Higashijima Jun, Tokunaga Takuya, Yoshimoto Toshiaki, Eto Shohei, Kashihara Hideya, Takasu Chie, Nishi Masaaki, Yoshikawa Kozo, Okitsu Hiroshi, Ishikawa Masashi, Miyake Hidenori, Yagi Toshiyuki, Kono Toru, Shimada Mitsuo
Department of Surgery, Institute of Health Biosciences, The University of Tokushima, Kuramoto 3-18-15, Tokushima, 770-8503, Japan.
Department of Surgery, Tokushima Red Cross Hospital, Tokushima, Japan.
Int J Clin Oncol. 2021 May;26(5):875-882. doi: 10.1007/s10147-021-01868-1. Epub 2021 Jan 23.
We clarified the safety and efficacy of preoperative chemoradiotherapy for locally advanced rectal cancer using a multidrug regimen (S-1 + oxaliplatin + bevacizumab).
This multicenter phase II trial involved 47 patients with locally advanced rectal cancer. All patients received S-1 orally (80 mg/m/day on days 1-5, 8-12, 15-19, and 22-26) and infusions of oxaliplatin (50 mg/m on days 1, 8, 15, and 22) and bevacizumab (5 mg/kg on days 1 and 15). The total radiation dose was 40 Gy delivered in daily fractions of 2 Gy via the four-field technique. The primary endpoint was the pathological complete response rate. The secondary endpoints were safety (incidence of adverse events) and clinical response, relapse-free survival, overall survival, local recurrence, R0 resection, downstaging, and treatment completion rates.
All 47 patients received chemoradiotherapy, and 44 patients underwent curative resection. Two patients refused surgery and selected a watch-and-wait strategy. The pathological complete response rate was 18.2% in patients who underwent curative resection. The clinical response rate was 91.3% in 46 patients. Concerning hematotoxicity, there was one grade 4 adverse event (2.1%) and seven grade 3 events (14.9%). Diarrhea was the most frequent non-hematotoxic event, and the grade 3 event rate was 25.5%.
Although preoperative chemoradiotherapy for patients with locally advanced rectal cancer using the S-1 + oxaliplatin + bevacizumab regimen did not achieve the expected pathological complete response rate, this regimen led to an improved clinical response rate.
我们使用多药联合方案（S-1+奥沙利铂+贝伐单抗）阐明了术前放化疗对局部晚期直肠癌的安全性和有效性。
这项多中心II期试验纳入了47例局部晚期直肠癌患者。所有患者口服S-1（第1-5天、8-12天、15-19天和22-26天，80mg/m²/天），并静脉输注奥沙利铂（第1、8、15和22天，50mg/m²）和贝伐单抗（第1和15天，5mg/kg）。总放射剂量为40Gy，通过四野技术每天分2Gy给予。主要终点是病理完全缓解率。次要终点包括安全性（不良事件发生率）、临床缓解、无复发生存期、总生存期、局部复发、R0切除、降期和治疗完成率。
47例患者均接受了放化疗，44例患者接受了根治性切除。2例患者拒绝手术，选择了观察等待策略。接受根治性切除的患者病理完全缓解率为18.2%。46例患者的临床缓解率为91.3%。关于血液毒性，有1例4级不良事件（2.1%）和7例3级事件（14.9%）。腹泻是最常见的非血液毒性事件，3级事件发生率为25.5%。
尽管使用S-1+奥沙利铂+贝伐单抗方案对局部晚期直肠癌患者进行术前放化疗未达到预期的病理完全缓解率，但该方案提高了临床缓解率。
