Phase II study of long-course chemoradiotherapy followed by consolidation chemotherapy as total neoadjuvant therapy in locally advanced rectal cancer in Japan: ENSEMBLE-2

IF 2.9 4区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Yoshinori Kagawa, Koji Ando, Mamoru Uemura, Jun Watanabe, Koji Oba, Yasunori Emi, Nobuhisa Matsuhashi, Naoki Izawa, Osamu Muto, Tatsuya Kinjo, Ichiro Takemasa, Eiji Oki
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引用次数: 0

Abstract

Aim

To evaluate the feasibility and safety of total neoadjuvant therapy with long-course chemoradiotherapy followed by consolidation chemotherapy in Japanese patients with locally advanced rectal cancer.

Methods

This prospective, multicenter, single-arm, phase II trial was conducted at 10 centers. The eligibility criteria included age ≥20 y, locally advanced rectal cancer within 12 cm of the anal verge, and cT3-4N0M or TanyN+M0 at diagnosis, enabling curative resection. The protocol treatment was capecitabine (1650 mg/m2/day)-based long-course chemoradiotherapy (50.4 Gy/28 fractions) and consolidation chemotherapy (CAPOX, four courses) followed by total mesorectal excision. Nonoperative management was allowed if a clinical complete response was achieved. The primary endpoint was the pathologic complete response rate.

Results

Among 28 enrolled patients (19 men, 9 women; median age, 69.5 [41–79] y), the long-course chemoradiotherapy and consolidation chemotherapy completion rates were 100% and 96.4%, respectively. The clinical responses included clinical complete response, (35.7%, 10/28), near-complete response (28.6%, 8/28), and incomplete response (32.1%, 9/28). Total mesorectal excision and nonoperative management were performed in 21 and six patients, respectively. The final analysis included 21 patients. Five patients (23.8% [90% confidence interval 11.8%–41.8%]) achieved pathologic complete response, while 10 of 28 patients (35.7%) achieved a pathological complete response or a sustained clinical complete response. No treatment-related deaths occurred. Grade ≥3 adverse events included diarrhea (7.1%) and leukopenia (7.1%).

Conclusion

ENSEMBLE-2 demonstrated comparable pathologic complete response rates and well-tolerated safety of total neoadjuvant therapy with long-course chemoradiotherapy followed by consolidation chemotherapy in Japanese patients with locally advanced rectal cancer.

日本对局部晚期直肠癌采用长程化放疗后巩固化疗作为新辅助治疗的 II 期研究:ENSEMBLE-2。
目的:评估日本局部晚期直肠癌患者接受长程化放疗和巩固化疗的新辅助治疗的可行性和安全性:这项前瞻性、多中心、单臂、II期试验在10个中心进行。入选标准包括年龄≥20岁,肛缘12厘米以内的局部晚期直肠癌,诊断时为cT3-4N0M或TanyN+M0,可进行根治性切除。治疗方案为以卡培他滨(1650 毫克/平方米/天)为基础的长程化放疗(50.4 Gy/28次)和巩固化疗(CAPOX,四个疗程),然后进行全直肠系膜切除术。如果达到临床完全反应,则允许进行非手术治疗。主要终点是病理完全反应率:在28名入组患者中(19名男性,9名女性;中位年龄69.5 [41-79]岁),长程化放疗和巩固化疗完成率分别为100%和96.4%。临床反应包括临床完全反应(35.7%,10/28)、接近完全反应(28.6%,8/28)和不完全反应(32.1%,9/28)。分别有 21 名和 6 名患者接受了全直肠系膜切除术和非手术治疗。最终分析包括 21 名患者。5例患者(23.8% [90%置信区间 11.8%-41.8%] )获得了病理完全应答,28例患者中有10例(35.7%)获得了病理完全应答或持续临床完全应答。无治疗相关死亡病例发生。≥3级不良反应包括腹泻(7.1%)和白细胞减少(7.1%):ENSEMBLE-2证明,在日本局部晚期直肠癌患者中,采用长程化放疗和巩固化疗的新辅助治疗具有相当的病理完全反应率和良好的耐受性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Annals of Gastroenterological Surgery
Annals of Gastroenterological Surgery GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
5.30
自引率
11.10%
发文量
98
审稿时长
11 weeks
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