Trastuzumab emtansine in advanced human epidermal growth factor receptor 2-positive breast cancer

Expert Opinion on Biological Therapy

Volumn 15, Issue 5, 2015, Pages 749-760

  Van Den Mooter, Tom ^a   Teuwen, Laure Anne ^a   Rutten, Annemie ^a   Dirix, Luc ^a  

^a SINT AUGUSTINUS HOSPITAL   (Belgium)

Author keywords

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

Indexed keywords

BIOLOGICAL MARKER; CAPECITABINE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; LAPATINIB; MAYTANSINE; TRASTUZUMAB; TRASTUZUMAB EMTANSINE; ANTINEOPLASTIC AGENT; ERBB2 PROTEIN, HUMAN; MONOCLONAL ANTIBODY;

ADVANCED CANCER; ALOPECIA; AREA UNDER THE CURVE; ARTICLE; BONE MARROW TOXICITY; BRAIN METASTASIS; BREAST CANCER; CANCER CONTROL; CANCER SURVIVAL; CARDIOTOXICITY; CHEMISTRY; CREATININE CLEARANCE; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG TOLERABILITY; HUMAN; HYPERTRANSAMINASEMIA; LIVER DYSFUNCTION; LIVER TOXICITY; LYMPHOID ORGAN; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; NEUROPATHY; NONHUMAN; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOLUME OF DISTRIBUTION; ANALOGS AND DERIVATIVES; ANIMAL; BREAST NEOPLASMS; CLINICAL TRIAL (TOPIC); DISEASE FREE SURVIVAL; DRUG SCREENING; FEMALE; GENETICS; PROCEDURES;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; CLINICAL TRIALS AS TOPIC; DISEASE-FREE SURVIVAL; DRUG EVALUATION, PRECLINICAL; FEMALE; HUMANS; MAYTANSINE; RECEPTOR, ERBB-2;

EID: 84927639626     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2015.1036026     Document Type: Article

References (58)

