Liao Chun-Kai, Kuo Ya-Ting, Chern Yih-Jong, Hsu Yu-Jen, Lin Yueh-Chen, Yu Yen-Lin, Hsieh Pao-Shiu, Chiang Jy-Ming, Yeh Chien-Yuh, You Jeng-Fu
Division of Colon and Rectal Surgery, Department of Surgery, Chang Gung Memorial Hospital, Linkou, No. 5, Fuxing Street, Guishan District, Taoyuan 333423, Taiwan.
Division of Colon and Rectal Surgery, Department of Surgery, Chang Gung Memorial Hospital, Keelung Branch, No. 222, Maijin Road, Anle District, Keelung City 204201, Taiwan.
J Clin Med. 2022 May 22;11(10):2920. doi: 10.3390/jcm11102920.
This study aimed to explore the safety and efficacy of neoadjuvant SCRT and tegafur−uracil/leucovorin plus oxaliplatin (TEGAFOX) for LARC in comparison to those of the modified 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX-6) regimen. We retrospectively evaluated 15 and 22 patients with LARC who underwent SCRT, followed by consolidation chemotherapy with TEGAFOX and mFOLFOX-6 before surgery, respectively, between January 2015 and December 2019. The primary endpoint was the tumor response rate. The secondary endpoints were compliance, toxicity, complications, overall survival (OS), and disease-free survival (DFS). The dose reduction rate was lower in the TEGAFOX group (0 vs. 9.1% (n = 2)). No grade III-IV toxicities occurred in the TEGAFOX group. Two and four patients in the TEGAFOX and mFOLFOX-6 groups, respectively, achieved clinical complete responses. The pathologic complete response rate was lower in the TEGAFOX group (7.7% vs. 17.6%). Overall, 11 (73.3%) and 17 (81.0%) patients had a neoadjuvant rectal (NAR) score of <16 in the TEGAFOX and mFOLFOX-6 groups, respectively. All patients in this study received sphincter-preservation surgery. One patient in each group developed Clavien−Dindo grade III complications. There were no significant between-group differences in the 3-year OS (81.8% vs. 84.8%, p = 0.884) and 3-year DFS (72% vs. 71.6%, p = 0.824) rates. TEGAFOX, as consolidation chemotherapy after SCRT, achieves good tumor downstaging and patient compliance in LARC. The toxicity, complications, and surgical outcomes are similar to those of mFOLFOX-6. Thus, TEGAFOX can be considered a chemotherapy option for rectal cancer treatment.
本研究旨在探讨新辅助同步放化疗（SCRT）联合替加氟-尿嘧啶/亚叶酸钙加奥沙利铂（TEGAFOX）方案与改良的氟尿嘧啶、亚叶酸钙和奥沙利铂（mFOLFOX-6）方案相比，用于局部晚期直肠癌（LARC）的安全性和疗效。我们回顾性评估了2015年1月至2019年12月期间分别接受SCRT治疗，随后在手术前分别接受TEGAFOX和mFOLFOX-6巩固化疗的15例和22例LARC患者。主要终点是肿瘤反应率。次要终点是依从性、毒性、并发症、总生存期（OS）和无病生存期（DFS）。TEGAFOX组的剂量降低率较低（0%对9.1%（n = 2））。TEGAFOX组未发生Ⅲ-Ⅳ级毒性反应。TEGAFOX组和mFOLFOX-6组分别有2例和4例患者达到临床完全缓解。TEGAFOX组的病理完全缓解率较低（7.7%对17.6%）。总体而言，TEGAFOX组和mFOLFOX-6组分别有11例（73.3%）和17例（81.0%）患者的新辅助直肠（NAR）评分<16。本研究中的所有患者均接受了保留括约肌手术。每组各有1例患者发生Clavien-DindoⅢ级并发症。3年OS率（81.8%对84.8%，p = 0.884）和3年DFS率（72%对71.6%，p = 0.824）在组间无显著差异。TEGAFOX作为SCRT后的巩固化疗，在LARC中能实现良好的肿瘤降期和患者依从性。其毒性、并发症和手术结果与mFOLFOX-6相似。因此，TEGAFOX可被视为直肠癌治疗的一种化疗选择。
