Kottschade Lisa, Novotny Paul, Lyss Alan, Mazurczak Miroslaw, Loprinzi Charles, Barton Debra
Mayo Clinic, Rochester, MN, USA.
Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Support Care Cancer. 2016 Jun;24(6):2661-7. doi: 10.1007/s00520-016-3080-y. Epub 2016 Jan 15.
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 CINV on 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.
尽管有了新型药物,但化疗引起的恶心和呕吐(CINV)仍是一部分接受全身抗癌治疗患者的痛苦副作用。
我们最近对之前报道的一项阴性III期试验(N08C3)进行了一项非计划的二次分析,该试验观察加巴喷丁/安慰剂联合地塞米松和5-HT3受体拮抗剂对413例接受高致吐性化疗(HEC)方案患者预防CINV的疗效。在当前研究中,我们试图更好地理解尽管两组的完全缓解率较低,但总体患者满意度却高于预期的原因。此外,我们研究了患者变量及其与CINV发生率的关系。
约三分之一的患者经历了不止轻度的恶心,并在功能性生活指数-呕吐量表上报告了表明对活动有干扰的分数。35%的患者报告恶心程度在0至10分的量表上大于2.5(0表示无恶心),19%的患者报告至少有一次呕吐发作,49%的患者报告使用了救援药物。第1天的恶心和呕吐、顺铂治疗以及晕动病史显著预测了延迟性CINV。年龄、联合化疗(HEC与中度致吐性化疗联合)以及乳腺癌治疗预测了第1天的CINV。
这些数据证实了之前的报道,即患者亚组可能更容易发生急性和延迟性CINV。未来CINV研究设计可能会受益于更个体化的CINV管理方法,针对那些尽管不断有药物研发努力但真正有CINV风险的患者。