A Postmarketing Surveillance Study on Erbitux (Cetuximab) in Patients with Metastatic Colorectal Cancer Refractory to Irinotecan-Containing Treatment

Wen Tsung Huang, Hong Hwa Chen, Chung Hung Yeh, Yin Che Lu, Wei Shou Hwang, Jen Seng Huang, Chou Pin Chen, Peng Chan Lin, Wu Ching Uen, Yang Cheng Lee, Hwei Ming Wang, Hong Cheng Wu, Jinn Shiun Chen, Ruey Ho Kao, Chi Chou Huang, Hao Hsuan Jeng, Chia Jung Lin, Ruey Kuen Hsieh

研究成果: 雜誌貢獻文章

1 引文 (Scopus)

摘要

Objective: This postmarketing surveillance study evaluated the safety and efficacy of cetuximab therapy in patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) in Taiwan. Methods: Patients with EGFR-expressing mCRC who had failed prior irinotecan-based chemotherapy and were receiving cetuximab therapy were monitored for treatment efficacy and safety from the time of first infusion until 28 days after the last infusion regardless of the reasons for discontinuation. The study followed 269 patients for approximately 2 years. Results: No unexpected adverse events associated with cetuximab therapy were reported, and most events were grade 1 or 2. The most common drug-related adverse events of any grade were rash (21.6%) and dermatitis acneiform (4.8%). Reported grade 3/4 events were rash (4.5%), dermatitis acneiform (0.4%), and diarrhea (0.4%). Cetuximab treatment for patients receiving second-/third-line (177 patients) or above therapy (92 patients) was associated with a median progressionfree survival time of 3.37 and 3.90 months, respectively, and a median overall survival time of 17.6 and 21.1 months, respectively. The response rates for the second-/third-line treatment and fourth-line or above cetuximab treatment groups were similar (21.5% vs 17.4%; P = 0.428). Conclusion: Cetuximab showed no unexpected safety findings and was efficacious in treating patients with EGFR-expressing mCRC in community practice in Taiwan.
原文英語
頁(從 - 到)1108-1114
頁數7
期刊Journal of Investigative Medicine
61
發行號7
DOIs
出版狀態已發佈 - 一月 1 2013
對外發佈Yes

指紋

irinotecan
Refractory materials
Colorectal Neoplasms
Epidermal Growth Factor Receptor
Dermatitis
Exanthema
Taiwan
Safety
Therapeutics
Chemotherapy
Survival
Cetuximab
Drug-Related Side Effects and Adverse Reactions

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

引用此文

A Postmarketing Surveillance Study on Erbitux (Cetuximab) in Patients with Metastatic Colorectal Cancer Refractory to Irinotecan-Containing Treatment. / Huang, Wen Tsung; Chen, Hong Hwa; Yeh, Chung Hung; Lu, Yin Che; Hwang, Wei Shou; Huang, Jen Seng; Chen, Chou Pin; Lin, Peng Chan; Uen, Wu Ching; Lee, Yang Cheng; Wang, Hwei Ming; Wu, Hong Cheng; Chen, Jinn Shiun; Kao, Ruey Ho; Huang, Chi Chou; Jeng, Hao Hsuan; Lin, Chia Jung; Hsieh, Ruey Kuen.

於: Journal of Investigative Medicine, 卷 61, 編號 7, 01.01.2013, p. 1108-1114.

研究成果: 雜誌貢獻文章

Huang, WT, Chen, HH, Yeh, CH, Lu, YC, Hwang, WS, Huang, JS, Chen, CP, Lin, PC, Uen, WC, Lee, YC, Wang, HM, Wu, HC, Chen, JS, Kao, RH, Huang, CC, Jeng, HH, Lin, CJ & Hsieh, RK 2013, 'A Postmarketing Surveillance Study on Erbitux (Cetuximab) in Patients with Metastatic Colorectal Cancer Refractory to Irinotecan-Containing Treatment', Journal of Investigative Medicine, 卷 61, 編號 7, 頁 1108-1114. https://doi.org/10.231/JIM.0b013e3182a6799d
Huang, Wen Tsung ; Chen, Hong Hwa ; Yeh, Chung Hung ; Lu, Yin Che ; Hwang, Wei Shou ; Huang, Jen Seng ; Chen, Chou Pin ; Lin, Peng Chan ; Uen, Wu Ching ; Lee, Yang Cheng ; Wang, Hwei Ming ; Wu, Hong Cheng ; Chen, Jinn Shiun ; Kao, Ruey Ho ; Huang, Chi Chou ; Jeng, Hao Hsuan ; Lin, Chia Jung ; Hsieh, Ruey Kuen. / A Postmarketing Surveillance Study on Erbitux (Cetuximab) in Patients with Metastatic Colorectal Cancer Refractory to Irinotecan-Containing Treatment. 於: Journal of Investigative Medicine. 2013 ; 卷 61, 編號 7. 頁 1108-1114.
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abstract = "Objective: This postmarketing surveillance study evaluated the safety and efficacy of cetuximab therapy in patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) in Taiwan. Methods: Patients with EGFR-expressing mCRC who had failed prior irinotecan-based chemotherapy and were receiving cetuximab therapy were monitored for treatment efficacy and safety from the time of first infusion until 28 days after the last infusion regardless of the reasons for discontinuation. The study followed 269 patients for approximately 2 years. Results: No unexpected adverse events associated with cetuximab therapy were reported, and most events were grade 1 or 2. The most common drug-related adverse events of any grade were rash (21.6{\%}) and dermatitis acneiform (4.8{\%}). Reported grade 3/4 events were rash (4.5{\%}), dermatitis acneiform (0.4{\%}), and diarrhea (0.4{\%}). Cetuximab treatment for patients receiving second-/third-line (177 patients) or above therapy (92 patients) was associated with a median progressionfree survival time of 3.37 and 3.90 months, respectively, and a median overall survival time of 17.6 and 21.1 months, respectively. The response rates for the second-/third-line treatment and fourth-line or above cetuximab treatment groups were similar (21.5{\%} vs 17.4{\%}; P = 0.428). Conclusion: Cetuximab showed no unexpected safety findings and was efficacious in treating patients with EGFR-expressing mCRC in community practice in Taiwan.",
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T1 - A Postmarketing Surveillance Study on Erbitux (Cetuximab) in Patients with Metastatic Colorectal Cancer Refractory to Irinotecan-Containing Treatment

