福沙吡坦与阿瑞匹坦预防接受顺铂化疗患者化疗引起的恶心和呕吐的多中心、随机、双盲、双模拟、阳性对照III期试验
Fosaprepitant versus aprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy: a multicenter, randomized, double-blind, double-simulated, positive-controlled phase III trial.
作者信息
Zhang Zhonghan, Yang Yunpeng, Lu Ping, Li Xiaoqin, Chang Jianhua, Zheng Rongsheng, Zhou Lei, Chen Shaoshui, Chen Xiaopin, Ren Biyong, Gu Wei, Jiang Xiaodong, Peng Jiyong, Huang Miaolong, Feng Guosheng, Shen Peng, Zhang Qingyuan, Zhang Baihong, Huang Yan, He Jingdong, Chen Yinglan, Cao Jingxu, Wang Hong, Li Wei, Wan Huiping, Nan Kejun, Liao Zijun, Zhang Cuiying, Lin Zhong, Zhong Diansheng, Xu Qing, Liu Hailong, Sun Tao, Deng Yanming, Zhang Li
机构信息
Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China.
Oncology Internal Medicine, the First Affiliated Hospital of Xinxiang Medical College, Xinxiang 453000, China.
出版信息
Ann Transl Med. 2020 Mar;8(5):234. doi: 10.21037/atm.2019.12.158.
BACKGROUND
To establish the role of antiemetic therapy with neurokinin-1 (NK-1) receptor antagonists (RAs) in Chinese patients associated with cisplatin-base chemotherapy regimens, this study evaluated the efficacy and safety of single-dose intravenous fosaprepitant-based triple antiemetic regimen to a 3-day orally aprepitant-based antiemetic triplet schedule for the prevention of chemotherapy-induced nausea and vomiting (CINV).
METHODS
A randomized, double-blind, positive-control design was used to test the noninferiority of fosaprepitant towards aprepitant. Patients receiving cisplatin-base (≥50 mg/m) chemotherapy were administrated palonosetron and dexamethasone with a single-dose fosaprepitant (150 mg on day 1) or a standard aprepitant regimen (125 mg on day 1, 80 mg on day 2 and day 3). The primary endpoint was complete response (CR) during overall phase (OP). Secondary endpoints include CR during acute phase (AP) and delayed phase (DP), no vomiting and no significant nausea during OP, AP and DP. Accrual of 324 patients per treatment arm was planned to confirm noninferiority with expected CR of 75% and noninferiority margin of minus 10 percentage points.
RESULTS
A total of 648 patients were randomly assigned, and 644 were evaluable for efficacy and safety. Antiemetic efficacy of CR during the OP with fosaprepitant and aprepitant was equivalent (71.96% versus 69.35%, P=0.4894). And a between-group difference of 2.61 percentage points was finally achieved (95% CI, -4.42 to 9.64) within predefined bounds for noninferiority (primary end point achieved). Both regimens were well tolerated and commonly reported adverse events (≥1%) were similar between these two group.
CONCLUSIONS
Single-dose intravenous fosaprepitant (150 mg) combined with palonosetron and dexamethasone was well tolerated and demonstrated noninferior control of CINV to aprepitant-based triple regimen in Chinese patients treating with cisplatin-base chemotherapy.
背景
为确定神经激肽-1（NK-1）受体拮抗剂（RA）在接受含顺铂化疗方案的中国患者中进行止吐治疗的作用，本研究评估了单剂量静脉注射磷丙泊酚二钠的三联止吐方案与3天口服阿瑞匹坦的三联止吐方案预防化疗引起的恶心和呕吐（CINV）的疗效和安全性。
方法
采用随机、双盲、阳性对照设计来检验磷丙泊酚二钠相对于阿瑞匹坦的非劣效性。接受含顺铂（≥50mg/m）化疗的患者接受帕洛诺司琼和地塞米松治疗，同时给予单剂量磷丙泊酚二钠（第1天150mg）或标准阿瑞匹坦方案（第1天125mg，第2天和第3天80mg）。主要终点是整个阶段（OP）的完全缓解（CR）。次要终点包括急性期（AP）和延迟期（DP）的CR、OP、AP和DP期间无呕吐和无明显恶心。计划每个治疗组招募324例患者，以确认非劣效性，预期CR为75%，非劣效性界值为负10个百分点。
结果
共随机分配648例患者，644例可进行疗效和安全性评估。磷丙泊酚二钠和阿瑞匹坦在OP期间的CR止吐疗效相当（71.96%对69.35%，P=0.4894）。最终在预先定义的非劣效性界限内实现了2.61个百分点的组间差异（95%CI，-4.42至9.64）（达到主要终点）。两种方案耐受性良好，两组常见不良事件（≥1%）相似。
结论
单剂量静脉注射磷丙泊酚二钠（150mg）联合帕洛诺司琼和地塞米松耐受性良好，在接受含顺铂化疗的中国患者中，对CINV的控制显示出不劣于基于阿瑞匹坦的三联方案。
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