The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study

The Lancet Oncology - Tập 16 - Trang 25-35 - 2015
Richard S Finn1, John P Crown2, Istvan Lang3, Katalin Boer4, Igor M Bondarenko5, Sergey O Kulyk6, Johannes Ettl7, Ravindranath Patel8, Tamas Pinter9, Marcus Schmidt10, Yaroslav Shparyk11, Anu R Thummala12, Nataliya L Voytko13, Camilla Fowst14, Xin Huang15, Sindy T Kim15, Sophia Randolph15, Dennis J Slamon1
1University of California Los Angeles, Los Angeles, CA, USA
2Irish Cooperative Oncology Research Group, Dublin, Ireland
3Orszagos Onkologiai Intezet, Budapest, Hungary
4Szent Margit Korhaz, Onkologia, Budapest, Hungary
5Dnipropetrovsk Medical Academy, City Multiple-Discipline Clinical Hospital 4, Dnipropetrovsk, Ukraine
6Municipal Treatment and Prophylactic Institution, Donetsk, Ukraine
7Technical University of Munich, Munich, Germany
8Comprehensive Blood and Cancer Center, Bakersfield, CA, USA
9Petz Aladar Megyei Oktato Korhaz, Gyor, Hungary
10University Hospital Mainz, Mainz, Germany
11Lviv State Oncologic Regional Treatment and Diagnostic Centre, Lviv, Ukraine
12Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA
13Kyiv City Clinical Oncology Centre, Kyiv, Ukraine
14Pfizer Oncology, Milan, Italy
15Pfizer Oncology, San Diego, CA, USA

Tài liệu tham khảo

Perou, 2000, Molecular portraits of human breast tumours, Nature, 406, 747, 10.1038/35021093 Jemal, 2011, Global cancer statistics, CA Cancer J Clin, 61, 69, 10.3322/caac.20107 Slamon, 2001, Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2, N Engl J Med, 344, 783, 10.1056/NEJM200103153441101 Baselga, 2012, Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer, N Engl J Med, 366, 520, 10.1056/NEJMoa1109653 Hanahan, 2011, Hallmarks of cancer: the next generation, Cell, 144, 646, 10.1016/j.cell.2011.02.013 2012, Comprehensive molecular portraits of human breast tumours, Nature, 490, 61, 10.1038/nature11412 Malumbres, 2009, Cell cycle, CDKs and cancer: a changing paradigm, Nat Rev Cancer, 9, 153, 10.1038/nrc2602 Stone, 2012, Inhibitors of cell cycle kinases: recent advances and future prospects as cancer therapeutics, Crit Rev Oncog, 17, 175, 10.1615/CritRevOncog.v17.i2.40 Fry, 2004, Specific inhibition of cyclin-dependent kinase 4/6 by PD 0332991 and associated antitumor activity in human tumor xenografts, Mol Cancer Ther, 3, 1427, 10.1158/1535-7163.1427.3.11 Choi, 2014, Signaling through cyclin D-dependent kinases, Oncogene, 33, 1890, 10.1038/onc.2013.137 Finn, 2009, PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro, Breast Cancer Res, 11, R77, 10.1186/bcr2419 Finn, 2009, Cancer Res, 69 Mouridsen, 2003, Phase III study of letrozole versus tamoxifen as first-line therapy of advanced breast cancer in postmenopausal women: analysis of survival and update of efficacy from the International Letrozole Breast Cancer Group, J Clin Oncol, 21, 2101, 10.1200/JCO.2003.04.194 Grambsch, 1994, Proportional hazards tests and diagnostics based on weighted residuals, Biometrika, 81, 515, 10.1093/biomet/81.3.515 Chlebowski, 2013, Changing concepts of hormone receptor-positive advanced breast cancer therapy, Clin Breast Cancer, 13, 159, 10.1016/j.clbc.2012.11.002 Johnston, 2009, Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer, J Clin Oncol, 27, 5538, 10.1200/JCO.2009.23.3734 Martin, 2012, Phase III trial evaluating the addition of bevacizumab to endocrine therapy as first-line treatment for advanced breast cancer—first efficacy results from the LEA study, Cancer Res, 72, 10.1158/0008-5472.SABCS12-S1-7 Robertson, 2013, Ganitumab with either exemestane or fulvestrant for postmenopausal women with advanced, hormone-receptor-positive breast cancer: a randomised, controlled, double-blind, phase 2 trial, Lancet Oncol, 14, 228, 10.1016/S1470-2045(13)70026-3 Piccart, 2014, Everolimus plus exemestane for hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2–) advanced breast cancer (BC): overall survival results from BOLERO-2, Eur J Cancer, 50, S1, 10.1016/S0959-8049(14)00221-4 Dean, 2012, Therapeutic response to CDK4/6 inhibition in breast cancer defined by ex vivo analyses of human tumors, Cell Cycle, 11, 2756, 10.4161/cc.21195 Miller, 2011, ERα-dependent E2F transcription can mediate resistance to estrogen deprivation in human breast cancer, Cancer Discov, 1, 338, 10.1158/2159-8290.CD-11-0101 DeMichele A, Clark AS, Heitjan D, et al. A phase II trial of an oral CDK 4/6 inhibitor, PD0332991, in advanced breast cancer. 2013 ASCO Annual Meeting; Chicago, IL, USA; May 31–June 4, 2013. Abstr 519. Roberts, 2012, Multiple roles of cyclin-dependent kinase 4/6 inhibitors in cancer therapy, J Natl Cancer Inst, 104, 476, 10.1093/jnci/djs002