Clinical activity of FOLFIRI plus cetuximab in elderly patients (pts) according to extended gene mutation status by next generation sequencing (NGS) in the CAPRI- GOIM trial

Date

08 Oct 2016

Session

Poster Display

Presenters

Erika Martinelli

Citation

Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370

Authors

E. Martinelli1, C. Cardone1, T. Troiani1, N. Normanno2, S. Pisconti3, R. Bordonaro4, G. Francesco5, M. Biglietto6, C. Barone7, A.M. Rachiglio8, V. Montesarchio9, G. Tonini10, S. Cinieri11, D. Rizzi12, A. Febbraro13, T.P. Latiano14, G. Modoni15, C. Giuseppe5, E. Maiello14, F. Ciardiello1

Author affiliations

  • 1 Medical Oncology, AOU Seconda Università degli Studi di Napoli (AOU-SUN), 81130 - Napoli/IT
  • 2 Dept. Biologia Cellulare E Bioterapie, Istituto Nazionale Tumori – I.R.C.C.S - Fondazione Pascale, 80131 - Napoli/IT
  • 3 Medical Oncology,, Ospedale Moscati, 74100 - Taranto/IT
  • 4 Medical Oncology, Azienda Ospedaliera ARNAS Garibaldi, 95100 - Catania/IT
  • 5 Medical Oncology, Istituto Tumori Giovanni Paolo II, Bari/IT
  • 6 Medical Oncology, Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"-AORN A. Cardarelli, 80100 - Napoli/IT
  • 7 Medical Oncology, Università Cattolica del Sacro Cuore, 00168 - Roma/IT
  • 8 Laboratory Of Pharmacogenomics, CROM, Istituto Nazionale Tumori “Fondazione G. Pascale”-IRCCS, Mercogliano (AV)/IT
  • 9 Medical Oncology, Azienda Ospedaliera Dei Colli-Monaldi, 80100 - Napoli/IT
  • 10 Medical Oncology, Campus Bio-Medico di Roma, 00128 - Roma/IT
  • 11 U.o.c. Oncologia, Ospedale A. Perrino, 72100 - Brindisi/IT
  • 12 Goim, GOIM, Bari/IT
  • 13 Medical Oncology, Ospedale "Sacro Cuore di Gesù" Fatebenefratelli, Benevento/IT
  • 14 Onco-hematology, Ospedale Casa Sollievo della Sofferenza, 71013 - San Giovanni Rotondo/IT
  • 15 Medical Oncology, Ospedale Moscati, Taranto/IT
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Background

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.

Methods

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).

Results

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

Conclusions

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.

Clinical trial identification

EudraCT 2009-014041-81

Legal entity responsible for the study

Department of Clinical and Experimental Medicine “F. Magrassi”, Second University of Naples, Italy

Funding

Merck Serono

Disclosure

All authors have declared no conflicts of interest.

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