预防奥沙利铂为基础的中致吐化疗方案所致胃肠肿瘤患者恶心和呕吐的现状及危险因素分析

Current status and risk factors for the prevention of oxaliplatin-based moderate emetic chemotherapy-induced nausea and vomiting in patients with gastrointestinal cancer

目的:分析真实世界中胃肠道肿瘤预防奥沙利铂为基础的中致吐化疗方案所致恶心、呕吐的现状及风险因素。方法:本研究为一项真实世界的前瞻性观察性研究。选取2019年10月至2019年12月接受奥沙利铂为基础的MEC方案的胃肠道肿瘤患者。收集患者临床资料,化疗方案以及止吐药物使用情况。采用多国癌症支持治疗协会止吐评价工具评估化疗所致恶心和呕吐。主要终点为恶心、呕吐完全控制率。CINV预防给药指南依从性为遵从中国临床肿瘤学会抗肿瘤治疗相关恶心呕吐预防和治疗指南(2019版)。采用线上工具(http://www.cinvrisk.org)对止吐药物选择进行个体化评估。多因素Logistic回归分析患者全程恶心和呕吐的风险因素。结果:本研究共纳入239例患者。恶心、呕吐的完全控制率在全程阶段(0~120 h)为33.1%和83.7%,急性期(0~24 h)为61.9%和93.3%,延迟期(24~120 h)为38.9%和87.0%。CINV预防给药指南依从性为66.9%。根据线上工具,低危患者212例(88.7%),高危患者27例(11.3%),线上工具预防给药依从性为24.3%。多因素分析显示孕吐史(P=0.041),先前化疗中发生CINV(P<0.001)是全程恶心的独立风险因素,而预期性恶心、呕吐(P<0.001),孕吐史(P<0.001),先前化疗中发生CINV(P=0.021),指南依从性(P=0.032)是全程呕吐的独立风险因素。结论:真实世界中,胃肠道肿瘤采用奥沙利铂为基础的MEC方案全程呕吐控制尚可,但全程恶心控制不佳,尤其是延迟期恶心。依从指南选择止吐方案能够提高CINV的控制率,但临床实践中CINV预防止吐方案多样,指南依从性有待进一步提高。CINV存在个体化风险因素,未来可扩大人群进一步筛选CINV的风险因素并开发奥沙利铂个体化的风险预测模型,优化CINV管理并指导临床实践。

Objective:To analyze the current status and risk factors for the prevention of oxaliplatinbased moderate emetic chemotherapy(MEC)-induced nausea and vomiting in patients with gastrointestinal cancer in the real world.Methods:This was a prospective observational study.Patients with gastrointestinal cancer who received oxaliplatin-based MEC were enrolled from October 2019 to December 2019.Data of clinical characteristics,chemotherapy regimens,and antiemetic medication were collected.Chemotherapy-induced nausea and vomiting(CINV)was measured with the Multinational Association for Supportive Care in Cancer Antiemesis Tool(MAT).The primary endpoint was complete control rates of nausea and vomiting.Guideline consistency followed the Chinese Society of Clinical Oncology antiemesis guideline version 2019.Individual antiemetic was evaluated according to the online tool(http://www.cinvrisk.org).Multivariate logistic regression was used to analyze risk factors of nausea and vomiting in overall phase.Results:In total,239 patients were enrolled.The complete control rates of nausea and vomiting(0~120 h)were 33.1%and 83.7%in overall phase;61.9%and 93.3%in acute phase(0~24 h);and 38.9%and 87.0%in delayed phase(24~120 h),respectively.The prevalence of guideline consistency for CINV prophylaxis was 66.9%.According to the online tool,there were 212(88.7%)low-risk patients and 27(11.3%)high-risk patients.The prevalence of online tool consistency for CINV prophylaxis was 24.3%.Multivariate analysis showed that history of morning sickness(P=0.041)and CINV in the prior chemotherapy(P<0.001)were independent risk factors of nausea in overall phase,while anticipatory nausea and vomiting(P<0.001),history of morning sickness(P<0.001),CINV in the prior chemotherapy(P=0.021)and guideline consistency(P=0.032)were independent risk factors of vomiting in overall phase.Conclusion:In the real world,complete control of vomiting in overall phase was well in gastrointestinal cancer patients receiving oxaliplatin-based MEC,while complete control of nausea was unsatisfied,especially in delayed phase.Guideline consistency for CINV prophylaxis could improve the control rate of CINV.However,regimens CINV prophylaxis was diverse in clinical practice.Guideline consistency needs to be further improved.Several individualized risk factors were related to CINV.We could expand the population to further screen risk factors and develop an individualized risk model of oxaliplatin to optimize CINV management and guide clinical practice in the future.