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

2016; Elsevier BV; Volume: 1; Issue: 6 Linguagem: Inglês

10.1136/esmoopen-2016-000086

2059-7029

Erika Martinelli, Claudia Cardone, Teresa Troiani, Nicola Normanno, Salvatore Pisconti, Vincenzo Sforza, Roberto Bordonaro, Anna Maria Rachiglio, Matilde Lambiase, T. Latiano, G. Modoni, Stefano Cordio, Francesco Giuliani, M. Biglietto, Vincenzo Montesarchio, Carlo Barone, Giuseppe Tonini, Saverio Cinieri, Antonio Febbraro, Daniele Rizzi, Ferdinando De Vita, Michele Orditura, Giuseppe Colucci, Evaristo Maiello, Fortunato Ciardiello, Vincenzo Rosario Iaffaioli, Guglielmo Nasti, Anna Nappi, Gerardo Botti, Fabiana Tatangelo, Nicoletta Chicchinelli, Michele Montrone, Annamaria Sebastio, Tiziana Guarino, Gianni Simone, Paolo Graziano, Cinzia Chiarazzo, GabrieleDi Maggio, Laura Longhitano, M Manusia, Giacomo Cartenì, Oscar Nappi, Pietro Micheli, Luigi Leo, Sabrina Rossi, Alessandra Cassano, Eugenio Tommaselli, Guido Giordano, F. Sponziello, Antonella Marino, Antonio Rinaldi, S. Romito, Andrea Onetti Muda, Vito Lorusso, Silvana Leo, Sandro Barni, Giuseppe Grimaldi, Michele Aieta,

Hepatocellular Carcinoma Treatment and Prognosis

BackgroundIn 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.MethodsA 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).Results340 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.ConclusionsTolerability 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 number2009-014041-81.