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<i>CYP2D6</i> Genotype and Adjuvant Tamoxifen: Meta-Analysis of Heterogeneous Study Populations
Province, M A,Goetz, M P,Brauch, H,Flockhart, D A,Hebert, J M,Whaley, R,Suman, V J,Schroth, W,Winter, S,Zembutsu, H,Mushiroda, T,Newman, W G,Lee, M-T M,Ambrosone, C B,Beckmann, M W,Choi, J-Y,Dieudonn& C. V. Mosby 2014 Clinical Pharmacology & Therapeutics Vol. No.
<P>The International Tamoxifen Pharmacogenomics Consortium was established to address the controversy regarding cytochrome P450 2D6 (<I>CYP2D6</I>) status and clinical outcomes in tamoxifen therapy. We performed a meta-analysis on data from 4,973 tamoxifen-treated patients (12 globally distributed sites). Using strict eligibility requirements (postmenopausal women with estrogen receptor–positive breast cancer, receiving 20 mg/day tamoxifen for 5 years, criterion 1); CYP2D6 poor metabolizer status was associated with poorer invasive disease–free survival (IDFS: hazard ratio = 1.25; 95% confidence interval = 1.06, 1.47; <I>P</I> = 0.009). However, <I>CYP2D6</I> status was not statistically significant when tamoxifen duration, menopausal status, and annual follow-up were not specified (criterion 2, <I>n</I> = 2,443; <I>P</I> = 0.25) or when no exclusions were applied (criterion 3, <I>n</I> = 4,935; <I>P</I> = 0.38). Although <I>CYP2D6</I> is a strong predictor of IDFS using strict inclusion criteria, because the results are not robust to inclusion criteria (these were not defined <I>a priori</I>), prospective studies are necessary to fully establish the value of <I>CYP2D6</I> genotyping in tamoxifen therapy.</P>