Chemotherapy-induced nausea and vomiting: incidence and characteristics of persistent symptoms and future directions NCCTG N08C3 (Alliance).
Chemotherapy-induced nausea and vomiting: incidence and characteristics of persistent symptoms and future directions NCCTG N08C3 (Alliance).
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DOI：
10.1007/s00520-016-3080-y
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发表时间：
2016-06
期刊：
影响因子：
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通讯作者：
Barton D
中科院分区：
文献类型：
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作者：
Kottschade L;Novotny P;Lyss A;Mazurczak M;Loprinzi C;Barton D
尽管有新的药物，化疗引起的恶心和呕吐（CINV）仍然是一个令人痛苦的副作用，接受全身抗癌治疗的患者的比例。我们最近对先前报道的阴性III期试验（N 08 C3）进行了计划外的二次分析，观察加巴喷丁/安慰剂联合地塞米松和5 HT 3受体拮抗剂在413例接受高致吐化疗（HEC）方案的患者中预防CINV的疗效。在目前的研究中，我们试图更好地理解高于预期的总体患者满意度，尽管两组的完全缓解率较低。此外，我们还研究了患者变量及其与CINV发生率的关系。大约三分之一的患者发生了轻度以上的恶心，并报告了功能性生活指数-呕吐评分，表明活动受到干扰。35%的患者报告恶心超过2.5分（0分为无），19%的患者报告至少有一次呕吐发作，49%的患者报告正在服用急救药物。第1天的恶心和呕吐、顺铂治疗和运动病史显著预测迟发性CINV。年龄、联合化疗（HEC+中度致吐）和接受乳腺癌治疗可预测第1天的CINV。这些数据证实了以前的报告，亚组的患者可能更容易发生急性和迟发性CINV。未来的CINV研究设计可能会受益于一种更加个性化的CINV管理方法，针对那些尽管持续药物开发努力但确实存在CINV风险的患者。
Despite newer agents, chemotherapy-induced nausea and vomiting (CINV) continues to remain a distressing side effect to a proportion of patients undergoing systemic anti-cancer therapy. We recently performed an unplanned secondary analysis on a previously reported negative phase III trial (N08C3) looking at the efficacy of gabapentin/placebo in combination with dexamethasone and a 5HT3 receptor antagonist in the prevention of CINV for 413 patients undergoing regimens with highly emetogenic chemotherapy (HEC). In the current study, we attempted to better understand the higher than expected rate of overall patient satisfaction, despite a low complete response rate in both arms. Additionally, we looked at patient variables and their relationship to rates of CINV. Approximately one third of patients experienced more than mild nausea and reported scores on the Functional Living Index–Emesis that indicated interference with activities. Thirty-five percent reported nausea greater than 2.5 on a scale of 0 to 10 (0 being none), 19 % reported at least one emetic episode, and 49 % reported taking rescue medication. Nausea and vomiting on day 1, cisplatin therapy, and history of motion sickness significantly predicted delayed CINV. Age, combination chemotherapy (HEC with moderately emetogenic), and getting treatment for breast cancer predicted CINVon day 1. These data confirm previous reports that subgroups of patients may be more prone to acute and delayed CINV. Future CINV study design may benefit from a more individualized approach to CINV management, targeting those patients who are truly at risk for CINV despite continued drug development efforts.