Abstract：
OBJECTIVE: Eribulin is used in taxane and anthracycline refractory HER2-negative metastatic breast cancers (MBC). Patients treated in pivotal clinical trials achieved low survival rates, therefore, the identification of prognostic criteria for long progression-free survival (PFS) is still an unmet medical need. In this study, we sought to determine potential prognostic criteria for long-term eribulin response in HER2-negative MBC.
METHODS: Our retrospective cohort includes female patients with HER2-negative MBC treated with eribulin in Franche-Comté, France. We defined a long-term response as at least 6 months of eribulin treatment. The primary endpoint was the analysis of criteria that differ according to the progression-free survival. Secondary outcomes concerned overall survival and response rate.
RESULTS: From January 2011 to April 2020, 431 patients treated with eribulin were screened. Of them, 374 patients were included. Median PFS was 3.2 months (2.8-3.7). Eighty-eight patients (23.5%) had a long-term response to eribulin. Four discriminant criteria allowed to separate PFS in 2 arms (PFS < 3 months or > 6 months) with a 78% positive predictive value: histological grade, absence of meningeal metastasis, response to prior chemotherapy, and OMS status. We have developed a nomogram combining these 4 criteria. Median overall survival was 8.5 months (7.0-9.5).
CONCLUSIONS: Eribulin response in MBC can be driven by clinical and biological factors. Application of our nomogram could assist in the prescription of eribulin.
METHODS: Our retrospective cohort includes female patients with HER2-negative MBC treated with eribulin in Franche-Comté, France. We defined a long-term response as at least 6 months of eribulin treatment. The primary endpoint was the analysis of criteria that differ according to the progression-free survival. Secondary outcomes concerned overall survival and response rate.
RESULTS: From January 2011 to April 2020, 431 patients treated with eribulin were screened. Of them, 374 patients were included. Median PFS was 3.2 months (2.8-3.7). Eighty-eight patients (23.5%) had a long-term response to eribulin. Four discriminant criteria allowed to separate PFS in 2 arms (PFS < 3 months or > 6 months) with a 78% positive predictive value: histological grade, absence of meningeal metastasis, response to prior chemotherapy, and OMS status. We have developed a nomogram combining these 4 criteria. Median overall survival was 8.5 months (7.0-9.5).
CONCLUSIONS: Eribulin response in MBC can be driven by clinical and biological factors. Application of our nomogram could assist in the prescription of eribulin.
摘要：
目的：Eribulin用于紫杉烷和蒽环类药物难治性HER2阴性转移性乳腺癌（MBC）。在关键临床试验中接受治疗的患者生存率较低，因此,确定长期无进展生存期(PFS)的预后标准仍是一项未满足的医疗需求.在这项研究中,我们试图确定HER2阴性MBC长期艾瑞布林反应的潜在预后标准.
方法：我们的回顾性队列包括在Franche-Comté接受eribulin治疗的HER2阴性MBC女性患者，法国。我们将长期反应定义为至少6个月的eribulin治疗。主要终点是根据无进展生存期而不同的标准分析。次要结果涉及总生存率和缓解率。
结果：从2011年1月至2020年4月，筛查了431名接受艾瑞布林治疗的患者。其中,包括374名患者。PFS中位数为3.2个月（2.8-3.7）。88例患者(23.5%)对艾日布林有长期反应。四个判别标准允许在2个分组（PFS<3个月或>6个月）中分离PFS，阳性预测值为78％：组织学等级，没有脑膜转移，对先前化疗的反应，OMS状态。我们开发了结合这4个标准的列线图。中位总生存期为8.5个月（7.0-9.5）。
结论：MBC中的Eribulin反应可由临床和生物学因素驱动。我们的列线图的应用可以帮助处方艾瑞布林。
方法：我们的回顾性队列包括在Franche-Comté接受eribulin治疗的HER2阴性MBC女性患者，法国。我们将长期反应定义为至少6个月的eribulin治疗。主要终点是根据无进展生存期而不同的标准分析。次要结果涉及总生存率和缓解率。
结果：从2011年1月至2020年4月，筛查了431名接受艾瑞布林治疗的患者。其中,包括374名患者。PFS中位数为3.2个月（2.8-3.7）。88例患者(23.5%)对艾日布林有长期反应。四个判别标准允许在2个分组（PFS<3个月或>6个月）中分离PFS，阳性预测值为78％：组织学等级，没有脑膜转移，对先前化疗的反应，OMS状态。我们开发了结合这4个标准的列线图。中位总生存期为8.5个月（7.0-9.5）。
结论：MBC中的Eribulin反应可由临床和生物学因素驱动。我们的列线图的应用可以帮助处方艾瑞布林。
