Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Department of Specialized Surgeries, Graduate School, Tokyo Medical and Dental University, Tokyo, Japan.
Jpn J Clin Oncol. 2021 Apr 30;51(5):700-706. doi: 10.1093/jjco/hyaa243.
The novel oral nucleoside antineoplastic agent trifluridine/tipiracil was approved for metastatic colorectal cancer in Japan in March 2014. In this post-marketing surveillance study, we investigated the safety and efficacy of trifluridine/tipiracil in a real-world setting, particularly haematological drug reactions classified according to the baseline renal and hepatic functions.
We investigated patients with metastatic colorectal cancer who received trifluridine/tipiracil during the first four treatment cycles prospectively. The patients typically received 35 mg/m2 trifluridine/tipiracil twice daily on days 1-5 and 8-12 every 28 days. The primary objective was to assess the safety of trifluridine/tipiracil, but its efficacy was also evaluated.
Between July 2014 and June 2016, 860 patients were enrolled in the study, and the safety and efficacy of trifluridine/tipiracil were evaluated in 823 patients. Adverse drug reactions occurred in 89.7% of the patients. The most common adverse drug reactions were decreased white blood cell count (67.0%) and neutrophil count (63.9%). Haematological drug reactions of grade ≥3 were observed in 41.7% of the patients with normal renal function; 50.3, 65.6 and 78.9% of the patients had mild, moderate and severe renal impairments, respectively. Hepatic impairment was not associated with a higher incidence of haematological drug reactions. The median overall survival was 8.4 months, with a 1-year survival rate of 33.7%.
This post-marketing surveillance study further confirmed the safety and tolerability profile of trifluridine/tipiracil observed in a clinical study setting.
新型口服核苷抗肿瘤药物替氟尿苷/盐酸托泊替康于 2014 年 3 月在日本被批准用于转移性结直肠癌。在这项上市后监测研究中，我们根据基线肾功能和肝功能对替氟尿苷/盐酸托泊替康的安全性和疗效进行了调查，特别是血液学药物反应。
我们前瞻性地调查了在头四个治疗周期中接受替氟尿苷/盐酸托泊替康治疗的转移性结直肠癌患者。患者通常接受 35mg/m2替氟尿苷/盐酸托泊替康，每天两次，第 1-5 天和第 8-12 天，每 28 天一次。主要目的是评估替氟尿苷/盐酸托泊替康的安全性，但也评估了其疗效。
2014 年 7 月至 2016 年 6 月，共有 860 例患者入组该研究，对 823 例患者评估了替氟尿苷/盐酸托泊替康的安全性和疗效。89.7%的患者发生药物不良反应。最常见的药物不良反应是白细胞计数（67.0%）和中性粒细胞计数（63.9%）下降。肾功能正常的患者中有 41.7%观察到血液学药物反应≥3 级；肾功能轻度、中度和重度损害的患者分别为 50.3%、65.6%和 78.9%。肝损伤与血液学药物反应发生率增加无关。中位总生存期为 8.4 个月，1 年生存率为 33.7%。
这项上市后监测研究进一步证实了临床研究环境中观察到的替氟尿苷/盐酸托泊替康的安全性和耐受性特征。
