Elsevier

Annals of Oncology

Volume 25, Issue 1, January 2014, Pages 107-116
Annals of Oncology

original articles
gastrointestinal tumors
Final results from a randomized phase 3 study of FOLFIRI ± panitumumab for second-line treatment of metastatic colorectal cancer

https://doi.org/10.1093/annonc/mdt523Get rights and content
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ABSTRACT

Background

The study 20050181 demonstrated significant improvements in progression-free survival (PFS), objective response, and a nonsignificant trend toward increased overall survival (OS) with panitumumab–FOLFIRI versus FOLFIRI alone for second-line wild-type (WT) KRAS metastatic colorectal cancer (mCRC). Updated long-term data from a prespecified descriptive analysis are reported.

Patients and methods

Patients receiving one prior mCRC treatment were randomly assigned (1:1) to panitumumab (6.0 mg/kg)–FOLFIRI versus FOLFIRI every 2 weeks. Co-primary end points (PFS and OS) were prospectively analyzed by tumor KRAS status.

Results

One thousand one hundred and eighty-six patients were randomly assigned. In patients with WT KRAS tumors, panitumumab–FOLFIRI significantly improved PFS versus FOLFIRI [median 6.7 versus 4.9 months; hazard ratio (HR) 0.82 [95% confidence interval (CI) 0.69, 0.97]; P = 0.023]. A trend toward longer OS was observed (median 14.5 versus 12.5 months; HR 0.92 [95% CI 0.78, 1.10]; P = 0.37). Response rates improved from 10% to 36% (P < 0.0001). From post hoc analyses in patients receiving prior oxaliplatin–bevacizumab, panitumumab–FOLFIRI improved PFS (median 6.4 versus 3.7 months; HR 0.58 [95% CI 0.37, 0.90]; P = 0.014). PFS and OS appeared longer for worst-grade skin toxicity of 2–4, versus 0–1 or FOLFIRI. Safety results were as previously reported and consistent with the known toxicities with anti-epidermal growth factor receptor therapy.

Conclusions

These data confirm the primary efficacy and safety findings of this trial and support panitumumab–FOLFIRI as a second-line treatment of WT KRAS mCRC.

Key words

antibody
chemotherapy
FOLFIRI
metastatic colorectal cancer
panitumumab

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