Hara Shinsuke, Sakai Daisuke, Ikemura Kenji, Shintani Takuya, Yamamoto Tomoya, Satoh Taroh, Okuda Masahiro
Department of Pharmacy, Osaka University Hospital, Suita, Japan.
Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.
Anticancer Res. 2024 Mar;44(3):1219-1226. doi: 10.21873/anticanres.16917.
BACKGROUND/AIM: Trifluridine/tipiracil (FTD/TPI) is used to treat metastatic colorectal cancer (mCRC). Since the standard regimen of FTD/TPI features a complex dosing schedule and frequently results in severe hematological toxicities, a simplified regimen has emerged, in which FTD/TPI is orally administered biweekly. However, the survival benefits and potential adverse events associated with the biweekly FTD/TPI regimen have not been fully evaluated in previous reports. Therefore, in this study, the differences in efficacy and safety between the standard and biweekly FTD/TPI regimens were retrospectively investigated in patients with mCRC.
Data from 90 patients who received FTD/TPI for mCRC were extracted from the electronic medical records at the Osaka University Hospital. According to the inclusion and exclusion criteria, 85 of the 90 patients were enrolled in the study. We compared patient characteristics, overall survival (OS), progression-free survival (PFS), and adverse events between the standard (n=56) and biweekly groups (n=29).
The biweekly group exhibited prolonged OS and PFS compared to patients in the standard group. Multivariate analysis for OS and PFS demonstrated that the biweekly regimen was the only significant factor that affected OS, and not PFS (HR=0.561, p=0.049). Kaplan-Meier analysis indicated that neutropenia (grade ≥3) in the biweekly group was significantly prolonged compared to the standard group (p=0.012). However, there were no significant differences in adverse events between the two groups (p>0.999).
The biweekly FTD/TPI regimen, compared to the standard regimen, should enhance both OS and PFS in patients with mCRC without escalating any adverse event.
背景/目的：曲氟尿苷/替匹嘧啶（FTD/TPI）用于治疗转移性结直肠癌（mCRC）。由于FTD/TPI的标准方案给药时间表复杂且常导致严重血液学毒性，一种简化方案应运而生，即FTD/TPI每两周口服一次。然而，之前的报告尚未充分评估每两周一次FTD/TPI方案的生存获益及潜在不良事件。因此，本研究对mCRC患者中标准和每两周一次FTD/TPI方案的疗效和安全性差异进行了回顾性调查。
从大阪大学医院的电子病历中提取90例接受FTD/TPI治疗mCRC患者的数据。根据纳入和排除标准，90例患者中的85例纳入本研究。我们比较了标准组（n = 56）和每两周一次组（n = 29）的患者特征、总生存期（OS）、无进展生存期（PFS）及不良事件。
与标准组患者相比，每两周一次组的OS和PFS延长。OS和PFS的多因素分析表明，每两周一次方案是影响OS的唯一显著因素，而非PFS（风险比=0.561，p = 0.049）。Kaplan-Meier分析表明，每两周一次组的中性粒细胞减少（≥3级）与标准组相比显著延长（p = 0.012）。然而，两组间不良事件无显著差异（p>0.999）。
与标准方案相比，每两周一次FTD/TPI方案可提高mCRC患者的OS和PFS，且不增加任何不良事件。
