Standard treatments of metastatic colorectal cancer (mCRC) have been studied in a limited number of elderly patients (pts) despite the increasing incidence of cancer due to population aging.
This ongoing prospective, multicenter non-interventional study, evaluates 1st line bevacizumab (Bv) combined with standard chemotherapy (CT) in elderly mCRC pts over 24 months (mo) in French daily practice. The primary objective was to describe progression-free survival. Secondary objectives include pts characteristics, overall survival, Bv modalities of use, safety and autonomy criteria. Interim results at 12 mo of follow-up (FU) according to chemotherapy regimens are presented.
On a total of 351 patients (efficacy population), among 403 pts consecutively included between 2012 and 2014, initiating Bv + CT, 181 pts (52%) are men, mean age is 81 years ±4, and 282 pts (80%) had primary tumor in the colon. At diagnosis, 192 pts (56%) had synchronous metastatic disease and 74 pts (22%) had metachronous metastatic disease. Main metastatic sites were liver (229 pts, 65%), including liver only (134 pts, 38%). Main CT combined with Bv was FOLFOX for 127 pts (36%), FOLFIRI (102 pts, 29%), 5 FU-LV (75 pts, 21%), Xeloda monotherapy (32 pts, 9%) and other CT (15 pts, 4%). Mean treatment duration for FOLFOX was 4.71 mo ±2.99, FOLFIRI 4.72 mo ±3.38, 5FU-LV 4.40 mo ±3.49, and; XELODA 3.88 mo ±3.23. At 12 mo FU, median PFS was 10.8 mo [95% CI:9.0; 12.5] with oxaliplatin-based CT (131 pts; 37.3%), 9.8 mo [8.2; 11.1] with irinotecan-based CT (103 pts; 29.3%) and 7.7 mo [5.8; 9.3] with 5FU-based CT (107 pts; 30.5%). Median Overall survival was 20.7 mo [18.5; -] with oxaliplatin-based CT, 19.8 mo [15.1;-] with irinotecan-based CT, and 13.7 mo [11.1; 17.5] with 5FU-based CT. AEs grade ≥ 3 occurred in 34% pts (safety population, n= 382) including 28% Bv related AEs, and 3% pts died of an AE.
CASSIOPEE provides an overview of 1st line CTs pattern combined with Bv in elderly patients with mCRC in daily French practice. Polychemotherapy was administered in nearly 70% pts. PFS and safety results are comparable to published randomized studies.
Clinical trial identification
Clinicaltrials gov NCT01555762
Legal entity responsible for the study
L. Mineur: Advisory Board. P. Laplaige: Roche, Pfizer, Sanofi, Genomic Health, Pierre Fabre. S. Gourgou, J. Telliez, S. Gandon: Roche. All other authors have declared no conflicts of interest.