MEDLINE/PubMed Journal Browser Search

Pubmed for Handhelds

PUBMED FOR HANDHELDS

Search MEDLINE/PubMed

Title: [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].
Author: Huang HQ, Bai B, Gao YH, Zou DH, Zou SH, Tan H, Song YP, Li ZY, Jin J, Li W, Su H, Gong YP, Zhong MZ, Shuang YR, Zhu J, Zhang JQ, Cai Z, Teng QL, Sun WJ, Yang Y, Xia ZJ, Chen HL, Hua LM, Bao YY, Wu N.
Journal: Zhonghua Xue Ye Xue Za Zhi; 2017 Oct 14; 38(10):825-830. PubMed ID: 29166732.
Abstract:
Objective: 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. Methods: 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. Results: 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 neutropenia after prophylactic use of PEG-rhG-CSF were 19.14% (49/256) , 12.5% (32/256) , 12.18% (24/197) , 13.61% (20/147) , respectively. The incidences of FN were 3.52% (9/256) , 0.39% (1/256) , 2.54% (5/197) , 2.04% (3/147) , respectively. After secondary prophylactic use of PEG-rhG-CSF, the incidences of Ⅳ grade neutropenia decreased from 61.54% (40/65) in the screening cycle to 16.92% (11/65) , 18.46% (12/65) and 20.75% (11/53) in 1-3 cycles, respectively. The incidences of FN decreased from 16.92% (11/65) in the screening cycle to 1.54% (1/65) , 4.62% (3/65) , 3.77% (2/53) in 1-3 cycles, respectively. ③The proportion of patients who received antibiotic therapy during the whole period of chemotherapy was 34.39% (141/410) . ④The incidence of adverse events associated with PEG-rhG-CSF was 4.63% (19/410) . The most common adverse events were bone pain[3.90% (16/410) ], fatigue (0.49%) and fever (0.24%) . Conclusion: During the chemotherapy in patients with lymphoma, the prophylactic use of PEG-rhG-CSF could effectively reduce the incidences of grade Ⅲ/Ⅳ neutropenia and FN, which ensures that patients with lymphoma receive standard-dose chemotherapy to improve its cure rate. 目的： 评价聚乙二醇化重组人粒细胞刺激因子（PEG-rhG-CSF）预防淋巴瘤患者化疗后发生中性粒细胞减少症的有效性和安全性。 方法： 本研究为多中心、开放、单臂、Ⅳ期临床试验。纳入410例淋巴瘤患者接受多周期化疗并预防性使用PEG-rhG-CSF。主要观察患者各化疗周期Ⅲ/Ⅳ度中性粒细胞减少症和发热性中性粒细胞减少（FN）的发生率，同时观察患者整个化疗期间抗生素的使用率。 结果： ①410例患者中，违背入选标准8例（1.95%），失访35例（8.54%），发生不良事件19例（4.63%），出现符合终止研究标准者12例（2.93%），疾病进展或复发15例（3.66%），故最终321例（78.29%）进入符合方案集。②在第1~4个治疗周期，初级预防给予PEG-rhG-CSF后，Ⅳ度中性粒细胞减少症的发生率分别为19.14%（49/256）、12.50%（32/256）、12.18%（24/197）、13.61%（20/147），FN的发生率分别为3.52%（9/256）、0.39%（1/256）、2.54%（5/197）、2.04%（3/147）；次级预防给药后，Ⅳ度中性粒细胞减少症的发生率从61.54%（40/65）降至16.92%（11/65）、18.46%（12/65）、20.75%（11/53），FN的发生率从16.92%（11/65）降至1.54%（1/65）、4.62%（3/65）、3.77%（2/53）。③整个化疗期间接受抗生素治疗的受试者比例为34.39%（141/410）。④与PEG-rhG-CSF相关的不良事件发生率为4.63%（19/410），最常见的不良反应为骨痛[3.90%（16/410）]、乏力（0.49%）和发热（0.24%）。 结论： 在淋巴瘤患者化疗过程中，预防性使用PEG-rhG-CSF能够有效降低化疗过程中Ⅲ/Ⅳ度中性粒细胞减少症和FN的发生率，确保淋巴瘤患者接受标准剂量化疗，提高治愈率。.

[Abstract] [Full Text] [Related] [New Search]