The efficacy of sequential second-line endocrine therapies (ETs) in postmenopausal estrogen receptor-positive and HER2-negative metastatic breast cancer patients with lower sensitivity to initial ETs
The efficacy of sequential second-line endocrine therapies (ETs) in postmenopausal estrogen receptor-positive and HER2-negative metastatic breast cancer patients with lower sensitivity to initial ETs
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DOI：
10.1007/s12282-020-01095-y
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发表时间：
2020-05-11
期刊：
影响因子：
4
通讯作者：
Taira, Naruto
中科院分区：
文献类型：
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作者：
Iwamoto, Takayuki;Fujisawa, Tomomi;Taira, Naruto
目的根据一线内分泌治疗（ET）的疗效，为雌激素受体（ER）阳性和人表皮生长因子2（HER 2）阴性的转移性乳腺癌（MBC）提供二线内分泌治疗（ET）。然而，没有临床试验评估了继发性血管紧张素转换酶抑制剂在对初始ET反应差的患者中的疗效和安全性。本研究评价了对初始ET敏感性低或极低的ER阳性和HER 2阴性绝经后MBC患者的二线ET疗效。方法采用多中心、前瞻性、观察性、队列研究的方法，对49例对ET敏感性低或极低的绝经后乳腺癌患者进行了二线化疗。主要终点是24周的临床获益率（CBR）。结果在49例患者中，40例（82%）接受氟维司群二线治疗，5例（10%）接受选择性雌激素受体调节剂治疗，3例（6%）单独接受芳香酶抑制剂（AI）治疗，1例接受依维莫司与类固醇AI联合治疗。总体CBR为44.9% [90%置信区间（CI）：34.6-57.6，p = 0.009]; CBR在孕酮受体阳性患者中表现出相似的显著性。（n = 39，51.3%，90% CI：39.6-65.2，p = 0.002），灵敏度极低（n = 17，58.8%，90% CI：42.0-78.8，p = 0.003）和非内脏转移（n = 25，48.0%，90% CI：34.1-65.9，p = 0.018）组。中位无进展生存期为7.1个月（95% CI：5.6-10.6）。结论二线ET可能是一个可行的治疗选择与初始ET敏感性低和极低的绝经后MBC患者。未来的研究需要更大的和独立的队列来验证这些发现。
Purpose Second-line endocrine therapy (ET) for estrogen receptor (ER)-positive and human epidermal growth factor 2 (HER2)-negative metastatic breast cancer (MBC) is offered based on the response to first-line ET. However, no clinical trials have evaluated the efficacy and safety of secondary ETs in patients with poor responses to initial ET. This study evaluated the efficacy of second-line ET in ER-positive and HER2-negative postmenopausal MBC patients with low or very low sensitivity to initial ET. Methods This multicenter prospective observational cohort study evaluated the response of 49 patients to second-line ETs in postmenopausal MBC patients with low or very low sensitivity to initial ET. The primary endpoint was the clinical benefit rate (CBR) for 24 weeks. Results Of the 49 patients assessed, 40 (82%) received fulvestrant in the second line, 5 (10%) received selective estrogen receptor modulators, 3 (6%) received aromatase inhibitors (AIs) alone, and 1 received everolimus with a steroidal AI. The overall CBR was 44.9% [90% confidence interval (CI): 34.6-57.6, p = 0.009]; CBR demonstrated similar significance across the progesterone receptor-positive (n = 39, 51.3%, 90% CI: 39.6-65.2, p = 0.002), very low sensitivity (n = 17, 58.8%, 90% CI: 42.0-78.8, p = 0.003), and non-visceral metastases (n = 25, 48.0%, 90% CI: 34.1-65.9, p = 0.018) groups. The median progression-free survival was 7.1 months (95% CI: 5.6-10.6). Conclusion Second-line ET might be a viable treatment option for postmenopausal patients with MBC with low and very low sensitivity to initial ET. Future studies based on larger and independent cohorts are needed to validate these findings.