Neoadjuvant Chemotherapy With Oxaliplatin and Fluoropyrimidine Versus Upfront Surgery for Locally Advanced Colon Cancer: The Randomized, Phase III OPTICAL Trial

被引：17

作者：

Hu, Huabin ^{[1
,2
,3
]}

Zhang, Jianwei ^{[1
,2
,3
]}

Li, Yunfeng ^{[4
]}

Wang, Xiaozhong ^{[5
]}

Wang, Ziqiang ^{[6
]}

Wang, Hui ^{[2
,3
,7
]}

Kang, Liang ^{[2
,3
,7
]}

Liu, Ping ^{[4
]}

Lan, Ping ^{[2
,3
,7
]}

Wu, Xiaojian ^{[2
,3
,7
]}

Zhen, Yunhuan ^{[8
]}

Pei, Haiping ^{[9
]}

Huang, Zhongcheng ^{[10
]}

Zhang, Hao ^{[11
]}

Chen, Wenbin ^{[12
]}

Zeng, Yongming ^{[13
]}

Lai, Jiajun ^{[14
]}

Wei, Hongbo ^{[15
]}

Huang, Xuefeng ^{[16
]}

Chen, Jiansi ^{[17
]}

Chen, Jigui ^{[18
]}

Tao, Kaixiong ^{[19
]}

Xu, Qingwen ^{[20
]}

Peng, Xiang ^{[21
]}

Liang, Junlin ^{[22
]}

Cai, Guanfu ^{[23
]}

Ding, Kefeng ^{[24
]}

Ding, Zhijie ^{[25
]}

Hu, Ming ^{[26
]}

Zhang, Wei ^{[27
]}

Tang, Bo ^{[28
]}

Hong, Chuyuan ^{[29
]}

Cao, Jie ^{[30
]}

Huang, Zonghai ^{[31
]}

Cao, Wuteng ^{[32
]}

Li, Fangqian ^{[32
]}

Wang, Xinhua ^{[32
]}

Wang, Chao ^{[33
]}

Huang, Yan ^{[33
]}

Zhao, Yandong ^{[33
]}

Cai, Yue ^{[1
,2
,3
]}

Ling, Jiayu ^{[1
,2
,3
]}

Xie, Xiaoyu ^{[1
,2
,3
]}

Wu, Zehua ^{[1
,2
,3
]}

Shi, Lishuo ^{[34
]}

Ling, Li ^{[35
,36
]}

Liu, Hao ^{[37
]}

Wang, Jianping ^{[2
,3
,7
]}

Huang, Meijin ^{[2
,3
,7
]}

Deng, Yanhong ^{[1
,2
,3
]}

机构：

[1] Sun Yat Sen Univ, Affiliated Hosp 6, Dept Med Oncol, Guangzhou, Peoples R China

[2] Guangdong Prov Key Lab Colorectal & Pelv Floor Dis, Guangzhou, Peoples R China

[3] Sun Yat Sen Univ, Affiliated Hosp 6, Biomed Innovat Ctr, Guangzhou, Peoples R China

[4] Kunming Med Univ, Yunnan Canc Hosp, Affiliated Hosp 3, Dept Colorectal Surg, Kunming, Peoples R China

[5] Shantou Cent Hosp, Dept Gastrointestinal Surg, Shantou, Peoples R China

[6] Sichuan Univ, West China Hosp, Colorectal Canc Ctr, Dept Gen Surg,Sch Med, Chengdu, Peoples R China

[7] Sun Yat Sen Univ, Affiliated Hosp 6, Dept Gen Surg, Guangzhou, Peoples R China

[8] Guizhou Med Univ, Affiliated Hosp, Dept Colorectal Surg, Guiyang, Peoples R China

[9] Cent South Univ, Xiangya Hosp, Dept Gen Surg, Changsha, Peoples R China

[10] Hunan Prov Peoples Hosp, Dept Gen Surg, Changsha, Peoples R China

[11] Dongguan Kanghua Hosp, Dept Gen Surg, Dongguan, Peoples R China

[12] Zhejiang Univ, Affiliated Hosp 1, Sch Med, Dept Colorectal Surg, Hangzhou, Peoples R China

[13] Shantou Univ, Affiliated Hosp 1, Med Coll, Dept Gastrointestinal Surg, Shantou, Peoples R China

[14] Yuebei Peoples Hosp, Dept Gastrointestinal Surg, Shaoguan, Peoples R China

[15] Sun Yat Sen Univ, Affiliated Hosp 3, Dept Gastrointestinal Surg, Guangzhou, Peoples R China

[16] Zhejiang Univ, Sir Run Run Shaw Hosp, Dept Colorectal Surg, Schoolof Med, Hangzhou, Peoples R China

[17] Guangxi Med Univ, Canc Hosp, Dept Gastrointestinal Surg, Nanning, Peoples R China

