1. Chemoradiotherapy with FOLFOX plus cetuximab in locally advanced oesophageal cancer: The GERCOR phase II trial ERaFOX.
- Author
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Lledo G, Huguet F, Chibaudel B, Di Fiore F, Mineur L, Galais MP, Artru P, Blondin V, Dupuis O, Abdiche MS, Jovenin N, Pozet A, Bonnetain F, Attia M, Dahan L, and de Gramont A
- Subjects
- Antineoplastic Combined Chemotherapy Protocols adverse effects, Cetuximab adverse effects, Disease-Free Survival, Esophageal Neoplasms mortality, Esophageal Neoplasms pathology, Esophagogastric Junction pathology, Fluorouracil administration & dosage, France, Humans, Kaplan-Meier Estimate, Leucovorin administration & dosage, Neoplasm Staging, Organoplatinum Compounds administration & dosage, Proportional Hazards Models, Prospective Studies, Radiotherapy Dosage, Time Factors, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Cetuximab administration & dosage, Chemoradiotherapy adverse effects, Esophageal Neoplasms therapy, Esophagogastric Junction drug effects, Esophagogastric Junction radiation effects
- Abstract
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., (Copyright © 2015 Elsevier Ltd. All rights reserved.)
- Published
- 2016
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