Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: A randomized phase II study of patients with previously untreated HER2-positive metastatic breast cancer

Breast Cancer Research

Volumn 16, Issue 3, 2014, Pages

  Perez, Edith A ^a   Hurvitz, Sara A ^b   Amler, Lukas C ^c   Mundt, Kirsten E ^c   Ng, Vivian ^c   Guardino, Ellie ^c   Gianni, Luca ^d  

^a MAYO CLINIC   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c GENENTECH INC   (United States)

^d SAN RAFFAELE HOSPITAL   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESTROGEN RECEPTOR; GLUCOSE 6 PHOSPHATE DEHYDROGENASE; MESSENGER RNA; PROGESTERONE RECEPTOR; TRASTUZUMAB; TRASTUZUMAB EMTANSINE; ANTINEOPLASTIC AGENT; ERBB2 PROTEIN, HUMAN; MAYTANSINE; MONOCLONAL ANTIBODY; TAXOID; ANTHRACYCLINE; TAXANE DERIVATIVE;

ADULT; ADVANCED CANCER; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CONTROLLED STUDY; DRUG EFFICACY; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; HUMAN; IMMUNOHISTOCHEMISTRY; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; TREATMENT DURATION; AGED; ANALOGS AND DERIVATIVES; BIOSYNTHESIS; BREAST NEOPLASMS; CLINICAL TRIAL; DISEASE FREE SURVIVAL; GENETICS; METABOLISM; MIDDLE AGED; RETROSPECTIVE STUDY; TREATMENT OUTCOME; VERY ELDERLY; BREAST METASTASIS; DISEASE COURSE; DRUG DOSE REDUCTION; EXPLORATORY RESEARCH; HUMAN TISSUE; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MAYTANSINE; MIDDLE AGED; RECEPTOR, ERBB-2; RETROSPECTIVE STUDIES; RNA, MESSENGER; TAXOIDS; TREATMENT OUTCOME;

EID: 84904343628     PISSN: 14655411     EISSN: 1465542X     Source Type: Journal    
DOI: 10.1186/bcr3661     Document Type: Article

References (18)

1. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001, 344:783-792. 10.1056/NEJM200103153441101, 11248153.
2. Marty M, Cognetti F, Maraninchi D, Snyder R, Mauriac L, Tubiana-Hulin M, Chan S, Grimes D, Antón A, Lluch A, Kennedy J, O'Byrne K, Conte P, Green M, Ward C, Mayne K, Extra JM. 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 2005, 23:4265-4274. 10.1200/JCO.2005.04.173, 15911866.
3. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, Jagiello-Gruszfeld A, Crown J, Chan A, Kaufman B, Skarlos D, Campone M, Davidson N, Berger M, Oliva C, Rubin SD, Stein S, Cameron D. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006, 355:2733-2743. 10.1056/NEJMoa064320, 17192538.
4. Baselga J, Cortés J, Kim SB, Im SA, Hegg R, Im YH, Roman L, Pedrini JL, Pienkowski T, Knott A, Clark E, Benyunes MC, Ross G, Swain SM, CLEOPATRA Study Group Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012, 366:109-119. 10.1056/NEJMoa1113216, 22149875, CLEOPATRA Study Group.
5. Swain SM, Kim S-B, Cortés J, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Knott A, Clark E, Ross G, Benyunes MC, Baselga J. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013, 14:461-471. 10.1016/S1470-2045(13)70130-X, 4076842, 23602601.
6. Lewis Phillips GD, Li G, Dugger DL, Lewis Phillips GD, Li G, Dugger DL, Crocker LM, Parsons KL, Mai E, Blättler WA, Lambert JM, Chari RV, Lutz RJ, Wong WL, Jacobson FS, Koeppen H, Schwall RH, Kenkare-Mitra SR, Spencer SD, Sliwkowski MX. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res 2008, 68:9280-9290. 10.1158/0008-5472.CAN-08-1776, 19010901.
7. LoRusso PM, Weiss D, Guardino E, Girish S, Sliwkowski MX. Trastuzumab emtansine: a unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positive cancer. Clin Cancer Res 2011, 17:6437-6447. 10.1158/1078-0432.CCR-11-0762, 22003071.
8. Junttila TT, Li G, Parsons K, Phillips GL, Sliwkowski MX. Trastuzumab-DM1 (T-DM1) retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast cancer. Breast Cancer Res Treat 2011, 128:347-356. 10.1007/s10549-010-1090-x, 20730488.
9. Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Diéras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K, EMILIA Study Group Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012, 367:1783-1791. Erratum in N Engl J Med 2013, 368:2442, 10.1056/NEJMoa1209124, 23020162, EMILIA Study Group.
10. Hurvitz SA, Dirix L, Kocsis J, Bianchi GV, Lu J, Vinholes J, Guardino E, Song C, Tong B, Ng V, Chu YW, Perez EA. Phase II randomized study of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer. J Clin Oncol 2013, 31:1157-1163. Erratum in J Clin Oncol 2013, 31:2977, 10.1200/JCO.2012.44.9694, 23382472.
11. Burris HA, Rugo HS, Vukelja SJ, Vogel CL, Borson RA, Limentani S, Tan-Chiu E, Krop IE, Michaelson RA, Girish S, Amler L, Zheng M, Chu YW, Klencke B, O'Shaughnessy JA. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J Clin Oncol 2011, 29:398-405. 10.1200/JCO.2010.29.5865, 21172893.
12. Krop I, LoRusso P, Miller KD, Modi S, Yardley D, Rodriguez G, Guardino E, Lu M, Zheng M, Girish S, Amler L, Winer EP, Rugo HS. A phase II study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. J Clin Oncol 2012, 30:3234-3241. 10.1200/JCO.2011.40.5902, 22649126.
13. Therasse P, Arbuck SG, Eisenhauser EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. 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 2000, 92:205-216. 10.1093/jnci/92.3.205, 10655437.
14. Genentech I. Herceptin (trastuzumab) Package Insert 2012, South San Francisco, CA: Genentech, Inc.
15. Perez EA, Reinholz MM, Hillman DW, Tenner KS, Schroeder MJ, Davidson NE, Martino S, Sledge GW, Harris LN, Gralow JR, Dueck AC, Ketterling RP, Ingle JN, Lingle WL, Kaufman PA, Visscher DW, Jenkins RB. HER2 and chromosome 17 effect on patient outcome in the N9831 adjuvant trastuzumab trial. J Clin Oncol 2010, 28:4307-4315. 10.1200/JCO.2009.26.2154, 2954132, 20697084.
16. Fabi A, Di Benedetto A, Metro G, Perracchio L, Nisticò C, Di Filippo F, Ercolani C, Ferretti G, Melucci E, Buglioni S, Sperduti I, Papaldo P, Cognetti F, Mottolese M. HER2 protein and gene variation between primary and metastatic breast cancer: significance and impact on patient care. Clin Cancer Res 2011, 17:2055-2064. 10.1158/1078-0432.CCR-10-1920, 21307144.
17. Xiao C, Gong Y, Han EY, Gonzalez-Angulo AM, Sneige N. Stability of HER2-positive status in breast carcinoma: a comparison between primary and paired metastatic tumors with regard to the possible impact of intervening trastuzumab treatment. Ann Oncol 2011, 22:1547-1553. 10.1093/annonc/mdq623, 21239403.
18. Baselga J, Verma S, Ro J, Huober J, Guardino E, Fang L, Olsen S, Lewis Phillips G, de Haas S, Pegram M. Relationship between tumor biomarkers and efficacy in EMILIA, a phase 3 study of trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer [abstract]. Cancer Res 2013, 73(suppl 8):nr LB-63.