Nimotuzumab Plus Gemcitabine for K-Ras Wild-Type Locally Advanced or Metastatic Pancreatic Cancer

著者: Shukui Qin, Jin Li, Yuxian Bai, Zishu Wang, Zhendong Chen, Rui‐Hua Xu, Jianming Xu, Hongmei Zhang, Jia Chen, Ying Yuan, Tianshu Liu, Lin Yang, Haijun Zhong, Donghui Chen, Lin Shen, Chunyi Hao, Deliang Fu, Ying Cheng, Jianwei Yang, Qiong Wang, Baoli Qin, Hongming Pan, Jun Zhang, Xianhong Bai, Qingshan Zheng - Journal of Clinical Oncology 2023 被引用: 54

PURPOSE: In a phase IIb trial of nimotuzumab plus gemcitabine, substantial clinical benefits were observed in patients with locally advanced or metastatic pancreatic cancer (PC). Therefore, we conducted a phase III clinical study to verify the efficacy and safety of this combination regimen in patients with K-Ras wild-type tumors (ClinicalTrials.gov identifier: NCT02395016). PATIENTS AND METHODS: on days 1, 8, and 15, once every 4 weeks) until disease progression or unacceptable toxicity. The primary end point was overall survival (OS) and the secondary end points were progression-free survival (PFS), response rates, and safety. RESULTS: = .036). Both OS and PFS were longer in the nimotuzumab group than in the placebo group. The objective response rates and disease control rates were 7% versus 10% and 68% versus 63% for the investigational and control groups, respectively. The incidence of adverse events were comparable between the two groups. CONCLUSION: In patients with locally advanced or metastatic K-Ras wild-type PC, nimotuzumab plus gemcitabine significantly improved OS and PFS with a good safety profile.