Chemoradiotherapy with FOLFOX plus cetuximab in locally advanced oesophageal cancer: The GERCOR phase II trial ERaFOX
| Autor: | Benoist Chibaudel, Frédéric Di Fiore, Gérard Lledo, Astrid Pozet, Pascal Artru, Nicolas Jovenin, Olivier Dupuis, Valérie Blondin, Mohamed Attia, Laurent Mineur, Aimery de Gramont, Laetitia Dahan, Menouar Samir Abdiche, Franck Bonnetain, Florence Huguet, Marie-Pierre Galais |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Oncology Cancer Research medicine.medical_specialty Time Factors Esophageal Neoplasms Organoplatinum Compounds Leucovorin Cetuximab Phases of clinical research Kaplan-Meier Estimate Disease-Free Survival 03 medical and health sciences Folinic acid 0302 clinical medicine FOLFOX Chemoimmunotherapy Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Prospective Studies Neoplasm Staging Proportional Hazards Models business.industry Radiotherapy Dosage Chemoradiotherapy digestive system diseases Oxaliplatin Regimen Treatment Outcome 030104 developmental biology 030220 oncology & carcinogenesis Esophagogastric Junction Fluorouracil France business medicine.drug |
| Zdroj: | European Journal of Cancer. 56:115-121 |
| ISSN: | 0959-8049 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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