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. Perou CM, Sorlie T, Eisen MB, et al. Molecular portraits of human breast tumours. Nature 2000; 406: 747-52
4. 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
5. 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
6. Perez EA, Romond EH, Suman VJ, et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABP B-31 and NCCTG N9831. J Clin Oncol 2014; 32: 3744-52
7. Gianni L, Dafni U, Gelber RD, et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol 2011; 12: 236-44
8. 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
9. 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
10. Swain SM, Kim SB, Cortés J, et al. 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: 461-71
11. 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(7): 1124-30
12. Teicher BA, Chari RVJ antibody conjugate Therapeutics: challenges and potential. Clin Cancer Res 2011; 17: 6389-97
13. 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
14. 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
15. Erickson HK, Park PU, Widdison WC, et al antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linkerdependent intracellular processing. Cancer Res 2006; 66: 4426-33
16. 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
17. Junutula JR, Flagella 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
18. Barok M, Tanner M, Konicke K, Isola J. Trastuzumab-DM1 is highly effective in preclinical models of HER2-positive gastric cancer. Cancer Lett 2011; 306: 171-9
19. 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
20. Barok M, Tanner M, Köninki 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
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, 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
24. Poon KA, Flagella K, Beyer J, et al. Preclinical safety profile of trastuzumab emtansine (T-DM1): mechanism of action of its cytotoxic component retained with improved tolerability. Toxicol Appl Pharmacol 2013; 273(2): 298-313
25. 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
26. 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
27. 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
28. 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
29. Girish S, Gupta M, Wang B, et al. Clinical pharmacology of trastuzumab emtansine (T-DM1): a unique antibodydrug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother Pharmacol 2012; 69: 1229-40
30. 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
31. 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
32. Lu D, Joshi A, Wang B, et al an integrated multiple-Analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer. Clin Pharmacokinet 2013; 52: 657-72
33. Lu D, Girish S, Gao Y, et al. Population pharmacokinetics of trastuzumab emtansine (T-DM1), a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer: clinical implications of the effect of various covariates. Cancer Chemother Pharmacol 2014; 74: 399-410
34. LI C, Agarwal P, Dent S, et al. Phase 1 study of trastuzumab emtansine in HER2-positive metastatic breast cancer patients with normal or reduced hepatic function. SABCS 2014; P4-15-09
35. 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
36. 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 trastuzumab, lapatinib, an anthracycline, a taxane and capecitabine. J Clin Oncol 2012; 30: 3234-41
37. Hurvitz SA, Dirix L, Kocsis J, et al. Trastuzumab emtansine versus trastuzumab plus docetaxel for HER2-positive metastatic breast cancer. J Clin Oncol 2013; 31: 1157-63
38. Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012; 367: 1783-91
39. Kropp IE, Kim S-B, Gonzalez-Martin A, et al. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol 2014; 15: 689-99
40. Kropp IE, Lin NU, Blackwell K, et al. Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer and central nervous system metastases: a retrospective, exploratory analysis in EMILIA ann Oncol 2015; 26: 113-19
41. Kalsi R, Feigenberg S, Kwok Y, et al. Brain metastasis and response to adotrastuzumab emtansine: a case-report and literature review. Clin Breast Cancer 2015; 15(2): e163-6
42. Bartsch R, Berghoff AS, Vogl U, et al activity of T-DM1 in HER2-positive breast cancer brain metastases. SABCS 2014; P6-16-10
43. 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
44. Dieras V, Harbeck N, Budd GT, et al. Trastuzumab emtansine in human epidermal growth factor receptor 2-positive breast cancer: an integrated safety analysis. J Clin Oncol 2014; 32: 2750-7
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
46. Uppal H, Doudement E, Mahapatra K, et al. Potential mechanisms for thrombocytopenia development with trastuzumab emtansine (T-DM1). Clin Cancer Res 2015; 21: 123-33
47. Krop IE, Suter TM, Dang CT, et al. Feasibility and cardiac safety of trastuzumab emtansine (T-DM1) following anthracycline-based chemotherapy as (Neo) adjuvant therapy for human epidermal growth factor receptor 2-positive early-stage breast cancer. J Clin Onc 2015; In press
48. Gupta M, Wang B, Carrothers TJ, et al. Effects of trastuzumab emtansine (T -DM1) on QT interval and safety of pertuzumab plus T - DM1 in patients with previously treated human epidermal growth factor receptor 2-positive metastatic breast cancer. Clin Pharmacol Drug Dev 2013; 2: 11-24
49. Force J, Saxena R, Schneider BP, et al. Nodular regenerative hyperplasia after treatment with trastuzumab emtansine. J Clin Oncol 2014; 32: 1-4
50. Welslau M, Diéras V, Sohn JH, et al. Patient-reported outcomes from EMILIA, a randomized phase 3 study of trastuzumab emtansine (T-DM1) versus capecitabine and lapatinib in human epidermal growth factor receptor 2-positive locally advanced or metastatic breast cancer. Cancer 2014; 120: 642-51
51. 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
52. Perez EA, Hurvitz SA, Lukas C Amler LC, et al. 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 Res 2014; 16: R50
53. Baselga J, Verma S, Ro J, et al. Relationship between tumor biomarkers (BM) and efficacy in EMILIA, a phase III study of trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer (MBC) aACR 2013; LB-63
54. Majewski IJ, Nuciforo P, Mittempergher L, et al. PIK3CA mutations are associated with decreased benefit to neoadjuvant human epidermal growth factor receptor 2-targeted therapies in breast cancer. J Clin Oncol 2015. pii: JCO.2014.55.2158
55. Phillips GD, Fields CT, Li G, et al. Dual targeting of HER2-positive cancer with trastuzumab emtansine and pertuzumab: critical role for neuregulin blockade in antitumor response to combination therapy. Clin Cancer Res 2014; 20: 456-68
56. Gwin WR, Spector NL. Pertuzumab protects the achilles' heel of trastuzumab-emtansine. Clin Cancer Res 2014; 20: 278-80
57. Miller KD, Diéras V, Harbeck N, et al. Phase IIa trial of trastuzumab emtansine with pertuzumab for patients with human epidermal growth factor receptor 2-positive, locally advanced, or metastatic breast cancer. J Clin Oncol 2014; 32: 1437-44
58. Korkola JE, Liu M, Liby T, Heiser L. Detrimental effects of sequential compared to concurrent treatment of pertuzumab plus T-DM1 in HER2+ breast cancer cell lines. SABCS 2014; S6-07