AU - Huang, Wen Tsung

AU - Chen, Hong Hwa

AU - Yeh, Chung Hung

AU - Lu, Yin Che

AU - Hwang, Wei Shou

AU - Huang, Jen Seng

AU - Chen, Chou Pin

AU - Lin, Peng Chan

AU - Uen, Wu Ching

AU - Lee, Yang Cheng

AU - Wang, Hwei Ming

AU - Wu, Hong Cheng

AU - Chen, Jinn Shiun

AU - Kao, Ruey Ho

AU - Huang, Chi Chou

AU - Jeng, Hao Hsuan

AU - Lin, Chia Jung

AU - Hsieh, Ruey Kuen

PY - 2013/1/1

Y1 - 2013/1/1

N2 - Objective: This postmarketing surveillance study evaluated the safety and efficacy of cetuximab therapy in patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) in Taiwan. Methods: Patients with EGFR-expressing mCRC who had failed prior irinotecan-based chemotherapy and were receiving cetuximab therapy were monitored for treatment efficacy and safety from the time of first infusion until 28 days after the last infusion regardless of the reasons for discontinuation. The study followed 269 patients for approximately 2 years. Results: No unexpected adverse events associated with cetuximab therapy were reported, and most events were grade 1 or 2. The most common drug-related adverse events of any grade were rash (21.6%) and dermatitis acneiform (4.8%). Reported grade 3/4 events were rash (4.5%), dermatitis acneiform (0.4%), and diarrhea (0.4%). Cetuximab treatment for patients receiving second-/third-line (177 patients) or above therapy (92 patients) was associated with a median progressionfree survival time of 3.37 and 3.90 months, respectively, and a median overall survival time of 17.6 and 21.1 months, respectively. The response rates for the second-/third-line treatment and fourth-line or above cetuximab treatment groups were similar (21.5% vs 17.4%; P = 0.428). Conclusion: Cetuximab showed no unexpected safety findings and was efficacious in treating patients with EGFR-expressing mCRC in community practice in Taiwan.

AB - Objective: This postmarketing surveillance study evaluated the safety and efficacy of cetuximab therapy in patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) in Taiwan. Methods: Patients with EGFR-expressing mCRC who had failed prior irinotecan-based chemotherapy and were receiving cetuximab therapy were monitored for treatment efficacy and safety from the time of first infusion until 28 days after the last infusion regardless of the reasons for discontinuation. The study followed 269 patients for approximately 2 years. Results: No unexpected adverse events associated with cetuximab therapy were reported, and most events were grade 1 or 2. The most common drug-related adverse events of any grade were rash (21.6%) and dermatitis acneiform (4.8%). Reported grade 3/4 events were rash (4.5%), dermatitis acneiform (0.4%), and diarrhea (0.4%). Cetuximab treatment for patients receiving second-/third-line (177 patients) or above therapy (92 patients) was associated with a median progressionfree survival time of 3.37 and 3.90 months, respectively, and a median overall survival time of 17.6 and 21.1 months, respectively. The response rates for the second-/third-line treatment and fourth-line or above cetuximab treatment groups were similar (21.5% vs 17.4%; P = 0.428). Conclusion: Cetuximab showed no unexpected safety findings and was efficacious in treating patients with EGFR-expressing mCRC in community practice in Taiwan.

KW - Cetuximab

KW - KRAS

KW - metastatic colorectal cancer

KW - overall survival

KW - progression-free survival

KW - safety

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