Trastuzumab emtansine in breast cancer

Expert Opinion on Biological Therapy

Volumn 13, Issue 4, 2013, Pages 607-614

  Dirix, Luc Y ^a   Rutten, Annemie ^a   Huget, Philippe ^a   Dirix, Marie ^a  

^a SINT AUGUSTINUS HOSPITAL   (Belgium)

Author keywords

Human epidermal growth factor receptor 2; Metastatic breast cancer; Trastuzumab; Trastuzumab emtansine

Indexed keywords

ALBUMIN; ANTHRACYCLINE; ASPARTATE AMINOTRANSFERASE; CAPECITABINE; CYCLOPHOSPHAMIDE; CYTOCHROME P450 3A4; CYTOCHROME P450 3A5; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIRUBICIN; FLUOROURACIL; LAPATINIB; MAYTANSINE; NERATINIB; PACLITAXEL; PERTUZUMAB; TRASTUZUMAB; TRASTUZUMAB EMTANSINE; ANTIBODY CONJUGATE; ANTINEOPLASTIC AGENT; BRIDGED COMPOUND; DEOXYCYTIDINE; ERBB2 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; QUINAZOLINE DERIVATIVE; TAXANE; TAXOID;

ALBUMIN BLOOD LEVEL; ALOPECIA; ANTIBODY RESPONSE; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BODY WEIGHT; BREAST CANCER; BREAST TUMOR; CARDIOTOXICITY; CELL GROWTH; CELL MEMBRANE; COMPARATIVE STUDY; CONCENTRATION (PARAMETERS); CYTOTOXICITY; DISULFIDE BOND; DRUG CLEARANCE; DRUG EFFICACY; DRUG EXCRETION; DRUG EXPOSURE; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; HALF LIFE TIME; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; HYPERTRANSAMINASEMIA; IN VITRO STUDY; INTERNALIZATION; JAPANESE; LIVER DYSFUNCTION; MAXIMUM TOLERATED DOSE; MICROTUBULE; MOLECULAR SIZE; NEUROPATHY; NONALCOHOLIC FATTY LIVER; NONHUMAN; OVERALL SURVIVAL; PERSONAL EXPERIENCE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; QT INTERVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; STOMACH CANCER; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TUMOR MODEL; TUMOR VOLUME; ANALOGS AND DERIVATIVES; ANIMAL; ANTAGONISTS AND INHIBITORS; BREAST NEOPLASMS; CLINICAL TRIAL (TOPIC); DISEASE FREE SURVIVAL; FEMALE; PROCEDURES;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; BRIDGED COMPOUNDS; CLINICAL TRIALS AS TOPIC; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; IMMUNOCONJUGATES; MAYTANSINE; QUINAZOLINES; RECEPTOR, ERBB-2; TAXOIDS;

EID: 84879589636     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.2013.778238     Document Type: Article

References (45)

