Tsukada Yuichiro, Saito Norio, Nishizawa Yuji, Ohno Riki, Fujita Fumihiko, Koda Keiji, Ohue Masayuki, Shinto Eiji, Murata Akihiko, Koide Yoshikazu, Ikeda Koji, Bando Hideaki, Suzuki Motoko, Misumi Toshihiro, Yoshino Takayuki, Ito Masaaki
From the Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Department of General Surgery, Saito Rosai Hospital, Chiba, Japan.
Ann Surg Open. 2025 May 16;6(2):e579. doi: 10.1097/AS9.0000000000000579. eCollection 2025 Jun.
To determine whether neoadjuvant chemotherapy (NAC) followed by total mesorectal excision (TME) and adjuvant chemotherapy (AC) is superior to TME followed by AC for very low-lying clinical (c) T3 rectal cancer.
Preoperative radiation is widely used for preoperative treatment of cT3 rectal cancer; however, it worsens patient-reported outcomes (PROs). Preoperative treatment without radiation is expected to preserve PROs.
Patients with cT3N-anyM0 rectal cancer located within 5 cm from the anal verge were randomly assigned (1:1) to the NAC group (3 months of NAC followed by TME and 3 months of AC) or AC group (TME followed by 6 months of AC). NAC and AC comprised mFOLFOX6 (oxaliplatin, l-folinic acid, and fluorouracil) or CAPOX (oxaliplatin and capecitabine). The primary endpoint was the 3-year recurrence-free survival (RFS). PROs were analyzed.
Between February 2013 and March 2019, 130 patients were randomly assigned to the NAC (n = 65) or AC (n = 65) groups; of these, 127 were evaluable (NAC, n = 65; AC, n = 62). At a median follow-up of 37.4 months, the 3-year RFS was 75.5% and 70.9% in NAC and AC groups, respectively [hazard ratio (HR) = 0.67, 60% confidence interval (CI) = 0.48-0.86, 95% CI = 0.34-1.32; = 0.098 by log-rank test] and the primary endpoint was met. There was no significant intergroup difference in the local recurrence rate (LRR) or overall survival. Histologically, good responders to NAC showed a trend toward better RFS than poor responders. The study groups showed similar PROs.
NAC for very low-lying cT3 rectal cancer improved RFS without worsening PROs although LRR remained high.
UMIN Clinical Trials Registry: UMIN000009510/Japan Registry of Clinical Trials: jRCTs031180278.
确定新辅助化疗（NAC）后行全直肠系膜切除术（TME）及辅助化疗（AC）是否优于先行TME再行AC用于治疗低位临床（c）T3期直肠癌。
术前放疗广泛用于cT3期直肠癌的术前治疗；然而，它会使患者报告结局（PROs）恶化。预计无放疗的术前治疗可保留PROs。
距肛缘5 cm内的cT3N任意M0期直肠癌患者被随机分组（1:1）至NAC组（3个月NAC后行TME及3个月AC）或AC组（先行TME再行6个月AC）。NAC和AC方案包括mFOLFOX6（奥沙利铂、亚叶酸钙和氟尿嘧啶）或CAPOX（奥沙利铂和卡培他滨）。主要终点为3年无复发生存率（RFS）。对PROs进行分析。
2013年2月至2019年3月，130例患者被随机分至NAC组（n = 65）或AC组（n = 65）；其中127例可评估（NAC组，n = 65；AC组，n = 62）。中位随访37.4个月时，NAC组和AC组的3年RFS分别为75.5%和70.9%[风险比（HR）= 0.67，60%置信区间（CI）= 0.48 - 0.86，95% CI = 0.34 - 1.32；对数秩检验P = 0.098]，达到主要终点。局部复发率（LRR）或总生存期无显著组间差异。组织学上，NAC治疗反应良好者的RFS有优于反应不良者的趋势。研究组的PROs相似。
低位cT3期直肠癌行NAC可改善RFS且不恶化PROs，尽管LRR仍然较高。
UMIN临床试验注册中心：UMIN000009510/日本临床试验注册中心：jRCTs031180278 。
