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

• DOI: 10.1007/s00384-017-2800-1
• Publication Date: 2017-04-19T03:41:22Z
• Authors: Fernando Rivera; Meinolf Karthaus; J. Randolph Hecht; Isabel Sevilla; Frédéric Forget; Gianpiero Fasola; Jean-Luc Canon; Xuesong Guan; Gaston Demonty; Lee S. Schwartzberg
• Keywords: Panitumumab; Clinical endpoint; Progression-free survival

To 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 (DoR), time response, resection safety. Treatment effect by tumour RAS status a prespecified objective. Exploratory early shrinkage (ETS) depth (DpR). One hundred seventy patients had WT 156 WT/BRAF mCRC. Median PFS longer for versus bevacizumab in (12.8 vs 10.1 months; hazard ratio (HR) = 0.68 [95% confidence intervals (CI) 0.48–0.96]; p 0.029) (13.1 HR 0.61 CI 0.42–0.88]; 0.0075) populations. OS (68% events) 36.9 28.9 months (HR 0.76 0.53–1.11]; 0.15) 41.3 0.70 0.48–1.04]; 0.08), populations, respectively. DoR (11.4 9.0 0.59 0.39–0.88]; 0.011) DpR (65.0 46.3%; 0.0018) improved group. More experienced ≥30% ETS at week 8 (64 45%; 0.052); associated PFS/OS. No new safety signals occurred. First-line + increases