[18] Eighth Hosp Wuhan, Dept Surg, Wuhan, Peoples R China

[19] Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Dept Gastrointestinal Surg, Wuhan, Peoples R China

[20] Guangdong Med Univ, Affiliated Hosp, Dept Gastrointestinal Surg, Zhanjiang, Peoples R China

[21] First Peoples Hosp Foshan, Dept Gastrointestinal Surg, Foshan, Peoples R China

[22] Guangxi Med Univ, Affiliated Hosp 1, Dept Coloproctol Surg, Nanning, Peoples R China

[23] Guangdong Prov Peoples Hosp, Dept Gastrointestinal Surg, Guangzhou, Peoples R China

[24] Zhejiang Univ, Affiliated Hosp 2, Canc Ctr, Peoples Dept Colorectal Surg & Oncol,Sch Med, Hangzhou, Peoples R China

[25] Xiamen Univ, Zhongshan Hosp, Dept Gastrointestinal Surg, Xiamen, Peoples R China

[26] Guangzhou Med Univ, Affiliated Hosp 1, Dept Gastrointestinal Surg, Guangzhou, Peoples R China

[27] Naval Med Univ, Affiliated Hosp 1, Dept Colorectal Surg, Shanghai, Peoples R China

[28] Army Med Univ, Hosp Affiliated 1, Dept Gen Surg, Chongqing, Peoples R China

[29] Guangzhou Med Univ, Affiliated Hosp 2, Dept Gastrointestinal Surg, Guangzhou, Peoples R China

[30] Guangzhou First Peoples Hosp, Dept Gen Surg, Guangzhou, Peoples R China

[31] Southern Med Univ, Zhujiang Hosp, Dept Gen Surg, Guangzhou, Peoples R China

[32] Sun Yat Sen Univ, Affiliated Hosp 6, Dept Radiol, Guangzhou, Peoples R China

[33] Sun Yat Sen Univ, Affiliated Hosp 6, Dept Pathol, Guangzhou, Peoples R China

[34] Sun Yat Sen Univ, Affiliated Hosp 6, Clin Res Ctr, Guangzhou, Peoples R China

[35] Sun Yat Sen Univ, Sch Publ Hlth, Dept Med Stat, Guangzhou, Peoples R China

[36] Sun Yat Sen Univ, Ctr Migrant Hlth Policy, Guangzhou, Peoples R China

[37] Rutgers Canc Inst New Jersey, Rutgers Sch Publ Hlth, Dept Biostat & Epidemiol, Biostat Shared Resource, Brunswick, NJ USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2024年 / 42卷 / 25期

关键词：

ADJUVANT TREATMENT; COMPUTED-TOMOGRAPHY; PREOPERATIVE CHEMOTHERAPY; OPEN-LABEL; FLUOROURACIL; LEUCOVORIN; BEVACIZUMAB; IRINOTECAN; CARCINOMA; CETUXIMAB;

D O I：

10.1200/JCO.23.01889

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOSEThe role of neoadjuvant chemotherapy (NAC) in colon cancer remains unclear. This trial investigated whether 3 months of modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine and oxaliplatin (CAPOX) as NAC could improve outcomes in patients with locally advanced colon cancer versus upfront surgery.PATIENTS AND METHODSOPTICAL was a randomized, phase III trial in patients with clinically staged locally advanced colon cancer (T3 with extramural spread into the mesocolic fat >= 5 mm or T4). Patients were randomly assigned 1:1 to receive six preoperative cycles of mFOLFOX6 or four cycles of CAPOX, followed by surgery and adjuvant chemotherapy (NAC group), or immediate surgery and the physician's choice of adjuvant chemotherapy (upfront surgery group). The primary end point was 3-year disease-free survival (DFS) assessed in the modified intention-to-treat (mITT) population.RESULTSBetween January 2016 and April 2021, of the 752 patients enrolled, 744 patients were included in the mITT analysis (371 in the NAC group; 373 in the upfront surgery group). At a median follow-up of 48.0 months (IQR, 46.0-50.1), 3-year DFS rates were 82.1% in the NAC group and 77.5% in the upfront surgery group (stratified hazard ratio [HR], 0.74 [95% CI, 0.54 to 1.03]). The R0 resection was achieved in 98% of patients who underwent surgery in both groups. Compared with upfront surgery, NAC resulted in a 7% pathologic complete response rate (pCR), significantly lower rates of advanced tumor staging (pT3-4: 77% v 94%), lymph node metastasis (pN1-2: 31% v 46%), and potentially improved overall survival (stratified HR, 0.44 [95% CI, 0.25 to 0.77]).CONCLUSIONNAC with mFOLFOX6 or CAPOX did not show a significant DFS benefit. However, this neoadjuvant approach was safe, resulted in substantial pathologic downstaging, and appears to be a viable therapeutic option for locally advanced colon cancer.

引用

页码：2978 / 2988

页数：29

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