A randomized, open-label, multicenter trial of the concurrent chemoradiotherapy of capecitabine with or without oxaliplatin versus cisplatin with 5-FU for Chinese squamous esophageal cancer: An interim report from CRTCOESC.

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 , Fuyou Zhou , Anping Zheng , Lixin Wan , Zhiqiao Xu , Guobao Zheng , Xiaoyong Luo , Yingjuan Zheng , Yanhui Cui , Guifang Zhang , Dan Zhou , Jiachun Sun , Guoqiang Kong , Xiaozhi Yuan , Ruina Yang , Jing Ren , Wei Wang , Xinshuai Wang , 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, Anyang Tumor Hospital, The Affiliated Hospital, College of Clinical Medicine, Medical College of Henan University of Science and Technology, Anyang, China, Nanyang Central Hospital, Nanyang, China, Tumor Center, Kaifeng Central Hospital, Kaifeng, China, Cancer Hospital, 150th Central Hospital of PLA, Luoyang, China, Radiation Department, Luoyang Central Hospital, Luoyang, China, Department of Oncology, The 371st Central Hospital of PLA, Xinxiang, China, Oncology Department, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China, Oncology Department, Xinxiang Central Hospital, Xinxiang, China

Research Funding

Other

Background: CRT with 5- FU and cisplatin (PF) has shown greater clinical efficacy for local advanced esophageal cancer (EC) but with high rate of acute toxicities (ATs). CRTCOESC is a randomized, open-label, multicenter trial designed to evaluate the effect and safety of capecitabine with or without oxaliplatin versus PF with CRT in Chinese EC. Methods: Pts with biopsy-proven squamous EC (T2-4N0-2M0) were randomized to single capecitabine (Arm1), capecitabine plus oxaliplatin (Arm2), or PF (Arm3), while daily radiation 50Gy/2Gy for all. Pts were stratified by different regimens cycles. Both grade3-5 ATs and 2-year OS were the primary endpoint, with a planned accrual of 249 pts to detect a decrease in Grade3-5 ATs from 40% to 20%. The secondary endpoint included objective response rate (ORR) and 2-year progression free survival (PFS). Interim analysis of ATs and ORR was planned for the first 120 pts. Results: The study accrued 128 pts from 2014.10-2016.12, 118 were eligible. 86 patients were finished 16-weeks follow-up at least and analyzed in the interim report (Arm1: Arm2: Arm3 = 24: 37: 25). There was no difference between three arms on pts pretreatment characters (age, gender, weight, performance status, clinical stage, lymphonodus status, and pathology grade). Incidence of grade3-5 ATs in Arm1/2/3 were 25%: 32.4%: 64% (p = 0.03); it was significantly lower in Arm1/2 than Arm3 (Arm1 vs Arm3, p = 0.041; Arm2 vs Arm3, p = 0.022); and there no meaningful different between Arm1 and Arm2 (p = 0.738). The pCR rate and ORR were 50%: 48.6%: 48% and 87.5%: 83.8%: 100% in Arm1/2/3 (p = 0.99; p = 0.133). 56 patients had been finished 1 year follow-up (Arm1: Arm2: Arm3 = 12: 26: 18). The 1-year OS and PFS were 75%: 91.9%: 76% and 66.7%: 62.2%: 60% in Arm1/2/3 (p = 0.166; p= 0.926). Conclusions: Compared with PF, CRT with single capecitabine with or without oxaliplatin shown lower incidence of ATs and similar ORR and 1-year OS. The single capecitabine seemly carried out a benefit of lower ATs than it plus oxaliplatin; there was no meaningful difference for them on ORR and 1-year OS. Ruinuo Jia and Tanyou Shan did equal work. Clinical trial information: NCT02025036

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT02025036

Citation

J Clin Oncol 35, 2017 (suppl; abstr 4063)

DOI

10.1200/JCO.2017.35.15_suppl.4063

Abstract #

4063

Poster Bd #

55

Abstract Disclosures