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曲妥珠单抗联合顺铂与曲妥珠单抗联合卡培他滨治疗老年HER2阳性晚期胃癌患者的回顾性比较

A Retrospective Comparison of Trastuzumab Plus Cisplatin and Trastuzumab Plus Capecitabine in Elderly HER2-Positive Advanced Gastric Cancer Patients.

作者信息

Zhu Bo, Wu Jun-Rong, Zhou Xiao-Ping

机构信息

From the Department of Clinical Laboratory, The Afffiliated Tumor Hospital of Guangxi Medical University, Nanning, Guangxi, China (BZ, J-RW); and Department of Clinical Laboratory, First Affiliated Hospital of Guangxi University of Chinese Medicine (X-PZ).

出版信息

Medicine (Baltimore). 2015 Aug;94(34):e1428. doi: 10.1097/MD.0000000000001428.

Abstract

A combination of trastuzumab and cisplatin or trastuzumab and capecitabine has been confirmed to be effective for treating adverse effects in with HER2-positive advanced gastric cancer (AGC) patients. We retrospectively compared the activity and safety of trastuzumab plus cisplatin (HP) and trastuzumab plus capecitabine (HX) for elderly HER2-positive AGC patients.Ninety two HER2-positive AGC patients were included in this study; of those 48 patients received trastuzumab (course 1, 8 mg/kg followed by course 2, onward, 6 mg/kg on day 1) plus cisplatin (60 mg/m) intravenously on day 1 of a 3-week cycle and 44 patients received trastuzumab (course 1, 8 mg/kg; course 2 onward, 6 mg/kg) plus intravenous oral capecitabine (1000 mg/m twice daily on days 1-14), every 3 weeks. The primary end point was overall survival (OS). The secondary end points included objective response rate (ORR), progression-free survival (PFS), and toxicity.The median age was 71 years in both groups. The median OS was 15.5 months in the HP group and 17.0 months in the HX group, with no significant difference between the 2 groups (P = 0.78). There were also no significant differences in PFS (median 6.6 months vs 7.2 months, respectively; P = 0.90) and ORR (58.3% vs 59.1%, respectively; P = 1.00) between the HP group and the HX group. The major grade 3 or 4 adverse events in the HP group and the HX group were neutropenia (35.4% vs 29.5%, respectively), followed by anorexia (25.0% vs 22.7%, respectively), and anemia (16.7% vs 13.6%, respectively), no significant differences were observed.HP and HX were associated with similar efficacy and safety in HER2-positive AGC patients.

摘要

曲妥珠单抗联合顺铂或曲妥珠单抗联合卡培他滨已被证实可有效治疗HER2阳性晚期胃癌(AGC)患者的不良反应。我们回顾性比较了曲妥珠单抗联合顺铂(HP)和曲妥珠单抗联合卡培他滨(HX)对老年HER2阳性AGC患者的有效性和安全性。本研究纳入了92例HER2阳性AGC患者;其中48例患者在3周周期的第1天接受曲妥珠单抗(第1疗程,8mg/kg,随后第2疗程及以后,第1天6mg/kg)联合顺铂(60mg/m²)静脉滴注,44例患者接受曲妥珠单抗(第1疗程,8mg/kg;第2疗程及以后,6mg/kg)联合静脉口服卡培他滨(第1 - 14天,1000mg/m²,每日2次),每3周一次。主要终点为总生存期(OS)。次要终点包括客观缓解率(ORR)、无进展生存期(PFS)和毒性。两组患者的中位年龄均为71岁。HP组的中位OS为15.5个月,HX组为17.0个月,两组之间无显著差异(P = 0.78)。HP组和HX组在PFS(中位分别为6.6个月和7.2个月;P = 0.90)和ORR(分别为58.3%和59.1%;P = 1.00)方面也无显著差异。HP组和HX组的主要3级或4级不良事件为中性粒细胞减少(分别为35.4%和29.5%),其次是厌食(分别为25.0%和22.7%)和贫血(分别为16.7%和13.6%),未观察到显著差异。HP和HX在HER2阳性AGC患者中具有相似的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f90/4602910/ef8f3da073d1/medi-94-e1428-g001.jpg

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