Koizumi Michihiro, Yamada Takeshi, Shinji Seiichi, Yokoyama Yasuyuki, Takahashi Goro, Iwai Takuma, Takeda Kohki, Hara Keisuke, Ohta Keiichiro, Uchida Eiji, Yoshida Hiroshi
Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan.
Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery, Nippon Medical School, Tokyo, Japan
In Vivo. 2018 Jul-Aug;32(4):937-943. doi: 10.21873/invivo.11332.
BACKGROUND/AIM: The combination of oxaliplatin, leucovorin and fluorouracil (FOLFOX) has been established as postoperative adjuvant chemotherapy for stage III colon cancer. However, the safety and efficacy of neoadjuvant FOLFOX in patients with rectal cancer are still controversial. This prospective pilot study aimed to evaluate the feasibility of neoadjuvant FOLFOX therapy without radiation for baseline resectable rectal cancer (RC).
The study included 30 patients with clinical stage II/III RC between February 2012 and December 2015. The patients were treated with six cycles of FOLFOX followed by elective surgery. The primary endpoint was the R0 resection rate. The secondary endpoints were the scheduled treatment completion rate, adverse events, pathological response and the disease-free survival (DFS) rate.
All the patients underwent elective R0 resection after neoadjuvant FOLFOX therapy. The completion rate of the 6-cycle regimen was 93.3% (28/30 patients). Grade 3-4 adverse events occurred in seven patients (23.3%). Pathological complete response was noted in two patients (6.7%). The 3-year DFS rate was 77.5% (95% confidence interval, 61.4%-93.7%).
Neoadjuvant FOLFOX therapy without radiation is a feasible therapeutic strategy for baseline resectable RC.
背景/目的：奥沙利铂、亚叶酸钙和氟尿嘧啶联合方案（FOLFOX）已被确立为III期结肠癌的术后辅助化疗方案。然而，新辅助FOLFOX方案用于直肠癌患者的安全性和疗效仍存在争议。这项前瞻性试点研究旨在评估新辅助FOLFOX治疗在无放疗情况下用于基线可切除直肠癌（RC）的可行性。
该研究纳入了2012年2月至2015年12月期间30例临床II/III期RC患者。患者接受6个周期的FOLFOX治疗，随后进行择期手术。主要终点是R0切除率。次要终点是预定治疗完成率、不良事件、病理反应和无病生存（DFS）率。
所有患者在接受新辅助FOLFOX治疗后均接受了择期R0切除。6周期方案的完成率为93.3%（28/30例患者）。7例患者（23.3%）发生3-4级不良事件。2例患者（6.7%）出现病理完全缓解。3年DFS率为77.5%（95%置信区间，61.4%-93.7%）。
无放疗的新辅助FOLFOX治疗是基线可切除RC的一种可行治疗策略。
