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Ann Oncol. 2016 Jun;27(6):1055-61. doi: 10.1093/annonc/mdw136. Epub 2016 Mar 21.

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

Author information

1
Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples fortunato.ciardiello@unina2.it.
2
Cell Biology and Biotherapy Unit, National Cancer Institute 'Fondazione Giovanni Pascale', Naples.
3
Medical Oncology, Department of Clinical and Experimental Medicine 'F. Magrassi', Second University of Naples, Naples.
4
Medical Oncology, Hospital SS. Annunziata, Taranto.
5
Medical Oncology, Hospital Garibaldi, Nesima, Catania.
6
Cell Biology and Biotherapy Unit, National Cancer Institute 'Fondazione Giovanni Pascale', Naples Laboratory of Pharmacogenomics, Centro di Ricerche Oncologiche di Mercogliano (CROM)-National Cancer Institute 'Fondazione Giovanni Pascale', Naples.
7
Medical Oncology, Hospital Casa Sollievo della Sofferenza, San Giovanni Rotondo (Foggia).
8
Medical Oncology, National Cancer Institute Giovanni Paolo II, Bari.
9
Medical Oncology, Hospital 'A. Cardarelli', Naples.
10
Medical Oncology, Hospital Monaldi- Azienda Ospedaliera dei Colli, Naples.
11
Medical Oncology, University Hospital A. Gemelli, Rome.
12
Policlinico Universitario Campus Bio-Medico, Rome.
13
Medical Oncology, Hospital A. Perrino, Brindisi.
14
Medical Oncology, Hospital Sacro Cuore di Gesù, Fatebenefratelli, Benevento.
15
GOIM Trial Office, Bari, Italy.

Abstract

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 progression-free 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.

KEYWORDS:

FOLFOX; NGS; cetuximab; colorectal cancer

PMID:
27002107
DOI:
10.1093/annonc/mdw136
[Indexed for MEDLINE]

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