An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy
Articolo
Data di Pubblicazione:
2008
Citazione:
An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy / E. Van Cutsem, S. Siena, Y. Humblet, J.-. Canon, J. Maurel, E. Bajetta, B. Neyns, D. Kotasek, A. Santoro, W. Scheithauer, S. Spadafora, R.G. Amado, N. Hogan, M. Peeters. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 19:1(2008), pp. 92-98. [10.1093/annonc/mdm399]
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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
crossover; egfr; extension study; fully human antibody; metastatic colorectal cancer; panitumumab; adenocarcinoma; adult; aged; aged, 80 and over; antibodies, monoclonal; antineoplastic combined chemotherapy protocols; colorectal neoplasms; disease progression; disease-free survival; drug eruptions; drug resistance, neoplasm; female; humans; male; middle aged; neoplasm proteins; receptor, epidermal growth factor; survival analysis; immunotherapy; salvage therapy; oncology; cancer research
Elenco autori:
E. Van Cutsem, S. Siena, Y. Humblet, J.-. Canon, J. Maurel, E. Bajetta, B. Neyns, D. Kotasek, A. Santoro, W. Scheithauer, S. Spadafora, R.G. Amado, N. Hogan, M. Peeters
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