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.
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.
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]|
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
Legal entity responsible for the study
Programme Hospitalier de Recherche Clinique and Roche laboratory
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.