吉西他滨长疗程维持化疗有助于中国晚期乳腺癌患者生存获益的多中心真实世界研究  

Gemcitabine long-term maintenance chemotherapy benefits patients with survival:a multicenter,real-world study of advanced breast cancer treatment in China

作　　者：岳健 宋国红[2] 李惠平[2] 孙涛[3] 宋丽华[4] 佟仲生 张莉莉[6] 宋振川[7] 欧阳取长[8] 杨谨 潘跃银 袁芃 Yue Jian;Song Guohong;Li Huiping;Sun Tao;Song Lihua;Tong Zhongsheng;Zhang Lili;Song Zhenchuan;Ouyang Quchang;Yang Jin;Pan Yueyin;Yuan Peng(Department of VIP Medical Services,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Key Laboratory of Carcinogenesis and Translational Research,Ministry of Education,Department of Breast Oncology,Peking University Cancer Hospital&Institute,Beijing 100142,China;Department of Breast Medicine,Cancer Hospital of China Medical University,Liaoning Cancer Hospital&Institute,Shenyang 110042,China;Department of Medical Oncology,Cancer Research Center,Shandong Cancer Hospital and Institute,Shandong First Medical University and Shandong Academy of Medical Sciences,Jinan 250117,China;Department of Breast Oncology,Tianjin Medical University Cancer Hospital,National Clinical Research Center of Cancer,Key Laboratory of Breast Cancer Prevention and Therapy,Key Laboratory of Cancer Prevention and Therapy,Tianjin 300060,China;Department of Medical Oncology,Jiangsu Cancer Hospital&Jiangsu Institute of Cancer Research&The Affiliated Cancer Hospital of Nanjing Medical University,Nanjing 210009,China;Breast Cancer,The Fourth Hospital of Hebei Medical University,Shijiazhuang 050011,China;Department of Breast Cancer Medical Oncology,Hunan Cancer Hospital,Changsha 410006,China;Department of Medical Oncology,The First Affiliated Hospital of Xi'an Jiaotong University,Xi'an 710049,China;Department of Medical Oncology,Provincial Hospital Affiliated to Anhui Medical University,Hefei 230001,China)

机构地区：[1]国家癌症中心、国家肿瘤临床医学研究中心、中国医学科学院北京协和医学院肿瘤医院特需医疗部,北京100021 [2]北京大学肿瘤医院暨北京市肿瘤防治研究所乳腺肿瘤内科、恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [3]中国医科大学附属肿瘤医院、辽宁省肿瘤医院乳腺内科,沈阳110042 [4]山东省肿瘤防治研究院、山东省肿瘤医院肿瘤内科、山东第一医科大学山东省医学科学院,济南250117 [5]天津医科大学肿瘤医院乳腺内科、国家肿瘤临床医学研究中心、乳腺癌防治教育部重点实验室、天津市肿瘤防治重点实验室、天津市恶性肿瘤临床医学研究中心,天津300060 [6]江苏省肿瘤医院、江苏省肿瘤防治研究所、南京医科大学附属肿瘤医院内科,南京210009 [7]河北医科大学第四医院乳腺疾病诊疗中心,石家庄050011 [8]湖南省肿瘤医院乳腺内科,长沙410006 [9]西安交通大学第一附属医院肿瘤内科,西安710049 [10]安徽医科大学附属省立医院肿瘤内科,合肥230001

出　　处：《中华肿瘤杂志》2024年第3期249-255,共7页Chinese Journal of Oncology

基　　金：希思科临床肿瘤学研究基金(Y-HR2020QN-0306)。

摘　　要：目的探讨吉西他滨为主的维持治疗对晚期乳腺癌治疗疗效的影响及影响治疗持续时间的主要原因。方法研究为前瞻性多中心研究,2017年1月至2019年1月期间从10家医疗中心选取接受含吉西他滨单药或联合其他化疗或靶向治疗的晚期乳腺癌患者,收集吉西他滨为主方案的治疗线数、剂量、周期数、不良反应、停药原因以及疗效等数据,生存分析采用Kaplan-Meier方法,预后影响因素的单因素分析采用log rank检验,多因素分析采用Cox回归模型。结果研究共筛选全国10家医院共239例晚期乳腺癌患者,最终纳入224例患者进行分析。全组患者中位年龄52岁(26~77岁),其中Luminal型83例,三阴性97例,人表皮生长因子受体2阳性型44例。55.4%(124/224)为绝经后患者。完全缓解(CR)5例,部分缓解(PR)77例,疾病稳定(SD)112例,疾病进展(PD)27例。客观有效率为36.6%(82/224)。Ⅲ级及以上不良反应主要包括白细胞下降(9例)、中性粒细胞下降(49例)、血小板下降(15例)、转氨酶升高(2例)。中位随访时间41个月(26~61个月),中位无进展生存时间(PFS)为5.6个月。引起治疗结束的主要原因包括疾病进展90例、患者个人原因终止治疗51例、严重不良反应不耐受18例、医师评估后治疗结束65例。治疗周期>6个周期较≤6个周期患者在PFS有明显的延长(8.2和5.4个月,HR=2.474,95%CI:1.730~3.538,P<0.001)。结论吉西他滨为主的治疗方案在中国人群中有较好的疗效和耐受性,长程维持治疗有利于改善生存。Objective This study collected a real-world data on survival and efficacy of gemcitabine-containing therapy in advanced breast cancer.Aimed to find the main reasons of affecting the duration of gemcitabine-base therapy in advanced breast cancer patients.Methods Advanced breast cancer patients who received gemcitabine-base therapy from January 2017 to January 2019 were enrolled(10 hospitals).The clinicopathological data,the number of chemotherapy cycles and the reasons for treatment termination were collected and analyzed.To identify the reasons related with continuous treatment for advanced breast cancer and the factors which affect the survival and efficacy.Results A total of 224 patients with advanced breast cancer were enrolled in this study,with a median age of 52 years(26-77 years),55.4%(124/224)was postmenopausal.Luminal type were 83 cases,TNBC were 97 cases,and human epidermal growth factor receptor 2(HER's-2)overexpression were 44.At the analysis,224 patients who received the gemcitabine-based regimens were evaluated,included 5 complete reponse(CR),77 partial response(PR),112 stable disease(SD)and 27 progressive disease(PD).The objective response rate(ORR)was 36.6%(82/224).Seventy patients had serious adverse diseases,including leukopenia(9),neutrophilia(49),thrombocytopenia(15),and elevated transaminase(2).The median follow-up time was 41 months(26~61 months),and the median PFS was 5.6 months.The reasons of termination treatment were listed:disease progression were 90 patients;personal reasons were 51 patients;adverse drug reactions were 18 patients;completed treatment were 65 patients.It was found that progression-free survival(PFS)was significantly longer in patients receiving>6 cycles than that in patients with≤6 cycles(8.2 months vs 5.4 months,HR=2.474,95%CI:1.730-3.538,P<0.001).Conclusions Gemcitabine-based regimen is generally well tolerated in the Chinese population and has relatively ideal clinical efficacy in the real world.The median PFS is significantly prolonged when the number of treatment

关 键 词：乳腺肿瘤 晚期 吉西他滨 治疗周期 生存 

分 类 号：R737.9[医药卫生—肿瘤]