医学
多西紫杉醇
内科学
肿瘤科
乳腺癌
紫杉烷
转移性乳腺癌
脑转移
卡培他滨
临床终点
吉西他滨
人口
艾瑞布林
癌症
随机对照试验
转移
结直肠癌
环境卫生
作者
Javier Cortés,Hope S. Rugo,Ahmad Awada,Chris Twelves,Edith A. Perez,Seock‐Ah Im,Patricia Gómez-Pardo,Lee S. Schwartzberg,Véronique Dièras,Denise A. Yardley,David A. Potter,Audrey Mailliez,Alvaro Moreno-Aspitia,Jin Seok Ahn,Carol Zhao,Ute Hoch,Mary Tagliaferri,Alison L. Hannah,Joyce O’Shaughnessy
标识
DOI:10.1007/s10549-017-4304-7
摘要
Abstract Purpose Conventional chemotherapy has limited activity in patients with breast cancer and brain metastases (BCBM). Etirinotecan pegol (EP), a novel long-acting topoisomerase-1 inhibitor, was designed using advanced polymer technology to preferentially accumulate in tumor tissue including brain metastases, providing sustained cytotoxic SN38 levels. Methods The phase 3 BEACON trial enrolled 852 women with heavily pretreated locally recurrent or metastatic breast cancer between 2011 and 2013. BEACON compared EP with treatment of physician’s choice (TPC; eribulin, vinorelbine, gemcitabine, nab-paclitaxel, paclitaxel, ixabepilone, or docetaxel) in patients previously treated with anthracycline, taxane, and capecitabine, including those with treated, stable brain metastases. The primary endpoint, overall survival (OS), was assessed in a pre-defined subgroup of BCBM patients; an exploratory post hoc analysis adjusting for the diagnosis-specific graded prognostic assessment (GPA) index was also conducted. Results In the trial, 67 BCBM patients were randomized (EP, n = 36; TPC, n = 31). Treatment subgroups were balanced for baseline characteristics and GPA indices. EP was associated with a significant reduction in the risk of death (HR 0.51; P < 0.01) versus TPC; median OS was 10.0 and 4.8 months, respectively. Improvement in OS was observed in both poorer and better GPA prognostic groups. Survival rates at 12 months were 44.4% for EP versus 19.4% for TPC. Consistent with the overall BEACON population, fewer patients on EP experienced grade ≥3 toxicity (50 vs. 70%). Conclusions The significant improvement in survival in BCBM patients provides encouraging data for EP in this difficult-to-treat subgroup of patients. A phase three trial of EP in BCBM patients is underway (ClinicalTrials.gov NCT02915744).
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