730P - Multicentric phase II randomized trial comparing chemoradiation (CHRT) with 5-fluorouracil, cisplatin (CDDP) and 50 GY versus chemotherapy alone (CH...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Surgery and/or Radiotherapy of Cancer
Presenter Jean Marc Phelip
Authors J.M. Phelip1, V. Vendrely2, J. Jouve3, F. Subtil4, M. Gasmi5, P. Michel6, D. Smith7, J. Seitz8, L. Bedenne9, B. Chauffert10
  • 1Gastroenterology And Digestive Oncology, University Jean Monnet, 42055 - Saint Etienne/FR
  • 2Service D'oncologie Médicale Et Radiothérapie, Hôpital Saint André, 33075 - BORDEAUX cedex/FR
  • 3Hepatogastrolentorology Department, CHU Le Bocage, 21079 - DIJON Cedex/FR
  • 4Data Center, FFCD, 21079 - DIJON Cedex/FR
  • 5Hepatogastroenterology Department, Hôpital Nord, 13915 - Marseille cedex 20/FR
  • 6Gastroenterology And Digestive Oncology, CHU de Rouen, 76000 - Rouen/FR
  • 7Oncologie Digestive, Hôpital Saint André, 33075 - Bordeaux/FR
  • 8Oncologie Digestive, Hôpital de La Timone, Marseille/FR
  • 9Hepatogastroenterology Department, University Hospital, 21079 - DIJON Cedex/FR
  • 10University Hospital, 80054 - AMIENS CEDEX/FR

Abstract

Background

No study is available to determine the best strategy for inoperable locally advanced biliary tract cancer. CHRT has shown its efficacy in small series to control the local evolution. However CHRT results were not compared to palliative CH.

Methods

This prospective multicentric phase II trial randomized patients with hilar or extrahepatic non metastatic and locally advanced biliary tract cancer between CHRT (50 Gy plus 5FU infusion 300 mg/m2/D, D1 to D33 and CDDP 20 mg/m2/D D1 to D4 and D29 to D32 or CDDP 80 mg/m2 D1 and D29) and CH (G 1000 mg/m2 D1 + O 100mg/m2 D1; D1 = D15, 6 months). Main inclusion criteria required WHO performance status <2, bilirubinemia < 50microM/l after biliary drainage if necessary and tumor accessibility to external radiotherapy. Endpoints were progression free survival (PFS), toxicity, rate of biliary complications and overall survival (OS). Stratification was performed according to center, localisation, biliary drainage and PS.

Results

The study was closed before completion of the planned number of patients due to slow accrual. Eighteen patients and 16 patients were included in CHRT and CH arms, respectively. All prognostic factors were well balanced between the two arms. A second line of chemotherapy was given after progression to 55.6% and 25% of the patients in the CHRT and CH. Most frequent grade 3-4 adverse events respectively for CHRT and CH arms were haematological (23.5% and 25.0%), gastrointestinal (11.8% and 6.2%) and neurological toxicities (0 and 18.7%). Treatment had to be stopped due to toxicity in 1 and 2 patients. Median PFS was 5.8 months in CHRT group and 11.0 months in CH group (HR: 0.65 [0.32-1.33]). Median OS was 13.5 months in CHRT group and 19.9 months in CT group (HR: 0.69 [0.31-1.55]) with a median follow-up of 22.8 months in the CTRT group and 22.5 months in the CT group. Biliary complications, occurred in 27.8% of the patients in CHRT arm and 43.7% of the patients in CH arm (RR: 1.6[0.65-3.9]). It was mainly obstruction (26.7% and 18.2%) or angiocholitis (20.0% and 36.4%).

Conclusion

Our results suggest that G and O chemotherapy is a valuable option in locally advanced biliary tract cancer. Efficacy outcomes seem to be better than CHRT without increase of clinically relevant adverse events. This study was supported by grant from Sanofi France

Disclosure

J.M. Phelip: Sanofi.

All other authors have declared no conflicts of interest.