聚乙二醇化重组人粒细胞刺激因子对转移性激素敏感性前列腺癌化疗后粒细胞减少的预防效果分析

Analysis of the preventive effect of pegylated recombinant human granulocyte stimulating factor on granulocytopenia in metastatic hormone-sensitive prostate cancer after chemotherapy

目的分析聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)对前列腺癌化疗后粒细胞减少的预防效果,并评价其安全性和有效性。方法选取2019年2月至2019年12月接受多西他赛(75 mg/m^2,21 d为1个化疗周期)或多西他赛(75 mg/m^2,第1天)联合顺铂(30 mg/m^2,第1~3天)/卡铂(400 mg/m^2,第1~3天)每21 d为1个化疗周期方案的转移性激素敏感性前列腺癌(metastatic hormone-sensitive prostate cancer,mHSPC)患者61例,年龄53~82岁。治疗期间所有患者同时进行内分泌治疗,包括去势手术、药物去势、去势联合抗雄激素药物治疗,共6个周期。61例患者分为对照组30例、观察组31例,对照组不予任何升白药物干预,出现粒细胞减少后再予重组人粒细胞刺激因子(rhG-CSF)治疗,直至外周血白细胞计数>10×109/L;观察组在化疗结束后48 h内给予PEG-rhG-CSF。结果61例患者死亡1例,因肝功能异常终止化疗2例,失访1例,最终57例纳入研究,其中对照组27例、观察组30例。观察组中性粒细胞减少发生率为33.3%,其中3级中性粒细胞减少发生率为10.0%,粒细胞缺乏及减少化疗剂量发生率均为0,分别低于对照组的77.8%、33.3%、18.5%,差异有统计学意义(P<0.05);两组的不良反应有骨痛、肌肉疼痛、乏力和注射部位疼痛,差异无统计学意义(P>0.05)。结论PEG-rhG-CSF用于mHSPC多西他赛单药或多西他赛联合顺铂/卡铂方案化疗患者,疗效肯定,能降低患者发生粒细胞减少、粒细胞缺乏的概率,减少因骨髓抑制导致化疗药物剂量降低的概率,确保患者能够接受标准剂量化疗,提高治愈率。

Objective To analyze the preventing effect of pegylated recombinant human granulocyte stimulating factor(PEG-rhG-CSF)on granulocytopenia after chemotherapy for prostate cancer,and to evaluate its safety and effectiveness.Methods A total of 61 patients aged 53-82 with metastatic hormone-sensitive prostate cancer(mHSPC),who received docetaxel(75 mg/m^2,21 days constitute one chemotherapy course)alone or docetaxel(75 mg/m^2 on d1)combined with cisplatin(30 mg/m^2,from d1 to d3)and carboplatin(400 mg/m^2,from d1 to d3)during a 21-day chemotherapy course from February 2019 to December 2019,were included.These patients also received endocrine therapy over the same period,including surgical and medical castration,and castration combined with antiandrogen medications,lasting 6 cycles in total.Patients were divided into two groups,the control group(30 cases)and the observation group(31 cases).The control group received no leukogenic drugs,and was given human granulocyte stimulating factor(rhG-CSF)treatment only after the occurrence of granulocytopenia until the WBC count in peripheral blood was above 10×109/L.The observation group was given PEG-rhG-CSF within 48 hours after chemotherapy.Results Among the 61 patients,one patient died,two stopped receiving chemotherapy due to liver dysfunction,one was lost to follow-up.A total of 57 valid cases were included in per protocol set(PPS)in the end,of which 30 cases were from the observation group and 27 cases from the control group.The incidence of neutropenia in the observation group was 33.3%,of which the incidence of grade 3 neutropenia was 10.0%,the incidence of agranulocytosis was 0,and the drug doses reduction of chemotherapy was 0,which were lower than the 77.8%,33.3%,18.5%,and 18.5%,respectively,in the control group,with statistically significant differences(P<0.05).The differences in adverse reactions in both groups,included aching bones,muscle pain,lack of strength,and soreness at the injection sites,were of no statistical significance(P>0.05).Conclusion The curative effect of PEG-rhG-CSF is definite on the patients with mHSPC who received chemotherapy either with docetaxel alone or docetaxel combined with cisplatin and carboplatin.It can reduce the incidence of granulocytopenia,agranulocytosis,and chemotherapy drug dose reduction caused by myelosuppression.It,therefore,can ensure the patients receive chemotherapy with standard dosage,and thus improve the cure rate.