Randomized, Phase III Trial of Mixed Formulation of Fosrolapitant and Palonosetron (HR20013) in Preventing Cisplatin-Based Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: PROFIT.

• Tác giả: Fengjun Cao, Ke Cao, Gang Chen, Jinping Chen, Wenfeng Fang, Yan Huang, Shuang Leng, Na Li, Weiwei Li, Xiang Li, Xiumin Li, Dang Lin, Li Lin, Yanda Lu, Jiazhuan Mei, Xia Qin, Zhiquan Qin, Huan Wang, Ruoyu Wang, Yujiao Wang, Zhenghua Wang, Runxiang Yang, Xue Yang, Yunpeng Yang, Jun Yao, Tienan Yi, Yan Yu, Aimin Zang, Li Zhang, Mingjun Zhang, Songnan Zhang, Yaxiong Zhang, Yuanyuan Zhao, Qinhong Zheng, Huaqiang Zhou, Ningning Zhou, Ting Zhou, Yan Zhou
• Ngôn ngữ: eng
• Ký hiệu phân loại: 943.02 843-1519
• Thông tin xuất bản: United States : Journal of clinical oncology : official journal of the American Society of Clinical Oncology , 2025
• Bộ sưu tập: NCBI
• ID: 700340

Tóm tắt

 PURPOSE: Mixed formulation of fosrolapitant and palonosetron (PALO), HR20013, is a novel fixed-dose intravenous antiemetic combination that could simultaneously antagonize neurokinin-1 and 5-hydroxytryptamine-3 receptors. This study was designed to evaluate the efficacy and safety of HR20013 plus dexamethasone (DEX) versus fosaprepitant (FAPR) plus PALO + DEX for preventing chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC). METHODS: This is a noninferiority study. Chemotherapy-naïve patients were randomly assigned 1:1 to receive HR20013 (day 1) or FAPR + PALO (day 1) before each cycle of cisplatin-based HEC (two cycles in total), together with oral DEX (day 1-4). The primary end point was overall (0-120 hours) complete response (CR
  no vomiting/no rescue therapy) rate in cycle 1. The key secondary end point was CR rate at the beyond delayed phase (120-168 hours) in cycle 1. RESULTS: Three hundred seventy-three patients were enrolled to receive HR20013 + DEX and 377 to FAPR + PALO + DEX. The overall CR rate in cycle 1 was 77.7% for HR20013 + DEX and 78.2% for FAPR + PALO + DEX (difference = -0.9% [95% CI, -6.7 to 5.0]
  one-sided CONCLUSION: HR20013 + DEX was noninferior to FAPR + PALO + DEX for preventing HEC-CINV and well tolerated, with the potential to reduce the impact of CINV on daily life.