Metformin in Chemotherapy-naive Castration-resistant Prostate Cancer: A Multicenter Phase 2 Trial (SAKK 08/09)

European Urology - Tập 66 - Trang 468-474 - 2014
Christian Rothermundt1, Stefanie Hayoz2, Arnoud J. Templeton1,2, Ralph Winterhalder3, Räto T. Strebel4, Daniela Bärtschi2, Michael Pollak5, Lillianne Lui5, Kathrin Endt6, Ralph Schiess6, Jan H. Rüschoff7, Richard Cathomas4, Silke Gillessen1
1Cantonal Hospital St. Gallen, St. Gallen, Switzerland
2SAKK Coordinating Center Bern, Bern, Switzerland
3Cantonal Hospital Lucerne, Lucerne, Switzerland
4Cantonal Hospital Chur, Chur, Switzerland
5Lady Davis Institute for Medical Research, Jewish General Hospital Montréal, Montréal, Canada
6ProteoMediX, Schlieren, Switzerland
7Institute of Surgical Pathology, University Hospital Zurich, Zurich, Switzerland

Tài liệu tham khảo

Basaria, 2006, Hyperglycemia and insulin resistance in men with prostate carcinoma who receive androgen-deprivation therapy, Cancer, 106, 581, 10.1002/cncr.21642 Keating, 2012, Diabetes and cardiovascular disease during androgen deprivation therapy: observational study of veterans with prostate cancer, J Natl Cancer Inst, 104, 1518 Smith, 2006, Insulin sensitivity during combined androgen blockade for prostate cancer, J Clin Endocrinol Metab, 91, 1305, 10.1210/jc.2005-2507 Ma, 2008, Prediagnostic body-mass index, plasma C-peptide concentration, and prostate cancer-specific mortality in men with prostate cancer: a long-term survival analysis, Lancet Oncol, 9, 1039, 10.1016/S1470-2045(08)70235-3 Flanagan, 2011, Presence of the metabolic syndrome is associated with shorter time to castration-resistant prostate cancer, Ann Oncol, 22, 801, 10.1093/annonc/mdq443 Zakikhani, 2006, Metformin is an AMP kinase-dependent growth inhibitor for breast cancer cells, Cancer Res, 66, 10269, 10.1158/0008-5472.CAN-06-1500 Dowling, 2007, Metformin inhibits mammalian target of rapamycin-dependent translation initiation in breast cancer cells, Cancer Res, 67, 10804, 10.1158/0008-5472.CAN-07-2310 Zakikhani, 2008, The effects of adiponectin and metformin on prostate and colon neoplasia involve activation of AMP-activated protein kinase, Cancer Prevent Res, 1, 369, 10.1158/1940-6207.CAPR-08-0081 Margel, 2013, Metformin use and all-cause and prostate cancer – specific mortality among men with diabetes, J Clin Oncol, 31, 3069, 10.1200/JCO.2012.46.7043 Goodwin, 2008, Insulin-lowering effects of metformin in women with early breast cancer, Clin Breast Cancer, 8, 501, 10.3816/CBC.2008.n.060 Ou, 2006, Metformin increases insulin sensitivity and plasma beta-endorphin in human subjects, Horm Metab Res, 38, 106, 10.1055/s-2006-925128 Romualdi, 2008, Metformin improves endothelial function in normoinsulinemic PCOS patients: a new prospective, Hum Reprod, 23, 2127, 10.1093/humrep/den230 Goldenberg, 2005, Metformin-diet benefits in women with polycystic ovary syndrome in the bottom and top quintiles for insulin resistance, Metabolism, 54, 113, 10.1016/j.metabol.2004.08.007 Cima, 2011, Cancer genetics-guided discovery of serum biomarker signatures for diagnosis and prognosis of prostate cancer, Proc Natl Acad Sci U S A, 108, 3342, 10.1073/pnas.1013699108 2001, ICH harmonized tripartite guideline: guideline for good clinical practice, J Postgrad Med, 47, 45 CTCAE v4.0 open comment period. National Cancer Institute, Cancer Therapy Evaluation Program Web site. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm Scher, 2008, Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group, J Clin Oncol, 26, 1148, 10.1200/JCO.2007.12.4487 Matthews, 1985, Homeostasis model assessment: insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man, Diabetologia, 28, 412, 10.1007/BF00280883 Templeton, 2013, Phase 2 trial of single-agent everolimus in chemotherapy-naive patients with castration-resistant prostate cancer (SAKK 08/08), Eur Urol, 64, 150, 10.1016/j.eururo.2013.03.040 Ryan, 2013, Abiraterone in metastatic prostate cancer without previous chemotherapy, N Engl J Med, 368, 138, 10.1056/NEJMoa1209096 Antonarakis, 2012, Changes in PSA kinetics predict metastasis-free survival in men with PSA-recurrent prostate cancer treated with nonhormonal agents: combined analysis of 4 phase II trials, Cancer, 118, 1533, 10.1002/cncr.26437 Colloca, 2012, Prostate-specific antigen kinetics as a surrogate endpoint in clinical trials of metastatic castration-resistant prostate cancer: a review, Cancer Treat Rev, 38, 1020, 10.1016/j.ctrv.2012.03.008 Goodwin, 2002, Fasting insulin and outcome in early-stage breast cancer: results of a prospective cohort study, J Clin Oncol, 20, 42, 10.1200/JCO.2002.20.1.42 Giovannucci, 2007, Metabolic syndrome, hyperinsulinemia, and colon cancer: a review, Am J Clin Nutr, 86, s836, 10.1093/ajcn/86.3.836S Wolpin, 2009, Insulin, the insulin-like growth factor axis, and mortality in patients with nonmetastatic colorectal cancer, J Clin Oncol, 27, 176, 10.1200/JCO.2008.17.9945 Pollak, 2012, The insulin and insulin-like growth factor receptor family in neoplasia: an update, Nature Rev Cancer, 12, 159, 10.1038/nrc3215 Firth, 2002, Cellular actions of the insulin-like growth factor binding proteins, Endocr Rev, 23, 824, 10.1210/er.2001-0033 Butt, 2004, Insulin-like growth factor binding protein-3 expression is associated with growth stimulation of T47D human breast cancer cells: the role of altered epidermal growth factor signaling, J Clin Endocrinol Metab, 89, 1950, 10.1210/jc.2003-030914 Lubik, 2011, Insulin increases de novo steroidogenesis in prostate cancer cells, Cancer Res, 71, 5754, 10.1158/0008-5472.CAN-10-2470 Venkateswaran, 2007, Association of diet-induced hyperinsulinemia with accelerated growth of prostate cancer (LNCaP) xenografts, J Nat Cancer Inst, 99, 1793, 10.1093/jnci/djm231 Zhu, 2008, Androgen receptor and growth factor signaling cross-talk in prostate cancer cells, Endocr Relat Cancer, 15, 841, 10.1677/ERC-08-0084 Goodwin, 2012, Insulin- and obesity-related variables in early-stage breast cancer: correlations and time course of prognostic associations, J Clin Oncol, 30, 164, 10.1200/JCO.2011.36.2723