艾立布林单药治疗乳腺癌肝肺转移结局
艾立布林是一种人工合成的软海绵素类似物化疗药，可抑制肿瘤细胞的有丝分裂和转移能力，2010年、2011年、2019年被美国、欧盟、中国先后批准用于至少两种化疗方案失败的晚期乳腺癌转移患者。
2020年8月17日，德国施普林格旗下《乳腺癌研究与治疗》在线发表美国癌症治疗中心、卫材株式会社、佛蒙特大学癌症中心、拉纳医学院的真实世界研究报告，对艾立布林、吉西他滨、卡培他滨三种单药三线治疗三种类型晚期乳腺癌肝或肺转移患者的总生存进行了比较。
该回顾观察研究对2012年1月1日～2018年10月13日接受艾立布林或吉西他滨或卡培他滨三药之一三线化疗的443例晚期乳腺癌肝或肺转移患者电子病历进行回顾分析。通过生存曲线，对6、12、24、36个月时的生存患者比例进行比较，通过对数秩分析，对各个治疗组的三阴性乳腺癌、激素受体阳性HER2阴性乳腺癌、HER2阳性乳腺癌患者总生存比例进行比较。通过多因素比例风险回归模型，对三阴性乳腺癌、激素受体阳性HER2阴性乳腺癌、HER2阳性乳腺癌不同治疗方法的总生存比例进行比较。
结果，其中艾立布林、吉西他滨、卡培他滨三线治疗患者分别为229例、134例、80例。
艾立布林、吉西他滨、卡培他滨相比，生存患者比例：
6个月时：65.1%、55.2%、48.8%
12个月时：38.0%、29.9%、30%
24个月时：14.0%、11.9%、12.5%
36个月时：7%、6.7%、10%
中位总生存：9.8、7.2、9.1个月
对于三阴性乳腺癌，艾立布林、吉西他滨、卡培他滨相比，生存患者比例：
6个月时：48.5%、50.0%、45.0%
12个月时：34.9%、30.6%、25.0%
24个月时：19.7%、11.1%、15.0%
36个月时：7.6%、2.8%、15.0%
中位总生存：7.0、6.0、5.5个月
对于激素受体阳性HER2阴性乳腺癌，艾立布林、吉西他滨、卡培他滨相比，生存患者比例：
6个月时：71.8%、50.7%、46.3%
12个月时：41.6%、27.3%、24.4%
24个月时：11.3%、10.4%、12.2%
36个月时：7.0%、6.5%、7.3%
中位总生存：11、6.4、9.1个月
对于HER2阳性乳腺癌，艾立布林、吉西他滨、卡培他滨相比，生存患者比例：
6个月时：71.4%、81.0%、57.9%
12个月时：23.8%、38.1%、47.4%
24个月时：14.3%、19.1%、10.5%
36个月时：4.8%、14.3%、10.5%
中位总生存：10.3、12.8、15.4个月
因此，该真实世界研究结果表明，对于晚期乳腺癌肺或肝转移患者，尤其对于三阴性乳腺癌、激素受体阳性HER2阴性乳腺癌患者，艾立布林与吉西他滨或卡培他滨相比，总生存比例较高、总生存时间较长。
相关链接
Breast Cancer Res Treat. 2020 Aug 17. Online ahead of print.
Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine.
Shayma Kazmi, Debanjana Chatterjee, Dheeraj Raju, Rob Hauser, Peter A. Kaufman.
Cancer Treatment Centers of America, Philadelphia, PA, USA; US Health Economics Outcomes Research and Real World Evidence, Eisai Inc., Woodcliff Lake, NJ, USA; Cancer Treatment Centers of America Global, Inc., Boca Raton, FL, USA; Larner College of Medicine, University of Vermont Cancer Center, Burlington, VT, USA.
PURPOSE: The purpose of this study was to estimate the overall survival (OS) in real-world clinical practice in patients with metastatic breast cancer (MBC) and visceral metastases (liver or lung) treated in the third-line setting with eribulin, gemcitabine or capecitabine overall and in the major clinical categories of MBC (TNBC, HR+/HER2-, and HER2+).
METHODS: A retrospective, observational study was conducted with de-identified patient electronic health records from the Cancer Treatment Centers of America (CTCA). Patients with a diagnosis of metastatic breast with lung or liver metastases, and treated with eribulin, gemcitabine, or capecitabine as third-line therapy were included in the analysis. Landmark survival was calculated as percentage of patients alive at 6, 12, 24, and 36 months. Overall survival was compared between treatment arms within TNBC and HR+/HER2- using log-rank analysis. Cox regression analyses was performed to estimate hazard ratios for comparison of treatments within TNBC and HR+/HER2- subtype.
RESULTS: 443 patients with liver or lung metastases received third-line therapy with eribulin (n=229), gemcitabine (n=134), or capecitabine (n=80). Eribulin patients had a higher percentage of patients alive at all landmark timepoints vs. gemcitabine, and a higher percentage of patients alive until 36 months vs. capecitabine. Median survival times showed that overall, and within the TNBC and HR+/HER2- subtype, patients receiving eribulin had a numerically higher median overall survival.
CONCLUSIONS: This real-world evidence study is consistent with randomized clinical trial data and demonstrates consistency of eribulin effectiveness in MBC patients with lung or liver metastases overall and in TNBC and HR+/HER2- disease.
KEYWORDS: Metastatic breast cancer; Visceral metastases; Overall survival; Eribulin; Real-world evidence
DOI: 10.1007/s10549-020-05867-0