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
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 Disclosures
2013 ASCO Annual Meeting
First Author: Lee Steven Schwartzberg
2022 ASCO Annual Meeting
First Author: Takayuki Yoshino
2024 ASCO Gastrointestinal Cancers Symposium
First Author: Giulia Maddalena
2021 Gastrointestinal Cancers Symposium
First Author: Eric Van Cutsem