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Br J Cancer. 2016 Nov 8;115(10):1215-1222. doi: 10.1038/bjc.2016.343. Epub 2016 Oct 20.

Impact of tumour RAS/BRAF status in a first-line study of panitumumab + FOLFIRI in patients with metastatic colorectal cancer.

Author information

1
Klinikum Neuperlach/Klinikum Harlaching, Oskar-Maria-Graf-Ring 51, D81737 Munich, Germany.
2
Universitätsmedizin Mannheim, Theodor-Kutzer Ufer 1-3, 68167 Mannheim, Germany.
3
Institut Sainte-Catherine GI and Liver Cancer Unit, 84 000 Avignon, France.
4
Oncology Clinic, Västmanland's Hospital, 721 89 Västerås, Sweden.
5
IIIrd Medical Department, Paracelsus Medical University Salzburg and CCCIT Salzburg Cancer Research Institute, Müllner Hauptstrasse 45, 5020 Salzburg, Austria.
6
Klinikum Wels-Grieskirchen, Grieskirchner Straße 42, A-4600 Wels, Austria.
7
Central Hospital, Strandvägen 8, 35185 Växjö, Sweden.
8
Formerly of Amgen Inc., 1 Amgen Center Dr MS 30E-2-C, Thousand Oaks, CA 91320, USA.
9
Amgen Inc., 1 Amgen Center Dr MS 30E-2-C, Thousand Oaks, CA 91320, USA.
10
Amgen GmbH, Dammstrasse 23, 6301 Zug, Switzerland.
11
Onkologie Klinikum Oldenburg, Rahel-Straus-Str. 10, 26133 Oldenburg, Germany.

Abstract

BACKGROUND:

To investigate tumour biomarker status and efficacy of first-line panitumumab+FOLFIRI for metastatic colorectal carcinoma (mCRC).

METHODS:

154 patients received first-line panitumumab + FOLFIRI every 14 days. Primary end point was objective response rate (ORR). Data were analysed by tumour RAS (KRAS/NRAS) and BRAF status, and baseline amphiregulin (AREG) expression.

RESULTS:

Objective responses occurred more frequently in RAS wild type (WT) (59%) vs RAS mutant (MT) (41%) mCRC and in RAS WT/BRAF WT (68%) vs RAS or BRAF MT (37%) disease. Median response duration was longer in RAS WT (13.0 months) vs RAS MT (5.8 months) (hazard ratio (HR): 0.16). Median progression-free survival was longer in RAS WT vs MT (11.2 vs 7.3 months; HR, 0.37) and was also longer in RAS WT/BRAF WT vs RAS or BRAF MT (13.2 vs 6.9 months; HR, 0.25). Incidence of adverse events was similar regardless of RAS/BRAF status, and no new safety signals were noted. Among patients with RAS WT tumours, ORR was 67% with high AREG expression and 38% with low AREG expression.

CONCLUSIONS:

First-line panitumumab+FOLFIRI was associated with favourable efficacy in patients with RAS WT and RAS WT/BRAF WT vs MT mCRC tumours and was well tolerated.

PMID:
27764839
PMCID:
PMC5104899
DOI:
10.1038/bjc.2016.343
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

MK is an advisor for, and has received honoraria from, Amgen Ltd. R-DH has received honoraria from Amgen Ltd. LM is an advisor for, and has received honoraria and research funding from, Amgen. HL has acted as a consultant/advisor for Amgen Ltd & Roche Ltd. RG has received research support from Amgen. JT has received honoraria and research funding from Amgen Ltd. KSO is a former employee of Amgen Inc. MB, BT, YZ, GD are employees of Amgen Inc. C-HK has acted as a consultant/advisor to Amgen Ltd, Merck KG Darmstadt & Roche Ltd. EF declares no conflict of interest.

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