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Int J Colorectal Dis. 2017 Aug;32(8):1179-1190. doi: 10.1007/s00384-017-2800-1. Epub 2017 Apr 19.

Final analysis of the randomised PEAK trial: overall survival and tumour responses during first-line treatment with mFOLFOX6 plus either panitumumab or bevacizumab in patients with metastatic colorectal carcinoma.

Author information

1
Hospital Universitario Marqués de Valdecilla, Av. de Valdecilla, 39008, Santander, Spain. oncrhf@humv.es.
2
Städtisches Klinikum München, Klinikum Neuperlach, Munich, Germany.
3
David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
4
Virgen de la Victoria University Hospital, Malaga, Spain.
5
Centre Hospitalier de l'Ardenne, Libramont, Belgium.
6
University Hospital Santa Maria della Misericordia, Udine, Italy.
7
Grand Hôpital de Charleroi, Charleroi, Belgium.
8
Amgen Inc., Biostatistics, Thousand Oaks, CA, USA.
9
Medical Development - Oncology, Amgen (Europe) GmbH, Zug, Switzerland.
10
West Clinic, Memphis, TN, USA.

Abstract

PURPOSE:

To report planned final overall (OS) and progression-free survival (PFS) analyses from the phase II PEAK trial (NCT00819780).

METHODS:

Patients with previously untreated, KRAS exon 2 wild-type (WT) metastatic colorectal cancer (mCRC) were randomised to mFOLFOX6 plus panitumumab or bevacizumab. The primary endpoint was PFS; secondary endpoints included OS, objective response rate, duration of response (DoR), time to response, resection and safety. Treatment effect by tumour RAS status was a prespecified objective. Exploratory analyses included early tumour shrinkage (ETS) and depth of response (DpR).

RESULTS:

One hundred seventy patients had RAS WT and 156 had RAS WT/BRAF WT mCRC. Median PFS was longer for panitumumab versus bevacizumab in the RAS WT (12.8 vs 10.1 months; hazard ratio (HR) = 0.68 [95% confidence intervals (CI) = 0.48-0.96]; p = 0.029) and RAS WT/BRAF WT (13.1 vs 10.1 months; HR = 0.61 [95% CI = 0.42-0.88]; p = 0.0075) populations. Median OS (68% OS events) for panitumumab versus bevacizumab was 36.9 versus 28.9 months (HR = 0.76 [95% CI = 0.53-1.11]; p = 0.15) and 41.3 versus 28.9 months (HR = 0.70 [95% CI = 0.48-1.04]; p = 0.08), in the RAS WT and RAS WT/BRAF WT populations, respectively. Median DoR (11.4 vs 9.0 months; HR = 0.59 [95% CI = 0.39-0.88]; p = 0.011) and DpR (65.0 vs 46.3%; p = 0.0018) were improved in the panitumumab group. More panitumumab patients experienced ≥30% ETS at week 8 (64 vs 45%; p = 0.052); ETS was associated with improved PFS/OS. No new safety signals occurred.

CONCLUSIONS:

First-line panitumumab + mFOLFOX6 increases PFS versus bevacizumab + mFOLFOX6 in patients with RAS WT mCRC.

KEYWORDS:

Bevacizumab; First-line; Metastatic colorectal cancer; Overall survival; Panitumumab

PMID:
28424871
PMCID:
PMC5522523
DOI:
10.1007/s00384-017-2800-1
[Indexed for MEDLINE]
Free PMC Article

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