Stefanou Dimitra, Kokkali Stefania, Tripodaki Elli-Sophia, Drizou Maria, Magou Elpida, Zylis Dimosthenis, Prevezanou Maria, Kapiris Matthaios, Nasi Despoina, Ntokou Anna, Dede Mary, Ardavanis Alexandros
First Medical Oncology Clinic, Saint Savvas Anticancer Hospital, Athens, Greece.
First Medical Oncology Clinic, Saint Savvas Anticancer Hospital, Athens, Greece
Anticancer Res. 2018 Nov;38(11):6565-6569. doi: 10.21873/anticanres.13023. Epub 2018 Nov 5.
BACKGROUND/AIM: Subcutaneous (s.c.) trastuzumab was introduced in the (neo)adjuvant setting, based on the non-inferiority results and patient preference. In the advanced setting, preliminary safety data have only been reported. We conducted an observational study of s.c. trastuzumab in combination with i.v. pertuzumab and docetaxel in the first-line setting of human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer.
In this single-institution study, patients received 600 mg s.c. trastuzumab in combination with 840 mg pertuzumab for the first cycle and 420 mg for the following cycles, and 75-100 mg/m docetaxel, followed by maintenance with s.c. trastuzumab and pertuzumab until disease progression or unacceptable toxicity. Endpoints were efficacy and safety.
Forty patients were enrolled. The median number of cycles with docetaxel was six, while the median number of maintenance cycles was 21. With a median follow-up of 37 months, median progression-free survival and overall survival were 24 and 35 months.
Subcutaneous trastuzumab in combination with pertuzumab and docetaxel is well tolerated and effective in HER2-positive advanced breast cancer.
背景/目的：基于非劣效性结果和患者偏好，皮下注射曲妥珠单抗已被引入（新）辅助治疗。在晚期治疗中，仅报道了初步的安全性数据。我们开展了一项关于皮下注射曲妥珠单抗联合静脉注射帕妥珠单抗和多西他赛用于一线治疗人表皮生长因子受体2（HER2）阳性晚期乳腺癌的观察性研究。
在这项单机构研究中，患者在第一个周期接受600 mg皮下注射曲妥珠单抗联合840 mg帕妥珠单抗，后续周期接受420 mg帕妥珠单抗，以及75 - 100 mg/m²多西他赛，之后继续接受皮下注射曲妥珠单抗和帕妥珠单抗维持治疗，直至疾病进展或出现不可接受的毒性。观察终点为疗效和安全性。
共纳入40例患者。多西他赛的中位周期数为6个，而维持治疗的中位周期数为21个。中位随访37个月，中位无进展生存期和总生存期分别为24个月和35个月。
皮下注射曲妥珠单抗联合帕妥珠单抗和多西他赛在HER2阳性晚期乳腺癌中耐受性良好且疗效显著。
