The potential for trastuzumab emtansine in human epidermal growth factor receptor 2 positive metastatic breast cancer: Latest evidence and ongoing studies

Therapeutic Advances in Medical Oncology

Volumn 4, Issue 5, 2012, Pages 235-245

  Hurvitz, Sara A ^a   Kakkar, Reva ^b  

^a Division of Hematology Oncology   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

breast cancer; HER2 positive; T DM1; trastuzumab emtansine

Indexed keywords

ANTINEOPLASTIC AGENT; BP 22572; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; LAPATINIB; PACLITAXEL; PERTUZUMAB; PICTILISIB; TRASTUZUMAB EMTANSINE; UNCLASSIFIED DRUG;

ANOREXIA; ARTHRALGIA; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EPISTAXIS; FATIGUE; FEVER; HUMAN; HYPERTRANSAMINASEMIA; IN VITRO STUDY; IN VIVO STUDY; NAUSEA; NEUTROPENIA; OPEN STUDY; PRIORITY JOURNAL; PROTEIN EXPRESSION; QUALITY OF LIFE; REVIEW; THROMBOCYTOPENIA;

EID: 84871809195     PISSN: 17588340     EISSN: 17588359     Source Type: Journal    
DOI: 10.1177/1758834012451205     Document Type: Review

References (36)

