Axitinib and/or bevacizumab with modified FOLFOX‐6 as first‐line therapy for metastatic colorectal cancer: A randomized phase 2 study. Issue 14 (19th April 2013)

• Record Type: Journal Article
• Authors: Infante, Jeffrey R.; Reid, Tony R.; Cohn, Allen L.; Edenfield, William J.; Cescon, Terrence P.; Hamm, John T.; Malik, Imtiaz A.; Rado, Thomas A.; McGee, Philip J.; Richards, Donald A.; Tarazi, Jamal; Rosbrook, Brad; Kim, Sinil; Cartwright, Thomas H.
• Is Part Of: Cancer. Volume 119:Issue 14(2013)
• Page Start: 2555
• Page End: 2563
• Publication Date: 2013-04-19
• Subjects: Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.28112
• Languages: English
• ISSNs: 0008-543X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncr28112-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>In this multicenter, open‐label, randomized phase 2 trial, the authors evaluated the vascular endothelial growth factor receptor inhibitor axitinib, bevacizumab, or both in combination with chemotherapy as first‐line treatment of metastatic colorectal cancer (mCRC).</p> </sec> <sec id="cncr28112-sec-0002" sec-type="section"> <title>METHODS</title> <p>Patients with previously untreated mCRC were randomized 1:1:1 to receive continuous axitinib 5 mg twice daily, bevacizumab 5 mg/kg every 2 weeks, or axitinib 5 mg twice daily plus bevacizumab 2 mg/kg every 2 weeks, each in combination with modified 5‐fluorouracil/leucovorin/oxaliplatin (FOLFOX‐6). The primary endpoint was the objective response rate (ORR).</p> </sec> <sec id="cncr28112-sec-0003" sec-type="section"> <title>RESULTS</title> <p>In all, 126 patients were enrolled from August 2007 to September 2008. The ORR was numerically inferior in the axitinib arm (n = 42) versus the bevacizumab arm (n = 43; 28.6% vs 48.8%; 1‐sided <italic>P</italic> = .97). Progression‐free survival (PFS) (11.0 months vs 15.9 months; 1‐sided <italic>P</italic> = .57) and overall survival (OS) (18.1 months vs 21.6 months; 1‐sided <italic>P</italic> = .69) also were numerically inferior in the axitinib arm. Similarly, efficacy endpoints for the axitinib/bevacizumab arm (n = 41) were numerically inferior (ORR, 39%; PFS, 12.5 months; OS, 19.7 months). The patients who received axitinib had fewer treatment cycles compared with other arms. Common all‐grade adverse events across all 3 treatment arms were fatigue, diarrhea, and nausea (all ≥49%). Hypertension and headache were more frequent in the patients who received axitinib. Patients in the bevacizumab arm had the longest treatment exposures and the highest rates of peripheral neuropathy.</p> </sec> <sec id="cncr28112-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>Neither the addition of continuous axitinib nor the axitinib/bevacizumab combination to FOLFOX‐6 improved ORR, PFS, or OS compared with bevacizumab as first‐line treatment of mCRC. <bold><italic>Cancer</italic> 2013;119:2555–2563</bold>. © <italic>2013 American Cancer Society</italic>.</p> </sec> </abstract>