Rivera, FernandoKarthaus, MeinolfHecht, J RandolphSevilla, IsabelForget, FrédéricFasola, GianpieroCanon, Jean-LucGuan, XuesongDemonty, GastonSchwartzberg, Lee S2023-01-252023-01-252017-04-19http://hdl.handle.net/10668/11115To report planned final overall (OS) and progression-free survival (PFS) analyses from the phase II PEAK trial (NCT00819780). 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). 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. First-line panitumumab + mFOLFOX6 increases PFS versus bevacizumab + mFOLFOX6 in patients with RAS WT mCRC.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/BevacizumabFirst-lineMetastatic colorectal cancerOverall survivalPanitumumabAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBevacizumabColorectal NeoplasmsDemographyDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateMaleMiddle AgedPanitumumabSurvival AnalysisTreatment OutcomeYoung AdultFinal 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.research article28424871open access10.1007/s00384-017-2800-11432-1262PMC5522523https://link.springer.com/content/pdf/10.1007%2Fs00384-017-2800-1.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5522523/pdf