CYP2D6 Genotype and tamoxifen response in postmenopausal women with endocrine-responsive breast cancer: The breast international group 1-98 trial

Journal of the National Cancer Institute

Volumn 104, Issue 6, 2012, Pages 441-451

  Regan, Meredith M ^a,b   Leyland Jones, Brian ^c   Bouzyk, Mark ^c,d   Pagani, Olivia ^e,f,g   Tang, Weining ^h,i   Kammler, Roswitha ^j,k   Dell'Orto, Patrizia ^l,m   Biasi, Maria Olivia ^m   Thürlimann, Beat ^g,n   Lyng, Maria B ^o,p   Ditzel, Henrik J ^o,p,q   Neven, Patrick ^r   Debled, Marc ^s   Maibach, Rudolf ^j   Price, Karen N ^a,t   Gelber, Richard D ^a,b,t   Coates, Alan S ^u,v   Goldhirsch, Aron ^m,w   Rae, James M ^x   Viale, Giuseppe ^l,m,y  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^c EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d AKESOgen Inc   (United States)

^e ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND   (Switzerland)

^f Ospedale Italiano   (Switzerland)

^g SWISS GROUP FOR CLINICAL CANCER RESEARCH SAKK   (Switzerland)

^h EMORY UNIVERSITY   (United States)

ⁱ Omega Bio tek Inc   (United States)

^j IBCSG Coordinating Center   (Switzerland)

^k IBCSG Central Pathology Office   (Switzerland)

^l IBCSG Central Pathology Office   (Italy)

^m EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

ⁿ CANTONAL HOSPITAL ST GALLEN   (Switzerland)

^o UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^p Danish Breast Cancer Cooperative Group   (Denmark)

^q ODENSE UNIVERSITY HOSPITAL   (Denmark)

^r UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^s INSTITUT BERGONIÉ   (France)

^t FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^u IBCSG   (Australia)

^v UNIVERSITY OF SYDNEY   (Australia)

^w Swiss Center for Breast Health   (Switzerland)

^x UNIVERSITY OF MICHIGAN COMPREHENSIVE CANCER CENTER   (United States)

^y UNIVERSITY OF MILAN   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 2D6; LETROZOLE; TAMOXIFEN;

ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER RISK; CANCER TISSUE; CLINICAL ASSESSMENT; CONTROLLED STUDY; DNA ISOLATION; DNA POLYMORPHISM; DRUG RESPONSE; ENZYME METABOLISM; FEMALE; GENETIC ASSOCIATION; GENOTYPE; HOT FLUSH; HUMAN; HUMAN CELL; HUMAN TISSUE; MAJOR CLINICAL STUDY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL (TOPIC); POLYMERASE CHAIN REACTION; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SINGLE NUCLEOTIDE POLYMORPHISM; SURVIVAL;

AGED; ANTINEOPLASTIC AGENTS, HORMONAL; AROMATASE INHIBITORS; BREAST NEOPLASMS; CYTOCHROME P-450 CYP2D6; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; GENOTYPE; HUMANS; INTERNATIONAL COOPERATION; KAPLAN-MEIER ESTIMATE; MIDDLE AGED; NITRILES; POLYMERASE CHAIN REACTION; POLYMORPHISM, GENETIC; POLYMORPHISM, SINGLE NUCLEOTIDE; POSTMENOPAUSE; TAMOXIFEN; TREATMENT OUTCOME; TRIAZOLES;

EID: 84859093970     PISSN: 00278874     EISSN: 14602105     Source Type: Journal    
DOI: 10.1093/jnci/djs125     Document Type: Article

References (35)

1. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effect of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;365(9472):1687-1717.
2. The Breast International Group (BIG) 1-98 Collaborative Group. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005;353(26):2747-2757.
3. Coates AS, Keshaviah A, Thürlimann B, et al. Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98. J Clin Oncol. 2007;25(5):486-492.
4. The Breast International Group (BIG) 1-98 Collaborative Group. Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer. N Engl J Med. 2009;361(8):766-776.
5. Colleoni M, Giobbie-Hurder A, Regan MM, et al. Analyses adjusting for selective crossover show improved overall survival with adjuvant letrozole compared with tamoxifen in the BIG 1-98 study. J Clin Oncol. 2011;29(9):1117-1124.
6. Viale G, Regan MM, Dell'Orto P, et al. Which patients benefit most from adjuvant aromatase inhibitors? Results using a composite measure of prognostic risk in the BIG 1-98 randomized trial. Ann Oncol. 2011;22(10):2201-2207.
7. Goetz MP, Rae JM, Suman VJ, et al. Pharmacogenetics of tamoxifen biotransformation is associated with clinical outcomes of efficacy and hot flashes. J Clin Oncol. 2005;23(36):9312-9318.
8. Punglia RS, Burstein HJ, Winer EP, Weeks JC. Pharmacogenomic variation of CYP2D6 and the choice of optimal adjuvant endocrine therapy for postmenopausal breast cancer: a modeling analysis. J Natl Cancer Inst. 2008;100(9):642-648.
9. Ferraldeschi R, Newman WG. The impact of CYP2D6 genotyping on tamoxifen treatment. Pharmaceuticals. 2010;3(4):1122-1138.
10. Higgins MJ, Stearns V. Pharmacogenetics of endocrine therapy for breast cancer. Annu Rev Med. 2011;62:281-293.
11. Brauch H, Mürdter TE, Eichelbaum M, Schwab M. Pharmacogenomics of tamoxifen therapy. Clin Chem. 2009;55(10):1770-1782.
12. Desta Z, Ward BA, Soukhova NV, Flockhart DA. Comprehensive evaluation of tamoxifen sequential biotransformation by the human cytochrome P450 system in vitro: prominent roles for CYP3A and CYP2D6. J Pharmacol Exp Ther. 2004;310(3):1062-1075.
13. Jordan VC. Metabolites of tamoxifen in animals and man: identification, pharmacology, and significance. Breast Cancer Res Treat. 1982;2(2):123-128.
14. Johnson MD, Zuo H, Lee KH, et al. Pharmacological characterization of 4-hydroxy-N-desmethyl tamoxifen, a novel active metabolite of tamoxifen. Breast Cancer Res Treat. 2004;85(2):151-159.
15. Lim YC, Desta Z, Flockhart DA, Skaar TC. Endoxifen (4-hydroxy-N- desmethyl-tamoxifen) has anti-estrogenic effects in breast cancer cells with potency similar to 4-hydroxy-tamoxifen. Cancer Chemother Pharmacol. 2005;55(5):471-478.
16. Jin Y, Desta Z, Stearns V, et al. CYP2D6 genotype, antidepressant use, and tamoxifen metabolism during adjuvant breast cancer treatment. J Natl Cancer Inst. 2005;97(1):30-39.
17. Wu X, Hawse JR, Subramaniam M, Goetz MP, Ingle JN, Spelsberg TC. The tamoxifen metabollite, endoxifen, is a potent antiestrogen that targets estrogen receptor a for degradation in breast cancer cells. Cancer Res. 2009;69(5):1722-1727.
18. Stearns V, Johnson MD, Rae JM, et al. Active tamoxifen metabolite plasma concentrations after coadministration of tamoxifen and the selective serotonin reuptake inhibitor paroxetine. J Natl Cancer Inst. 2003;95(23):1758-1764.
19. Borges S, Desta Z, Li L, et al. Quantitative effect of CYP2D6 genotype and inhibitors on tamoxifen metabolism: implication for optimization of breast cancer treatment. Clin Pharm Ther. 2006;80(1):61-74.
20. Bonanni B, Macis D, Maisonneuve P, et al. Polymorphism in the CYP2D6 tamoxifen-metabolizing gene influences clinical effect but not hot flashes: data from the Italian Tamoxifen Trial. J Clin Oncol. 2006;24(22):3708.
21. Henry NL, Rae JM, Li L, et al.; for Consortium on Breast Cancer Pharmacogenomics Investigators. Association between CYP2D6 genotype and tamoxifen-induced hot flashes in a prospective cohort. Breast Cancer Res Treat. 2009;117(3):571-575.
22. Sikora MJ, Thibert JN, Salter J, Dowsett M, Johnson MD, Rae JM. High-efficiency genotype analysis from formalin-fixed, paraffin-embedded tumor tissues. Pharmacogenomics J. 2011;11(5):348-358.
23. Schroth W, Goetz MP, Hamann U, et al. Association between CYP2D6 polymorphisms and outcomes among women with early stage breast cancer treated with tamoxifen. JAMA. 2009;302(13):1429-1436.
24. Hudis CA, Barlow WE, Costantino JP, et al. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007;25(15):2127-2132.
25. Robins JM, Finkelstein DM. Correcting for noncompliance and dependent censoring in and AIDS clinical trial with inverse probability of censoring weighted (IPCW) log-rank tests. Biometrics. 2000;56(3):779-788.
26. McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM. Reporting recommendations for tumor marker prognostic studies. J Clin Oncol. 2005;23(36):9067-9072.
27. Cuzick J, Sestak I, Cella D, Fallowfield L; on behalf of the ATAC Trialists' Group. Treatment-emergent endocrine symptoms and the risk of breast cancer recurrence: a retrospective analysis of the ATAC trial. Lancet Oncol. 2008;9(12):1143-1148.
28. Mortimer JE, Flatt SW, Parker BA, et al. Tamoxifen, hot flashes and recurrence in breast cancer. Breast Cancer Res Treat. 2008;108(3):421-426.
29. Ahmad A, Shahabuddin S, Sheikh S, et al. Endoxifen, a new cornerstone of breast cancer therapy: demonstration of safety, tolerability, and systemic bioavailability in healthy human subjects. Clin Pharmacol Ther. 2010;88(6):814-817.
30. Dowsett M, Haynes BP. Hormonal effects of aromatase inhibitors: focus on premenopausal effects and interaction with tamoxifen. J Steroid Biochem Mol Biol. 2003;86(3-5):255-263.
31. Smith IE, Dowsett M, Ebbs SR, et al. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen or both in combination: the Immediate Preoperative Anastrozole, Tamoxifen or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial. J Clin Oncol. 2005;23(22):5108-5116.
32. Madlensky L, Natarajan L, Tchu S. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011;89(5):718-725.
33. Rae JR, Druzy S, Hayes DF, et al. CYP2D6 and UGT2B7 genotype and risk of recurrence in tamoxifen-treated breast cancer patients. J Natl Cancer Inst. 2012:104(6):452-460.
34. Lash TL, Cronin-Fenton D, Ahern TP, et al. CYP2D6 inhibition and breast cancer recurrence in a population-based study in Denmark. J Natl Cancer Inst. 2011;103(6):1-12.
35. Rae JM, Sikora MJ, Henry NL, et al. Cytochrome P450 2D6 activity predicts discontinuation of tamoxifen therapy in breast cancer patients. Pharmacogenomics J. 2009;9(4):258-264.