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

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.

• Authors: E 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
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 19 Issue 1 Pg. 92-8 (Jan 2008) ISSN: 1569-8041 [Electronic] England
• PMID: 17785764 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal
• Neoplasm Proteins
• Panitumumab
• EGFR protein, human
• ErbB Receptors

Topics

• Adenocarcinoma (drug therapy, mortality, therapy)
• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Colorectal Neoplasms (drug therapy, mortality, therapy)
• Disease Progression
• Disease-Free Survival
• Drug Eruptions (etiology)
• Drug Resistance, Neoplasm
• ErbB Receptors (antagonists & inhibitors, immunology)
• Female
• Humans
• Immunotherapy (adverse effects, statistics & numerical data)
• Male
• Middle Aged
• Neoplasm Proteins (antagonists & inhibitors, immunology)
• Panitumumab
• Salvage Therapy (statistics & numerical data)
• Survival Analysis