Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial

E Martinelli, C Cardone, T Troiani, N Normanno, S Pisconti, V Sforza, A R Bordonaro, A M Rachiglio, M Lambiase, T P Latiano, G Modoni, S Cordio, F Giuliani, M Biglietto, V Montesarchio, C Barone, G Tonini, S Cinieri, A Febbraro, D RizziF De Vita, M Orditura, G Colucci, E Maiello, F Ciardiello

Research output: Contribution to journalArticle

Abstract

BACKGROUND: In the cetuximab after progression in KRAS wild-type colorectal cancer patients (CAPRI) trial patients with metastatic colorectal cancer (mCRC) received 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) and cetuximab in first line followed by 5-Fluorouracil, folinic acid, oxaliplatin (FOLFOX) with or without cetuximab until progression. Limited data are available on the efficacy and safety of anti-epidermal growth factor receptor (anti-EGFR) agents on elderly patients with mCRC. In the current study we evaluated the efficacy and safety of FOLFIRI plus cetuximab in age-defined subgroups.

METHODS: A post-hoc analysis was performed in CAPRI trial patients; outcomes (progression-free survival (PFS), overall response rate (ORR), safety) were analysed by age-groups and stratified according to molecular characterisation. 3 age cut-offs were used to define the elderly population (≥65; ≥70 and ≥75 years).

RESULTS: 340 patients with mCRC were treated in first line with FOLFIRI plus cetuximab. Among those, 154 patients were >65 years, 86 >70 years and 35 >75 years. Next-generation sequencing (NGS) was performed in 182 patients. Among them, 87 patients were >65 years, 46 >70 and 17 >75. 104 of 182 patients were wild type (WT) for KRAS, NRAS, BRAF, PIK3CA genes. In the quadruple WT group, 51 patients were ≥65 years; 29 were ≥70; 9 were ≥75. Median PFS was similar within the age-subgroups in the intention-to-treat population, NGS cohort and quadruple WT patients, respectively. Likewise, ORR was not significantly different among age-subgroups in the 3 populations. Safety profile was acceptable and similarly reported among all age-groups, with the exception of grade ≥3 diarrhoea (55% vs 25%, p=0.04) and neutropaenia (75% vs 37%, p=0.03) in patients ≥75 years and grade ≥3 fatigue (31% vs 20%, p=0.01) in patients <75 years.

CONCLUSIONS: Tolerability of cetuximab plus FOLFIRI was acceptable in elderly patients. Similar ORR and PFS were observed according to age-groups. No differences in adverse events were reported among the defined subgroups with the exception of higher incidence of grade ≥3 diarrhoea and neutropaenia in patients ≥75 years and grade ≥3 fatigue in patients <75 years.

TRIAL REGISTRATION NUMBER: 2009-014041-81.

Original languageEnglish
Pages (from-to)e000086
JournalESMO Open
Volume1
Issue number6
DOIs
Publication statusPublished - 2016

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  • Cite this

    Martinelli, E., Cardone, C., Troiani, T., Normanno, N., Pisconti, S., Sforza, V., Bordonaro, A. R., Rachiglio, A. M., Lambiase, M., Latiano, T. P., Modoni, G., Cordio, S., Giuliani, F., Biglietto, M., Montesarchio, V., Barone, C., Tonini, G., Cinieri, S., Febbraro, A., ... Ciardiello, F. (2016). Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial. ESMO Open, 1(6), e000086. https://doi.org/10.1136/esmoopen-2016-000086