Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial

The Lancet Oncology - Tập 13 Số 1 - Trang 25-32 - 2012
Luca Gianni1, Tadeusz Pieńkowski2, Young‐Hyuck Im3, Laslo Roman4, Ling‐Ming Tseng5, Mei-Ching Liu6, Aña Lluch7, Elżbieta Starosławska8, Juan de la Haba-Rodríguez9, Seock‐Ah Im10, José Luiz Pedrini11, Brigitte Poirier12, Paolo Morandi13, Semiglazov Vf14, Vichien Srimuninnimit15, Giulia Bianchi16, Tania Szado17, Jayantha Ratnayake18, Graham Ross18, Pinuccia Valagussa19
1Oncologia Medica, San Raffaele Cancer Centre, Milan, Italy
2Centrum Onkologii, Warsaw, Poland
3Samsung Medical Centre, Seoul, South Korea
4Leningrad Regional Oncology Dispensary, St Petersburg, Russia
5Taipei Veterans General Hospital, National Yang Ming University, Taipei, Taiwan
6Koo Foundation Sun Yat-Sen Cancer Centre, Taipei, Taiwan
7Hospital Clínico Universitario, INCLIVA Health Research Institute, University of Valencia, Valencia, Spain
8St. John’s Cancer Centre, Lublin, Poland
9Hospital Reina Sofia, Córdoba, Spain
10Division of Hematology/Medical Oncology, Department of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea
11Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil
12Hôpital du Saint-Sacrément, Centre Hospitalier Affilié Universitaire de Québec, Québec, Canada
13Reparto di Oncologia Medica, Ospedale S Bortolo, Vicenza, Italy
14NN Petrov Research Institute of Oncology, St. Petersburg, Russia
15Medical Oncology Unit, Department of Medicine, Siriraj Hospital, Bangkok, Thailand
16Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy
17Genentech, South San Francisco, CA, USA
18Roche Products Limited, Welwyn, UK
19Fondazione Michelangelo, Milan, Italy

Tóm tắt

Từ khóa


Tài liệu tham khảo

Ross, 2009, The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine, Oncologist, 14, 320, 10.1634/theoncologist.2008-0230

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

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

Abramson, 2011, New strategies in HER2-overexpressing breast cancer: many combinations of targeted drugs available, Clin Cancer Res, 17, 952, 10.1158/1078-0432.CCR-09-1947

Franklin, 2004, Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex, Cancer Cell, 5, 317, 10.1016/S1535-6108(04)00083-2

Junttila, 2009, Ligand-independent HER2/HER3/PI3K complex is disrupted by trastuzumab and is effectively inhibited by the PI3K inhibitor GDC-0941, Cancer Cell, 15, 429, 10.1016/j.ccr.2009.03.020

Agus, 2002, Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth, Cancer Cell, 2, 127, 10.1016/S1535-6108(02)00097-1

Nahta, 2004, The HER-2-targeting antibodies trastuzumab and pertuzumab synergistically inhibit the survival of breast cancer cells, Cancer Res, 64, 2343, 10.1158/0008-5472.CAN-03-3856

Scheuer, 2009, Strongly enhanced antitumor activity of trastuzumab and pertuzumab combination treatment on HER2-positive human xenograft tumor models, Cancer Res, 69, 9330, 10.1158/0008-5472.CAN-08-4597

Baselga, 2010, Phase II trial of pertuzumab and trastuzumab in patients with Human Epidermal Growth Factor Receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy, J Clin Oncol, 28, 1138, 10.1200/JCO.2009.24.2024

Fisher, 1998, Effect of preoperative chemotherapy on the outcome of women with operable breast cancer, J Clin Oncol, 16, 2672, 10.1200/JCO.1998.16.8.2672

Mieog, 2007, Preoperative chemotherapy for women with operable breast cancer, Cochrane Database Syst Rev, 2

Gianni, 2010, Lancet, 375, 377, 10.1016/S0140-6736(09)61964-4

Rastogi, 2008, Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27, J Clin Oncol, 26, 778, 10.1200/JCO.2007.15.0235

Buzdar, 2005, Significantly higher pathologic complete remission rate after neoadjuvant therapy with trastuzumab, paclitaxel, and epirubicin chemotherapy: results of a randomized trial in human epidermal growth factor receptor 2-positive operable breast cancer, J Clin Oncol, 23, 3676, 10.1200/JCO.2005.07.032

Therasse, 2000, New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada, J Natl Cancer Inst, 92, 205, 10.1093/jnci/92.3.205

Baselga J, Bradbury I, Eidtmann H, et al. First results of the NeoALTTO Trial (BIG 01-06/EGF 106903): a phase III, randomized, open label, neoadjuvant study of lapatinib, trastuzumab, and their combination plus paclitaxel in women with HER2-positive primary breast cancer. San Antonio Breast Cancer Symposium; San Antonio, TX, USA; Dec 8–12, 2010. Abstract S3–3.

Gianni, 2005, Feasibility and tolerability of sequential doxorubicin/paclitaxel followed by cyclophosphamide, methotrexate, and fluorouracil and its effects on tumor response as preoperative therapy, Clin Cancer Res, 11, 8715, 10.1158/1078-0432.CCR-05-0539

Kaufmann, 2007, Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: new perspectives 2006, Ann Oncol, 18, 1927, 10.1093/annonc/mdm201

von Minckwitz, 2011, Impact of treatment characteristics on response of different breast cancer phenotypes: pooled analysis of the German neo-adjuvant chemotherapy trials, Breast Cancer Res Treat, 125, 145, 10.1007/s10549-010-1228-x

von Minckwitz, 2011, Correlation of various pathologic complete response (pCR) definitions with long-term outcome and prognostic value of pCR in various breast cancer subtypes: results from the German neoadjuvant meta-analysis, Proc Am Soc Clin Oncol, 29

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, Proc Am Soc Clin Oncol, 23, 4265, 10.1200/JCO.2005.04.173

Moreira, 2010, Lapatinib and breast cancer: current indications and outlook for the future, Expert Rev Anticancer Ther, 10, 1171, 10.1586/era.10.113

Sequist, 2010, Neratinib, an irreversible pan-ErbB receptor tyrosine kinase inhibitor: results of a phase II trial in patients with advanced non-small-cell lung cancer, J Clin Oncol, 28, 3076, 10.1200/JCO.2009.27.9414

Slamon, 2011, Adjuvant trastuzumab in HER2-positive breast cancer, N Engl J Med, 365, 1273, 10.1056/NEJMoa0910383

Schutze, 2007, Combination of EGFR/HER2 tyrosine kinase inhibition by BIBW 2992 and BIBW 2669 with irradiation in FaDu human squamous cell carcinoma, Strahlenther Onkol, 183, 256, 10.1007/s00066-007-1696-z

Rabindran, 2004, Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase, Cancer Res, 64, 3958, 10.1158/0008-5472.CAN-03-2868

Jumbe, 2010, Modeling the efficacy of trastuzumab-DM1, an antibody drug conjugate, in mice, J Pharmacokinet Pharmacodyn, 37, 221, 10.1007/s10928-010-9156-2

Burstein, 2011, Novel agents and future directions for refractory breast cancer, Semin Oncol, 38, S17, 10.1053/j.seminoncol.2011.04.002