Control of nausea with palonosetron versus granisetron, both combined with dexamethasone, in patients receiving cisplatin- or anthracycline plus cyclophosphamide-based regimens.
Control of nausea with palonosetron versus granisetron, both combined with dexamethasone, in patients receiving cisplatin- or anthracycline plus cyclophosphamide-based regimens.
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DOI：
10.1007/s00520-016-3203-5
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发表时间：
2016-09
期刊：
影响因子：
--
通讯作者：
Ogura T
中科院分区：
文献类型：
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作者：
Kubota K;Saito M;Aogi K;Sekine I;Yoshizawa H;Yanagita Y;Sakai H;Inoue K;Kitagawa C;Ogura T
在一项涉及1114例接受高度致吐化疗（HEC）的日本患者的3期比较研究中，发现帕洛诺司琼（PALO）在预防延迟期化疗诱导的恶心和呕吐（CINV）方面上级优于格拉司琼（GRA）。这项III期研究的事后分析评价了PALO控制恶心的疗效。在急性期（0-24 h）、延迟期（24-120 h）和总体期（0-120 h），每隔24 h评估一次无恶心的患者比例。还根据性别、化疗类型（顺铂或多柔比星/表柔比星+环磷酰胺[AC/EC]）和年龄（<55岁vs. ≥55岁）评价了无恶心发生率。使用4分Likert量表（0 =无恶心至3 =重度恶心）对恶心严重程度进行分类。在延迟期（37.8% vs. 27.2%; p = 0.002）和总体（31.9% vs. 25.0%; p = 0.0117），PALO组中无恶心的患者比例显著高于GRA组。当按分层因素分析时，PALO组中女性、年轻或接受顺铂治疗的患者在延迟期和总体中无恶心的患者比例显著较高，而老年或接受多柔比星或表柔比星+环磷酰胺治疗的患者在延迟期无恶心的患者比例显著较高（所有p < 0.05）。在延迟期和总体上，PALO在预防HEC诱导的恶心方面比GRA更有效。此外，在延迟期和总体上，PALO在年轻和女性患者中比GRA更有效，这些患者具有CINV的高风险。
In a comparative phase 3 study involving 1114 Japanese patients receiving highly emetogenic chemotherapy (HEC), palonosetron (PALO) was found to be superior to granisetron (GRA) for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in the delayed phase. This post hoc analysis of the phase 3 study evaluated the efficacy of PALO for the control of nausea. The proportion of patients without nausea was assessed at 24-h intervals during the acute phase (0–24 h), delayed phase (24–120 h), and overall (0–120 h). No nausea rates were also evaluated by sex, type of chemotherapy (cisplatin or doxorubicin/epirubicin plus cyclophosphamide [AC/EC]), and age (<55 vs. ≥55 years). Nausea severity was categorized using a 4-point Likert scale (0 = no nausea to 3 = severe nausea). The proportion of patients without nausea was significantly higher in the PALO arm than in the GRA arm in the delayed phase (37.8 % vs. 27.2 %; p = 0.002) and overall (31.9 % vs. 25.0 %; p = 0.0117). When analyzed by stratification factors, the proportion of patients without nausea was significantly higher in the PALO arm in the delayed phase and overall in patients who were female, younger, or treated with cisplatin and in the delayed phase in patients who were older or treated with doxorubicin or epirubicin plus cyclophosphamide (all p < 0.05). PALO was more effective than GRA in prophylaxis of HEC-induced nausea in the delayed phase and overall. In addition, PALO was more effective than GRA in young and female patients, who are at high risk of CINV, both in the delayed phase and overall.