1,862
Views
68
CrossRef citations to date
0
Altmetric
Oncology: Review

Trastuzumab emtansine (T-DM1) for HER2-positive breast cancer

, , , , , , & show all
Pages 405-414 | Accepted 07 Feb 2013, Published online: 01 Mar 2013

References

  • Jemal A, Siegel R, Xu J, et al. Cancer statistics, 2010. CA Cancer J Clin 2010;60:277-300
  • 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;235:177-182
  • 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
  • Owens MA, Horten BC, Da Silva MM. HER2 amplification ratios by fluorescence in situ hybridization and correlation with immunohistochemistry in a cohort of 6556 breast cancer tissues. Clin Breast Cancer 2004;5:63-9
  • Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol 2001;2:127-37
  • Dawood S, Broglio K, Buzdar AU, et al. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J Clin Oncol 2010;28:92-8
  • Gabos Z, Sinha R, Hanson J, et al. Prognostic significance of human epidermal growth factor receptor positivity for the development of brain metastasis after newly diagnosed breast cancer. J Clin Oncol 2006;24:5658-63
  • Press MF, Cordon-Cardo C, Slamon DJ. Expression of the HER-2/neu proto-oncogene in normal human adult and fetal tissues. Oncogene 1990;5:953-62
  • Azim H, Azim HA Jr. Targeting Her-2/neu in breast cancer: as easy as this! Oncology 2008;74:150-7
  • Junttila TT, Akita RW, Parsons K, et al. Ligand-independent HER2/HER3/PI3K complex is disrupted by trastuzumab and is effectively inhibited by the PI3K inhibitor GDC-0941. Cancer Cell 2009;15:429-40
  • Albanell J, Codony J, Rovira A, et al. Mechanism of action of anti-HER2 monoclonal antibodies: scientific update on trastuzumab and 2C4. Adv Exp Med Biol 2003;532:253-68
  • Molina MA, Codony-Servat J, Albanell J, et al. Trastuzumab (herceptin), a humanized anti-Her2 receptor monoclonal antibody, inhibits basal and activated Her2 ectodomain cleavage in breast cancer cells. Cancer Res 2001;61:4744-9
  • Lewis GD, Figari I, Fendly B, et al. Differential responses of human tumor cell lines to anti-p185HER2 monoclonal antibodies. Cancer Immunol Immunother 1993;37:255-63
  • Cooley S, Burns LJ, Repka T, et al. Natural killer cell cytotoxicity of breast cancer targets is enhanced by two distinct mechanisms of antibody-dependent cellular cytotoxicity against LFA-3 and HER2/neu. Exp Hematol 1999;27:1533-41
  • Mohsin SK, Weiss HL, Gutierrez MC, et al. Neoadjuvant trastuzumab induces apoptosis in primary breast cancers. J Clin Oncol 2005;23:2460-8
  • 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
  • Marty M, Cognetti F, Maraninchi D, et al. 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;23:4265-74
  • Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al. Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 2006;354:809-20
  • 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
  • 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
  • Slamon D, Eiermann W, Robert N, et al. BCIRG 006: 2nd interim analysis phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2neu positive early breast cancer patients. Breast Cancer Res Treat 2006;100(Suppl 1): Abstract 2
  • Carlson RW, Allred DC, Anderson BO, et al. Metastatic breast cancer, version 1.2012: featured updates to the NCCN guidelines. J Natl Compr Canc Netw 2012;10:821-9
  • Cardoso F, Fallowfield L, Costa A, et al. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2011;22(Suppl 6):vi25-30
  • Aebi S, Davidson T, Gruber G, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2011;22(Suppl 6):vi12-24
  • Sendur MA, Aksoy S, Altundag K. Pertuzumab in Her2-positive breast cancer. Curr Med Res Opin 2012;28(10):1709-16
  • Chari RV. Targeted cancer therapy: conferring specificity to cytotoxic drugs. Acc Chem Res 2008;41:98-107
  • Wu AM, Senter PD. Arming antibodies: prospects and challenges for immunoconjugates. Nat Biotechnol 2005;23:1137-46
  • Carter PJ. Potent antibody therapeutics by design. Nat Rev Immunol 2006;6:343-57
  • Trail PA, Bianchi AB. Monoclonal antibody drug conjugates in the treatment of cancer. Curr Opin Immunol 1999;11:584-8
  • Damle NK, Frost P. Antibody-targeted chemotherapy with immunoconjugates of calicheamicin. Curr Opin Pharmacol 2003;3:386-90
