title: Safety experience with IMC-C225, an anti-epidermal growth factor receptor antibody.
abstract: In phase II trials, the anti-epidermal growth factor receptor antibody IMC-C225 did not appear to significantly exacerbate the common toxicities associated with cytotoxic chemotherapy when combined with standard anticancer treatments in patients with colorectal cancer, squamous cell carcinoma of the head and neck, or pancreatic cancer. The most common treatment-related adverse events reported during therapy with IMC-C225 were an acne-like rash and hypersensitivity reactions. The acne-like rash appeared as a sterile, suppurative form of folliculitis, commonly starting on the face, scalp, chest, and upper back. It resolved without scarring once treatment was stopped. Notably, the appearance of acne-like rash, particularly grade 3, was associated with higher treatment responses in patients with refractory colorectal cancer. The hypersensitivity reactions occurred less often than acne-like rash. They responded to standard treatments and were less common after the first dose. In summary, IMC-C225 is generally well tolerated as a single agent and when combined with chemotherapy or radiotherapy and possesses a manageable toxicity profile.
authors.affiliation: Department of Clinical Affairs, ImClone Systems Incorporated, Somerville, NJ 08876, USA.
authors.forename: Michael N
authors.initials: MN
authors.lastname: Needle
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000068818:Cetuximab; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D002986:Clinical Trials as Topic; D015179:Colorectal Neoplasms / Q000188:drug therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003875:Drug Eruptions / Q000209:etiology; D004342:Drug Hypersensitivity / Q000209:etiology; D004347:Drug Interactions; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000532:radiotherapy; D006801:Humans; D000077146:Irinotecan; D010190:Pancreatic Neoplasms / Q000188:drug therapy; D000093542:Gemcitabine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000077146:Irinotecan; D000068818:Cetuximab; D002945:Cisplatin; D002166:Camptothecin; D000093542:Gemcitabine