阿瑞匹坦在消化道肿瘤中预防中度致吐性化学治疗药物所致恶心呕吐的临床观察

Aprepitant therapy for prevention of moderately chemotherapy-induced nausea and vomiting in patients with gastrointestinal cancer

目的·探讨阿瑞匹坦联合帕洛诺司琼和地塞米松方案在预防中度致吐性化学治疗(化疗)方案治疗消化道肿瘤所致的恶心呕吐的作用。方法·纳入2014年7月至2015年8月在上海交通大学医学院附属瑞金医院肿瘤科住院接受中度致吐性化疗方案的消化道肿瘤患者130例。所有患者均完成4个周期以上的化疗。109例在第1周期化疗开始时即使用阿瑞匹坦、帕洛诺司琼和地塞米松(第1日),第2~3日使用阿瑞匹坦和地塞米松;21例在第1周期化疗使用帕洛诺司琼、地塞米松(第1日),第2~3日使用地塞米松,未使用阿瑞匹坦,在第2周期及后续化疗中均在第1~3日加用阿瑞匹坦。患者完成MASCC止吐工具量表。主要研究终点是第2周期化疗全程(0~120 h)的完全缓解(无呕吐及无挽救治疗),次要研究终点是第2周期化疗全程、急性期(0~24 h)和延迟期(24~120 h)的完全保护(无呕吐及无明显恶心)。结果·第2周期全程、急性期、延迟期完全缓解率分别为90.0%、94.6%、90.8%。第2周期全程、急性期、延迟期的完全保护率分别为83.8%、87.8%、84.6%。21例患者在第2周期加用阿瑞匹坦后急性期完全缓解率由42.9%提高至57.1%,延迟期完全缓解率由9.5%提高至90.5%。主要不良反应为便秘、食欲减退、呃逆。结论·阿瑞匹坦联合帕洛诺司琼、地塞米松的三联止吐方案能够有效预防消化道肿瘤中度致吐性化疗所致恶心呕吐的发生,且能在多周期化疗中维持有效的止吐疗效。

Objective · To investigate antiemetic effect of aprepitant for moderately chemotherapy-induced nausea and vomiting in patients with gastrointestinal cancer. Methods · From 2014 July to 2015 August, 130 cases of gastrointestinal cancer patients were collected in Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, who received moderate emetogenic risk of chemotherapy for at least four courses. One hundred and nine patients were treated with aprepitant, palonosetron and dexamethasone on day 1, and aprepitant and dexamethasone on day 2 and 3. Twenty-one patients only received aprepitant and dexamethasone on day 1 and dexamethasone on day 2 and 3 in the first course of chemotherapy. During subsequent courses of chemotherapy they received aprepitant and treated in the same way as 109 patients. MASCC antiemetic tool （MAT） was used to evaluate the intensity of nausea. The primary endpoint was complete response （CR, no emesis and use of no rescue antiemetics） during the overall study phase （0-120 h after chemotherapy） at the second course. The secondary endpoint was complete protection （CP, CR plus no significant nausea） during the overall, acute （0-24 h）, and delayed （24-120 h） phases at the second course. Results · The CR rates were 90.0%, 94.6% and 90.8% of patients in the overall, acute and delayed phases, respectively. The corresponding CP rates were 83.8%, 87.8% and 84.6 %, respectively. The CR rate increased from 42.9% to 57.1% during acute phase and increased from 9.5% to 90.5% during delayed phase for 21 patients after treatment with aprepitant. The main adverse reactions include constipation, anorexia and hiccups. Conclusion · Aprepitant combined with palonosetron and dexamethasone can effectively prevent moderately chemotherapy-induced nausea and vomiting in patients with gastrointestinal cancer. Aprepitant therapy can effectively maintain antiemetic effect in patients with many chemotherapy courses.