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
Sun Yat-Sen University Cancer Center, Guangzhou 510060, China.
Zhonghua Xue Ye Xue Za Zhi. 2017 Oct 14;38(10):825-830. 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 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%) . 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.
评估聚乙二醇化重组人粒细胞集落刺激因子（PEG-rhG-CSF）预防淋巴瘤患者化疗后中性粒细胞减少的疗效和安全性。这是一项多中心、单臂、开放性Ⅳ期临床试验。纳入410例接受多周期化疗的淋巴瘤患者，并给予PEG-rhG-CSF进行预防。主要终点是每个化疗周期后Ⅲ/Ⅳ级中性粒细胞减少和发热性中性粒细胞减少（FN）的发生率。同时观察化疗全期抗生素应用率。①410例患者中，8例（1.95%）不符合入选标准，35例（8.54%）失访，19例（4.63%）发生不良事件，12例（2.93%）符合终止标准，15例（3.66%）疾病进展或复发，因此其余321例（78.29%）进入符合方案集。②在第1至第4个治疗周期，预防性使用PEG-rhG-CSF后Ⅳ级中性粒细胞减少的发生率分别为19.14%（49/256）﹑12.5%（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）。二次预防性使用PEG-rhG-CSF后，Ⅳ级中性粒细胞减少的发生率从筛查周期的61.54%（40/65）分别降至第1至3周期的16.92%（11/65）﹑18.46%（12/65）和20.75%（11/53）。FN的发生率从筛查周期的16.92%（11/65）分别降至第1至3周期的1.54%（1/65）﹑4.62%（3/65）﹑3.77%（2/53）。③化疗全期接受抗生素治疗的患者比例为34.39%（141/410）。④与PEG-rhG-CSF相关的不良事件发生率为4.63%（19/410）。最常见的不良事件为骨痛[3.90%（16/410）]、乏力（0.49%）和发热（0.24%）。在淋巴瘤患者化疗期间，预防性使用PEG-rhG-CSF可有效降低Ⅲ/Ⅳ级中性粒细胞减少和FN的发生率，确保淋巴瘤患者接受标准剂量化疗以提高治愈率。
