SOX 与 mFOLFOX6 作为局部晚期直肠癌新辅助化疗（KSCC1301）且不联合放疗的疗效和安全性的随机 II 期研究。
Randomized phase II study comparing the efficacy and safety of SOX versus mFOLFOX6 as neoadjuvant chemotherapy without radiotherapy for locally advanced rectal cancer (KSCC1301).
机构信息
Multidisciplinary Treatment Cancer Center, Kurume University Hospital, Kurume, Japan.
Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Maidashi 3-1-1, Higashi-ku, Fukuoka, 812-8582, Japan.
出版信息
BMC Cancer. 2021 Jan 5;21(1):23. doi: 10.1186/s12885-020-07766-5.
BACKGROUND
Preoperative chemoradiotherapy (CRT), the current standard of care for locally advanced rectal cancer (LARC), is associated with many radiotherapy (RT)-related side effects. We aimed to evaluate whether S-1 and oxaliplatin (SOX) or folinic acid, 5-FU, and oxaliplatin (mFOLFOX6) can be as effective as neoadjuvant chemotherapy (NAC) regimens for LARC without RT.
METHODS
Patients with untreated resectable LARC were randomly assigned to receive SOX or mFOLFOX6. The NAC protocol period was 3 months. The primary endpoint was 3-year disease-free survival (DFS), and the secondary endpoints included pathological effects, surgical completion rate, 3-year survival, and safety.
RESULTS
From September 2013 to October 2015, 56 and 54 patients were enrolled in the SOX and mFOLFOX6 arms, respectively. The 3-year DFS rates were 69.4% (95% confidence interval [CI] 54.9-83.6) and 73.4% (95% CI 58.7-83.6) in the SOX and mFOLFOX6 arms, respectively; no significant differences were found between the arms (log-rank test; P = 0.5315, hazard ratio: 0.808, 95% CI 0.414-1.578). The 3-year survival rates were 92.3 and 91.8% in the SOX and mFOLFOX6 arms, respectively. The surgical completion rate was 98.1% overall, 100% in the SOX arm, and 96.0% in the mFOLFOX6 arm. The incidences of pathological response rates ≥grade 1b were 41.5 and 43.8% in the SOX and mFOLFOX6 arms, respectively. Both treatments were manageable and tolerable.
CONCLUSION
We demonstrated the effectiveness and safety of SOX and mFOLFOX6, both of which may be new neoadjuvant treatment candidates in previously untreated LARC cases.
TRIAL REGISTRATION
Date of enrolment of the first participant to the trial: 3rd Oct 2013; This study was registered in the UMIN clinical trials registry on 14th Aug, 2013. (Prospectively registered, UMIN-CTR number UMIN000011486). https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&recptno=R000013441&language=J.
背景
术前放化疗（CRT）是局部晚期直肠癌（LARC）的当前标准治疗方法，与许多放射治疗（RT）相关的副作用有关。我们旨在评估 S-1 和奥沙利铂（SOX）或亚叶酸、5-FU 和奥沙利铂（mFOLFOX6）是否可以作为 LARC 的新辅助化疗（NAC）方案而不进行 RT。
方法
未经治疗可切除的 LARC 患者被随机分配接受 SOX 或 mFOLFOX6。NAC 方案期为 3 个月。主要终点是 3 年无病生存率（DFS），次要终点包括病理效应、手术完成率、3 年生存率和安全性。
结果
从 2013 年 9 月至 2015 年 10 月，SOX 和 mFOLFOX6 组分别入组 56 例和 54 例患者。SOX 和 mFOLFOX6 组的 3 年 DFS 率分别为 69.4%（95%置信区间[CI] 54.9-83.6）和 73.4%（95% CI 58.7-83.6）；两组之间无显著差异（对数秩检验；P=0.5315，风险比：0.808，95% CI 0.414-1.578）。SOX 和 mFOLFOX6 组的 3 年生存率分别为 92.3%和 91.8%。手术完成率总体为 98.1%，SOX 组为 100%，mFOLFOX6 组为 96.0%。病理反应率≥1b 级的发生率分别为 41.5%和 43.8%，SOX 和 mFOLFOX6 组。两种治疗均易于管理且耐受良好。
结论
我们证明了 SOX 和 mFOLFOX6 的有效性和安全性，两者都可能是未经治疗的 LARC 病例的新辅助治疗候选药物。
试验注册
第一个参与者入组的日期：2013 年 10 月 3 日；这项研究于 2013 年 8 月 14 日在 UMIN 临床试验注册处注册。（前瞻性注册，UMIN-CTR 编号 UMIN000011486）。https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&recptno=R000013441&language=J.
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