The CAPRI trial, a phase II randomised trial suggested the potential role of maintaining Epidermal Growth Factor Receptor inhibition in combination with FOLFOX after first progression from cetuximab plus FOLFIRI in molecularly selected, by NGS technique, metastatic colorectal (mCRC) pts. Few data are currently available on elderly population. This subgroup analysis evaluated the efficacy and safety of FOLFIRI plus cetuximab in age-defined pts subgroups.
A post hoc analysis was performed in CAPRI trial pts; outcomes (Progression Free Survival [PFS], Overall Response Rate [ORR], Safety) were analysed by age groups and stratified according to molecular characterization. Three age cut-offs were used to define elderly population (≥65 years; ≥70 years; ≥75 years).
340 mCRC pts were treated in first line with FOLFIRI plus cetuximab. Among those, 154 pts were aged more than 65 years, 86 over 70, 35 over 75. NGS was performed in 182 pts. Among them, 87 pts were aged more than 65 years, 46 over 70, 17 over 75. 104 of 182 pts were WT for KRAS, NRAS, BRAF, PIK3CA genes. In the quadruple WT group, 51 pts were ≥65 years; 29 were ≥70 years; 9 were ≥75 years. Median PFS was similar within the age subgroups in the intention to treat population, NGS cohort and quadruple WT pts, respectively. Likewise, ORR was not significantly different among age-subgroups in the three populations. Safety profile was acceptable and similarly reported among all age-groups, with the exception of grade ≥3 diarrhea (55% vs 25% p 0.04) and neutropenia (75% vs 37% p 0.03) in pts ≥75 years and grade ≥3 fatigue (31% vs 20 % p 0.01) in pts
Tolerability of cetuximab plus FOLFIRI was acceptable in elderly pts. Similar ORR and PFS were observed according to age groups. No major differences in adverse events were reported among the defined subgroups.
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Department of Clinical and Experimental Medicine “F. Magrassi”, Second University of Naples, Italy
All authors have declared no conflicts of interest.