Abstract
BackgroundAn upgraded understanding of factors (sex/estrogen) associated with survival benefit in advanced colorectal carcinoma (CRC) could improve personalised management and provide innovative insights into anti-tumour mechanisms. The aim of this study was to assess the efficacy and safety of cetuximab (CET) versus bevacizumab (BEV) following prior 12 cycles of fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus BEV in postmenopausal women with advanced KRAS and BRAF wild-type (wt) CRC.MethodsProspectively maintained databases were reviewed from 2013 to 2017 to assess postmenopausal women with advanced KRAS and BRAF wt CRC who received up to 12 cycles of FOLFOXIRI plus BEV inductive treatment, followed by CET or BEV maintenance treatment. The primary endpoints were overall survival (OS), progression-free survival (PFS), response rate. The secondary endpoint was the rate of adverse events (AEs).ResultsAt a median follow-up of 27.0 months (IQR 25.1–29.2), significant difference was detected in median OS (17.7 months [95% confidence interval [CI], 16.2–18.6] for CET vs. 11.7 months [95% CI, 10.4–12.8] for BEV; hazard ratio [HR], 0.63; 95% CI, 0.44–0.89; p=0.007); Median PFS was 10.7 months (95% CI, 9.8–11.3) for CET vs. 8.4 months (95% CI, 7.2–9.6) for BEV (HR, 0.67; 95% CI 0.47–0.94; p=0.02). Dose reduction due to intolerable AEs occurred in 29 cases (24 [24.0%] for CET vs. 5 [4.8%] for BEV; p< 0.001).ConclusionsCET tends to be superior survival benefit when compared with BEV, with tolerated AEs.
Highlights
Colorectal cancer (CRC), an aggressive disease, is historically the prominent cause of cancer-related deaths worldwide [1, 2]
Comparison of baseline data In total, 492 individuals with advanced KRAS and BRAF wt CRC were reviewed, 288 of whom were deemed to be ineligible per the exclusion criteria, leaving 204 patients (CET: n=100, mean age 64.2 years [Standard deviation (SD) 9.5] and BEV: n= 104, 64.5 years [SD 8.7]) who were eventually included for study eligibility (Fig. 1)
Comparison of efficacy At final follow-up, significant difference was detected in median overall survival (OS) (17.7 months [95% Confidence interval (CI), 16.2–18.6] for CET vs. 11.7 months [95% CI, 10.4–12.8] for BEV)
Summary
Colorectal cancer (CRC), an aggressive disease, is historically the prominent cause of cancer-related deaths worldwide [1, 2]. For patients with advanced CRC, the combination schedules with fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus either cetuximab (CET) or bevacizumab (BEV) have been proven to be effective according to previous clinical efficacy and safety profiles [6, 7]. In an open-label, randomized, phase 3 trial [9], the addition of CET to capecitabine, oxaliplatin, and BEV resulted in poor progression-free survival (PFS) and inferior quality of life. In another open-label, randomised, phase 3 trial [1], a noteworthy gain in OS and a positive but not significant trend of increased median PFS were observed. The aim of this study was to assess the efficacy and safety of cetuximab (CET) versus bevacizumab (BEV) following prior 12 cycles of fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus BEV in postmenopausal women with advanced KRAS and BRAF wild-type (wt) CRC
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