不同疗程的洛哌丁胺可预防吡罗替尼引起的腹泻:PHAEDRA II期试验的随机平行分组子研究

Changjun Wang, Yan Lin, Ying Xu, Feng Mao, Jinghong Guan, Xuejing Wang, Yanna Zhang, Xiaohui Zhang, Songjie Shen, Ying Zhong, Bo Pan, Li Peng, Xin Huang, Xi Cao, Ru Yao, Xintong Zhou, Zecheng He, Yuhan Liu, Jie Lang, Chenggang Li, Yidong Zhou, Qiang Sun
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引用次数: 0

摘要

背景:派罗替尼是一种泛HER酪氨酸激酶抑制剂,在治疗HER2阳性乳腺癌方面疗效显著。然而,由于经常出现治疗突发腹泻而不得不停药,这影响了患者的治疗效果:在这项多中心、开放标签的 PHAEDRA II 期研究中,120 名早期 HER2 阳性患者接受了纳布-紫杉醇和吡罗替尼的术后治疗,他们被纳入了一项子研究,并被随机分为两组,分别接受 21 天和 42 天的洛哌丁胺治疗,作为腹泻的主要预防措施,随后按需用药。主要结果是≥3级腹泻的发生率。研究结果21天组和42天组分别有58名和59名患者接受了至少一次派罗替尼治疗。中位随访时间为12.1个月,所有患者均发生过任何程度的腹泻,其中21天组有39.7%的患者发生过≥3级腹泻,42天组有42.4%的患者发生过≥3级腹泻(相对风险:0.94;95%置信区间:0.61-1.45)。除腹泻外,最常见的治疗突发不良反应是低麻、呕吐、恶心和皮疹,大多为1-2级,但各组均有一例中性粒细胞计数下降≥3级的病例。结论在预防≥3级腹泻方面,21天和42天的洛哌丁胺用药时间没有明显差异。考虑到经济成本和患者的依从性,21 天的洛哌丁胺预防可能是一种更实用、更适合临床应用的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Different treatment durations of loperamide in preventing pyrotinib-induced diarrhea: A randomized, parallel-group sub-study of the phase II PHAEDRA trial
Background: Pyrotinib, a pan-HER tyrosine kinase inhibitor, demonstrates efficacy in the treatment of HER2-positive breast cancer. However, the frequent occurrence of treatment-emergent diarrhea necessitating discontinuation, impacts patient outcomes. Methods: In this multicenter, open-label, phase II PHAEDRA study enrolling early stage HER2-positive patients for postoperative treatment with nab-paclitaxel and pyrotinib, 120 patients were included for a sub-study and randomly divided into two groups to receive 21 days and 42 days of loperamide for primary prophylaxis of diarrhea, followed by as-needed usage. The primary outcome was the incidence of grade ≥3 diarrhea. Results: Fifty-eight patients in the 21-day group and 59 patients in the 42-day group received at least one dose of pyrotinib. With a median follow-up of 12.1 months, all patients experienced diarrhea of any grade, with grade ≥3 events in 39.7% of the 21-day group and 42.4% of the 42-day group (relative risk: 0.94; 95% confidence interval: 0.61-1.45). The most common treatment-emergent adverse events, other than diarrhea, were hypoesthesia, vomiting, nausea, and rash, mostly grade 1-2, except for one case of grade ≥3 decreased neutrophil count in each group. Conclusion: No significant differences were observed between 21-day and 42-day loperamide durations in preventing grade ≥3 diarrhea. Considering the economic cost and patient compliance, 21-day loperamide prophylaxis might represent a more pragmatic and appropriate approach for clinical application.
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