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A Japanese Post-marketing Surveillance of Cetuximab (Erbitux(®)) in Patients with Metastatic Colorectal Cancer

OBJECTIVE: Cetuximab (Erbitux(®)) was approved for the treatment of metastatic colorectal cancer in Japan in 2008. To verify information on the safety in practical use of cetuximab, we conducted post-marketing surveillance in accordance with the conditions for approval. METHODS: All patients to be t...

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Autores principales: Ishiguro, Megumi, Watanabe, Toshiaki, Yamaguchi, Kensei, Satoh, Taroh, Ito, Hideyuki, Seriu, Taku, Sakata, Yuh, Sugihara, Kenichi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3314322/
https://www.ncbi.nlm.nih.gov/pubmed/22327124
http://dx.doi.org/10.1093/jjco/hys005
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author Ishiguro, Megumi
Watanabe, Toshiaki
Yamaguchi, Kensei
Satoh, Taroh
Ito, Hideyuki
Seriu, Taku
Sakata, Yuh
Sugihara, Kenichi
author_facet Ishiguro, Megumi
Watanabe, Toshiaki
Yamaguchi, Kensei
Satoh, Taroh
Ito, Hideyuki
Seriu, Taku
Sakata, Yuh
Sugihara, Kenichi
author_sort Ishiguro, Megumi
collection PubMed
description OBJECTIVE: Cetuximab (Erbitux(®)) was approved for the treatment of metastatic colorectal cancer in Japan in 2008. To verify information on the safety in practical use of cetuximab, we conducted post-marketing surveillance in accordance with the conditions for approval. METHODS: All patients to be treated with cetuximab were enrolled by the central enrolment method. Data on treatment status, and incidence and severity of adverse drug reactions were collected. The target number of patients was 1800. RESULTS: A total of 2126 patients were enrolled from 637 institutions. Among 2006 patients analysed, 93.2% received cetuximab as third-line or later treatment. The median duration of treatment was 15.3 weeks, and 11.1% of patients received treatment for >48 weeks. The incidence of adverse drug reactions was 89.6%, of which ≥grade 3 was 21.5%. The incidence of infusion reactions was 5.7% (any grade), with 83.3% of them occurring at the first administration. The incidence of skin disorders was 83.7% (any grade), and the time to event varied for each skin disorder. The incidence of interstitial lung diseases was 1.2% (any grade). Diarrhoea and haematotoxicity scarcely occurred with cetuximab alone. CONCLUSIONS: In this surveillance, the incidence and categories of adverse drug reactions are not distinct from previous reports. Although most patients received cetuximab as third-line or later treatment, treatment was maintained with a median duration of 15 weeks. Cetuximab treatment in practical use is considered to be well tolerated and clinically useful in Japanese patients with metastatic colorectal cancer.
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spelling pubmed-33143222012-03-30 A Japanese Post-marketing Surveillance of Cetuximab (Erbitux(®)) in Patients with Metastatic Colorectal Cancer Ishiguro, Megumi Watanabe, Toshiaki Yamaguchi, Kensei Satoh, Taroh Ito, Hideyuki Seriu, Taku Sakata, Yuh Sugihara, Kenichi Jpn J Clin Oncol Original Articles OBJECTIVE: Cetuximab (Erbitux(®)) was approved for the treatment of metastatic colorectal cancer in Japan in 2008. To verify information on the safety in practical use of cetuximab, we conducted post-marketing surveillance in accordance with the conditions for approval. METHODS: All patients to be treated with cetuximab were enrolled by the central enrolment method. Data on treatment status, and incidence and severity of adverse drug reactions were collected. The target number of patients was 1800. RESULTS: A total of 2126 patients were enrolled from 637 institutions. Among 2006 patients analysed, 93.2% received cetuximab as third-line or later treatment. The median duration of treatment was 15.3 weeks, and 11.1% of patients received treatment for >48 weeks. The incidence of adverse drug reactions was 89.6%, of which ≥grade 3 was 21.5%. The incidence of infusion reactions was 5.7% (any grade), with 83.3% of them occurring at the first administration. The incidence of skin disorders was 83.7% (any grade), and the time to event varied for each skin disorder. The incidence of interstitial lung diseases was 1.2% (any grade). Diarrhoea and haematotoxicity scarcely occurred with cetuximab alone. CONCLUSIONS: In this surveillance, the incidence and categories of adverse drug reactions are not distinct from previous reports. Although most patients received cetuximab as third-line or later treatment, treatment was maintained with a median duration of 15 weeks. Cetuximab treatment in practical use is considered to be well tolerated and clinically useful in Japanese patients with metastatic colorectal cancer. Oxford University Press 2012-04 2012-02-10 /pmc/articles/PMC3314322/ /pubmed/22327124 http://dx.doi.org/10.1093/jjco/hys005 Text en © The Author 2012. Published by Oxford University Press. http://creativecommons.org/licenses/by-nc/2.0/uk/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Ishiguro, Megumi
Watanabe, Toshiaki
Yamaguchi, Kensei
Satoh, Taroh
Ito, Hideyuki
Seriu, Taku
Sakata, Yuh
Sugihara, Kenichi
A Japanese Post-marketing Surveillance of Cetuximab (Erbitux(®)) in Patients with Metastatic Colorectal Cancer
title A Japanese Post-marketing Surveillance of Cetuximab (Erbitux(®)) in Patients with Metastatic Colorectal Cancer
title_full A Japanese Post-marketing Surveillance of Cetuximab (Erbitux(®)) in Patients with Metastatic Colorectal Cancer
title_fullStr A Japanese Post-marketing Surveillance of Cetuximab (Erbitux(®)) in Patients with Metastatic Colorectal Cancer
title_full_unstemmed A Japanese Post-marketing Surveillance of Cetuximab (Erbitux(®)) in Patients with Metastatic Colorectal Cancer
title_short A Japanese Post-marketing Surveillance of Cetuximab (Erbitux(®)) in Patients with Metastatic Colorectal Cancer
title_sort japanese post-marketing surveillance of cetuximab (erbitux(®)) in patients with metastatic colorectal cancer
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3314322/
https://www.ncbi.nlm.nih.gov/pubmed/22327124
http://dx.doi.org/10.1093/jjco/hys005
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