每周期4.5mg聚乙二醇化重组人粒细胞集落刺激因子支持乳腺癌剂量密集型化疗疗效观察  

Clinical observation of 4.5 mg once-per-cycle pegfilgrastim on supporting the dose-dense chemotherapy in breast cancer

作　　者：曹威[1] 何英剑[1] 欧阳涛[1] 李金锋[1] 解云涛[1] 王天峰[1] 王歆光[1] 汪星[1] 祁萌[1] 范照青[1] CAO Wei;HE Ying-jian;OUYANG Tao;LI Jin-feng;XIE Yun-tao;WANG Tian-feng;WANG Xin-guang;WANG Xing;QI Meng;FAN Zhao-qing(Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education),Breast Cancer Center,Peking University Cancer Hospital&Institute,Bei jing 100142,China)

机构地区：[1]北京大学肿瘤医院暨北京市肿瘤防治研究所乳腺癌预防治疗中心,恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142

出　　处：《中华肿瘤防治杂志》2021年第19期1488-1492,共5页Chinese Journal of Cancer Prevention and Treatment

基　　金：首都卫生发展科研专项基金(2018-2-2152)。

摘　　要：目的探讨每周期4.5 mg聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF)支持乳腺癌剂量密集型表柔比星和环磷酰胺(ddEC)化疗的有效性和安全性。方法选择2019-05-01-2021-04-31在北京大学肿瘤医院乳腺癌预防治疗中心就诊、有化疗指征且适合ddEC方案化疗的103例浸润性乳腺癌患者,患者均为女性,术前给予4个周期ddEC(表柔比星100 mg/m^(2),环磷酰胺600 mg/m^(2))方案化疗和每周期4.5 mg PEG-rhG-CSF。主要评价指标为化疗相对剂量强度(RDI)和中性粒细胞(ANC)减少导致的化疗剂量调整和化疗延迟,次要评价指标为化疗期间ANC减少和粒细胞减少性发热(FN)等不良事件以及白细胞增多症(白细胞>20×10^(9)L^(-1))的发生率。结果 103例患者的化疗完成率为94.17%(97/103,95%CI为89.64~98.70)。共完成401个周期ddEC化疗,总体RDI为97.33%(401/412,95%CI为94.22~99.99)。11例患者(10.68%,95%CI为4.72~16.64)出现化疗延迟,其中2例(1.94%,95%CI为0.01~4.60)与FN有关,未出现化疗剂量调整。化疗期间3~4级ANC减少和FN的发生率均为6.80%(7/103,95%CI为1.94~11.66)。白细胞增多症的发生率为6.80%(7/103,95%CI为1.94~11.66)。其他不良事件主要为骨痛,发生率为17.48%(18/103,95%CI为10.15~24.81)。结论每周期4.5 mg PEG-rhG-CSF可安全有效的支持乳腺癌ddEC方案化疗,且化疗延迟、ANC减少、FN和骨痛发生率均较低。与标准剂量(6 mg)相比,4.5 mg剂量不能减少白细胞增多症的发生率。Objective To investigate the efficacy and safety of once-per-cycle 4.5 mg pegfilgrastim in breast cancer receiving dose-dense epirubicin and cyclophosphamide(ddEC)chemotherapy regimen.Methods From May 1,2019 to April 31,2021,103 female patients with invasive breast cancer,who were suitable for ddEC chemotherapy,were enrolled in Peking university cancer hospital breast cancer prevention and treatment center.Patients were projected to receive four cycles of ddEC(E 100 mg/m^(2),C 600 mg/m^(2))and 4.5 mg pegfilgrastim for each cycle preoperatively.The primary endpoint was to measure the relative dose intensity(RDI)of chemotherapy and chemotherapy dose adjustment and delay due to neutropenia.The secondary endpoint was to evaluate the incidence of neutropenia,febrile neutropenia(FN),leukocytosis(WBC>20×10^(9) L^(-1))and any other adverse events.Results Data of 103 patients were counted.The completion rate of chemotherapy was 94.17%(97/103,95%CI:89.64-98.70).A total of 401 cycles of ddEC were accomplished and the overall RDI was 97.33%(401/412,95%CI:94.22-99.99).There was no dose adjustment in any chemotherapy cycle.Chemotherapy delay was observed in 11 patients(10.68%,95%CI:4.72-16.64),with among whom 2 patients(1.94%,95%CI:0.01-4.60)was related to FN.The incidence of grade 3-4 neutropenia and FN was 6.80%(7/103,95%CI:1.94-11.66).The incidence of leukocytosis was 6.80%(7/103,95%CI:1.94-11.66).Bone pain was the major adverse event with an incidence of 17.48%(18/103,95%CI:10.15-24.81).Conclusions 4.5 mg once-per-cycle pegfilgrastim is effective and safe in facilitating ddEC,with low incidence of chemotherapy delay,neutropenia,FN and bone pain.Compared with standard dosage(6 mg),4.5 mg pegfilgrastim is unable to reduce the incidence of leukocytosis.

关 键 词：乳腺癌 剂量密集型化疗 聚乙二醇化重组人粒细胞集落刺激因子 粒细胞减少性发热 白细胞增多症 

分 类 号：R737.9[医药卫生—肿瘤]