title: 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.
abstract: The epidermal growth factor receptor inhibitors cetuximab and panitumumab have demonstrated activity against colorectal cancer (CRC), with decreased systemic toxicities compared with cytotoxic chemotherapy. However, most patients experience dermatologic adverse drug reactions (dADRs). Our study examines completeness of reporting of dADRs to cetuximab and panitumumab in clinical trials for CRC. The PubMed MEDLINE database was searched for "cetuximab and CRC" or "panitumumab and CRC." Searches were limited to phase II or phase III clinical trials. Each result was evaluated for type of dADRs, grades included, correlation with survival, and dose modification. Ten of the 13 cetuximab articles (76.9%) analyzed included data on dADRs. Eight of ten (80%) reported all grades of rash, effect on dose modification was reported in 20%, and patient discontinuation in 30%. Five (50%) reported a positive correlation between dADRs and survival or response. Three of 7 (42.9%) panitumumab articles reported dADRs. None of the articles reported lower-grade rash. Information on drug dose adjustments was reported in one (33.3%), while discontinuation was reported 3 (100%) articles. Correlation between dADRs and survival was included in 2 panitumumab articles (66.6%). Our results indicate considerable variability in reporting of dADRs. This suggests that the ability to determine patient risk and the capability to compare dermatologic toxicity profiles between agents is limited by current reporting methods. To improve patient counseling and prophylactic antitoxicity interventions, implementation of standards for reporting of dADRs is critical.
authors.affiliation: Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Bauer
authors.forename: Scott
authors.initials: S
authors.lastname: Hammerman
authors.forename: Bernardo
authors.initials: B
authors.lastname: Rapoport
authors.forename: Mario E
authors.initials: ME
authors.lastname: Lacouture
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000068818:Cetuximab; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003875:Drug Eruptions / Q000175:diagnosis / Q000453:epidemiology*; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D006801:Humans; D000077544:Panitumumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000077544:Panitumumab; D066246:ErbB Receptors; D000068818:Cetuximab