背景:氟尿苷/替吡嘧啶(TAS-102)是一种口服抗癌药物,在不可切除的结直肠癌中具有足够的疗效,但也经常引起化疗引起的恶心和呕吐(CINV)。探讨TAS-102(JASCC-CINV2001)治疗结直肠癌患者CINV的发生和止吐治疗。
方法:我们进行了多中心,prospective,首次接受TAS-102但未减少剂量的结直肠癌患者的观察性研究。主要终点是整个期间呕吐的发生率。次要终点是恶心的发生率,严重的恶心,厌食症,其他不良事件(便秘,腹泻,失眠,疲劳,味觉障碍)和患者满意度。患者日记用于主要和次要终点。所有不良事件均使用PRO-CTCAE版本1.0进行主观评估。和CTCAE版本5.0。
结果:分析了119名入选患者中的100名患者的数据。呕吐的发生率,恶心,显著的恶心是13%,67%,36%,分别。预防性止吐和未预防性止吐的患者呕吐发生率分别为20.8%和10.5%,分别。24%的患者给予了预防性止吐药,其中70%接受D2拮抗剂。多因素Cox比例风险分析显示,既往治疗经历CINV倾向于与呕吐相关(风险比[HR]:7.13,95%置信区间[CI]:0.87-58.5,P=0.07),而预防性止吐没有(HR:1.61,95CI:0.50-5.21,P=0.43).关于患者满意度,“非常满意”的患者比例,\"\"满意,“”“稍微满意”或“稍微满意”为81.8%。
结论:呕吐发生率低,患者满意度高,提示TAS-102不需要使用统一的预防性止吐治疗。然而,既往有CINV治疗经验的患者可能需要预防性止吐治疗.
BACKGROUND: Trifluridine/tipiracil (TAS-102) is an oral anticancer drug with adequate efficacy in unresectable colorectal cancer, but frequently also induces chemotherapy-induced nausea and vomiting (CINV). To investigate the occurrence of CINV and antiemetic therapy in patients with colorectal cancer treated with TAS-102 (JASCC-CINV 2001).
METHODS: We conducted a multicenter, prospective, observational study in patients with colorectal cancer who received TAS-102 without dose reduction for the first time. Primary endpoint was the incidence of vomiting during the overall period. Secondary endpoints were the incidence of nausea, significant nausea, anorexia, other adverse events (constipation, diarrhea, insomnia, fatigue, dysgeusia) and patient satisfaction. Patient diaries were used for primary and secondary endpoints. All adverse events were subjectively assessed using PRO-CTCAE ver 1.0. and CTCAE ver 5.0.
RESULTS: Data from 100 of the 119 enrolled patients were analyzed. The incidence of vomiting, nausea, and significant nausea was 13%, 67%, and 36%, respectively. The incidence of vomiting in patients with and without prophylactic antiemetic therapy were 20.8% and 10.5%, respectively. Prophylactic antiemetics were given to 24% of patients, of whom 70% received D2 antagonists. Multivariate Cox proportional hazards analysis showed that experience of CINV in previous treatment tended to be associated with vomiting (hazard ratio [HR]: 7.13, 95% confidence interval [CI]: 0.87-58.5, P = 0.07), whereas prophylactic antiemetic administration was not (HR: 1.61, 95 CI: 0.50-5.21, P = 0.43). With regard to patient satisfaction, the proportion of patients who were \"very satisfied,\" \"satisfied,\" \"slightly satisfied\" or \"somewhat satisfied\" was 81.8%.
CONCLUSIONS: The low incidence of vomiting and high patient satisfaction suggest that TAS-102 does not require the use of uniform prophylactic antiemetic treatments. However, patients with the experience of CINV in previous treatment might require prophylactic antiemetic treatment.