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Clinical Trial
. 2021 Aug 1;156(8):721-729.
doi: 10.1001/jamasurg.2021.2373.

Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial

Hong Yang  1 , Hui Liu  2 , Yuping Chen  3 , Chengchu Zhu  4 , Wentao Fang  5 , Zhentao Yu  6   7 , Weimin Mao  8 , Jiaqing Xiang  9 , Yongtao Han  10 , Zhijian Chen  11   12 , Haihua Yang  13 , Jiaming Wang  14 , Qingsong Pang  15 , Xiao Zheng  16 , Huanjun Yang  17 , Tao Li  18 , Xu Zhang  1 , Qun Li  2 , Geng Wang  3 , Baofu Chen  4 , Teng Mao  5 , Min Kong  4 , Xufeng Guo  5 , Ting Lin  1 , Mengzhong Liu  2 , Jianhua Fu  1
Affiliations
Clinical Trial

Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial

Hong Yang et al. JAMA Surg. .

Erratum in

  • Errors in a Figure.
    [No authors listed] [No authors listed] JAMA Surg. 2022 Sep 1;157(9):859. doi: 10.1001/jamasurg.2022.3765. JAMA Surg. 2022. PMID: 35921117 Free PMC article. No abstract available.

Abstract

Importance: The prognosis of patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains poor after surgery. Neoadjuvant chemoradiotherapy (NCRT) has been shown to potentially improve survival.

Objective: To compare the treatment efficacy of NCRT plus surgery with surgery alone for long-term survival among patients with locally advanced ESCC.

Design, setting, and participants: The Neoadjuvant Chemoradiotherapy for Esophageal Cancer 5010 study was a multicenter open-label randomized phase 3 clinical trial that enrolled patients between June 1, 2007, and December 31, 2014. Follow-up ended on December 31, 2019. The study was conducted at 8 centers in China. A total of 451 patients aged 18 to 70 years with thoracic ESCC stage T1-4N1M0/T4N0M0 were enrolled and randomized. Data were analyzed from December 1, 2019, to June 30, 2020.

Interventions: Patients randomized to receive NCRT plus surgery (NCRT group) received preoperative chemotherapy (25 mg/m2 of vinorelbine on days 1 and 8 and 75 mg/m2 of cisplatin on day 1 or 25 mg/m2 of cisplatin on days 1 to 4) every 3 weeks for 2 cycles and concurrent radiotherapy (40.0 Gy, administered in 20 fractions of 2.0 Gy for 5 days per week) followed by surgery. Patients randomized to receive surgery alone (surgery group) underwent surgery after randomization.

Main outcomes and measures: The primary end point was overall survival in the intention-to-treat population. The secondary end point was disease-free survival.

Results: A total of 451 patients (mean [SD] age, 56.5 [7.0] years; 367 men [81.4%]) were randomized to the NCRT (n = 224) and surgery (n = 227) groups and were eligible for the intention-to-treat analysis. By December 31, 2019, 224 deaths had occurred. The median follow-up was 53.5 months (interquartile range, 18.2-87.4 months). Patients receiving NCRT plus surgery had prolonged overall survival compared with those receiving surgery alone (hazard ratio, 0.74; 95% CI, 0.57-0.97; P = .03), with a 5-year survival rate of 59.9% (95% CI, 52.9%-66.1%) vs 49.1% (95% CI, 42.3%-55.6%), respectively. Patients in the NCRT group compared with the surgery group also had prolonged disease-free survival (hazard ratio, 0.60; 95% CI, 0.45-0.80; P < .001), with a 5-year survival rate of 63.6% (95% CI, 56.0%-70.2%) vs 43.0% (95% CI, 36.0%-49.7%), respectively.

Conclusions and relevance: In this randomized clinical trial, treatment with NCRT plus surgery significantly improved long-term overall survival and disease-free survival and therefore may be considered a standard of care for patients with locally advanced ESCC.

Trial registration: ClinicalTrials.gov Identifier: NCT01216527.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. CONSORT Flow Diagram
ESCC indicates esophageal squamous cell carcinoma; NCRT, neoadjuvant chemoradiotherapy.
Figure 2.
Figure 2.. Overall Survival
Overall survival for the intention-to-treat population. HR indicates hazard ratio; NCRT, neoadjuvant chemoradiotherapy.
Figure 3.
Figure 3.. Disease-Free Survival
Disease-free survival for patients with margin-zero resection. HR indicates hazard ratio; NCRT, neoadjuvant chemoradiotherapy.
See this image and copyright information in PMC

Comment in

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