PRODIGE 20: Bevacizumab + Chemotherapy (BEV-CT) Versus Chemotherapy Alone (CT) in Elderly Patients (pts) with Untreated Metastatic Colorectal Cancer (mcrc)—a Randomized Phase II Trial.

3541 Background: AVEX study has demonstrated increased progression-free survival (PFS) with capecitabine + bevacizumab compared to capecitabine alone in pts aged over 70 with mCRC. The treatment with bevacizumab has so far not been evaluated in combination with other standard chemotherapy regimens for elderly pts. Methods: Pts aged 75 and over were randomly assigned in a 1:1 ratio to BEV-CT versus CT. Following regimens were authorized: LV5FU2, FOLFOX and FOLFIRI, chosen by the investigators. The primary endpoint, assessed 4 months after randomization was composite, based on efficacy: tumor control (stable disease or objective tumor response) and absence of decrease of the Spitzer QoL index and safety: absence of severe cardiovascular toxicities and unexpected hospitalization. The decision rules for the experimental arm were: if >15 pts met the efficacy criterion and if >25 pts met the safety criterion, the BEV-CT treatment is considered efficient and well tolerated. Results: 102 pts were randomized (51 BEV-CT and 51 CT arm), median age was 80 (range 75-91), men (55%), ECOG 0: 27%, 1: 53% and 2: 20%. CT was LV5FU2 in 53 pts (27 BEV-CT and 26 CT) and a doublet regimen in 49 pts (24 BEV-CT and 25 CT) including 23 FOLFOX and 26 FOLFIRI. Primary tumor was resected in 31 pts in BEV-CT and 30 pts in CT. Of the 46 pts evaluable in the BEV-CT arm, 23 pts (50% [90% CI: 37.1-62.9]) responded to the efficacy criterion and 28 pts (61% [90% CI: 47.7-73.0]) to the safety criterion. Multivariate analysis show that primary tumor resected and normal independent activity of daily living are predictive for the composite criterion. Conclusions: BEV-CT arm responded to the efficacy and safety criterion. Addition of bevacizumab to 1st line chemotherapy in pts aged over 75 years with a mCRC is efficient and well tolerated. Clinical trial information: NCT01417494.Preliminary follow-up results. CT BEV + CT Grade 3-5 toxicities 65% 80% Median time to autonomy failure in months (m) 5.5 [95% CI: 3.8-NA] 5.9 [95% CI: 3.8-14.8] Median time to QoL deterioration (m) 13.6 [95% CI: 11.6-NA] Not achieved Median PFS (m) 7.8 [95% CI: 6.6-10.6] 10.7 [95% CI: 8.2-13.8] Median overall survival (m) 19.7 [95% CI: 13.4-21.9] 21.7 [95% CI: 14.6-NA]