X versus XELOX versus PF in definitive concurrent chemoradiotherapy (DCRT) for local advanced squamous esophageal cancer (ESCC): Update from a multicenter, open-label, randomized III trial, CRTCOESC trial.

Authors

Ruinuo Jia

Ruinuo Jia

Henan Key Laboratory of Cancer Epigenetics, Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine, Medical College of Henan University of Science and Technology, Luoyang, China

Ruinuo Jia , Tanyou Shan , Lixin Wan , Anping Zheng , Shuang Hui , Zhiqiao Xu , Feng Wang , Guobao Zheng , Ping Lu , Guifang Zhang , Yingjuan Zheng , Yanhui Cui , Xiaoyong Luo , Weiguo Zhang , Wanying Li , Ruonan Li , Fuyou Zhou , Shegan Gao

Organizations

Henan Key Laboratory of Cancer Epigenetics, Cancer Hospital, The First Affiliated Hospital, College of Clinical Medicine, Medical College of Henan University of Science and Technology, Luoyang, China, Nanyang Central Hospital, Nanyang, China, Anyang Tumor Hospital, The Affiliated Hospital, College of Clinical Medicine, Medical College of Henan University of Science and Technology, Anyang, China, Kaifeng Center Hospital, Kaifeng, China, Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China, Cancer Hospital, 150th Central Hospital of PLA, Luoyang, China, Department of Medical Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China, Oncology Department, Xinxiang Central Hospital, Xinxiang, China, Department of Oncology, The 371st Central Hospital of PLA, Xinxiang, China, Oncology Department, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China, Radiation Department, Luoyang Central Hospital, Luoyang, China, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China

Research Funding

Other Foundation
National Natural Science Foundation of China

Background: PF (5-fluorouracil plus cisplatin) is the standard regimen for local advanced ESCC with DCRT. CRTCOESC aims to evaluate the effect and safety of X (capecitabine) regimen versus XELOX (capecitabine plus oxaliplatin) and PF in Chinese local advanced ESCC with DCRT by randomized, open-label, multicenter designed. Methods: Patients with ESCC (T2-4N0-2M0) were randomized to 3 groups as X (capecitabine 625mg/m2, bid d1-5, 6 weeks), XELOX (oxaliplatin: 65mg/m2, d1, 8, 22, 29; capecitabine: 625mg/m2, bid d1-5; 6 weeks), or PF (cisplatin: 75mg/m2 d1, 29, 5-Fu: 750mg/m2 CIV24h d1-4, d29-32), Intensity Modulated Radiation Therapy (IMRT) was delivered by 50Gy/2Gy currently. In addition, quadratic randomize were done within all groups to decide whether 2 cycles chemotherapy adding or not after DCRT. 2-year OS and Grade 3-5 AEs were the primary endpoints, 2-year PFS and short-term efficacy (STE) as rates of CR and ORR (CR+PR+SD) (confirmed by gastroscopy biopsy at 16 weeks) were the secondary endpoints. Results: 244 pts successfully were accrued from 13 centers during 2014.10-2020.1. 209 pts were finished DCRT and 193 were evaluated STE at 16 weeks. 192 and 147 pts were followed up for 1- and 2- years respectively. There were no differences between 3 groups on patients’ baseline characters including age, gender, ECGO score, clinical stage, pathology grade and smoking. In X, XELOX and PF groups, the 2-year OS were 63.8% (30/46), 61.5% (32/52) and 62.5% (30/49) (P = 0.973), the median OS were 39.7 (6.567), 40 (5.195) and 34 (5.736) (months, P = 0.703); the incidences of AEs (grade 3-5) were 26.5% (18/68), 33.8% (25/74) and 49.3% (33/67) (P = 0.0193); the 2-year PFS were 54.3% (25/46), 53.8% (28/52) and 51% (25/49) (P = 0.939), the median PFS were 29.06 (6.124), 17.4 (8.745) and 24.833 (6.777) (months, P = 0.811); the CR rate were 43.8% (28/64), 41.4% (29/70), and 42.4% (25/59) (P = 0.964), and the ORR were 85.6%, 88.6%, and 96.6% (P = 0.119), respectively. There were no differences on OS, PFS and rates of CR and ORR between 3 groups but the incidence of AEs in X group was the lowest significantly. Subgroup analysis results shown adding 2 cycles chemotherapy after CRT had both OS and PFS advantages but lacked statistically significance. Conclusions: Compared with PF, DCRT with X or XELOX shown lower incidence of AEs and similar OS, PFS and STE. X regimen carried out the lowest AEs incidence. Adding 2 cycles chemotherapy after DCRT seemly had advantages on OS and PFS. Clinical trial information: NCT02025036.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT02025036

Citation

J Clin Oncol 38: 2020 (suppl; abstr 4531)

DOI

10.1200/JCO.2020.38.15_suppl.4531

Abstract #

4531

Poster Bd #

139

Abstract Disclosures