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Gastrointestinal tumours, non-colorectal 2

4979 - Adjuvant GEMOX for biliary tract cancer: updated relapse-free survival and first overall survival results of the randomized PRODIGE 12-ACCORD 18 (UNICANCER GI) phase III trial.

Date

10 Sep 2017

Session

Gastrointestinal tumours, non-colorectal 2

Presenters

Julien Edeline

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

J. Edeline1, F. Bonnetain2, J. Phelip3, J. Watelet4, P. Hammel5, J. Joly6, M. Benabdelghani7, L. Fartoux8, K. Bouhier-Leporrier9, J. Jouve10, R. Faroux11, V. Guerin-Meyer12, E. Assenat13, J. Seitz14, D. Malka15, C. Louvet16, A. Bertaut17, B. Juzyna18, T. Stanbury18, E. Boucher1

Author affiliations

  • 1 Medical Oncology, Centre Eugene Marquis, 35042 - Rennes/FR
  • 2 Methodological And Quality Of Life Unit In Oncology (inserm Umr 1098), University Hospital Jean Minjoz, 25000 - Besançon/FR
  • 3 Gastro Enterology, CHU Saint-Etienne, Saint-Etienne/FR
  • 4 Gastroenterology, CHU Nancy, Nancy/FR
  • 5 Gastroenterology, Hôpital Beaujon, 92110 - Clichy/FR
  • 6 Gastroenterology, CHU Amiens, Amiens/FR
  • 7 Medical Oncology, Centre Paul Strauss, Strasbourg/FR
  • 8 Oncology, Hopital Saint-Antoine, Paris/FR
  • 9 Gastroenterology, CHU Caen, Caen/FR
  • 10 Gastroenterology, CHU Le Bocage (Dijon), 21079 - Dijon/FR
  • 11 Hepato-gastroenterology, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche sur Yon/FR
  • 12 Department Of Oncology And Radiotherapy, Insitut de Cancérologie de l'Ouest, Angers/FR
  • 13 Medical Oncology, CHU St Eloi, 34295 - Montpellier/FR
  • 14 Gastroenterology, APHM, 13385 - Marseille/FR
  • 15 Digestive Oncology, Institut de Cancérologie Gustave Roussy, 94800 - Villejuif/FR
  • 16 Medical Oncology, Institut Mutualiste Montsouris, 75014 - Paris/FR
  • 17 Biostatistics, Georges-Francois Leclerc Cancer Center, 21000 - Dijon/FR
  • 18 R&d Unicancer, Unicancer, 75654 - Paris/FR
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Abstract 4979

Background

No standard adjuvant treatment is currently recommended in localized biliary tract cancer (BTC). Standard treatment for advanced BTC is gemcitabine combined with platinum-based chemotherapy. We aimed to assess whether GEMOX would increase relapse-free survival (RFS) while maintaining health-related quality of life (HrQoL).

Methods

We performed a multicenter, randomized phase III trial. Patients were randomized, within 3 months of R0 or R1 resection of a localized BTC, to receive either GEMOX for 12 cycles (Experimental Arm A) or surveillance (Standard Arm B). Co-primary endpoints were RFS and HrQoL. 190 patients and 126 RFS events were required to show an increase of median RFS from 18 to 30 months.

Results

Between July 2009 and February 2014, 196 patients were included in 33 French centers. Baseline characteristics were balanced: R0 resection rate was 86% (Arm A) vs 88% (Arm B), lymph node invasion was present in 37% vs 36%. In Arm A, a median of 12 cycles was delivered. Maximal grade of adverse events was grade 3 in 58% (Arm A) vs 22% (Arm B), and grade 4 in 17% vs 9%. After a median of 46.5 months, 126 RFS events and 82 deaths were recorded. The final RFS analysis did not show any statistically significant difference between the 2 arms, with a median of 30.4 months in Arm A vs 18.5 months in Arm B (log-rank p = 0.47), Hazard Ratio (HR)=0.88 [95%CI: 0.62-1.25] (p = 0.48). The Overall Survival (OS) was not different between the 2 arms, with a median of 75.8 months [95%CI: 34.4–NE] in Arm A vs 50.8 months [95%CI: 38.0–NE] in Arm B (log-rank p = 0.74), HR = 1.08 [95%CI: 0.70-1.66] (p = 0.74). 24-months, 48-months and 72-months OS were 69%, 51% and 51% in Arm A vs 76%, 52% and 48% in Arm B, respectively. No benefit of adjuvant chemotherapy was seen in any subgroup analyses of RFS or OS.

Conclusions

Final RFS and first OS analysis confirmed the lack of benefit from adjuvant GEMOX in the PRODIGE 12 study. Combined analysis with other adjuvant trials is warranted.

Clinical trial identification

NCT01313377

Legal entity responsible for the study

UNICANCER, France

Funding

French Ministry of Health - PHRC-2008; Ligue Contre le Cancer, France

Disclosure

All authors have declared no conflicts of interest.

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