Application of pegylated recombinant human granulocyte colony-stimulating factor to prevent chemotherapy-induced neutropenia in patients with lymphoma: a prospective, multicenter, open-label clinical trial

• Published in: Zhōnghuá xuèyèxué zázhì Vol. 38; no. 10; pp. 825 - 830
• Main Authors: Huang, H Q, Bai, B, Gao, Y H, Zou, D H, Zou, S H, Tan, H, Song, Y P, Li, Z Y, Jin, J, Li, W, Su, H, Gong, Y P, Zhong, M Z, Shuang, Y R, Zhu, J, Zhang, J Q, Cai, Z, Teng, Q L, Sun, W J, Yang, Y, Xia, Z J, Chen, H L, Hua, L M, Bao, Y Y, Wu, N
• Format: Journal Article
• Language: Chinese
• Published: China 14.10.2017
• Subjects: Antineoplastic Combined Chemotherapy Protocols; Granulocyte Colony-Stimulating Factor - therapeutic use; Humans; Lung Neoplasms; Lymphoma; Neoplasm Recurrence, Local; Neutropenia - chemically induced; Neutropenia - prevention & control; Prospective Studies; Recombinant Proteins; Protective agent; Granulocyte colony-stimulating factor; Lymphoma; Polyethylene glycols; Neutropenia
• ISSN: 0253-2727
• DOI: 10.3760/cma.j.issn.0253-2727.2017.10.001

To evaluate the efficacy and safety of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in prophylaxis neutropenia after chemotherapy in patients with lymphoma. This was a multicenter, single arm, open, phase Ⅳ clinical trial. Included 410 patients with lymphoma received multiple cycles of chemotherapy and PEG-rhG-CSF was administrated as prophylactic. The primary endpoint was the incidence of Ⅲ/Ⅳ grade neutropenia and febrile neutropenia (FN) after each chemotherapy cycle. Meanwhile the rate of antibiotics application during the whole period of chemotherapy was observed. ①Among the 410 patients, 8 cases (1.95%) were contrary to the selected criteria, 35 cases (8.54%) lost, 19 cases (4.63%) experienced adverse events, 12 cases (2.93%) were eligible for the termination criteria, 15 cases (3.66%) develpoed disease progression or recurrence, thus the rest 321 cases (78.29%) were into the Per Protocol Set. ②During the first to fourth treatment cycles, the incidences of grade Ⅳ neutr