Michel Laura L, Hartkopf Andreas D, Fasching Peter A, Kolberg Hans-Christian, Hadji Peyman, Tesch Hans, Häberle Lothar, Ettl Johannes, Lüftner Diana, Wallwiener Markus, Müller Volkmar, Beckmann Matthias W, Belleville Erik, Volz Bernhard, Huebner Hanna, Wimberger Pauline, Hielscher Carsten, Mundhenke Christoph, Kurbacher Christian, Wuerstlein Rachel, Untch Michael, Overkamp Friedrich, Huober Jens, Janni Wolfgang, Taran Florin-Andrei, Lux Michael P, Wallwiener Diethelm, Brucker Sara Y, Schneeweiss Andreas, Fehm Tanja N
Department of Gynecology and Obstetrics, Heidelberg University Hospital, 69120 Heidelberg, Germany.
National Center for Tumor Diseases, Heidelberg University Hospital, German Cancer Research Center (DKFZ), 69120 Heidelberg, Germany.
Cancers (Basel). 2020 Oct 17;12(10):3021. doi: 10.3390/cancers12103021.
The approval of trastuzumab emtansine (T-DM1) was conducted without pertuzumab as previous therapy. Efficacy data on T-DM1 following pertuzumab treatment are therefore limited. This study explores this issue in a real-world setting. Within the prospective PRAEGNANT (Prospective Academic Translational Research Network for the Optimization of the Oncological Health Care Quality in the Advanced Setting) metastatic breast cancer registry (NCT02338167), patients in all therapy lines receiving any kind of treatment were eligible for inclusion. This report describes patient characteristics and progression-free survival (PFS) in human epidermal growth factor receptor 2 (HER2)-positive patients receiving T-DM1 after pertuzumab treatment. Seventy-six patients were identified, 39 of whom received T-DM1 as second-line therapy, 25 as third-line, and 12 as fourth-line therapy or higher. Pertuzumab was mostly administered as a first-line treatment ( = 61; 80.3%). The median PFS in all patients was 3.5 months (95% CI: 2.8-7.8); in second-line treatment, 7.7 months (95% CI: 2.8-11.0); in third-line, 3.4 months (95% CI: 2.3-not reached (NR)); and in fourth-line therapy or higher, 2.7 months (95% CI: 1.2-NR). T-DM1 was mainly administered second-line after pertuzumab, but also in more heavily pretreated patients. The PFS in higher therapy lines appears to be shorter than in second-line.
曲妥珠单抗（ado）曲妥珠单抗（T-DM1）的批准是在未使用帕妥珠单抗作为先前治疗的情况下进行的。因此，关于帕妥珠单抗治疗后T-DM1的疗效数据有限。本研究在真实世界环境中探讨了这一问题。在前瞻性PRAEGNANT（晚期环境中肿瘤医疗质量优化的前瞻性学术转化研究网络）转移性乳腺癌登记处（NCT02338167）中，所有接受任何治疗的治疗线患者均符合纳入条件。本报告描述了接受帕妥珠单抗治疗后接受T-DM1的人表皮生长因子受体2（HER2）阳性患者的特征和无进展生存期（PFS）。共确定了76例患者，其中39例接受T-DM1作为二线治疗，25例作为三线治疗，12例作为四线或更高线治疗。帕妥珠单抗大多作为一线治疗给药（n = 61；80.3%）。所有患者的中位PFS为3.5个月（95%CI：2.8-7.8）；二线治疗为7.7个月（95%CI：2.8-11.0）；三线治疗为3.4个月（95%CI：2.3-未达到（NR））；四线或更高线治疗为2.7个月（95%CI：1.2-NR）。T-DM1主要在帕妥珠单抗后二线给药，但也用于预处理更严重的患者。更高治疗线的PFS似乎比二线治疗短。
