Profiling and targeting HER2-positive breast cancer using trastuzumab emtansine

Pharmacogenomics and Personalized Medicine

Volumn 7, Issue , 2014, Pages 329-338

  Sadeghi, Saeed ^a   Olevsky, Olga ^a   Hurvitz, Sara A ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Ado trastuzumab emtansine; HER2; Kadcyla; Metastatic breast cancer; T DM1; Trastuzumab emtansine

Indexed keywords

ALPELISIB; ANTINEOPLASTIC AGENT; CAPECITABINE; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIDERMAL GROWTH FACTOR RECEPTOR 3; EPIRUBICIN; FLUOROURACIL; IRBINITINIB; LAPATINIB; MULTIDRUG RESISTANCE ASSOCIATED PROTEIN 1; MULTIDRUG RESISTANCE PROTEIN 1; NEU DIFFERENTIATION FACTOR; PACLITAXEL; PALBOCICLIB; PERTUZUMAB; PHOSPHATIDYLINOSITOL 3 KINASE; PHOSPHATIDYLINOSITOL 3 KINASE INHIBITOR; PICTILISIB; PLACEBO; PROTEIN PIK3CA; TRASTUZUMAB; TRASTUZUMAB EMTANSINE; UNCLASSIFIED DRUG;

ABNORMAL LABORATORY RESULT; ADJUVANT THERAPY; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; BLEEDING; BREAST CANCER; BREAST METASTASIS; CELLULITIS; CLINICAL DECISION MAKING; CONGESTIVE HEART FAILURE; DIARRHEA; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG RESPONSE; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; EPISTAXIS; FATIGUE; FEVER; GENE MUTATION; HEADACHE; HEART DISEASE; HUMAN; LIVER TOXICITY; LOADING DRUG DOSE; MOLECULARLY TARGETED THERAPY; NAUSEA; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIGNAL TRANSDUCTION; THROMBOCYTOPENIA; UNSPECIFIED SIDE EFFECT;

EID: 84908120836     PISSN: None     EISSN: 11787066     Source Type: Journal    
DOI: 10.2147/PGPM.S47524     Document Type: Review

References (41)

1. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235(4785): 177-182.
2. 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(11):783-792.
3. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684.
4. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16): 1659-1672.
5. Slamon D, Eiermann W, Robert N, et al; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283.
6. Dawood S, Broglio K, Esteva FJ, et al. Defining prognosis for women with breast cancer and CNS metastases by HER2 status. Ann Oncol. 2008;19(7):1242-1248.
7. Musolino A, Ciccolallo L, Panebianco M, et al. Multifactorial central nervous system recurrence susceptibility in patients with HER2-positive breast cancer: epidemiological and clinical data from a population-based cancer registry study. Cancer. 2011;117(9):1837-1846.
8. Geyer CE, Forster J, Lindquist D, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006;355(26): 2733-2743.
9. Cameron D, Casey M, Press M, et al. A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat. 2008;112(3):533-543.
10. Hurvitz SA, Hu Y, O'Brien N, Finn RS. Current approaches and future directions in the treatment of HER2-positive breast cancer. Cancer Treat Rev. 2013;39(3):219-229.
11. 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(2):347-356.
12. 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(22):9280-9290.
13. Austin CD, Wen X, Gazzard L, Nelson C, Scheller RH, Scales SJ. Oxidizing potential of endosomes and lysosomes limits intracellular cleavage of disulfide-based antibody-drug conjugates. Proc Natl Acad Sci U S A. 2005;102(50):17987-17992.
14. 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(22):9280-9290.
15. 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(8):4426-4433.
16. Girish S, Gupta M, Wang B, et al. Clinical pharmacology of trastuzumab emtansine (T-DM1): an antibody-drug conjugate in development for the treatment of HER2-positive cancer. Cancer Chemother Pharmacol. 2012;69(5):1229-1240.
17. Mahapatra K, Darbonne W, Bumbaca D, et al. T-DM1-induced thrombocytopenia results from impaired platelet production in a HER2-independent manner. Mol Cancer Ther. 2011;10(Suppl 1):A135.
18. Thon JN, Devine MT, Jurak Begonja A, Tibbitts J, Italiano JE Jr. High-content live-cell imaging assay used to establish mechanism of trastuzumab emtansine (T-DM1) - mediated inhibition of platelet production. Blood. 2012;120(10):1975-1984.
19. 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(16): 2698-2704.
20. Beeram M, Krop IE, Burris HA, et al. A phase 1 study of weekly dosing of trastuzumab emtansine (T-DM1) in patients with advanced human epidermal growth factor 2-positive breast cancer. Cancer. 2012;118(23): 5733-5740.
21. Modi SEA, LoRusso P, Samant M, Guardino E, Althaus B, Krop IE. 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. In: 2012 Annual Meeting of the American Society of Clinical Oncology; June 1-5, 2012; Chicago, Illinois. Abstract 528.
22. 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(4):398-405.
23. Krop IE, LoRusso P, Miller KD, et al. 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(26):3234-3241.
24. Hurvitz SA, Dirix L, Kocsis J, et al. 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(9):1157-1163.
25. 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(14):1437-1444.
26. Verma S, Miles D, Gianni L, et al; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783-1791.
27. Krop IE, Kim SB, González-Martín A, et al; TH3RESA study collaborators. 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(7):689-699.
28. Perez EA, Hurvitz SA, 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(3):R50.
29. 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). Cancer Res. 2013;73(Suppl 8):LB-63.
30. Takara K, Sakaeda T, Okumura K. An update on overcoming MDR1-mediated multidrug resistance in cancer chemotherapy. Curr Pharm Des. 2006;12(3):273-286.
31. Li G, Fields CT, Parsons KL, Guo J, Lewis Phillips GD. Trastuzumab-DM1: mechanisms of action and mechanisms of resistance. Eur J Cancer. 2010;8(7):73.
32. Tan X, Jin G, Myers J, et al. Tumor cells selected for resistance to an antibody-drug conjugate retain sensitivity to ADCs with modified linkers and payloads. Cancer Res. 2013;73(Suppl 8):4629.
33. Engelman JA. Targeting PI3K signalling in cancer: opportunities, challenges and limitations. Nat Rev Cancer. 2009;9(8):550-562.
34. Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70.
35. Hanker AB, Pfefferle AD, Balko JM, et al. Mutant PIK3CA accelerates HER2-driven transgenic mammary tumors and induces resistance to combinations of anti-HER2 therapies. Proc Natl Acad Sci U S A. 2013;110(35):14372-14377.
36. Gianni L, Bianchini G, Kiermaier A, et al. Neoadjuvant Pertuzumab (P) and Trastuzumab (H): Biomarker Analyses of a 4-Arm Randomized Phase II Study (NeoSphere) in Patients (pts) with HER2-Positive Breast Cancer (BC). Cancer Res. 2011;71(Suppl 24):S5-1.
37. Baselga J, Bradbury I, Eidtmann H, et al; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012;379(9816):633-640.
38. Baselga J, Majewski I, Nuciforo PG, et al. PI3KCA mutations and correlation with pCR in the NeoALTTO trial (BIG 01-06). European Cancer Congress 2013 Abstract Book in the European Journal of Cancer. 2013:Abstract 1859.
39. Gwin WRI, Spector NL. Pertuzumab protects the achilles' heel of trastuzumab - emtansine. Clin Cancer Res. 2014;20(2):278-280.
40. 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(2):456-468.
41. 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(20):6437-6447.