Emoto Shigenobu, Kawai Kazushige, Oba Koji, Nozawa Hiroaki, Sasaki Kazuhito, Murono Koji, Yokoyama Yuichiro, Abe Shinya, Kaneko Kensuke, Nagai Yuzo, Shinagawa Takahide, Tachikawa Yuichi, Okada Satoshi, Ishihara Soichiro
Department of Surgical Oncology, The University of Tokyo, 7-3-1, Hongo, Bunkyo-Ku, Tokyo, 113-8655, Japan.
Department of Surgery, Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital, Tokyo, Japan.
Int J Colorectal Dis. 2025 Mar 26;40(1):76. doi: 10.1007/s00384-025-04867-0.
This study aims to evaluate both the short- and long-term outcomes of preoperative chemoradiotherapy (CRT) using the tegafur-uracil/calcium folinate/irinotecan (TEGAFIRI) regimen in patients with locally advanced rectal cancer (LARC). While total neoadjuvant therapy (TNT) is becoming more common, CRT may still be the optimal approach in certain cases to improve prognosis and reduce adverse events.
This single-center, retrospective cohort study included patients with histologically confirmed nonmetastatic primary adenocarcinoma of the lower rectum treated with preoperative CRT using the TEGAFIRI regimen (TEGAFIRI group). The control group comprised patients treated with tegafur-uracil/calcium folinate (UFT group). The primary endpoint was the pathologic complete response (pCR) rate. Secondary endpoints included adverse events, overall survival (OS), disease-free survival (DFS), distant recurrence-free survival (DRFS), and local recurrence-free survival (LRFS). The background was adjusted using inverse probability weighting (IPW) calculated with the propensity score.
The TEGAFIRI group consisted of 79 patients, while the UFT group included 264. The standardized pCR rates through the IPW were as follows: TEGAFIRI group: 24.3%, UFT group: 8.8%, and the difference in pCR was 15.4% (P = 0.01). Adverse events of grade 3 or higher were observed in 15.2% vs. 8.7% (adjusted) (13.6% vs. 9.1% crude) in the TEGAFIRI group and the UFT group. The standardized LRFS was significantly higher in the TEGAFIRI group (HR = 0.39, (95% CI 0.16-0.98), P = 0.045). There were no significant differences in OS, DFS, or DRFS between groups.
The TEGAFIRI regimen for preoperative CRT in LARC demonstrated a high pCR rate and reduced local recurrence, with manageable adverse events.
本研究旨在评估替加氟-尿嘧啶/亚叶酸钙/伊立替康（TEGAFIRI）方案术前放化疗（CRT）在局部晚期直肠癌（LARC）患者中的短期和长期疗效。虽然全新辅助治疗（TNT）越来越普遍，但在某些情况下，CRT可能仍是改善预后和减少不良事件的最佳方法。
本单中心回顾性队列研究纳入了经组织学确诊为低位直肠非转移性原发性腺癌且接受TEGAFIRI方案术前CRT治疗的患者（TEGAFIRI组）。对照组包括接受替加氟-尿嘧啶/亚叶酸钙（UFT组）治疗的患者。主要终点是病理完全缓解（pCR）率。次要终点包括不良事件、总生存期（OS）、无病生存期（DFS）、远处无复发生存期（DRFS）和局部无复发生存期（LRFS）。使用倾向评分计算的逆概率加权（IPW）对背景进行调整。
TEGAFIRI组有79例患者，而UFT组有264例。通过IPW得出的标准化pCR率如下：TEGAFIRI组：24.3%，UFT组：8.8%，pCR差异为15.4%（P = 0.01）。TEGAFIRI组和UFT组3级或更高等级的不良事件发生率分别为15.2%和8.7%（调整后）（粗发生率分别为13.6%和9.1%）。TEGAFIRI组的标准化LRFS显著更高（HR = 0.39，（95% CI 0.16 - 0.98），P = 0.045）。两组之间的OS、DFS或DRFS无显著差异。
TEGAFIRI方案用于LARC术前CRT显示出高pCR率并减少了局部复发，不良事件可控。
