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Eur J Cancer. 2017 Sep;83:106-115. doi: 10.1016/j.ejca.2017.06.029. Epub 2017 Jul 20.

Treatment sequence with either irinotecan/cetuximab followed by FOLFOX-4 or the reverse strategy in metastatic colorectal cancer patients progressing after first-line FOLFIRI/bevacizumab: An Italian Group for the Study of Gastrointestinal Cancer phase III, randomised trial comparing two sequences of therapy in colorectal metastatic patients.

Author information

1
Modena Cancer Center, Department of Oncology/Hematology, Università di Modena e Reggio Emilia, Italy. Electronic address: stefano.cascinu@unimore.it.
2
Medical Oncology, S. Carlo Hospital, Potenza, Italy.
3
Abdominal Oncology Department, National Cancer Institute, Napoli, Italy.
4
Medical Oncology Unit, IRCCS Istituto Oncologico Veneto, Padova, Italy.
5
Medical Oncology, Fondazione Poliambulanza, Brescia, Italy.
6
Medical Oncology Unit, Policlinico Sant'Andrea, Roma, Italy.
7
Medical Oncology, University of Turin, Candiolo Cancer Institute, FPO, IRCCS, Italy.
8
Medical Oncology, Santa Anna Hospital, Como, Italy.
9
Medical Oncology, Ospedale San Giovanni Calibita FBF, Roma, Italy.
10
Medical Oncology Department, Ospedale S Vincenzo, Taormina, Italy.
11
Cancer Center, Ospedali Riuniti di Bergamo, Bergamo, Italy.
12
Medical Oncology, Istituto Scientifico San Raffaele, Milano, Italy.
13
Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy.
14
Laboratory of Methodology for Clinical Research, IRCCS - Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy.
15
Medical Oncology Unit, Cancer Center, Department of Oncology/Hematology, University of Modena e Reggio Emilia, Italy.
16
Medical Oncology Unit, S. Carlo Hospital, Potenza, Italy.
17
Medical Oncology Unit 1, IRCCS Istituto Oncologico Veneto, Padova, Italy.
18
Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.
19
Medical Oncology Unit, University of Turin Medical School, Candiolo Cancer Institute, IRCCS, Torino, Italy.
20
Medical Oncology Unit, Santa Anna Hospital, Como, Italy.
21
Medical Oncology Unit, Ospedale San Giovanni Calabita, Roma, Italy.
22
Medical Oncology, Ospedale S Vincenzo, Taormina, Italy.
23
Cancer Center, Papa Giovanni XXIII, Bergamo, Italy.
24
Medical Oncology Unit, Istituto Scientifico San Raffaele, IRCCS, Milano, Italy.
25
IRCCS Mario Negri Institute for Pharmacological Research, Milano, Italy.
26
Medical Oncology Unit, Santa Maria Della Misericordia Hospital; Rovigo, Italy.
27
Medical Oncology Unit, Civil Hospital, Brescia, Italy.
28
Medical Oncology Unit, Gorgonzola Hospital, Italy.
29
Medical Oncology Unit, Biella Hospital, Italy.
30
Medical Oncology Unit, Renzetti Hospital, Lanciano CH, Italy.
31
Medical Oncology Unit, AOU Riuniti Hospital, Ancona, Italy.
32
GISCAD Foundation, Parabiago MI, Italy.

Abstract

INTRODUCTION:

The optimal treatment strategy for RAS wild type (WT) mCRC is controversial. Our phase III study investigated the effect of introducing earlier (second-line) or later (third-line) cetuximab in patients progressed after FOLFIRI/bevacizumab first-line.

PATIENTS AND METHODS:

mCRC patients progressing after FOLFIRI/bevacizumab first-line were randomised to receive second-line irinotecan/cetuximab followed by third-line FOLFOX-4 (arm A) or the reverse sequence (arm B). Primary end-point was progression-free survival (PFS).

RESULTS:

About 54 and 56 patients were randomised in arm A and in arm B, respectively. After a median follow-up of 37.5 months, 100 PFS events were recorded. Median PFS was 9.9 months in arm A and 11.3 months in arm B (Hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.69-1.56, p = 0.854), while median overall survival was 12.3 months in arm A and 18.6 months in arm B (HR 0.84, 95% CI: 0.55-1.28; p = 0.411). No overall difference in side-effects were observed between the two treatment arms.

CONCLUSIONS:

This trial did not meet the primary end-point (PFS). Like other preclinical and clinical evidences, our study seems to suggest a reduced activity of cetuximab after a first-line bevacizumab-based therapy.

KEYWORDS:

Cetuximab; K-RAS wild type; Metastatic colorectal cancer; Treatment sequence; Treatment strategy

PMID:
28735067
DOI:
10.1016/j.ejca.2017.06.029
[Indexed for MEDLINE]

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