Final results from a randomized phase 3 study of FOLFIRI {+/-} panitumumab for second-line treatment of metastatic colorectal cancer.

  • Peeters M
  • Price T
  • Cervantes A
 et al. 
  • 34

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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.

Author-supplied keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal
  • Antineoplastic Combined Chemotherapy Protocols
  • Camptothecin
  • Colorectal Neoplasms
  • Disease-Free Survival
  • Female
  • Fluorouracil
  • Humans
  • Kaplan-Meier Estimate
  • Leucovorin
  • Liver Neoplasms
  • Male
  • Middle Aged
  • Quality of Life
  • Skin Diseases
  • Treatment Outcome
  • administration & dosage
  • adverse effects
  • analogs & derivatives
  • chemically induced
  • drug therapy
  • mortality
  • pathology
  • secondary
  • therapeutic use

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Authors

  • M Peeters

  • T J Price

  • A Cervantes

  • A F Sobrero

  • M Ducreux

  • Y Hotko

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