583P - Prognostic factor analysis for elderly patients treated for metastatic colorectal cancer in the randomized phase II trial PRODIGE 20

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Colon Cancer
Rectal Cancer
Presenter thomas Aparicio
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors T. Aparicio1, O. Bouché2, E. Francois3, E. Maillard4, S. Kirscher5, J. Taieb6, P. Etienne7, R. Faroux8, F. Khemissa Akouz9, F. El Hajbi10, C. Locher11, Y. Rinaldi12, T. Lecomte13, S. Lavau-Denes14, M. Baconnier15, A. Oden-Gangloff16, D. Genet17, E. Paillaud18, F. Retornaz19, L. Bedenne20
  • 1Service Hge, Hôpital Avicenne - AP-HP, 93000 - Bobigny/FR
  • 2Médecine Ambulatoire-cancérologie, CHU Robert Debré, Reims/FR
  • 3Service Oncologie, Centre Antoine Lacassagne, Nice/FR
  • 4Faculté De Médecine, FFCD, 21079 - Dijon/FR
  • 5-, Institut Ste Catherine, Avignon/FR
  • 6Service Hge, Hôpital européen G.Pompidou, Paris/FR
  • 7Service Oncologie, Centre CARIO - HPCA, Plerin sur mer/FR
  • 8Service D'hge, CHD Vendee - Hopital Les Oudairies, 85925 - La Roche sur Yon/FR
  • 9Service Hge, CH Saint Jean, Perpignan/FR
  • 10Service Cancérologie Digestive, Centre Oscar Lambret, 59037 - Lille/FR
  • 11Service Gastroentérologie, CH de Meaux, 77100 - Meaux/FR
  • 12Service D'hge, Hôpital européen, Marseille/FR
  • 13Service Hge, Hôpital Trousseau, Tours/FR
  • 14Service D'oncologie, CHU Limoges - Hopital Dupuytren, 87042 - Limoges/FR
  • 15Service Hge, CH Annecy Genevois, 74374 - Pringy/FR
  • 16Service Hge, CHU Charles Nicolle, 76031 - Rouen/FR
  • 17Service Oncologie, Clinique Chenieux, Limoges/FR
  • 18Service Médecine Interne Et Gériatrie, CHU Henri Mondor, Créteil/FR
  • 19-, Hôpital européen, Marseille/FR
  • 20Service Hge, CHU Le Bocage, INSERM U866, Dijon/FR

Abstract

Background

PRODIGE 20 randomized patients (pts) aged 75+ to receive bevacizumab + chemotherapy (LV5FU2, FOLFOX, FOLFIRI, according investigators choice) or chemotherapy alone. The primary endpoint based on efficacy and safety was reached in BEV-CT. This analysis presents updated progression-free survival (PFS) and overall survival (OS), including univariate and multivariate analyses.

Methods

PFS was defined as time from randomization to progression or death and OS as time from randomization to death. Prognostic factors analyzed were: treatment arm, age (≤80 vs >80), sex, rectum vs colon, primary tumor resected or not, doublet vs mono-chemotherapy, body mass index (≥21 vs 2N vs ≤2N), CA19.9 (>2N vs ≤2N) and Köhne criteria (low vs intermediate vs high). Baseline variables significant at 15% in univariate analysis were introduced in the multivariate Cox model.

Results

102 pts were randomized (51 BEV-CT, 51 CT) and 100 pts were treated: chemotherapy was LV5FU2 in 52 pts (26 BEV-CT, 26 CT) and a doublet regimen in 48 pts (23 BEV-CT, 25 CT) including 23 FOLFOX and 25 FOLFIRI. The median follow-up was 20.4 months. 25 pts BEV-CT and 31 pts CT received 2nde line chemotherapy. Multivariate analysis shows that Spitzer QoL, albumin and Köhne criteria were prognostic for OS. Spitzer QoL and Köhne criteria were also prognostic for PFS.

CT [95% CI] BEV + CT [95% CI]
Median PFS (m) 7.8 [6.6-10.2] 9.7 [8.2-12.0]
12 months PFS rate 23.5% [13.0-35.8] 37.3% [24.3-50.2]
Median OS (m) 19.8 [13.9-23.7] 21.7 [14.8-30.3]
36 months OS rate 10.1% [3.1-22.0] 27.0% [15.7-39.7]

Conclusions

Spitzer QoL and Köhne criteria are prognostic factors for OS and PFS and should be used as stratification factors in future trials in elderly pts. Pts with a prolonged OS were observed in BEV-CT.

Clinical trial identification

NCT01900717

Legal entity responsible for the study

CHU Dijon

Funding

Programme Hospitalier de Recherche Clinique and Roche laboratory

Disclosure

T. Aparicio: Roche/Genentech, Sanofi, Ipsen, Novartis. O. Bouché: Merck Serono, Roche, Teva, Novartis, Lilly, Amgen, Pierre Fabre. E. Francois: Roche Pharma AG, Merck Serono, Roche Pharma AG, Sanofi, Celgène. J. Taieb: Roche Pharma AG. R. Faroux: Merck, Amgen. C. Locher: Merck Serono, Novartis, Roche Pharma AG, Sanofi. S. Lavau-Denes: Sanofi, AstraZeneca. L. Bedenne: Merck Serono, Roche Pharma AG. All other authors have declared no conflicts of interest.