Chemoradiotherapy with FOLFOX plus cetuximab in locally advanced oesophageal cancer: The GERCOR phase II trial ERaFOX

被引:15
作者
Lledo, Gerard [1 ,2 ]
Huguet, Florence [2 ,3 ]
Chibaudel, Benoist [2 ,4 ]
Di Fiore, Frederic [5 ]
Mineur, Laurent [6 ]
Galais, Marie-Pierre [7 ]
Artru, Pascal [1 ]
Blondin, Valerie [5 ]
Dupuis, Olivier [8 ]
Abdiche, Menouar Samir [9 ]
Jovenin, Nicolas [10 ]
Pozet, Astrid [11 ]
Bonnetain, Franck [11 ]
Attia, Mohamed [2 ]
Dahan, Laetitia
de Gramont, Aimery [2 ,4 ]
机构
[1] Private Hosp Jean Mermoz, Dept Gastroenterol, F-69008 Lyon, France
[2] Grp Cooperateur Multidisciplinaire Oncol GERCOR, Paris, France
[3] Univ Paris 06, Tenon Univ Hosp, Assistance Publ Hop Univ Paris Est, Radiat Oncol Dept,Inst Univ Cancerol, Paris, France
[4] St Antoine Univ Hosp, Dept Med Oncol, Paris, France
[5] Univ Hosp, Digest Oncol Unit, Hepatogastroenterol Dept, Rouen, France
[6] Inst St Catherine, Dept Radiat Oncol, Avignon, France
[7] Ctr Reg Francois Baclesse, Digest Oncol Unit, Caen, France
[8] Clin Victor Hugo, Le Mans, France
[9] Robert Boulin Hosp, Dept Radiat Oncol, Libourne, France
[10] Inst Jean Godinot, Dept Med Oncol, Reims, France
[11] Univ Hosp Besancon, Methodol & Qual Life Unit Canc, EA 3181, Besancon, France
关键词
Oesophageal cancer; Oxaliplatin; Radiotherapy; Chemoradiotherapy; FOLFOX; Cetuximab; GROWTH-FACTOR RECEPTOR; FOLLOW-UP; CHEMOTHERAPY; CISPLATIN; RADIATION; CAPECITABINE; MULTICENTER; CARCINOMA;
D O I
10.1016/j.ejca.2015.12.020
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: To determine efficacy and toxicity of radiation therapy combined with oxaliplatin, 5-fluorouracil, and folinic acid (FOLFOX) and cetuximab in patients with locally advanced oesophageal cancer. Patients and methods: Patients with stage III oesophageal or gastro-oesophageal junction cancer were enrolled in a Simon's two-stage phase II study. Patients received FOLFOX and weekly cetuximab on week 1-10 with concurrent radiotherapy (50.4 Gy in 30 fractions) on week 5-10. Primary end-point was clinical overall response rate (ORR). An ORR rate of more than 50% was expected. Results: Among the 79 included patients, clinical ORR was 77% with 40% complete responses. Median overall survival and progression-free survival were 21.6 and 11.3 months, respectively. The most common grade III-IV toxicities observed during experimental chemoimmunotherapy followed by chemoradiation included neutropenia (28%), oesophagitis (12%), rash (11%), and allergy (9%). There was one treatment-related death due to oesophagitis with gastrointestinal bleeding. Conclusions: Cetuximab-FOLFOX regimen combined with radiotherapy demonstrated its efficacy and was well tolerated. Unfortunately, these results were not confirmed in two recent phase III studies. (C) 2015 Elsevier Ltd. All rights reserved.
引用
收藏
页码:115 / 121
页数:7
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