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ENGLISH ABSTRACT
吉西他滨联合奈达铂治疗人表皮生长因子受体2阴性晚期乳腺癌的疗效和安全性
岳健
胡南林
王雪
司怡然
高崧淋
郑方超
巨洁
袁芃
作者及单位信息
·
DOI： 10.3760/cma.j.cn112152-20200809-00723
Evaluation of the efficacy and safety of combination of gemcitabine and nedaplatin for patients with HER-2 negative metastatic breast cancer
Yue Jian
Hu Nanlin
Wang Xue
Si Yiran
Gao Songlin
Zheng Fangchao
Ju Jie
Yuan Peng
Authors Info & Affiliations
Yue Jian
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
Hu Nanlin
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Wang Xue
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
Si Yiran
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Gao Songlin
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Zheng Fangchao
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
Ju Jie
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
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
·
DOI： 10.3760/cma.j.cn112152-20200809-00723
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摘要

目的评估吉西他滨联合奈达铂(GN方案)治疗人表皮生长因子受体2(HER-2)阴性晚期乳腺癌的疗效及安全性。

方法选择既往接受过蒽环类和(或)紫杉类药物辅助或新辅助治疗的HER-2阴性复发转移性乳腺癌患者45例，2014年1月至2019年2月在中国医学科学院肿瘤医院接受GN方案治疗。根据实体瘤的疗效评价标准(RECIST)1.1进行疗效评价，根据通用不良事件评价标准(CTCAE)进行不良反应的评估和监测。随访患者的无进展生存时间(PFS)和总生存时间(OS)，分析预后影响因素。

结果45例患者接受中位4个周期的治疗，其中1例完全缓解，21例部分缓解，客观缓解率为48.9%(95% CI: 33.7%～64.1%)。10例(22.2%)患者出现3～4级白细胞减少，13例(28.9%)出现3～4级中性粒细胞减少，8例(17.8%)出现3～4级血小板减少。3～4级非血液学不良反应主要为恶心呕吐，发生率为4.4%(2/45)。45例患者中，34例死亡，中位PFS为5.1个月(95% CI: 3.9～6.1个月)，中位OS为17.6个月(95% CI: 13.1～20.9个月)。

结论对于既往接受过蒽环类和(或)紫杉类药物治疗的HER-2阴性复发转移性晚期乳腺癌患者，GN方案是一种有效且耐受性较好的化疗方案。

乳腺肿瘤;吉西他滨;奈达铂;人表皮生长因子受体2
ABSTRACT

ObjectiveTo assess the therapeutic efficacy and safety of the gemcitabine combined with nedaplatin (GN) chemotherapy for metastatic human epidermal growth factor receptor-2 (HER-2) negative breast cancer patients.

MethodsForty-five patients with HER-2 negative recurrent metastatic breast cancer who had received prior adjuvant or neoadjuvant therapy with anthracycline and/or taxanes were enrolled. All the patients received GN regime from January 2014 to February 2019. The therapeutic efficacy was evaluated according to response evaluation criteria in solid tumors (RECIST) 1.1. The adverse response was evaluated and monitored according to common terminology criteria for adverse events (CTCAE). The progression-free survival (PFS) and overall survival (OS) and prognostic factors were also analyzed.

ResultsAll of the 45 patients received 4 course GN, 1 of them achieved complete response, 21 achieved partial response. The objective response rate was 48.9 (95% CI: 33.7%-64.1%). Grade 3-4 hematological toxicities include leukopenia occurred in 10 (22.2%) of patients, neutropenia in 13 (28.9%) patients, and thrombocytopenia in 8 (17.6%) patients. The grade 3-4 hematological toxicities mainly manifested as nausea and vomiting, and the incidence was 4.4% (2/45). Among the 45 patients, 34 died, the median PFS was 5.1 (95% CI: 3.9-6.1) months and the median OS was 17.6 (95% CI: 13.1-20.9) months.

ConclusionThe combination of gemcitabine and nedaplatin is an effective and tolerable treatment for metastatic breast cancer patients previously treated with anthracyclines and/or taxanes.

Breast neoplasms;Gemcitabine;Nedaplatin;Human epidermal growth factor receptor-2
Yuan Peng, Email: mocdef.labiamtoh10gnepnauy
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引用本文

岳健,胡南林,王雪,等. 吉西他滨联合奈达铂治疗人表皮生长因子受体2阴性晚期乳腺癌的疗效和安全性[J]. 中华肿瘤杂志,2021,43(08)：883-888.

DOI:10.3760/cma.j.cn112152-20200809-00723

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在复发转移性晚期乳腺癌的治疗过程中，对治疗药物的耐药性是影响治疗的主要因素。对于复发转移性乳腺癌治疗的新化疗方案，要求在克服耐药、延长生存时间的同时，应有较为良好的耐受性。吉西他滨作为一种新型的嘧啶类抗代谢药物，广泛应用于恶性肿瘤治疗中 [ 1 ]，与铂类药物具有协同作用 [ 2 ]。吉西他滨联合顺铂方案治疗晚期肺癌的有效率为28%～54%，中位生存时间为7.6～15.4个月，1年生存率为35%～61% [ 3 , 4 ]。吉西他滨联合卡铂治疗晚期恶性肿瘤有效率约为25%～52%，中位生存时间为7.4～15.4个月 [ 5 , 6 , 7 , 8 , 9 ]。奈达铂为第2代铂类药物，其治疗机制与顺铂相似，主要通过阻断DNA修复发挥抗肿瘤作用 [ 4 , 10 ]。研究表明，奈达铂具有与顺铂同等或比顺铂更高的抗肿瘤活性，且肾毒性更小，其剂量限制性毒性为中性粒细胞和血小板减少 [ 2 ]。鉴于目前尚无吉西他滨联合奈达铂治疗复发转移性乳腺癌的相关数据，在本研究中，我们采用这一方案治疗了45例人表皮生长因子受体2(human epidermal growth factor receptor-2, HER-2)阴性复发转移性乳腺癌患者，前瞻性观察了其疗效和安全性。
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备注信息
A
袁芃，Email： mocdef.labiamtoh10gnepnauy
B
所有作者均声明不存在利益冲突
C
中国癌症基金会北京希望马拉松专项基金 (LC2018B15)
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