Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial

The Lancet Oncology - Tập 12 - Trang 236-244 - 2011
Luca Gianni1, Urania Dafni2, Richard D Gelber3, Evandro Azambuja4, Susanne Muehlbauer5, Aron Goldhirsch6,7, Michael Untch8, Ian Smith9, José Baselga10, Christian Jackisch11, David Cameron12, Max Mano13, José Luiz Pedrini14, Andrea Veronesi15, Cesar Mendiola16, Anna Pluzanska17, Vladimir Semiglazov18, Eduard Vrdoljak19, Michael J Eckart20, Zhenzhou Shen21
1Department of Medical Oncology, San Raffaele Institute, Milan, Italy
2Laboratory of Biostatistics, University of Athens, and Frontier Science Foundation-Hellas, Athens, Greece
3Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA
4Medical Oncology Clinic and Breast European Adjuvant Study Team (BrEAST) Data Centre, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium
5F. Hoffmann-La Roche, Basel, Switzerland
6Department of Medicine, European Institute of Oncology, Milan, Italy
7Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
8Department of Gynaecology and Obstetrics and Multidisciplinary Breast Cancer Center, Helios Klinikum Berlin-Buch, Germany
9Breast Unit, Royal Marsden Hospital, and Institute of Cancer Research, London, UK
10Division of Hematology/Oncology, Massachusetts General Hospital Cancer Center, Boston, MA, USA
11Department of Gynecology and Obstetrics, Klinikum Offenbach, Germany
12University of Edinburgh and Department of Oncology, Western General Hospital, Edinburgh, UK
13Department of Medical Oncology at the Instituto do Câncer do Estado de São Paulo, University of São Paulo, Brazil
14Unity of Mastology of Hospital Nossa Senhora da Conceição, Ministério da Saude, Brazil
15Division of Medical Oncology C, Centro di Riferimento Oncologico, National Cancer Institute, Aviano, Italy
16Médicos Colaboradores en Oncología Médica, Hospital Ruber Internacional, Madrid, Spain
17Oncological Chemotherapy Clinic, Regional Oncology Centre, Lodz, Poland
18Petrov Research Institute of Oncology, St Petersburg, Russian Federation
19University Hospital Split, Split, Croatia
20Onkologische Schwerpunktpraxis und Tagesklinik, Erlangen, Germany
21Cancer Hospital, Fudan University, Shanghai, China

Tài liệu tham khảo

Slamon, 1989, Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer, Science, 244, 707, 10.1126/science.2470152 Reese, 1997, HER-2/neu signal transduction in human breast and ovarian cancer, Stem Cells, 15, 1, 10.1002/stem.150001 Slamon, 1987, Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene, Science, 235, 177, 10.1126/science.3798106 Kelley, 1992, Antigen binding thermodynamics and antiproliferative effects of chimeric and humanized anti-p185HER2 antibody Fab fragments, Biochemistry, 31, 5434, 10.1021/bi00139a003 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 Vogel, 2001, Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer, J Clin Oncol, 20, 719, 10.1200/JCO.20.3.719 Baselga, 2005, Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule, J Clin Oncol, 23, 2162, 10.1200/JCO.2005.01.014 Marty, 2005, Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group, J Clin Oncol, 23, 4265, 10.1200/JCO.2005.04.173 Piccart-Gebhart, 2005, Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer, N Engl J Med, 353, 1659, 10.1056/NEJMoa052306 Romond, 2005, Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer, N Engl J Med, 353, 1673, 10.1056/NEJMoa052122 Eiermann, 2001, Trastuzumab combined with chemotherapy for the treatment of HER2-positive metastatic breast cancer: pivotal trial data, Ann Oncol, 12, S57, 10.1093/annonc/12.suppl_1.S57 Smith, 2007, 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial, Lancet, 369, 29, 10.1016/S0140-6736(07)60028-2 Perez, 2007, Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER2-positive breast cancer, Proc Soc Am Clin Oncol, 25, 512, 10.1200/jco.2007.25.18_suppl.512 Slamon D, Eiermann W, Robert N, et al. Phase III trial comparing AC-T with AC-TH and with TCH in the adjuvant treatment of HER2 positive early breast cancer patients: first interim analysis. 28th San Antonio Breast Cancer Symposium; San Antonio, TX, USA; Dec 7–10, 2005. Slamon D, Eiermann W, Robert N, et al. Phase III trial comparing AC-T with AC-TH and with TCH in the adjuvant treatment of HER2-amplified early breast cancer patients: third planned efficacy analysis. 32nd San Antonio Breast Cancer Symposium; San Antonio, TX, USA; Dec 9–13, 2009. Abstr 62. Suter, 2007, Trastuzumab-associated cardiac adverse effects in the Herceptin Adjuvant trial, J Clin Oncol, 25, 3859, 10.1200/JCO.2006.09.1611 Pocock, 1975, Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial, Biometrics, 31, 103, 10.2307/2529712 Cox, 1972, Regression models and life-tables, J R Stat Soc Ser B, 34, 187 Shuster, 1991, Median follow-up in clinical trials, J Clin Oncol, 9, 191, 10.1200/JCO.1991.9.1.191 Gray, 1988, A class of K-sample tests for comparing the cumulative incidence of a competing risk, Ann Statist, 16, 1141, 10.1214/aos/1176350951 Snapinn, 2005, Illustrating the impact of a time-varying covariate with an extended Kaplan-Meier estimator, Am Stat, 59, 301, 10.1198/000313005X70371 Perez EA, Suman VJ, Davidson NE, et al. Results of chemotherapy alone, with sequential or concurrent addition of 52 weeks of trastuzumab in the NCCTG N9831 HER2-positive adjuvant breast cancer trial. 32nd San Antonio Breast Cancer Symposium; San Antonio, TX, USA; Dec 10–13, 2009. Abstr 80. Rastogi, 2007, Five-year update of cardiac dysfunction on NSABP B-31, a randomized trial of sequential doxorubicin/cyclophosphamide (AC)→paclitaxel (T) compared to AC→T with trastuzumab (H), Proc Soc Am Clin Oncol, 25, LBA513, 10.1200/jco.2007.25.18_suppl.lba513 Seidman, 2002, Cardiac dysfunction in the trastuzumab clinical trials experience, J Clin Oncol, 20, 1215, 10.1200/JCO.20.5.1215