Cardiotoxicity of novel HER2-targeted therapies

References

• 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
   PubMed Web of Science ®Google Scholar
• Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med 2007;131:18-43
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist 2009;14:320-68
   PubMed Web of Science ®Google Scholar
• Azim H, Azim HA Jr. Targeting Her-2/neu in breast cancer: as easy as this! Oncology 2008;74:150-7
   PubMed Web of Science ®Google Scholar
• Fujita T, Doihara H, Kawasaki K, et al. PTEN activity could be a predictive marker of trastuzumab efficacy in the treatment of ErbB2-overexpressing breast cancer. Br J Cancer 2006;94:247-52
   PubMed Web of Science ®Google Scholar
• Spector NL, Blackwell KL. Understanding the mechanisms behind trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol 2009;27:5838-47
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Seidman A, Hudis C, Pierri MK, et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002;20:1215-21
   PubMed Web of Science ®Google Scholar
• Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 2011;365:1273-83
   PubMed Web of Science ®Google Scholar
• Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol 2011;29:3366-73
   PubMed Web of Science ®Google Scholar
• Erickson SL, O'Shea KS, Ghaboosi N, et al. ErbB3 is required for normal cerebellar and cardiac development: a comparison with ErbB2-and heregulin-deficient mice. Development 1997;124:4999-5011
   PubMed Web of Science ®Google Scholar
• Lee KF, Simon H, Chen H, et al. Requirement for neuregulin receptor erbB2 in neural and cardiac development. Nature 1995;378:394-8
   PubMed Web of Science ®Google Scholar
• Chien KR. Herceptin and the heart – a molecular modifier of cardiac failure. N Engl J Med 2006;354:789-90
   PubMed Web of Science ®Google Scholar
• Crone SA, Zhao YY, Fan L, et al. ErbB2 is essential in the prevention of dilated cardiomyopathy. Nat Med 2002;8:459-65
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Burris HA 3rd, Hurwitz HI, Dees EC, et al. Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases, in heavily pretreated patients with metastatic carcinomas. J Clin Oncol 2005;23:5305-13
   PubMed Web of Science ®Google Scholar
• Siegel-Lakhai WS, Beijnen JH, Vervenne WL, et al. Phase I pharmacokinetic study of the safety and tolerability of lapatinib (GW572016) in combination with oxaliplatin/fluorouracil/leucovorin (FOLFOX4) in patients with solid tumors. Clin Cancer Res 2007;13(15 Pt 1):4495-502
   PubMed Web of Science ®Google Scholar
• LoRusso PM, Jones SF, Koch KM, et al. Phase I and pharmacokinetic study of lapatinib and docetaxel in patients with advanced cancer. J Clin Oncol 2008;26:3051-6
   PubMed Web of Science ®Google Scholar
• Chu QS, Cianfrocca ME, Goldstein LJ, et al. A phase I and pharmacokinetic study of lapatinib in combination with letrozole in patients with advanced cancer. Clin Cancer Res 2008;14:4484-90
   PubMed Web of Science ®Google Scholar
• Burris HA 3rd, Taylor CW, Jones SF, et al. A phase I and pharmacokinetic study of oral lapatinib administered once or twice daily in patients with solid malignancies. Clin Cancer Res 2009;15:6702-8
   PubMed Web of Science ®Google Scholar
• Chu QS, Schwartz G, de Bono J, et al. Phase I and pharmacokinetic study of lapatinib in combination with capecitabine in patients with advanced solid malignancies. J Clin Oncol 2007;25:3753-8
   PubMed Web of Science ®Google Scholar
• Dogan E, Yorgun H, Petekkaya I, et al. Evaluation of cardiac safety of lapatinib therapy for ErbB2-positive metastatic breast cancer: a single center experience. Med Oncol 2012;29:3232-9
   PubMed Web of Science ®Google Scholar
• Jagiello-Gruszfeld A, Tjulandin S, Dobrovolskaya N, et al. A single-arm phase II trial of first-line paclitaxel in combination with lapatinib in HER2-overexpressing metastatic breast cancer. Oncology 2010;79:129-35
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Gomez HL, Doval DC, Chavez MA, et al. Efficacy and safety of lapatinib as first-line therapy for ErbB2-amplified locally advanced or metastatic breast cancer. J Clin Oncol 2008;26:2999-3005
   PubMed Web of Science ®Google Scholar
• Burstein HJ, Storniolo AM, Franco S, et al. A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer. Ann Oncol 2008;19:1068-74
   PubMed Web of Science ®Google Scholar
• Johnston S, Pippen J Jr, Pivot X, et al. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol 2009;27:5538-46
   PubMed Web of Science ®Google Scholar
• Di Leo A, Gomez HL, Aziz Z, et al. Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for metastatic breast cancer. J Clin Oncol 2008;26:5544-52
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Baselga J, Bradbury I, Eidtmann H, et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet 2012;379:633-40
   PubMed Web of Science ®Google Scholar
• Gelmon KABF, Kaufman B, Huntsman D. 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. 2012 ASCO Annual Meeting, LBA671, 2012
   Google Scholar
• Guan Z, Xu B, Desilvio ML, et al. Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol 2013;31:1947-53
   PubMed Web of Science ®Google Scholar
