A Postmarketing Surveillance Study on Erbitux (Cetuximab) in Patients with Metastatic Colorectal Cancer Refractory to Irinotecan-Containing Treatment
| Autor: | Yang Cheng Lee, Wei Shou Hwang, Chung Hung Yeh, Hong Hwa Chen, Jinn Shiun Chen, Chia Jung Lin, Ruey Kuen Hsieh, Hong Cheng Wu, Wu Ching Uen, Jen Seng Huang, Hao Hsuan Jeng, Yin Che Lu, Chi Chou Huang, Hwei Ming Wang, Ruey Ho Kao, Peng Chan Lin, Wen Tsung Huang, Chou Pin Chen |
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| Rok vydání: | 2013 |
| Předmět: |
Male
Oncology medicine.medical_specialty Colorectal cancer Cetuximab Postmarketing surveillance Antibodies Monoclonal Humanized Irinotecan medicine.disease_cause General Biochemistry Genetics and Molecular Biology Internal medicine Product Surveillance Postmarketing medicine Humans Treatment Failure Progression-free survival Adverse effect Aged business.industry General Medicine Middle Aged medicine.disease Rash digestive system diseases Treatment Outcome Camptothecin Female KRAS medicine.symptom Colorectal Neoplasms business medicine.drug |
| Zdroj: | Journal of Investigative Medicine. 61:1108-1114 |
| ISSN: | 1708-8267 1081-5589 |
| DOI: | 10.2310/jim.0b013e3182a6799d |
| Popis: | 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 fordiscontinuation. The study followed 269 patients for approximately 2years. 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 progression-free 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. |
| Databáze: | OpenAIRE |
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