期刊
CLINICAL CANCER RESEARCH
卷 18, 期 22, 页码 6373-6383出版社
AMER ASSOC CANCER RESEARCH
DOI: 10.1158/1078-0432.CCR-12-1627
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资金
- Institute for Personalized Cancer Therapy (IPCT), The University of Texas MD Anderson Cancer Center
- CTSA Grant Award, Center for Clinical and Translational Sciences [5UL1RR024148-04(PP-2)]
- CTSA Supplemental Grant Award [3UL1RR024148-04SI]
- Institute for Personalized Cancer Therapy
- Novartis
- Amgen
- Amplimen
- Angiochem
- Aronex
- AstraZeneca
- Callisto
- Centocor
- Concordia
- Enzon
- Exelixis
- Genentech
- GSK
- Globomax
- BPC Biotech
- Hoffman LaRoche
- Merck Co.
- MGI Pharmaceuticals
- Myriad
- NCCN
- NCI
- Nereus
- Otsuka
- Pfizer
- Ziopharm
- Wyeth
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 with advanced cancer were treated in the Clinical Center for Targeted Therapy. Molecular analysis was conducted in the MD Anderson Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Patients whose tumors had an aberration were treated with matched targeted therapy, when available. Treatment assignment was not randomized. The clinical outcomes of patients with molecular aberrations treated with matched targeted therapy were compared with those of consecutive patients who were not treated with matched targeted therapy. Results: Of 1,144 patients analyzed, 460 (40.2%) had 1 or more aberration. In patients with 1 molecular aberration, matched therapy (n = 175) compared with treatment without matching (n 116) was associated with a higher overall response rate (27% vs. 5%; P < 0.0001), longer time-to-treatment failure (TTF; median, 5.2 vs. 2.2 months; P < 0.0001), and longer survival (median, 13.4 vs. 9.0 months; P = 0.017). Matched targeted therapy was associated with longer TTF compared with their prior systemic therapy in patients with 1 mutation (5.2 vs. 3.1 months, respectively; P < 0.0001). In multivariate analysis in patients with 1 molecular aberration, matched therapy was an independent factor predicting response (P = 0.001) and TTF (P = 0.0001). Conclusion: Keeping in mind that the study was not randomized and patients had diverse tumor types and a median of 5 prior therapies, our results suggest that identifying specific molecular abnormalities and choosing therapy based on these abnormalities is relevant in phase I clinical trials. Clin Cancer Res; 18(22); 6373-83. (C) 2012 AACR.
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