Tai Cheng-Jeng, Huang Ming-Te, Wu Chih-Hsiung, Wang Chien-Kai, Tai Chen-Jei, Chang Chun-Chao, Hsieh Cheng-I, Chang Yu-Jia, Wu Chang-Jer, Kuo Li-Jen, Wei Po-Lei, Chen Ray-Jade, Chiou Hung-Yi
From the Division of Hematology and Oncology, Department of Internal Medicine, Taipei Medical University Hospital (C-JT, C-KW, C-CC, C-IH); Department of Internal Medicine (C-JT, C-KW, C-IH); Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University (M-TH, L-JK, P-LW, RJC); Division of General Surgery, Department of Surgery, Shuang Ho Hospital (M-TH, C-HW); Center of Excellence for Cancer Research, Taipei Medical University (C-HW); Department of Surgery, Taipei Medical University-Shuang Ho Hospital (C-HW); Department of Obstetrics and Gynecology, School of Medicine, College of Medicine, Taipei Medical University (C-KW, C-JT); Department of Chinese Medicine (C-KW, C-JT); Traditional Herbal Medicine Research Center (C-KW, C-JT); Division of Gastroenterology, Department of Internal Medicine (C-CC); Cancer Research Center, Taipei Medical University Hospital (Y-JC); Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University (Y-JC, L-JK, P-LW); Division of General Surgery, Department of Surgery, Taipei Medical University Hospital, Taipei (Y-JC, L-JK, P-LW, R-JC); Department of Food Science (C-JW); Center of Excellence for the Oceans, National Taiwan Ocean University, Keelung (C-JW); Program for Cancer Biology and Drug Discovery, College of Medical Science and Technology, Taipei Medical University (P-LW); and School of Public Health, College of Public Health and Nutrition, Taipei Medical University, Taipei, Taiwan (H-YC).
Medicine (Baltimore). 2016 Apr;95(15):e3259. doi: 10.1097/MD.0000000000003259.
The objective of this study is to evaluate the efficacy and safety profiles of the targeted medications, bevacizumab and cetuximab, in combination with cytostatic drugs in patients with locally advanced or metastatic pancreatic cancer. In this retrospective phase 2 study, a total of 59 patients with pancreatic cancer were recruited and received conventional (gemcitabine, cisplatin, and fluorouracil) or targeted regimen (conventional plus bevacizumab and cetuximab for the first cycle) in 2-week intervals for four cycles. The primary end-point for this study was the overall response rate. Secondary end-points were progression-free survival and the safety profiles of the combined therapy. The median time-to-progression and overall survival were 3 and 7 months, respectively, in the conventional treatment group as well as 11 and 13 months, respectively, in the targeted medications treatment group. The most common adverse events in both treatment groups were nausea and vomiting. Moderate (Grade 2) nausea and vomiting were more common in the conventional group than the targeted group but severe (Grade 3) nausea and vomiting were more common in the targeted group. Bevacizumab and cetuximab in combination with gemcitabine, cisplatin, and fluorouracil may help lengthen overall survival up to six months for patients with pancreatic cancer.
本研究的目的是评估靶向药物贝伐单抗和西妥昔单抗与细胞生长抑制剂联合应用于局部晚期或转移性胰腺癌患者的疗效和安全性。在这项回顾性2期研究中,共招募了59例胰腺癌患者,每2周接受一次常规治疗(吉西他滨、顺铂和氟尿嘧啶)或靶向治疗方案(第一个周期为常规治疗加贝伐单抗和西妥昔单抗),共四个周期。本研究的主要终点是总缓解率。次要终点是无进展生存期和联合治疗的安全性。常规治疗组的中位进展时间和总生存期分别为3个月和7个月,靶向药物治疗组分别为11个月和13个月。两个治疗组中最常见的不良事件是恶心和呕吐。中度(2级)恶心和呕吐在常规组比靶向组更常见,但严重(3级)恶心和呕吐在靶向组更常见。贝伐单抗和西妥昔单抗与吉西他滨、顺铂和氟尿嘧啶联合应用可能有助于将胰腺癌患者的总生存期延长至6个月。