Ohira Gaku, Miyauchi Hideaki, Hayano Koichi, Imanishi Shunsuke, Tochigi Toru, Maruyama Tetsuro, Hanaoka Toshiharu, Okada Koichiro, Kobayashi Hiroki, Uno Takashi, Matsubara Hisahiro
Department of Frontier Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.
Department of Radiology, Chiba University Graduate School of Medicine, Chiba, Japan.
J Anus Rectum Colon. 2019 Jan 29;3(1):43-48. doi: 10.23922/jarc.2018-026. eCollection 2019.
To clarify the safety and efficacy of celecoxib combined with chemoradiotherapy using S-1 for lower rectal cancer.
Twenty-one patients with pathologically proven lower rectal adenocarcinoma (cT3-T4, Tx N+, M0) were included in this study. A total dose of 45 Gy was administered in daily fractions of 1.8 Gy. Celecoxib was given orally twice daily with S-1 on the day of irradiation. The dose of celecoxib was set at 400 mg/day. In Phase I, the S-1 dose was started at 80 mg/m/day; in Phase II, S-1 was administered in the same dose as Phase I. Patients underwent surgery six to eight weeks after completing chemoradiotherapy, followed by six months of postoperative adjuvant chemotherapy.
The S-1 recommended dose was 80 mg/m/day. The pathological complete remission rate was 15.8%, the rate of protocol completion was 14.3%, and the rate of adverse events exceeding Grade 3 was 19.0%. Surgery was performed in 19 cases, with a sphincter-sparing rate of 31.6%. Postoperative complications exceeding Grade 3 occurred in 52.4% of cases. The three year overall survival and relapse-free survival rates were 89.3% and 67.0%, respectively.
We failed to show a synergistic or additive therapeutic effect of preoperative CRT using S-1, combined with celecoxib, for lower advanced rectal cancer beyond CRT using 5 FU or capecitabine alone. The incidence of complications, evidently involving intestinal ischemia, was relatively high. This treatment strategy is not recommended at present.
阐明塞来昔布联合S-1用于低位直肠癌放化疗的安全性和有效性。
本研究纳入21例经病理证实的低位直肠腺癌患者（cT3-T4，Tx N+，M0）。总剂量45 Gy，分每日1.8 Gy给予。在放疗当天，塞来昔布与S-1每日口服两次。塞来昔布剂量设定为400 mg/天。在I期，S-1剂量开始为80 mg/m²/天；在II期，S-1以与I期相同的剂量给药。患者在完成放化疗后6至8周接受手术，随后进行6个月的术后辅助化疗。
S-1推荐剂量为80 mg/m²/天。病理完全缓解率为15.8%，方案完成率为14.3%，3级以上不良事件发生率为19.0%。19例患者接受了手术，保肛率为31.6%。3级以上术后并发症发生率为52.4%。三年总生存率和无复发生存率分别为89.3%和67.0%。
对于晚期低位直肠癌，我们未能证明术前使用S-1联合塞来昔布进行放化疗比单独使用5-氟尿嘧啶或卡培他滨进行放化疗有协同或相加的治疗效果。并发症发生率相对较高，明显涉及肠道缺血。目前不推荐这种治疗策略。