  • Cassady JM, Chan KK, Floss HG, et al. Recent developments in the maytansinoid antitumor agents. Chem Pharm Bull (Tokyo) 2004;52:1-26
  • Sparano JA. Taxanes for breast cancer: an evidence-based review of randomized phase II and phase III trials. Clin Breast Cancer 2000;1:32-40; discussion 41-2
  • Remillard S, Rebhun LI, Howie GA, et al. Antimitotic activity of the potent tumor inhibitor maytansine. Science 1975;189:1002-5
  • Blum RH, Kahlert T. Maytansine: a phase I study of an ansa macrolide with antitumor activity. Cancer Treat Rep 1978;62:435-8
  • Cabanillas F, Rodriguez V, Hall SW, et al. Phase I study of maytansine using a 3-day schedule. Cancer Treat Rep 1978;62:425-8
  • Chabner BA, Levine AS, Johnson BL, et al. Initial clinical trials of maytansine, an antitumor plant alkaloid. Cancer Treat Rep 1978;62:429-33
  • Eagan RT, Ingle JN, Rubin J, et al. Early clinical study of an intermittent schedule for maytansine (NSC-153858): brief communication. J Natl Cancer Inst 1978;60:93-6
  • Issell BF, Crooke ST. Maytansine. Cancer Treat Rev 1978;5:199-207
  • 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
  • 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
  • Krop IE, Beeram M, Modi S, et al. Phase I study of trastuzumab-DM1, an HER2 antibody–drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol 2010;28:2698-704
  • 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
  • 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
  • Shen BQ, Bumbaca D, Saad O, et al. Catabolic fate and pharmacokinetic characterization of trastuzumab emtansine (T-DM1): an emphasis on preclinical and clinical catabolism. Curr Drug Metab 2012;13:901-10
  • Lu DMS, Elias A, Agarwal P, et al. Pharmacokinetics (PK) of trastuzumab-DM1 (T-DM1) and paclitaxel (T) in patients with HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with a trastuzumab-containing regimen. San Antonio Breast Cancer Symposium. 2011. Cancer Res 2011;71(24 Suppl):224s
  • Burris HA 3rd, 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
  • Thon JN, Devine MT, Jurak Begonja A, 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
  • Krop IEMS, Elias A, LoRusso P, et al. A dose-escalation study of trastuzumab-DM1 (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive, locally advanced or metastatic breast cancer (MBC) previously treated with a trastuzumab-containing regimen abstract P3-14-10. Cancer Res 2010;70(Suppl 2):295s
  • Modi SEA, LoRusso P, Samant M, et al. Results from a phase Ib study of trastuzumab emtansine (T-DM1), paclitaxel (T), and pertuzumab (P) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab. 2012 ASCO Annual Meeting. J Clin Oncol 2012;30(Suppl): Abstract 528
  • Dieras VHN, Albain K, Burris H, et al. A phase Ib/II trial of trastuzumab-DM1 with pertuzumab for patients with HER2-positive, locally advanced or metastatic breast cancer: interim efficacy and safety results [abstract P3-14-01]. Cancer Res 2010;70(Suppl 2):291s
  • Krop ILP, Miller KD. A phase 2 study of the HER2 antibody–drug conjugate trastuzumab-DM1 (T-DM1) in patients (pts) with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab, lapatinib, and chemotherapy. [abstract 277O]. Presented at: 35th ESMO Congress; 8–12 October 2010, Milan, Italy
  • Hurvitz S, Dirix L, Kocsis J, et al. Trastuzumab emtansine (T-DM1) vs trastuzumab plus docetaxel (H + T) in previously untreated HER2-positive metastatic breast cancer (MBC): primary results of a randomized, multicenter, open-label phase II study (TDM4450g/B021976). Eur J Cancer 2011;47(Suppl 330): Abstract 5001
  • Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367(19): 1783-91
  • A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-Based Chemotherapy, As Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-Positive Breast Cancer. ClinicalTrials.gov identifier: NCT01196052. Available at: www.clinicaltrials.gov [Last accessed August 2012]
  • An Extension Study of Trastusumab Emtansine in Patients Previously Treated With Trastusumab Emtansine. ClinicalTrials.gov identifier: NCT00781612. Available at: www.clinicaltrials.gov [Last accessed 19 December 2011]
