Multicenter Phase II and Translational Study of Cetuximab in Metastatic Colorectal Carcinoma Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidines
作者： Heinz-Josef Lenz , Eric Van Cutsem , Shirin Khambata-Ford , Robert J. Mayer , Philip Gold
关键词: Internal medicine 、 Irinotecan 、 Pathology 、 Cetuximab 、 Oncology 、 Oxaliplatin 、 Colorectal cancer 、 Epidermal growth factor receptor 、 Camptothecin 、 Genetic translation 、 Carcinoma 、 Medicine
摘要: Purpose This multicenter study evaluated the antitumor activity of cetuximab, an immunoglobulin G1 antibody directed at epidermal growth factor receptor (EGFR), in metastatic colorectal carcinoma (CRC) refractory to irinotecan, oxaliplatin, and a fluoropyrimidine. It also safety, pharmacokinetics, immunokinetics, biologic determinants activity. Patients Methods with CRC, whose tumors demonstrated EGFR immunostaining were fluoropyrimidines, treated cetuximab loading dose 400 mg/m2 followed by 250 weekly. An independent review committee (IRC) reviewed responses. Blood was collected for pharmacokinetics detect antibodies cetuximab. gene sequencing tyrosine kinase domain copy number assessments performed. Results The response rates 346 patients, as determined investigators IRC, 12.4% (95% CI, 9.1 16.4) 11.6% 8.4...
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