Gynecology and Obstetrics Department, University of Schleswig-Holstein, Campus Lübeck, Lübeck, Germany
Center for Gynecological Oncology and Palliative Medicine, University of Applied Sciences, Chemnitz, Germany.
Anticancer Res. 2020 Jul;40(7):3973-3981. doi: 10.21873/anticanres.14390.
BACKGROUND/AIM: HER2-positive breast cancers eventually relapse in about one third of patients. Is anti-HER2-directed therapy with Herceptin® (trastuzumab) effective in re-treatment? Between 2008 and 2018, 216 patients with recurrent HER2-positive breast cancer (BC) were re-treated with Herceptin (HER) during first-line therapy. This study assessed the effectiveness and tolerability of re-treatment with HER.
After approval from Ethical committee, the NIS was conducted according to German Drug Act. Re-treatment with HER was documented at routine visits starting with a basic observational period of maximum 12 months and a follow-up period of maximum additional four years.
HER2-positive BC relapsed after a median of 36.5 months (mos). Patients were re-treated with HER +/- chemotherapy +/- endocrine therapy. HER-containing regimens resulted in median progression-free survival (mPFS) of 12.7 (95%CI=10.5-14.8) mos and overall survival (OS-2) of 31.6 mos (95%CI=28.8-38.4) since recurrence diagnosis. Differentiation of recurrence types (local, visceral, non-visceral) unfolded worst prognosis for patients with visceral metastases. Cardiac monitoring within this non-interventional study (NIS) did not result in new safety concerns.
Re-therapy with HER in the first-line setting of advanced HER2-positive breast cancer is effective and without unexpected or intensified adverse events.
背景/目的：HER2 阳性乳腺癌约有三分之一的患者最终会复发。曲妥珠单抗（赫赛汀）等抗 HER2 定向治疗在复治中是否有效？在 2008 年至 2018 年间，216 例复发性 HER2 阳性乳腺癌（BC）患者在一线治疗中接受了赫赛汀（HER）的再治疗。本研究评估了再用 HER 治疗的有效性和耐受性。
在伦理委员会批准后，根据德国药品法进行了 NIS。HER 的再治疗在常规就诊时记录，起始有最长 12 个月的基础观察期和最长另外 4 年的随访期。
HER2 阳性 BC 在中位数 36.5 个月（mos）后复发。患者接受了 HER +/-化疗 +/-内分泌治疗的再治疗。含 HER 的方案导致中位无进展生存期（mPFS）为 12.7（95%CI=10.5-14.8）mos，自复发诊断以来的总生存期（OS-2）为 31.6 mos（95%CI=28.8-38.4）。复发类型（局部、内脏、非内脏）的分化对有内脏转移的患者预后最差。本非干预性研究（NIS）中的心脏监测未导致新的安全问题。
在晚期 HER2 阳性乳腺癌的一线治疗中，HER 的再治疗是有效的，且没有意外或加重的不良事件。
