格拉司琼透皮贴片预防抗肿瘤治疗所致恶心呕吐的前瞻性、多中心的真实世界研究报告

Granisetron transdermal delivery system in the prevention of nausea and vomiting induced by antineoplastic therapy: a multicenter real-world prospective study

目的探讨采用真实世界研究模式,在中国癌症患者中评价格拉司琼透皮贴片(granisetron transdermal delivery system,GTDS)预防抗肿瘤治疗所致恶心呕吐(antitumor drugs-induced nausea and vomiting,DINV)的效果、安全性和治疗价值。方法本研究是一项前瞻性、多中心、非干预性观察研究,自2019年4月至2020年4月期间共入选了48家医院1572例预防性使用GTDS止吐的成年癌症患者。所有患者的止吐治疗方案由其主管医师酌情决定。研究中收集患者的基线资料、抗肿瘤治疗方案及药物剂量、止吐治疗方案和不良事件等数据。结果从治疗开始至末剂治疗结束后24小时期间(PEEP期)有62.5%(983/1572)的患者获得了恶心呕吐的完全缓解(CR),59.4%(934/1572)的患者达到恶心呕吐的完全控制(CC)。此外,从治疗开始至末剂治疗期间逐日CR率从67.0%上升到93.1%,呈现逐步递增趋势。接受高致吐化疗(HEC)和中致吐化疗(MEC)方案患者的CR率分别为52.1%和61.0%。多因素Logistic回归分析结果表明,<50岁、女性、ECOG PS评分≥1和中/高度致吐化疗为影响PEEP期CR的危险因素。研究过程中,有19.8%的患者出现了轻微的便秘、头痛等症状,但未报告严重不良事件。结论真实临床实践中,GTDS可以有效地预防抗肿瘤治疗所致恶心和呕吐的发生,其安全性良好,依从性高,有利于实现DINV的全程管理。

Objective To evaluate the effectiveness,safety of granisetron transdermal delivery system(GTDS)in preventing antitumor drugs-induced nausea and vomiting(DINV)in Chinese cancer patients in a real-world clinical setting.Methods This study was a prospective,multicenter,non-interventional observational study.From April 2019 to April 2020,1572 cancer patients from 48 hospitals across the country were enrolled in the study.GTDS was administered to prevent nausea and vomiting.The choice of antiemetic prophylaxis was at the discretion of their treating physician.The baseline data,antineoplastic therapy and medications,antiemesis regimen,adverse events were collected in the study.Results During the first administration until 24 h after the last administration of chemotherapeutic agents(PEEP),62.5%(983/1572)of patients achieved complete response(CR),and 59.4%(934/1572)of patients achieved complete control(CC).In addition,during the period from the initiation of chemotherapy to last administration,the daily CR rate increased from 67.0%to 93.1%,with a significant increasing trend.The CR rates of patients receiving highly emetogenic chemotherapy(HEC)and moderately emetogenic chemotherapy(MEC)were 52.1%and 61.0%,respectively.Multivariate regression analysis showed that<50 years of age,female,ECOG PS score≥1 and moderately or highly emetogenic chemotherapy were risk factors affecting CR.During the course of the study,19.8%of the patients had mild constipation,headache and other symptoms,but no serious adverse events occurred.Conclusion In real clinical practice,GTDS effectively prevents the occurrence of nausea and vomiting caused by antineoplastic therapy.It has good safety and high compliance,and is useful for the whole-process management of DINV.