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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>
Ueta, M.,Sawai, H.,Sotozono, C.,Hitomi, Y.,Kaniwa, N.,Kim, M.K.,Seo, K.Y.,Yoon, K.C.,Joo, C.K.,Kannabiran, C.,Wakamatsu, T.H.,Sangwan, V.,Rathi, V.,Basu, S.,Ozeki, T.,Mushiroda, T.,Sugiyama, E.,Maekaw Mosby 2015 The Journal of allergy and clinical immunology Vol.135 No.6
Background: Stevens-Johnson syndrome (SJS) and its severe form, toxic epidermal necrolysis (TEN), are acute inflammatory vesiculobullous reactions of the skin and mucous membranes, including the ocular surface, oral cavity, and genitals. These reactions are very rare but are often associated with inciting drugs, infectious agents, or both. Objective: We sought to identify susceptibility loci for cold medicine-related SJS/TEN (CM-SJS/TEN) with severe mucosal involvement (SMI). Methods: A genome-wide association study was performed in 808 Japanese subjects (117 patients with CM-SJS/TEN with SMI and 691 healthy control subjects), and subsequent replication studies were performed in 204 other Japanese subjects (16 cases and 188 control subjects), 117 Korean subjects (27 cases and 90 control subjects), 76 Indian subjects (20 cases and 56 control subjects), and 174 Brazilian subjects (39 cases and 135 control subjects). Results: In addition to the most significant susceptibility region, HLA-A, we identified IKZF1, which encodes Ikaros, as a novel susceptibility gene (meta-analysis, rs4917014 [G vs T]; odds ratio, 0.5; P = 8.5 x 10<SUP>-11</SUP>). Furthermore, quantitative ratios of the IKZF1 alternative splicing isoforms Ik1 and Ik2 were significantly associated with rs4917014 genotypes. Conclusion: We identified IKZF1 as a susceptibility gene for CM-SJS/TEN with SMI not only in Japanese subjects but also in Korean and Indian subjects and showed that the Ik2/Ik1 ratio might be influenced by IKZF1 single nucleotide polymorphisms, which were significantly associated with susceptibility to CM-SJS/TEN with SMI.