Details

Autor(en) / Beteiligte

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

Titel

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

Ist Teil von

• Annals of oncology, 2016-06, Vol.27 (6), p.1055-1061

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2016

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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 progression-free survival (PFS). Tumour tissues were assessed by next-generation sequencing (NGS). This report is the final analysis. 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]. 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.