Kazmi Shayma, Chatterjee Debanjana, Raju Dheeraj, Hauser Rob, Kaufman Peter A
Cancer Treatment Centers of America, Philadelphia, PA, USA.
US Health Economics Outcomes Research and Real World Evidence, Eisai Inc., Woodcliff Lake, NJ, USA.
Breast Cancer Res Treat. 2020 Nov;184(2):559-565. doi: 10.1007/s10549-020-05867-0. Epub 2020 Aug 17.
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+).
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.
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.
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.
本研究旨在评估在三线治疗中接受艾日布林、吉西他滨或卡培他滨治疗的转移性乳腺癌（MBC）合并内脏转移（肝脏或肺部）患者在真实世界临床实践中的总生存期（OS），以及在MBC的主要临床分类（三阴乳腺癌、激素受体阳性/人表皮生长因子受体2阴性和人表皮生长因子受体2阳性）中的总生存期。
利用美国癌症治疗中心（CTCA）去识别化的患者电子健康记录进行了一项回顾性观察研究。分析纳入了诊断为伴有肺或肝转移的转移性乳腺癌且接受艾日布林、吉西他滨或卡培他滨作为三线治疗的患者。计算6个月、12个月、24个月和36个月时存活患者的百分比作为标志性生存期。使用对数秩分析比较三阴乳腺癌和激素受体阳性/人表皮生长因子受体2阴性治疗组之间的总生存期。进行Cox回归分析以估计三阴乳腺癌和激素受体阳性/人表皮生长因子受体2阴性亚型内治疗比较的风险比。
443例伴有肝或肺转移的患者接受了三线治疗，其中艾日布林治疗229例，吉西他滨治疗134例，卡培他滨治疗80例。与吉西他滨相比，艾日布林治疗的患者在所有标志性时间点的存活百分比更高，与卡培他滨相比，直到36个月时存活患者的百分比更高。中位生存时间表明，总体而言，以及在三阴乳腺癌和激素受体阳性/人表皮生长因子受体2阴性亚型中，接受艾日布林治疗的患者中位总生存期在数值上更高。
这项真实世界证据研究与随机临床试验数据一致，证明了艾日布林在伴有肺或肝转移的MBC患者总体以及三阴乳腺癌和激素受体阳性/人表皮生长因子受体2阴性疾病中的有效性具有一致性。
