Extended RAS analysis and subsequent anti-EGFR and anti-VEGF treatment (tx) in PEAK: A first-line phase 2 study of FOLFOX6 + panitumumab (pmab) or bevacizumab (bev) in metastatic colorectal cancer (mCRC).

Authors

Fernando Rivera

Fernando Rivera

Hospital Universitario Marqués de Valdecilla, Santander, Spain

Fernando Rivera , Lee Steven Schwartzberg , Meinolf Karthaus , Gianpiero Fasola , Jean-Luc Canon , J. Randolph Hecht , Ying Tian , Hua Yu , Kelly Smith Oliner , William Y. Go

Organizations

Hospital Universitario Marqués de Valdecilla, Santander, Spain, The University of Tennessee Health Science Center, Memphis, TN, Städtisches Klinikum München GmbH - Klinikum Neuperlach, Munich, Germany, University Hospital S. Maria della Misericordia, Udine, Italy, Grand Hôpital de Charleroi, Charleroi, Belgium, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, Amgen, Inc., Thousand Oaks, CA, Amgen Inc., Thousand Oaks, CA

Research Funding

Pharmaceutical/Biotech Company

Background: In PEAK, progression-free survival (PFS) was similar and overall survival (OS) was improved with pmab + FOLFOX6 relative to bev + FOLFOX6 in patients (pts) with WT KRAS exon 2 mCRC. In an extended RAS analysis (exons 2, 3, and 4 of KRAS/NRAS), this improvement was enhanced in pts with WT RAS. This analysis evaluates pts who received subsequent biologic therapy in PEAK. Methods: Kaplan-Meier medians for OS were estimated for pts receiving pmab/subsequent anti-VEGF tx and pts receiving bev/subsequent anti-EGFR tx. Analyses were performed on pts with WT KRAS exon 2 and WT RAS from an exploratory, updated analysis (03Jan2013). Results are from the time of randomization. Results: Demographic and baseline characteristics were generally similar with differences of < 20% between arms. Results are shown (Table). Prespecified analyses suggest that individual RAS exons that are WT favor the pmab arm and will be presented. Conclusions: In this exploratory analysis, the time and % of pts to biologic subsequent tx were similar between the arms. Median OS was observed to be longer for pts receiving pmab/subsequent anti-VEGF tx relative to pts receiving bev/subsequent anti-EGFR tx and the improvements were similar to that in the total populations of the WT KRAS exon 2 and WT RAS groups. Clinical trial information: NCT00819780.

Pmab + FOLFOX6 Bev + FOLFOX6 Pmab + FOLFOX6
subsequent anti-VEGF
Bev + FOLFOX6
subsequent anti-EGFR
WT KRAS Exon 2, n 142 143 57 54
OS, events (%) 52 (37) 78 (55) 24 (42) 36 (67)
Median (95% CI), mos 34.2 (26.6 - NA) 24.3 (21.0 - 29.2) 34.2 (23.0 - 41.3) 25.3 (22.1 - 29.2)
Median (range) time to
   subsequent tx, mos
anti-EGFR 12.0 (3 - 24)
anti-VEGF 12.5 (2 - 38)
WT RAS, n 88 82 35 30
OS, events (%) 30 (34) 40 (49) 13 (37) 15 (50)
Median (95% CI), mos 41.3 (28.8 - 41.3) 28.9 (23.9 - 31.3) 41.3 (26.6 - 41.3) 29.0 (26.0 - 34.4)
Median (range) time to
   subsequent tx, mos
anti-EGFR 15.4 (4 - 24)
anti-VEGF 13.0 (2 - 38)

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer

Clinical Trial Registration Number

NCT00819780

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 3629)

DOI

10.1200/jco.2014.32.15_suppl.3629

Abstract #

3629

Poster Bd #

92

Abstract Disclosures