Jean-Marc Phelip1, Véronique Vendrely2, Florian Rostain3, Fabien Subtil4, Jean-Louis Jouve3, Mohamed Gasmi5, Pierre Michel6, Karine Le Malicot4, Denis Smith7, Jean-François Seitz8, Jean-Pierre Fauchart9, Philippe Martin10, Jaafar Bennouna11, Thierry Morin12, Isabelle Bonnet13, Philippe Maingon14, Côme Lepage15, Bruno Chauffert16. 1. Department of Gastroenterology and Digestive Oncology, University Hospital of St Etienne, University Jean Monnet, LINA EA 4624, France. Electronic address: j.marc.phelip@chu-st-etienne.fr. 2. Radiotherapy Department, University Hospital Haut Lévêque Bordeaux, France. 3. Department of Gastroenterology, University Hospital Le Bocage, Dijon, France. 4. Fédération Francophone de Cancérologie Digestive, Dijon, France; Université de Lyon, F-69000 Lyon, France; Université Lyon 1, CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622 Villeurbanne, France; Hospices Civils de Lyon, Service de Biostatistique, F-69003 Lyon, France. 5. Department of Gastroenterology, University Hospital North, Marseille, France. 6. Oncology Department, University Hospital, Rouen, France. 7. Oncology Department, University Hospital Saint-André, Bordeaux, France. 8. Department of Gastroenterology and Digestive Oncology, University Hospital La Timone, Marseille, France. 9. Department of Gastroenterology, Hospital of Charleville-Mezieres, France. 10. Radiotherapy, Boulogne, France. 11. Oncology Department, René Gauducheau Center, St Herblain, France. 12. Hospital of Tarbes, France. 13. Oncology Department, Hospital of Valenciennes, France. 14. Radiotherapy Department, Center Georges-François Leclerc, Dijon, France. 15. Department of Gastroenterology, University Hospital Le Bocage, Dijon, France; Fédération Francophone de Cancérologie Digestive, Dijon, France; Université de Lyon, F-69000 Lyon, France; Université Lyon 1, CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, F-69622 Villeurbanne, France; Hospices Civils de Lyon, Service de Biostatistique, F-69003 Lyon, France. 16. Department of Medical Oncology, University Hospital Amiens, France.
Abstract
BACKGROUND:Chemoradiotherapy (CHRT) is often advocated for locally-advanced biliary tract cancer (LABTC). However there was not comparative study with chemotherapy alone (CH). PATIENTS AND METHODS: Patients with hilar or extrahepatic non-metastatic, LABTC could be included in this phase II trial. The inclusion criteria required World Health Organisation (WHO) performance status ⩽ 2, bilirubinemia ⩽ 50 μM/L after biliary drainage if necessary, and possibility of external radiotherapy. Fluorouracil (5 FU) infusion and cisplatin, were given in association to radiotherapy (50 Gy) in the CHRT arm. Gemcitabine+oxaliplatin (GEMOX) was planned for 6 months in the CH arm. End-points were progression-free survival (PFS), overall survival (OS), toxicity and rate of biliary complications. RESULTS: The trial was closed before completion due to slow recruitment. Eighteen and 16 patients were included in the CHRT and CH arms, respectively. Median follow up was 27.9 months (± 2.8). Grade III-IV toxicities were mostly haematological (23% and 25%), and gastrointestinal (11% and 6%), in the CHRT and CH arm, respectively. Biliary complications occurred in 28% of patients in the CHRT arm and 44% of patients in the CH arm (risk ratio (RR): 1.60 [0.65-3.92]). Median PFS was 5.8 months in the CHRT group and 11.0 months in the CH group (hazard ratio (HR): 0.65 [0.32-1.33]). Median OS was 13.5 months in the CHRT group and 19.9 months in the CH group (HR: 0.69 [0.31-1.55]). CONCLUSIONS: Combination of gemcitabine plus cisplatin seems to be at least as efficient as chemoradiotherapy (50 Gy plus 5 FU and cisplatin) in LABTC.
RCT Entities:
BACKGROUND: Chemoradiotherapy (CHRT) is often advocated for locally-advanced biliary tract cancer (LABTC). However there was not comparative study with chemotherapy alone (CH). PATIENTS AND METHODS: Patients with hilar or extrahepatic non-metastatic, LABTC could be included in this phase II trial. The inclusion criteria required World Health Organisation (WHO) performance status ⩽ 2, bilirubinemia ⩽ 50 μM/L after biliary drainage if necessary, and possibility of external radiotherapy. Fluorouracil (5 FU) infusion and cisplatin, were given in association to radiotherapy (50 Gy) in the CHRT arm. Gemcitabine+oxaliplatin (GEMOX) was planned for 6 months in the CH arm. End-points were progression-free survival (PFS), overall survival (OS), toxicity and rate of biliary complications. RESULTS: The trial was closed before completion due to slow recruitment. Eighteen and 16 patients were included in the CHRT and CH arms, respectively. Median follow up was 27.9 months (± 2.8). Grade III-IV toxicities were mostly haematological (23% and 25%), and gastrointestinal (11% and 6%), in the CHRT and CH arm, respectively. Biliary complications occurred in 28% of patients in the CHRT arm and 44% of patients in the CH arm (risk ratio (RR): 1.60 [0.65-3.92]). Median PFS was 5.8 months in the CHRT group and 11.0 months in the CH group (hazard ratio (HR): 0.65 [0.32-1.33]). Median OS was 13.5 months in the CHRT group and 19.9 months in the CH group (HR: 0.69 [0.31-1.55]). CONCLUSIONS: Combination of gemcitabine plus cisplatin seems to be at least as efficient as chemoradiotherapy (50 Gy plus 5 FU and cisplatin) in LABTC.
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