Completeness in the reporting of dermatologic adverse drug reactions associated with monoclonal antibody epidermal growth factor receptor inhibitors in phase II and III colorectal cancer clinical trials.

作者: Kimberly A. Bauer , Scott Hammerman , Bernardo Rapoport , Mario E. Lacouture

DOI: 10.3816/CCC.2008.N.040

关键词:

摘要: The epidermal growth factor receptor inhibitors cetuximab and panitumumab have demonstrated activity against colorectal cancer (CRC), with decreased systemic toxicities compared cytotoxic chemotherapy. However, most patients experience dermatologic adverse drug reactions (dADRs). Our study examines completeness of reporting dADRs to in clinical trials for CRC. PubMed MEDLINE database was searched "cetuximab CRC" or "panitumumab CRC." Searches were limited phase II III trials. Each result evaluated type dADRs, grades included, correlation survival, dose modification. Ten the 13 articles (76.9%) analyzed included data on dADRs. Eight ten (80%) reported all rash, effect modification 20%, patient discontinuation 30%. Five (50%) a positive between survival response. Three 7 (42.9%) None lower-grade rash. Information adjustments one (33.3%), while 3 (100%) articles. Correlation 2 (66.6%). results indicate considerable variability This suggests that ability determine risk capability compare toxicity profiles agents is by current methods. To improve counseling prophylactic antitoxicity interventions, implementation standards critical.

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