1. Aogi K. Ando M. Iwata H. Hara F. Matsubara M. Fujiwara Y. (2011) Phase I study of single agent trastuzumab emtansine in Japanese patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (JO22591). [Abstract P1-12-19] Cancer Res 71(24 Suppl.): 16s.
2. Barok M. Tanner M. Koninki K. Isola J. (2011) Trastuzumab-DM1 causes tumour growth inhibition by mitotic catastrophe in trastuzumab-resistant breast cancer cells in vivo. Breast Cancer Res 13 (2): R46.
3. Bender B.C. Schaedeli Stark F. Joshi A. Chu Y. Rugo H.S. Krop I.E. et al. (2011) A semi-physiologic population pharmacokinetic / pharmacodynamic (PK/PD) model of thrombocytopenia (TCP) characterizing the effect of trastuzumab-DM1 (T-DM1) on platelet counts in patients with HER2-positive MBC. J Clin Oncol 29(Suppl.): abstract 605.
4. Bianchi G.V. Kocsis J. Dirix L. Torigoe Y. Lalla D. Tong Y.B. et al. (2011) Patient-reported outcomes (PROs) from a randomized phase II study (TDM4450g/BO21976) of trastuzumab emtansine (T-DM1) vs trastuzumab plus docetaxel (HT) in previously untreated HER2-positive metastatic breast cancer (MBC) [Abstract P1-12-02]. Cancer Res 71(24 Suppl.): 15s.
5. Bross P.F. Beitz J. Chen G. Chen X.H. Duffy E. Kieffer L. et al. (2001) Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res 7: 1490–1496.
6. Burris H.A. Rugo H.S. Vukelja S.J. Vogel C.L. Borson R.A. Limentani S. et al. (2011) 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 29: 398–405.
7. Burris H.A. Lu D. Dees E.C. Cortes J. Yi J.-H. Shih T. et al. (2010) Pharmacokinetic (PK) interaction potential of trastuzumab-DM1 (T-DM1) and pertuzumab (P) in Pts with HER2-positive, locally advanced or MBC: results from a phase 1b/2 study [Abstract P3-14-06]. Cancer Res 70(Suppl. 2): 295s.
8. Cassady J.M. Chan K.K. Floss H.G. Leistner E. (2004) Recent developments in the maytansinoid antitumor agents. Chem Pharm Bull (Tokyo) 52: 1–26.
9. Desantis C. Siegel R. Bandi P. Jemal A. (2011) Breast cancer statistics, 2011. CA Cancer J Clin 61: 409–418.
10. Diéras V. Harbeck N. Albain K. Burris H. Awada A. Crivellari D. et al. (2010) 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 70(Suppl 2): 295s.
11. Honig A. Diessner J. Dietl J. Wischhusen J. (2011) T-DM1 and pertuzumab as new tools for HER 2 specific antibody-therapy against breast cancer stem cells in HER2-positive mammary carcinoma [Abstract P1-04-05]. Cancer Res 71(24 Suppl): 9s.
12. Hurvitz S. Dirix L. Kocsis J. Gianni L. Lu J. Vinholes J. (2011) 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 47(Suppl. 330): Abstract 5001.
13. Jemal A. Bray F. Center M.M. Ferlay J. Ward E. Forman D. (2011) Global cancer statistics. CA Cancer J Clin 61: 69–90.
14. Junttila T.T. Li G. Parsons K. Phillips G.L. Sliwkowski M.X. (2011) 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 128: 347–356.
15. Krop I.E. Beeram M. Modi S. Jones S.F. Holden S.N. Yu W. et al. (2010 a) Phase I study of trastuzumab-DM1, an HER 2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol 28: 2698–2704.
16. Krop I.E. LoRusso P. Miller K. Modi S. Yardley D. Rodriguez G. et al. (2009) A phase II study of trastuzumab-DM1 (T-DM1), a novel HER 2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer who were previously treated with an anthracycline, a taxane, capecitabine, lapatinib, and trastuzumab. Poster presented at: Annual San Antonio Breast Cancer Symposium. Cancer Res 70(Suppl): Abstract 710.
17. Krop I.E.M.M. Burris H.A. Yu W. Girish S. Tibbitts J. et al. (2008) A phase I study of weekly dosing of trastuzumab-DM1 (T-DM1) in patients with advanced HER2-positive breast cancer. Cancer Res 68(Suppl): abstract 3136.
18. Krop I.E. Modi S. Elias A. LoRusso P. Choi Y.J. Lu M. (2010 b) 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 70(Suppl. 2): 295s.
19. Krop I.E. Wolf A.C. Winer E.P. Miller K.D. Park B.H. Ware J. et al. (2010 c) A phase Ib study evaluating safety, tolerability, pharmacokinetics (PK), and activity of the phosphoinositide-3 kinase (PI3K) inhibitor GDC-0941 in combination with trastuzumab-MCC-DM1 (T-DM1) in patients with advanced HER2-positive breast cancer [Abstract P6-15-02]. Cancer Res 70(Suppl. 2): 295s.
20. Lewis Phillips G.D. Li G. Dugger D.L. Crocker L.M. Parsons K.L. Mai E. et al. (2008) Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res 68: 9280–9290.
21. LoRusso P. Krop I.E. Burris H.A. Vukelja S.J. Miller K. Zheng M. et al. (2010) Quantitative assessment of diagnostic markers and correlations with efficacy in two phase II studies of trastuzumab-DM1 (T-DM1) for patients (pts) with metastatic breast cancer (MBC) who had progressed on prior HER2-directed therapy. J Clin Oncol 28(15 Suppl.): abstract 1016.
22. Lu D. Krop I.E. Modi S. Elias A. LoRusso P. Huang J. et al. (2010) 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 [Abstract P3-14-22]. Cancer Res 70(Suppl. 2): 295s.
23. Lu D. Modi S. Elias A.D. Agarwal P. Yi J.-H. Guardino A.E. et al. (2011) Pharmacokinetics (PK) of trastuzumab emtansine and paclitaxel or docetaxel in patients with HER2-positive MBC previously treated with a trastuzumab-containing regimen [Abstract P1-12-07]. Cancer Res 71(24 Suppl.): 15s.
24. Perou C.M. Sorlie T. Eisen M.B. van de Rijn M. Jeffrey S.S. Rees C.A. et al. (2000) Molecular portraits of human breast tumours. Nature 406: 747–752.
25. Petersdorf S. Kopecky K. Stuart R.K. Larson R.A. Nevill T.J. Stenke L. et al. (2009) Preliminary results of Southwest Oncology Group Study S0106: an international intergroup phase 3 randomized trial comparing the addition of gemtuzumab ozogamicin to standard induction therapy versus standard induction therapy followed by a second randomization to post-consolidation gemtuzumab ozogamicin versus no additional therapy for previously untreated acute myeloid leukemia. Blood 114: 790.
26. Piccart-Gebhart M.J. Procter M. Leyland-Jones B. Goldhirsch A. Untch M. Smith I. et al. (2005) Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 353: 1659–1672.
27. Remillard S. Rebhun L.I. Howie G.A. Kupchan S.M. (1975) Antimitotic activity of the potent tumor inhibitor maytansine. Science 189: 1002–1005.
28. Ricart A.D. (2011) Antibody-drug conjugates of calicheamicin derivative: gemtuzumab ozogamicin and inotuzumab ozogamicin. Clin Cancer Res 17: 6417–6427.
29. Romond E.H. Perez E.A. Bryant J. Suman V.J. Geyer C.E. Davidson N.E. et al. (2005) Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med 353: 1673–1684.
30. Slamon D. Eiermann W. Robert N. Pienkowski T. Martin M. Press M. et al. (2011) Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 365: 1273–1283.
31. Slamon D.J. Clark G.M. Wong S.G. Levin W.J. Ullrich A. McGuire W.L. (1987) Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 235: 177–182.
32. Slamon D.J. Godolphin W. Jones L.A. Holt J.A. Wong S.G. Keith D.E. et al. (1989) Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 244: 707–712.
33. Slamon D.J. Leyland-Jones B. Shak S. Fuchs H. Paton V. Bajamonde A. et al. (2001) Use of chemotherapy plus a monoclonal antibody against HER 2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344: 783–792.
34. Sorlie T. Perou C.M. Tibshirani R. Aas T. Geisler S. Johnsen H. et al. (2001) Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A 98: 10869–10874.
35. Vogel C.L. Cobleigh M.A. Tripathy D. Gutheil J.C. Harris L.N. Fehrenbacher L. et al. (2002) Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 20: 719–726.
36. Widdison W.C. Wilhelm S.D. Cavanagh E.E. Whiteman K.R. Leece B.A. Kovtun Y. et al. (2006) Semisynthetic maytansine analogues for the targeted treatment of cancer. J Med Chem 49: 4392–4408.