Pegteograstim prophylaxis for chemotherapy-induced neutropenia and febrile neutropenia: a prospective, observational, postmarketing surveillance study in Korea
Tóm tắt
This observational study aimed to evaluate the safety and efficacy of pegteograstim prophylaxis in patients with lymphoma and solid malignancies. This study was conducted at 18 sites in Korea between November 2015 and August 2018. In total, 611 patients (female, 61.2%) with a median age of 58 (range, 18–88) years were included. Most patients had lymphomas (n = 371, 60.7%) and breast cancer (n = 230, 37.6%) and were administered R-CHOP21 (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone per 21 days) (n = 284, 46.5%) and AC (doxorubicin and cyclophosphamide) (n = 177, 29.0%). The total pegteograstim dose in the 611 patients was 14,970 mg (2495 doses), with each patient receiving an average daily dose of 6.0 mg. Neutropenia grade 4 occurred in 97 patients (15.9%), and febrile neutropenia (FN) occurred in 31 patients (5.1%). Among the 611 patients, 267 patients (43.7%) developed 882 adverse events (AEs), and 11 patients (1.8%) experienced 18 adverse drug reactions (ADRs). There were 62 patients (10.2%) who experienced 81 cases of serious adverse events (SAEs), with FN and pneumonia being the most frequent at 14 and 13 episodes, respectively, in 13 patients (2.1%). Meanwhile, 1 patient (0.2%) developed 2 episodes of serious ADRs (grade 1 and grade 2 hypotension). No safety concerns in the elderly and patients with liver and/or renal disease were identified. The prophylactic use of pegteograstim might have good overall safety and efficacy in patients with lymphomas and solid malignancies in routine clinical practice, even in those who are elderly and have liver and renal diseases.
Từ khóa
Tài liệu tham khảo
Cohen AM, Zsebo KM, Inoue H, Hines D, Boone TC, Chazin VR, Tsai L, Ritch T, Souza LM (1987) In vivo stimulation of granulopoiesis by recombinant human granulocyte colony-stimulating factor. Proc Natl Acad Sci 84(8):2484–2488. https://doi.org/10.1073/pnas.84.8.2484
Morstyn G, Campbell L, Souza LM, Alton NK, Keech J, Green M, Sheridan W, Metcalf D, Fox R (1988) Effect of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy. Lancet (London, England) 1(8587):667–672. https://doi.org/10.1016/s0140-6736(88)91475-4
Tanaka H, Satake-Ishikawa R, Ishikawa M, Matsuki S, Asano K (1991) Pharmacokinetics of recombinant human granulocyte colony-stimulating factor conjugated to polyethylene glycol in rats. Cancer Res 51(14):3710–3714
Hong J, Lee B, Kang K, Lee SH, Ryu J, Jung G, Oh J, Jo EC, Kim CW (2018) Characterisation of the site-specific monoPEGylated rhG-CSF analogue pegteograstim. Biologicals 51:54–61. https://doi.org/10.1016/j.biologicals.2017.10.002
Lee KH, Kim JY, Lee MH, Han HS, Lim JH, Park KU, Park IH, Cho EK, Yoon SY, Kim JH, Choi IS, Park JH, Choi YJ, Kim HJ, Jung KH, Kim SY, Oh DY, Im SA (2016) A randomized, multicenter, phase II/III study to determine the optimal dose and to evaluate the efficacy and safety of pegteograstim (GCPGC) on chemotherapy-induced neutropenia compared to pegfilgrastim in breast cancer patients: KCSG PC10-09. Support Care Cancer 24(4):1709–1717. https://doi.org/10.1007/s00520-015-2963-7
Ozer H, Mirtsching B, Rader M, Luedke S, Noga SJ, Ding B, Dreiling L (2007) Neutropenic events in community practices reduced by first and subsequent cycle pegfilgrastim use. Oncologist 12(4):484–494. https://doi.org/10.1634/theoncologist.12-4-484
Fiegl M, Steger GG, Studnicka M, Eisterer W, Jaeger C, Willenbacher W (2013) Pegfilgrastim prophylaxis in patients at different levels of risk for chemotherapy-associated febrile neutropenia: an observational study. Curr Med Res Opin 29(5):505–515. https://doi.org/10.1185/03007995.2013.781018
Almenar Cubells D, Bosch Roig C, Jimenez Orozco E, Alvarez R, Cuervo JM, Diaz Fernandez N, Sanchez Heras AB, Galan Brotons A, Giner Marco V, Codes MDVM (2013) Effectiveness of daily versus non-daily granulocyte colony-stimulating factors in patients with solid tumours undergoing chemotherapy: a multivariate analysis of data from current practice. Eur J Cancer Care (Engl) 22(3):400–412. https://doi.org/10.1111/ecc.12043
Lyman GH, Morrison VA, Dale DC, Crawford J, Delgado DJ, Fridman M (2003) Risk of febrile neutropenia among patients with intermediate-grade non-Hodgkin’s lymphoma receiving CHOP chemotherapy. Leuk Lymphoma 44(12):2069–2076. https://doi.org/10.1080/1042819031000119262
Timmer-Bonte JN, Punt CJ, vd Heijden HF, van Die CE, Bussink J, Beijnen JH, Huitema AD, Tjan-Heijnen VC (2008) Prophylactic G-CSF and antibiotics enable a significant dose-escalation of triplet-chemotherapy in non-small cell lung cancer. Lung Cancer 60(2):222–230. https://doi.org/10.1016/j.lungcan.2007.10.001
Cerchione C, De Renzo A, Nappi D, Di Perna M, Della Pepa R, Pugliese N, Catalano L, Pane F, Picardi M (2019) Pegfilgrastim in primary prophylaxis of febrile neutropenia in elderly patients with hematological malignancies-bendamustine and G-CSF support. Support Care Cancer 27(5):1587–1588. https://doi.org/10.1007/s00520-019-4651-5
Balducci L, Repetto L (2004) Increased risk of myelotoxicity in elderly patients with non-Hodgkin lymphoma. Cancer 100(1):6–11. https://doi.org/10.1002/cncr.11861
Salmon JP, Smakal M, Karanikiotis C, Wojtukiewicz MZ, Omnes Y, DeCosta L, Wetten S, O’Kelly J (2019) Febrile neutropenia (FN) and pegfilgrastim prophylaxis in breast cancer and non-Hodgkin’s lymphoma patients receiving high (> 20%) FN-risk chemotherapy: results from a prospective observational study. Support Care Cancer 27(4):1449–1457. https://doi.org/10.1007/s00520-018-4473-x
Wolff T, Schulz H, Losem C, Reichert D, Hurtz HJ, Sandner R, Harde J, Grebhardt S, Potthoff K, Mueller U, Fietz T (2019) Prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non-Hodgkin lymphoma (NADIR study). Eur J Haematol 102(2):174–181. https://doi.org/10.1111/ejh.13189
Lambertini M, Del Mastro L, Bellodi A, Pronzato P (2014) The five “Ws” for bone pain due to the administration of granulocyte-colony stimulating factors (G-CSFs). Crit Rev Oncol Hematol 89(1):112–128. https://doi.org/10.1016/j.critrevonc.2013.08.006
Xu H, Gong Q, Vogl FD, Reiner M, Page JH (2016) Risk factors for bone pain among patients with cancer receiving myelosuppressive chemotherapy and pegfilgrastim. Support Care Cancer 24(2):723–730. https://doi.org/10.1007/s00520-015-2834-2