• Capri G, Chang J, Chen SC, et al. An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer. Ann Oncol 2010;21:474-80
   PubMed Web of Science ®Google Scholar
• Perez EA, Koehler M, Byrne J, et al. Cardiac safety of lapatinib: pooled analysis of 3689 patients enrolled in clinical trials. Mayo Clin Proc 2008;83:679-86
   PubMed Web of Science ®Google Scholar
• Azim H, Azim HA Jr, Escudier B. Trastuzumab versus lapatinib: the cardiac side of the story. Cancer Treat Rev 2009;35:633-8
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Sendur MA, Aksoy S, Altundag K. Pertuzumab in HER2-positive breast cancer. Curr Med Res Opin 2012;28:1709-16
   PubMed Web of Science ®Google Scholar
• Baselga J, Swain SM. Novel anticancer targets: revisiting ERBB2 and discovering ERBB3. Nat Rev Cancer 2009;9:463-75
   PubMed Web of Science ®Google Scholar
• Scheuer W, Friess T, Burtscher H, et al. Strongly enhanced antitumor activity of trastuzumab and pertuzumab combination treatment on HER2-positive human xenograft tumor models. Cancer Res 2009;69:9330-6
   PubMed Web of Science ®Google Scholar
• Agus DB, Gordon MS, Taylor C, et al. Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer. J Clin Oncol 2005;23:2534-43
   PubMed Web of Science ®Google Scholar
• Portera CC, Walshe JM, Rosing DR, et al. Cardiac toxicity and efficacy of trastuzumab combined with pertuzumab in patients with [corrected] human epidermal growth factor receptor 2-positive metastatic breast cancer. Clin Cancer Res 2008;14:2710-16
   PubMed Web of Science ®Google Scholar
• Baselga J, Gelmon KA, Verma S, et al. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy. J Clin Oncol 2010;28:1138-44
   PubMed Web of Science ®Google Scholar
• Cortes J, Fumoleau P, Bianchi GV, et al. Pertuzumab monotherapy after trastuzumab-based treatment and subsequent reintroduction of trastuzumab: activity and tolerability in patients with advanced human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol 2012;30:1594-600
   PubMed Web of Science ®Google Scholar
• Gianni L, Llado A, Bianchi G, et al. Open-label, phase II, multicenter, randomized study of the efficacy and safety of two dose levels of pertuzumab, a human epidermal growth factor receptor 2 dimerization inhibitor, in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010;28:1131-7
   PubMed Web of Science ®Google Scholar
• Datko F, D'Andrea G, Dickler M, et al. Memorial. Phase II study of pertuzumab, trastuzumab, and weekly paclitaxel in patients with metastatic HER2-overexpressing metastatic breast cancer. Cancer Res 2012;72(24 Suppl.):474s.
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Ewer M., Baselga J, Clark E, et al. Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in the CLEOPATRA study. 2012 ASCO Annual Meeting. J Clin Oncol 2012;30(Suppl; abstr 533)
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• Sendur MA, Aksoy S, Altundag K. Pertuzumab in Her2-Positive Breast Cancer. Curr Med Res Opin 2012;28:1709-16
   PubMed Web of Science ®Google Scholar
• Cassady JM, Chan KK, Floss HG, Leistner E. Recent developments in the maytansinoid antitumor agents. Chem Pharm Bull (Tokyo) 2004;52:1-26
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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
   Google Scholar
• 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
   Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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;30:3234-41
   PubMed Web of Science ®Google Scholar
• 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-postive metastatic breast cancer. J Clin Oncol 2013;31:1157-63
   PubMed Web of Science ®Google Scholar
• Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367:1783-91
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Wong KK, Fracasso PM, Bukowski RM, et al. A phase I study with neratinib (HKI-272), an irreversible pan ErbB receptor tyrosine kinase inhibitor, in patients with solid tumors. Clin Cancer Res 2009;15:2552-8
   PubMed Web of Science ®Google Scholar
• Ito Y, Suenaga M, Hatake K, et al. Safety, efficacy and pharmacokinetics of neratinib (HKI-272) in Japanese patients with advanced solid tumors: a phase 1 dose-escalation study. Jpn J Clin Oncol 2012;42:278-86
   PubMed Web of Science ®Google Scholar
• 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
   PubMedGoogle Scholar
• Eskens FA, Mom CH, Planting AS, et al. A phase I dose escalation study of BIBW 2992, an irreversible dual inhibitor of epidermal growth factor receptor 1 (EGFR) and 2 (HER2) tyrosine kinase in a 2-week on, 2-week off schedule in patients with advanced solid tumours. Br J Cancer 2008;98:80-5
   PubMed Web of Science ®Google Scholar
• Yap TA, Vidal L, Adam J, et al. Phase I trial of the irreversible EGFR and HER2 kinase inhibitor BIBW 2992 in patients with advanced solid tumors. J Clin Oncol 2010;28:3965-72
   PubMed Web of Science ®Google Scholar
• Lin NU, Winer EP, Wheatley D, et al. A phase II study of afatinib (BIBW 2992), an irreversible ErbB family blocker, in patients with HER2-positive metastatic breast cancer progressing after trastuzumab. Breast Cancer Res Treat 2012;133:1057-65
   PubMed Web of Science ®Google Scholar