Department of Pharmacy, Gifu University Hospital, Gifu, Japan.
Department of Pharmacy, Miyagi Cancer Center, Miyagi, Japan.
Support Care Cancer. 2024 Apr 17;32(5):291. doi: 10.1007/s00520-024-08498-z.
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).
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.
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 D 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%.
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.
替氟尿苷/盐酸拓扑替康（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，但经常也会引起化疗引起的恶心和呕吐（CINV）。为了研究首次接受 TAS-102 治疗的结直肠癌患者的 CINV 和止吐治疗（JASCC-CINV 2001）。
我们在没有剂量减少的情况下首次对接受 TAS-102 治疗的结直肠癌患者进行了一项多中心、前瞻性、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、严重恶心、厌食、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 ver 1.0 和 CTCAE ver 5.0 进行主观评估。
对 119 名入组患者中的 100 名患者的数据进行了分析。呕吐、恶心和严重恶心的发生率分别为 13%、67%和 36%。有和没有预防性止吐治疗的患者呕吐发生率分别为 20.8%和 10.5%。预防性止吐药给予了 24%的患者，其中 70%的患者接受了 D 拮抗剂。多变量 Cox 比例风险分析显示，以前治疗中 CINV 的经验与呕吐有一定的相关性（风险比[HR]：7.13，95%置信区间[CI]：0.87-58.5，P=0.07），而预防性止吐治疗无相关性（HR：1.61，95%CI：0.50-5.21，P=0.43）。关于患者满意度，非常满意、满意、稍有满意或有些满意的患者比例为 81.8%。
呕吐发生率低且患者满意度高表明 TAS-102 不需要使用统一的预防性止吐治疗。然而，有以前 CINV 治疗经验的患者可能需要预防性止吐治疗。
