Lapatinib versus trastuzumab in combination with neoadjuvant anthracycline-taxane-based chemotherapy (GeparQuinto, GBG 44): a randomised phase 3 trial

作者: Michael Untch , Sibylle Loibl , Joachim Bischoff , Holger Eidtmann , Manfred Kaufmann

DOI: 10.1016/S1470-2045(11)70397-7

关键词:

摘要: Background We compared the efficacy and safety of the addition of lapatinib versus trastuzumab to anthracycline-taxane-based neoadjuvant chemotherapy. Methods In the GeparQuinto randomised phase 3 trial, patients with untreated HER2-positive operable or locally advanced breast cancer were enrolled between Nov 7, 2007, and July 9, 2010. Patients were eligible if their tumours were classified as cT3/4a-d, or hormone receptor (HR)-negative, HR-positive with clinically node-positive and cT2 disease (cT2 cN+), or HR …

参考文章(25)
H. Sinn, H. Schmid, H. Junkermann, J. Huober, G. Leppien, M. Kaufmann, G. Bastert, H. Otto, Histologische Regression des Mammakarzinoms nach primärer (neoadjuvanter) Chemotherapie Geburtshilfe Und Frauenheilkunde. ,vol. 54, pp. 552- 558 ,(1994) , 10.1055/S-2007-1022338
Luca Gianni, Wolfgang Eiermann, Vladimir Semiglazov, Alexey Manikhas, Ana Lluch, Sergey Tjulandin, Milvia Zambetti, Federico Vazquez, Mikhail Byakhow, Mikhail Lichinitser, Miguel Angel Climent, Eva Ciruelos, Belén Ojeda, Mauro Mansutti, Alla Bozhok, Roberta Baronio, Andrea Feyereislova, Claire Barton, Pinuccia Valagussa, Jose Baselga, Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. The Lancet. ,vol. 375, pp. 377- 384 ,(2010) , 10.1016/S0140-6736(09)61964-4
Aman U. Buzdar, Vicente Valero, Nuhad K. Ibrahim, Deborah Francis, Kristine R. Broglio, Richard L. Theriault, Lajos Pusztai, Marjorie C. Green, Sonja E. Singletary, Kelly K. Hunt, Aysegul A. Sahin, Francisco Esteva, William F. Symmans, Michael S. Ewer, Thomas A. Buchholz, Gabriel N. Hortobagyi, Neoadjuvant Therapy with Paclitaxel followed by 5-Fluorouracil, Epirubicin, and Cyclophosphamide Chemotherapy and Concurrent Trastuzumab in Human Epidermal Growth Factor Receptor 2–Positive Operable Breast Cancer: An Update of the Initial Randomized Study Population and Data of Additional Patients Treated with the Same Regimen Clinical Cancer Research. ,vol. 13, pp. 228- 233 ,(2007) , 10.1158/1078-0432.CCR-06-1345
Stuart J. Pocock, Richard Simon, Sequential Treatment Assignment with Balancing for Prognostic Factors in the Controlled Clinical Trial Biometrics. ,vol. 31, pp. 103- 115 ,(1975) , 10.2307/2529712
Angelo Di Leo, Henry L. Gomez, Zeba Aziz, Zanete Zvirbule, Jose Bines, Michael C. Arbushites, Stephanie F. Guerrera, Maria Koehler, Cristina Oliva, Steven H. Stein, Lisa S. Williams, Judy Dering, Richard S. Finn, Michael F. Press, Phase III, Double-Blind, Randomized Study Comparing Lapatinib Plus Paclitaxel With Placebo Plus Paclitaxel As First-Line Treatment for Metastatic Breast Cancer Journal of Clinical Oncology. ,vol. 26, pp. 5544- 5552 ,(2008) , 10.1200/JCO.2008.16.2578
E Alba, J Albanell, J de la Haba, A Barnadas, L Calvo, P Sánchez, M Ramos, F Rojo, O Burgués, I Porras, A Tibau, E Carrasco, MC Cámara, A Lluch, PD07-04: Lapatinib vs Trastuzumab in Combination with Standard EC-D Chemotherapy in the Neaodjuvant Treatment of HER2+ Patients. Results from the GEICAM 2006–14 Phase II Randomized Trial. Cancer Research. ,vol. 71, ,(2011) , 10.1158/0008-5472.SABCS11-PD07-04
Márk Barok, Jorma Isola, Zsuzsanna Pályi-Krekk, Péter Nagy, István Juhász, György Vereb, Päivikki Kauraniemi, Anita Kapanen, Minna Tanner, Gyorgy Vereb, Janos Szollosi, Trastuzumab causes antibody-dependent cellular cytotoxicity–mediated growth inhibition of submacroscopic JIMT-1 breast cancer xenografts despite intrinsic drug resistance Molecular Cancer Therapeutics. ,vol. 6, pp. 2065- 2072 ,(2007) , 10.1158/1535-7163.MCT-06-0766
Michael Untch, Peter A. Fasching, Gottfried E. Konecny, Stephan Hasmüller, Annette Lebeau, Rolf Kreienberg, Oumar Camara, Volkmar Müller, Andreas du Bois, Thorsten Kühn, Elmar Stickeler, Nadia Harbeck, Cornelia Höss, Steffen Kahlert, Thomas Beck, Werner Fett, Keyur M. Mehta, Gunter von Minckwitz, Sibylle Loibl, Pathologic Complete Response After Neoadjuvant Chemotherapy Plus Trastuzumab Predicts Favorable Survival in Human Epidermal Growth Factor Receptor 2–Overexpressing Breast Cancer: Results From the TECHNO Trial of the AGO and GBG Study Groups Journal of Clinical Oncology. ,vol. 29, pp. 3351- 3357 ,(2011) , 10.1200/JCO.2010.31.4930
M Kaufmann, G Von Minckwitz, HD Bear, A Buzdar, P McGale, H Bonnefoi, M Colleoni, C Denkert, W Eiermann, R Jackesz, A Makris, W Miller, J-Y Pierga, V Semiglazov, A Schneeweiss, R Souchon, V Stearns, M Untch, S Loibl, None, Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: new perspectives 2006 Annals of Oncology. ,vol. 18, pp. 1927- 1934 ,(2007) , 10.1093/ANNONC/MDM201
Stephen Johnston, John Pippen Jr, Xavier Pivot, Mikhail Lichinitser, Saeed Sadeghi, Veronique Dieras, Henry Leonidas Gomez, Gilles Romieu, Alexey Manikhas, M John Kennedy, Michael F Press, Julie Maltzman, Allison Florance, Lisa O'Rourke, Cristina Oliva, Steven Stein, Mark Pegram, None, Lapatinib Combined With Letrozole Versus Letrozole and Placebo As First-Line Therapy for Postmenopausal Hormone Receptor–Positive Metastatic Breast Cancer Journal of Clinical Oncology. ,vol. 27, pp. 5538- 5546 ,(2009) , 10.1200/JCO.2009.23.3734