An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy

Eric Van Cutsem, S. Siena, Y. Humblet, J. L. Canon, J. Maurel, E. Bajetta, B. Neyns, D. Kotasek, A. Santoro, W. Scheithauer, S. Spadafora, R. G. Amado, N. Hogan, M. Peeters

Research output: Contribution to journalArticle

Abstract

Background: A phase 3 study demonstrated that panitumumab, a human monoclonal anti-epidermal growth factor receptor antibody, significantly prolonged progression-free survival versus best supportive care (BSC) in patients with chemorefractory metastatic colorectal cancer. Patients and methods: This open-label extension study evaluated panitumumab monotherapy in BSC patients with radiographically documented disease progression in the phase 3 study. Patients received panitumumab 6 mg/kg every 2 weeks. The primary end point was safety; efficacy was also evaluated. Results: One hundred and seventy-six patients were randomly assigned to the BSC arm of the phase 3 study received ≥1 panitumumab dose in this extension study. Panitumumab was well tolerated. The most frequent treatment-related adverse events were skin toxic effects. Three (2%) patients had a grade 4 treatment-related adverse event. There were no infusion reactions. One (0.6%) patient had a complete response; 19 (11%) patients had a partial response; and 58 (33%) patients had stable disease. Median progression-free survival time was 9.4 [95% confidence interval (CI): 8.0-13.4) weeks. Median overall survival time was 6.3 (95% CI: 5.1-6.8) months. Anti-panitumumab antibodies were detected in 3 (4.2%) of 71 patients with a post-baseline sample. Conclusions: These findings are comparable to those from the phase 3 study and support panitumumab monotherapy for chemorefractory colorectal cancer.

Original languageEnglish
Pages (from-to)92-98
Number of pages7
JournalAnnals of Oncology
Volume19
Issue number1
DOIs
Publication statusPublished - Jan 2008

Keywords

  • Crossover
  • EGFr
  • Extension study
  • Fully human antibody
  • Metastatic colorectal cancer
  • Panitumumab

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Van Cutsem, E., Siena, S., Humblet, Y., Canon, J. L., Maurel, J., Bajetta, E., Neyns, B., Kotasek, D., Santoro, A., Scheithauer, W., Spadafora, S., Amado, R. G., Hogan, N., & Peeters, M. (2008). An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Annals of Oncology, 19(1), 92-98. https://doi.org/10.1093/annonc/mdm399