1. Schechter AL, Stern DF, Vaidyanathan L, et al. The neu oncogene: an erb-B-related gene encoding a 185, 000-Mr tumour antigen. Nature 1984;312:513-16
2. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987;235:177-82
3. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989;244:707-12
4. Perou CM, Sorlie T, Eisen MB, et al. Molecular portraits of human breast tumours. Nature 2000;406:747-52
5. Sorlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci USA 2001;98:10869-74
6. Seshadri R, Firgaira FA, Horsfall DJ, et al. Clinical significance of HER-2/neu oncogene amplification in primary breast cancer. J Clin Oncol 1993;11:1936-42
7. Sjogren S, Inganas M, Lindgren A, et al. Prognostic and predictive value of c-erbB-2 overexpression in primary breast cancer, alone and in combination with other prognostic markers. J Clin Oncol 1998;16:462-9
8. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-92
9. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 2005;353:1673-84
10. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353:1659-72
11. Buzdar AU, Valero V, Ibrahim NK, et al. 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. Clin Cancer Res 2007;13:228-33
12. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002;20:719-26
13. Gianni L, Pienkowsky T, Im Y-H, et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory or early HER2-positive breast cancer (NeoSphere): a randomized multicenter, open-label, phase 2 trial. Lancet Oncol 2012;13:25-32
14. Baselga J, Cortes J, Kim S-B, et al. Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer. N Engl J Med 2012;366:109-19
15. Teicher BA, Chari RVJ. Antibody conjugate Therapeutics: challenges and potential. Clin Cancer Res 2011;17:6389-97
16. Kovtun YV, Audette CA, Ye Y, et al. Antibody-drug conjugates designed to eradicate tumors with homogeneous and heterogeneous expression of the target antigen. Cancer Res 2006;66:3214-21
17. Lewis Phillips GD, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res 2008;68:9280-90
18. Pegram MD, Lopez A, Konecny G, Slamon DJ. Trastuzumab and chemotherapeutics: drug interactions and synergies. Semin Oncol 2000;27(6 Suppl 11):21-5; discussion 92-100
19. Junutula JR, Flagelmla KM, Graham RA, et al. Engineered thio-trastuzumab-DM1 conjugate with an improved therapeutic index to target human epidermal growth factor receptor 2-positive breast cancer. Clin Cancer Res 2010;16:4769-78
20. Junttila TT, Li G, Parsons K, et al. 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;128:347-56
21. Oroudjev E, Lopus M, Wilson L, et al. Maytansinoid-antibody conjugates induce mitotic arrest by suppressing microtubule dynamic instability. Mol Cancer Ther 2010;9:2700-13
22. Austin CD, Wen X, Gazzard L, et al. Oxidizing potential of endosomes and lysosomes limits intracellular cleavage of disulfide-based antibody-drug conjugates. Proc Natl Acad Sci USA 2005;102:17987-92
23. Erickson HK, Park PU, Widdison WC, et al. Antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linker-dependent intracellular processing. Cancer Res 2006;66:4426-33
24. Erickson HK, Philips GDL, Leipold DD, et al. The effect of different linkers on target cell catabolism and pharmacokinetics/pharmacodynamics of trastuzumab maytansinoid conjugates. Mol Cancer Res 2012;11:1133-42
25. Barok M, Tanner M, Koninki K, Isola J. Trastuzumab-DM1 causes tumour growth inhibition by mitotic catastrophe in trastuzumab-resistant breast cancer cells in vivo. Breast Cancer Res 2011;13:R46
26. Barok M, Tanner M, Koninki K, Isola J. Trastuzumab-DM1 is highly effective in preclinical models of HER2-positive gastric cancer. Cancer Lett 2011;306:171-9
27. Burris HA III, Rugo HS, Vukelja SJ, et al. 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
28. Krop I, LoRusso P, Miller KD, et al. A phase II study of trastuzumab emtansine in patients with human epidermal growth factor 2-positive metastatic breast cancer who were previously treated with tratuzumab, lapatinib, an anthracycline, a taxane and capecitabine. J Clin Oncol 2012;30:3234-41
29. LoRusso PM, Weiss D, Guardino E, et al. Trastuzumab emtansine: a unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positiive cancer. Clin Cancer Res 2011;17:6437-47
30. Jumbe NL, Xin Y, Leipold DD, et al. Modeling the efficacy of trastuzumab-DM1 an antibody drug conjugate, in mice. J Pharmacokinet Pharmacodyn 2010;37:221-42
31. Shen B-Q, Bumbaca D, Saad O, et al. Catabolic fate and pharmacokinetic characterization of trastuzumab emtansine: an emphasis on preclinical and clinical catabolism. Curr Drug Metab 2012;13:901-10
32. Girish S, Gupta M, Wang B, et al. Clinical pharmacology of trastuzumab emtansine (T-DM1): a unique antibody-drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother Pharmacol 2012;69:1229-40
33. Chudasama VL, Schaedeli Stark F, Harrold JM, et al. Semi-mechanistic population pharmacokinetic model of multivalent trastuzumab emtansine in patients with metastatic breast cancer. Clin Pharmacol Ther 2012;92:520-7
34. Gupta M, LoRusso PM, Wang B, et al. Clinical implications of pathophysiological and demographic covariates on the population pharmacokinetics of trastuzumab-DM1, a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer. J Clin Pharmacol 2012;52:691-703
35. Lu D, Girish S, Gao Y, et al. Population pharmacokinetics of trastuzumab emtansine, a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer: clinical implications of the effect of various covariates. Cancer Res 2012;72(24 Suppl):457s; (#P5-18-24)
36. Aogi K, Ando M, Iwata H, et al. (2011) Phase I study of single agent trastuzumab emtansine in Japanese patients with human epidermal growth factor receptor2 (HER2)-positive metastatic breast cancer (JO22591). Cancer Res 2011;71(24 Suppl):16s; (# P1-12-19)
37. Ito MN, Ito Y, Takao S, et al. A multicenter Phase II study evaluating the efficacy and safety of trastuzumab emtansine in Japanese patients with heavily pretreated HER2-positive metastatic breast cancer (JO22997). Cancer Res 2012;72(24 Suppl):472s; (# P5-18-16)
38. Krop IE, Beeram M, Modi S, et al. Phase I study of trastuzumab-DM1, a HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol 2010;28:2698-704
39. Beeram M, Krop IE, Burris HA, et al. A phase I study of weekly dosing of trastuzumab Emtansin (T-DM1) in patients with advanced Human epidermal growth factor 2-positive breast cancer. Cancer 2012;118:5733-40
40. Hurvitz SA, Dirix L, Kocsis J, et al. Trastuzumab Emtansine versus trastuzumab plus docetaxel for HER2-positive metastatic breast cancer. J Clin Oncology; In press
41. Verma S, Miles D, Gianni L, et al. Tratuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367:1783-91
42. Olson EM, Lin NU, DoPiro PJ, et al. Responses to subsequent anti-HER2 therapy after treatment with trastuzumab-DM1 in women with HER2-positive metastatic breast cancer. Ann Oncol 2012;23:93-7
43. Burstein HJ, Sun Y, Dirix L, et al. Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor, in patients with advanced erbb2-positive breast cancer. J Clin Oncol 2010;1301-7
44. Bender BC, Schaedeli-Stark F, Koch R, et al. A population pharmacokinetic/pharmacodynamics model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer. Cancer Chemother Pharmavol 2012;70:591-601
45. Thon JN, Devine MT, Begonja AJ, et al. High-content live-cell imaging assay used to establish mechanism of trastuzumab emtansine (T-DM1)-mediated inhibition of platelet production. Blood 2012;120:1975-84