Okamoto Hironao, Sugano Nobuhiro, Sato Maho, Iguchi Kenta, Asari Masahiro, Kazama Keisuke, Numata Masakatsu, Godai Teni, Higuchi Akio, Mushiake Hiroyuki, Saito Aya, Shiozawa Manabu
Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-Ku, Yokohama City, Kanagawa, 241-8515, Japan.
Department of Surgery, Hiratsuka Kyousai Hospital, 9-11 Oiwake Hiratsuka-Shi, Kanagawa, 254-0047, Japan.
Int J Colorectal Dis. 2025 Apr 2;40(1):82. doi: 10.1007/s00384-025-04873-2.
Although chemoradiotherapy is considered an efficacious treatment option for patients with locally advanced rectal cancer, the associated radiological toxicities and late anal dysfunction are concerning issues. Herein, we examined the efficacy and safety of folinic acid, 5-fluorouracil, oxaliplatin, and irinotecan (FOLFOXIRI) as upfront therapy for marginally unresectable local rectal cancers without distant metastasis.
This multicenter, prospective, observational study was designed by the Yokohama Colorectal Cancer Study Group. The primary endpoint was the conversion rate. Secondary endpoints were the R0 resection rate, response rate, pathological response rate, postoperative complication rate, relapse-free survival, local progression-free rate, and circumferential resection margin-negative rate.
Twenty patients were enrolled in this study. The study achieved its primary endpoint; the R0 resection rate was 80% (95% confidence interval, 56.3 to 94.3). Major grade ≥ 3 adverse effects included neutropenia in 7 (35%) patients, anemia in 3 (15%), fatigue in 2 (10%), enterocolitis in 2 (10%), febrile neutropenia in 1 (5%), leukopenia in 1 (5%), diarrhea in 1 (5%), fever in 1 (5%), and urinary tract infection in 1 (5%).
FOLFOXIRI therapy was well tolerated and showed comparable efficacy results, providing potential R0 resection in patients with marginally unresectable locally advanced rectal cancer without distant metastasis.
UMIN Clinical Trials Registry (UMIN000040275).
尽管放化疗被认为是局部晚期直肠癌患者的一种有效治疗选择，但相关的放射毒性和晚期肛门功能障碍是令人担忧的问题。在此，我们研究了亚叶酸、5-氟尿嘧啶、奥沙利铂和伊立替康（FOLFOXIRI）作为无远处转移的边缘不可切除局部直肠癌一线治疗的疗效和安全性。
本多中心、前瞻性、观察性研究由横滨结直肠癌研究组设计。主要终点是转化率。次要终点是R0切除率、缓解率、病理缓解率、术后并发症发生率、无复发生存率、局部无进展率和环周切缘阴性率。
本研究纳入了20例患者。该研究达到了其主要终点；R0切除率为80%（95%置信区间，56.3至94.3）。≥3级主要不良反应包括7例（35%）患者出现中性粒细胞减少、3例（15%）贫血、2例（10%）疲劳、2例（10%）小肠结肠炎、1例（5%）发热性中性粒细胞减少、1例（5%）白细胞减少、1例（5%）腹泻、1例（5%）发热和1例（5%）尿路感染。
FOLFOXIRI治疗耐受性良好，疗效结果相当，为无远处转移的边缘不可切除局部晚期直肠癌患者提供了潜在的R0切除机会。
UMIN临床试验注册中心（UMIN000040275）。
