of the SAEs was “fatal,” and CTCAE grade was mostly (89.6%) assessed as “1” or “2.” According to the treating physicians, 99.3% of all patients benefitted from lipegfilgrastim prophylaxis, and tolerability was mostly rated “very good” or “good.” Conclusion: These results suggest that primary lipegfilgrastim prophylaxis is effective and safe in clinical routine and is beneficial in primary breast cancer patients undergoing dd/idd-ETC CTx.

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References Aapro MS, Bohlius J, Cameron DA, Dal Lago L, Donnelly JP, Kearney N, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011 Jan;47(1):8–32. NCCN clinical practice guidelines in oncology breast cancer V 2. 2016. https://www.ago-online.de/de/infothek-fuer-aerzte/leitlinienempfehlungen/mamma/. Petrelli F, Cabiddu M, Coinu A, Borgonovo K, Ghilardi M, Lonati V, et al. Adjuvant dose-dense chemotherapy in breast cancer: a systematic review and meta-analysis of randomized trials. Breast Cancer Res Treat. 2015 Jun;151(2):251–9. Early Breast Cancer Trialists Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient-level meta-analysis of 37,298 women with early breast cancer in 26 randomised trials. Lancet. 2019 Apr 6;393(10179):1440–52. Hudis C, Dang C. The development of dose-dense adjuvant chemotherapy. Breast J. 2015 Jan–Feb;21(1):42–51. Möbus V. Adjuvant dose-dense chemotherapy in breast cancer: standard of care in high-risk patients. Breast Care. 2016 Feb;11(1):8–12. Wang L, Baser O, Kutikova L, Page JH, Barron R. The impact of primary prophylaxis with granulocyte colonystimulating factors on febrile neutropenia during chemotherapy: a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer. 2015 Nov;23(11):3131–40. Renner P, Milazzo S, Liu JP, Zwahlen M, Birkmann J, Horneber M. Primary prophylactic colony-stimulating factors for the prevention of chemotherapy-induced febrile neutropenia in breast cancer patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD007913. Link H, Böhme A, Cornely OA, Höffken K, Kellner O, Kern WV, et al. Antimicrobial therapy of unexplained fever in neutropenic patients – guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO), Study Group Interventional Therapy of Unexplained Fever, Arbeitsgemeinschaft Supportivmassnahmen in der Onkologie (ASO) of the Deutsche Krebsgesellschaft (DKG-German Cancer Society). Ann Hematol. 2003 Oct;82(Suppl 2):S105–17. Kuderer NM, Dale DC, Crawford J, Cosler LE, Lyman GH. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer. 2006 May;106(10):2258–66. Crawford J, Dale DC, Lyman GH. Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management. Cancer. 2004 Jan;100(2):228–37. Naeim A, Henk HJ, Becker L, Chia V, Badre S, Li X, 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 Jan;13:11. Pettengell R, Schwenkglenks M, Leonard R, Bosly A, Paridaens R, Constenla M, et al. Neutropenia occurrence and predictors of reduced chemotherapy delivery: results from the INC-EU prospective observational European neutropenia study. Support Care Cancer. 2008 Nov;16(11):1299–309. Padilla G, Ropka ME. Quality of life and chemotherapy-induced neutropenia. Cancer Nurs. 2005May–Jun;28(3):167–71. Cooper KL, Madan J, Whyte S, Stevenson MD, Akehurst RL. Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. BMC Cancer. 2011 Sep;11:404. Janni W. Guidelines of the AGO breast committee: diagnosis and treatment of patients with primary and metastatic breast cancer. München: W. Zuckschwerdt Verlag GmbH; 2017. Smith TJ, Bohlke K, Lyman GH, Carson KR, Crawford J, Cross SJ, et al. Recommendations for the use of WBC growth factors: American society of clinical oncology clinical practice guideline update. J Clin Oncol. 2015 Oct;33(28):3199–212. Möller H. Effectiveness studies: advantages and disadvantages dialogues. Clin Neurosci. 2011;13(2):199–207. Bond TC, Szabo E, Gabriel S, Klastersky J, Tomey O, Mueller U, et al. Meta-analysis and indirect treatment comparison of lipegfilgrastim with pegfilgrastim and filgrastim for the reduction of chemotherapy-induced neutropenia-related events. J Oncol Pharm Pract. 2018 Sep;24(6):412–23. Wuerstlein R, Harbeck N, Grischke EM, Forstmeyer D, von Schumann R, Krabisch P, et al. Protroca: a noninterventional study on prophylactic lipegfilgrastim against chemotherapy-induced neutropenia in nonselected breast cancer patients. Breast Care. 2021 Feb;16(1):50–8. Bondarenko I, Gladkov OA, Elsaesser R, Buchner A, Bias P. Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy. BMC Cancer. 2013 Aug;13(1):386. Buchner A, Elsässer R, Bias P. A randomized, double-blind, active control, multicenter, dose-finding study of lipegfilgrastim (XM22) in breast cancer patients receiving myelosuppressive therapy. Breast Cancer Res Treat. 2014 Nov;148(1):107–16. Article / Publication Details

First-Page Preview

Abstract of Research Article

Received: May 28, 2021
Accepted: May 10, 2022
Published online: May 11, 2022

Number of Print Pages: 6
Number of Figures: 0
Number of Tables: 3

ISSN: 1661-3791 (Print)
eISSN: 1661-3805 (Online)

For additional information: https://www.karger.com/BRC

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