Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): A randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

F. Ciardiello, N. Normanno, E. Martinelli, Enrica Martinelli, T. Troiani, S. Pisconti, C. Cardone, A. Nappi, A. R. Bordonaro, M. Rachiglio, M. Lambiase, Marianna Lambiase, T. P. Latiano, Tiziana Pia Latiano, G. Modoni, S. Cordio, F. Giuliani, Franca Giuliani, M. Biglietto, V. MontesarchioCarlo Antonio Barone, G. Tonini, S. Cinieri, A. Febbraro, D. Rizzi, F.De Vita, M. Orditura, G. Colucci, E. Maiello, Vincenzo Iaffaioli, Guglielmo Nasti, Gerardo Botti, F. Tatangelo, Nicoletta Chicchinelli, Mirko Montrone, Annamaria Sebastio, Tiziana Guarino, Gianni Simone, Paolo Graziano, Cinzia Chiarazzo, Gabriele Di Maggio, Laura Longhitano, Mario Manusia, Giacomo Cartenì, Oscar Nappi, Pietro Micheli, Luigi Leo, Sabrina Rossi, Alessandra Cassano, Eugenio Tommaselli, Guido Giordano, Francesco Sponziello, Antonella Marino, Antonio Rinaldi, Sante Romito, Andrea Onetti Muda, Vito Lorusso, Silvana Leo, Sandro Barni, Giuseppe Grimaldi, Michele Aieta

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Background: Cetuximab plus chemotherapy is a first-line treatment option in metastatic KRAS and NRAS wild-type colorectal cancer (CRC) patients. No data are currently available on continuing anti-epidermal growth factor receptor (EGFR) therapy beyond progression. Patients and methods: We did this open-label, 1:1 randomized phase II trial at 25 hospitals in Italy to evaluate the efficacy of cetuximab plus 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) as second-line treatment of KRAS exon 2 wild-type metastatic CRC patients treated in first line with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) plus cetuximab. Patients received FOLFOX plus cetuximab (arm A) or FOLFOX (arm B). Primary end point was progressionfree survival (PFS). Tumour tissues were assessed by next-generation sequencing (NGS). This report is the final analysis. Results: Between 1 February 2010 and 28 September 2014, 153 patients were randomized (74 in arm A and 79 in arm B). Median PFS was 6.4 [95% confidence interval (CI) 4.7-8.0] versus 4.5 months (95% CI 3.3-5.7); [hazard ratio (HR), 0.81; 95% CI 0.58-1.12; P = 0.19], respectively. NGS was performed in 117/153 (76.5%) cases; 66/117 patients (34 in arm A and 32 in arm B) had KRAS, NRAS, BRAF and PIK3CA wild-type tumours. For these patients, PFS was longer in the FOLFOX plus cetuximab arm [median 6.9 (95% CI 5.5-8.2) versus 5.3 months (95% CI 3.7-6.9); HR, 0.56 (95% CI 0.33-0.94); P = 0.025]. There was a trend in better overall survival: median 23.7 [(95% CI 19.4-28.0) versus 19.8 months (95% CI 14.9-24.7); HR, 0.57 (95% CI 0.32-1.02); P = 0.056]. Conclusions: Continuing cetuximab treatment in combination with chemotherapy is of potential therapeutic efficacy in molecularly selected patients and should be validated in randomized phase III trials.
Original languageEnglish
Pages (from-to)1055-1061
Number of pages7
JournalAnnals of Oncology
Publication statusPublished - 2016


  • Cetuximab
  • Colorectal cancer
  • Hematology
  • NGS
  • Oncology


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