Ando Yosuke, Matsuoka Hiroshi, Orito Hanaho, Ishihara Takuma, Mizuno Tomohiro, Hiraga Nanaho, Katsuno Hidetoshi, Morise Zenichi, Horiguchi Akihiko, Suda Koichi, Hayashi Takahiro, Yamada Shigeki
Department of Pharmacotherapeutics and Informatics, Fujita Health University School of Medicine, 1‑98 Dengakugakubo, Kutsukake‑cho, Toyoake‑shi, Aichi 470‑1192, Japan.
Department of Surgery, Fujita Health University School of Medicine, 1‑98 Dengakugakubo, Kutsukake‑cho, Toyoake‑shi, Aichi 470‑1192, Japan.
Jpn J Clin Oncol. 2025 Jul 8. doi: 10.1093/jjco/hyaf108.
Trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) is a standard third-line therapy for unresectable advanced or recurrent colorectal cancer. The standard dosing schedule (5 days of administration followed by 2 days off) is associated with a high incidence of severe neutropenia. Conversely, a biweekly dosing schedule (5 days of administration followed by 9 days off) reportedly reduces this incidence. However, no direct comparison of these regimens has been made. In this study, we retrospectively compared the efficacy and safety of these two dosing schedules.
We analyzed data from patients who received FTD/TPI + BEV treatment between June 2016 and January 2024 at three hospitals affiliated with Fujita Health University. The effects of the dosing schedules on hematological toxicity, overall survival (OS), and time to treatment failure (TTF) were assessed.
Among the 125 patients, 26 and 99 were classified into the standard and biweekly groups, respectively. Grade ≥ 3 neutropenia occurred in 50.0% of patients in the standard group and 29.3% of those in the biweekly group (P = .062), with multivariable analysis confirming the dosing schedule impact (P = .048). Median TTF was 5.4 and 7.0 months, while median OS was 16.4 and 14.5 months (P = .908, 0.947) in the standard and biweekly groups, respectively.
The biweekly regimen of FTD/TPI + BEV resulted in a lower tendency for severe neutropenia than that in the standard regimen, while maintaining comparable OS and TTF in patients with unresectable advanced or recurrent colorectal cancer.
曲氟尿苷/替匹嘧啶(FTD/TPI)联合贝伐单抗(BEV)是不可切除的晚期或复发性结直肠癌的标准三线治疗方案。标准给药方案(给药5天,随后停药2天)与严重中性粒细胞减少的高发生率相关。相反,据报道,每两周给药方案(给药5天,随后停药9天)可降低这一发生率。然而,尚未对这些方案进行直接比较。在本研究中,我们回顾性比较了这两种给药方案的疗效和安全性。
我们分析了2016年6月至2024年1月期间在藤田保健大学附属的三家医院接受FTD/TPI + BEV治疗的患者的数据。评估了给药方案对血液学毒性、总生存期(OS)和治疗失败时间(TTF)的影响。
在125例患者中,分别有26例和99例被归入标准组和每两周给药组。标准组中50.0%的患者发生≥3级中性粒细胞减少,每两周给药组中为29.3%(P = 0.062),多变量分析证实了给药方案的影响(P = 0.048)。标准组和每两周给药组的中位TTF分别为5.4个月和7.0个月,而中位OS分别为16.4个月和14.5个月(P = 0.908,0.947)。
FTD/TPI + BEV的每两周给药方案导致严重中性粒细胞减少的倾向低于标准方案,同时在不可切除的晚期或复发性结直肠癌患者中维持了相当的OS和TTF。