Personalized Medicine in a Phase I Clinical Trials Program: The MD Anderson Cancer Center Initiative

摘要: Purpose: We initiated a personalized medicine program in the context of early clinical trials, using targeted agents matched with tumor molecular aberrations. Herein, we report our observations. Patient and Methods: Patients advanced cancer were treated Clinical Center for Targeted Therapy. Molecular analysis was conducted MD Anderson Laboratory Improvement Amendments (CLIA)–certified laboratory. whose tumors had an aberration therapy, when available. Treatment assignment not randomized. The outcomes patients aberrations therapy compared those consecutive who therapy. Results: Of 1,144 analyzed, 460 (40.2%) 1 or more aberration. In aberration, ( n = 175) treatment without matching 116) associated higher overall response rate (27% vs. 5%; P 0.017). Matched longer TTF their prior systemic mutation (5.2 3.1 months, respectively; 0.001) 0.0001). Conclusion: Keeping mind that study randomized diverse types median 5 therapies, results suggest identifying specific abnormalities choosing based on these is relevant phase I trials. Clin Cancer Res; 18(22); 6373–83. ©2012 AACR .