  • A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer. ClinicalTrials.gov identifier: NCT00934856. Available at: www.clinicaltrials.gov [Last accessed 19 September 2012]
  • Ellis PA, Im Y, Patre M, et al. MARIANNE: A phase III, randomized study of trastuzumab-DM1 (T-DM1) with or without pertuzumab (P) compared with trastuzumab (H) plus taxane for first-line treatment of HER2-positive, progressive, or recurrent locally advanced or metastatic breast cancer (MBC). 2011 ASCO Annual Meeting. J Clin Oncol 2011;29(Suppl): Abstract TPS102
  • A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With HER2-Positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-Directed Therapy (TH3RESA). ClinicalTrials.gov identifier: NCT01419197. Available at: www.clinicaltrials.gov [Last accessed 6 July 2012]
  • Konecny GE, Pegram MD, Venkatesan N, et al. Activity of the dual kinase inhibitor lapatinib (GW572016) against HER-2-overexpressing and trastuzumab-treated breast cancer cells. Cancer Res 2006;66:1630-9
  • Toi M, Iwata H, Fujiwara Y, et al. Lapatinib monotherapy in patients with relapsed, advanced, or metastatic breast cancer: efficacy, safety, and biomarker results from Japanese patients phase II studies. Br J Cancer 2009;101:1676-82
  • Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355:2733-43
  • Cameron D, Casey M, Oliva C, et al. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist 2010;15:924-34
  • Lin NU, Dieras V, Paul D, et al. Multicenter phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer. Clin Cancer Res 2009;15:1452-9
  • Blackwell KL, Burstein HJ, Storniolo AM, et al. Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol 2010;28:1124-30
  • Gelmon KA, Boyle F, Kaufman B, et al. Open-label phase III randomized controlled trial comparing taxane-based chemotherapy (Tax) with lapatinib (L) or trastuzumab (T) as first-line therapy for women with HER2+ metastatic breast cancer: Interim analysis (IA) of NCIC CTG MA.31/GSK EGF 108919. (suppl; abstr LBA671) 2012 ASCO Annual Meeting 2012
  • Adams CW, Allison DE, Flagella K, et al. Humanization of a recombinant monoclonal antibody to produce a therapeutic HER dimerization inhibitor, pertuzumab. Cancer Immunol Immunother 2006;55:717-27
  • Baselga J, Swain SM. Novel anticancer targets: revisiting ERBB2 and discovering ERBB3. Nat Rev Cancer 2009;9:463-75
  • Baselga J, Cortes J, Kim SB, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012;366:109-19
  • Gianni L, Pienkowski T, Im YH, et al. 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. Lancet Oncol 2012;13:25-32
  • Schneeweiss ACS, Hickish T, Harvey V, et al. Neoadjuvant pertuzumab and trastuzumab concurrent or sequential with an anthracycline-containing or concurrent with an anthracycline-free standard regimen: a randomized phase II study (TRYPHAENA). Cancer Res 2011;71(Suppl 24): 112s
  • Burstein HJ, Sun Y, Dirix LY, et al. Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer. J Clin Oncol 2010;28:1301-7
  • Minkovsky N, Berezov A. BIBW-2992, a dual receptor tyrosine kinase inhibitor for the treatment of solid tumors. Curr Opin Investig Drugs 2008;9:1336-46
  • Hickish T, Lin N, Carey L, et al. Use of BIBW 2992, a novel irreversible EGFR/HER2 tyrosine kinase inhibitor (TKI), to treat patients with HER2-positive metastatic breast cancer after failure of treatment with trastuzumab. 2009 ASCO Annual Meeting. J Clin Oncol 2009;27(Suppl): 15s, Abstract 1023
  • Harbeck N, Huang C-S, Im Y-H, et al. LUX-breast 1: Randomized, phase III trial of afatinib and vinorelbine versus trastuzumab and vinorelbine in patients with HER2-overexpressing metastatic breast cancer (MBC) failing one prior trastuzumab treatment. 2012 ASCO Annual Meeting. J Clin Oncol 2012;30(Suppl): Abstract TPS649
  • Heikki Joensuu MOK. LUX-breast 3: Randomized phase II study of afatinib alone or with vinorelbine versus investigator’s choice of treatment in patients (pts) with HER2-positive breast cancer (BC) with progressive brain metastases (BM) after trastuzumab or lapatinib-based therapy. 2012 ASCO Annual Meeting. J Clin Oncol 2012;30(Suppl): Abstract TPS647

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.