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Panitumumab plus FOLFOX4 extended survival in metastatic colorectal cancer
The addition of panitumumab to chemotherapy improved PFS, OS and objective response rates in patients with KRAS wild-type metastatic colorectal cancer, according to final results of a randomized phase 3 study.
The PRIME trial was designed to compare the efficacy and safety of FOLFOX4 (oxaliplatin, leucovorin and 5-fluouroracil) plus 6 mg/kg panitumumab (Vectibix, Amgen) every 2 weeks vs. FOLFOX4 alone.
The analysis — which included 1,183 patients — was planned for 30 months after the final patient enrolled.
Researchers reported longer median PFS (10 months vs. 8.6 months; HR=0.8; 95% CI, 0.67-0.95) and longer median OS (23.9 months vs. 19.7 months; HR=0.88; 95% CI, 0.73-1.06) among patients assigned panitumumab.
An exploratory analysis after more than 80% of OS events occurred also suggested an OS benefit with panitumumab (HR=0.83; 95% CI, 0.7-0.98). Adverse events were consistent with those observed in the primary analysis.
“These data support a positive benefit–risk profile for panitumumab [plus] FOLFOX4 for patients with previously untreated wild-type KRAS metastatic colorectal cancer,” the researchers concluded. “KRAS testing is critical to select appropriate patients for treatment with panitumumab.”
Disclosure: The research was supported by Amgen. The researchers report research funding, grant support or other remuneration from, as well as advisory board/consultant roles with, Amgen, Bayer, GlaxoSmithKline, Merck, Novartis and Roche.