CIRCULATE-Japan: Circulating tumor DNA-guided adaptive platform trials to refine adjuvant therapy for colorectal cancer

被引：109

作者：

Taniguchi, Hiroya ^{[1
,2
]}

Nakamura, Yoshiaki ^{[1
,3
]}

Kotani, Daisuke ^{[1
]}

Yukami, Hiroki ^{[1
]}

Mishima, Saori ^{[1
]}

Sawada, Kentaro ^{[1
]}

Shirasu, Hiromichi ^{[4
]}

Ebi, Hiromichi ^{[5
]}

Yamanaka, Takeharu ^{[6
]}

Aleshin, Alexey ^{[7
]}

Bllings, Paul R. ^{[7
]}

Rabinowitz, Matthew ^{[7
]}

Oki, Eiji ^{[8
]}

Takemasa, Ichiro ^{[9
]}

Kato, Takeshi ^{[10
]}

Mori, Masaki ^{[8
,11
]}

Yoshino, Takayuki ^{[1
]}

机构：

[1] Natl Canc Ctr Hosp East, Dept Gastroenterol & Gastrointestinal Oncol, Kashiwa, Chiba, Japan

[2] Aichi Canc Ctr Hosp, Dept Clin Oncol, Nagoya, Aichi, Japan

[3] Natl Canc Ctr Hosp East, Translat Res Support Sect, Kashiwa, Chiba, Japan

[4] Shizuoka Canc Ctr, Div Gastrointestinal Oncol, Shizuoka, Japan

[5] Aichi Canc Ctr Res Inst, Div Mol Therapeut, Nagoya, Aichi, Japan

[6] Natl Canc Ctr Hosp East, Dept Biostat, Kashiwa, Chiba, Japan

[7] Natera Inc, San Carlos, CA USA

[8] Kyushu Univ, Grad Sch Med Sci, Dept Surg & Sci, Fukuoka, Japan

[9] Sapporo Med Univ, Dept Surg, Surg Oncol & Sci, Sapporo, Hokkaido, Japan

[10] Natl Hosp Org Osaka Natl Hosp, Dept Surg, Osaka, Japan

[11] Tokai Univ, Sch Med, Isehara, Kanagawa, Japan

来源：

CANCER SCIENCE | 2021年 / 112卷 / 07期

关键词：

adaptive clinical trial design; adjuvant chemotherapy; circulating tumor DNA; colorectal cancer; trifluridine;

D O I：

10.1111/cas.14926

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Adjuvant chemotherapy has reduced the risk of tumor recurrence and improved survival in patients with resected colorectal cancer. Potential utility of circulating tumor DNA (ctDNA) prior to and post surgery has been reported across various solid tumors. We initiated a new type of adaptive platform trials to evaluate the clinical benefits of ctDNA analysis and refine precision adjuvant therapy for resectable colorectal cancer, named CIRCULATE-Japan including three clinical trials. The GALAXY study is a prospectively conducted large-scale registry designed to monitor ctDNA for patients with clinical stage II to IV or recurrent colorectal cancer who can undergo complete surgical resection. The VEGA trial is a randomized phase III study designed to test whether postoperative surgery alone is noninferior to the standard therapy with capecitabine plus oxaliplatin for 3 months in patients with high-risk stage II or low-risk stage III colon cancer if ctDNA status is negative at week 4 after curative surgery in the GALAXY study. The ALTAIR trial is a double-blind, phase III study designed to establish the superiority of trifluridine/tipiracil as compared with placebo in patients with resected colorectal cancer who show circulating tumor-positive status in the GALAXY study. Therefore, CIRCULATE-Japan encompasses both "de-escalation" and "escalation" trials for ctDNA-negative and -positive patients, respectively, and helps to answer whether measuring ctDNA postoperatively has prognostic and/or predictive value. Our ctDNA-guided adaptive platform trials will accelerate clinical development toward further precision oncology in the field of adjuvant therapy. Analysis of ctDNA status could be utilized as a predictor of risk stratification for recurrence and to monitor the effectiveness of adjuvant chemotherapy. ctDNA is a promising, noninvasive tumor biomarker that can aid in tumor monitoring throughout disease management.

引用

页码：2915 / 2920

页数：6

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