Pertuzumab: evolving therapeutic strategies in the management of HER2-overexpressing breast cancer

Bibliography

• Slamon DJ, Clark GM, Wong SG, Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987;235(4785):177-82
   PubMed Web of Science ®Google Scholar
• Agus DB, Akita RW, Fox WD, Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell 2002;2(2):127-37
   PubMed Web of Science ®Google Scholar
• Slamon DJ, Godolphin W, Jones LA, Studies of the HER2/neu proto-oncogene in human breast and ovarian cancer. Science 1989;244:707-12
   PubMed Web of Science ®Google Scholar
• Stern HM. Improving treatment of HER2-positive cancers: opportunities and challenges. Sci Transl Med (United States) 2012;4(127):127rv2
   PubMed Web of Science ®Google Scholar
• Sarup JC, Johnson RM, King KL, Characterization of an anti-p185HER2 monoclonal antibody that stimulates receptor function and inhibits tumor cell growth. Growth Regul 1991;1(2):72-82
   PubMedGoogle Scholar
• Clynes RA, Towers TL, Presta LG, Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets. Nat Med 2000;6(4):443-6
   PubMed Web of Science ®Google Scholar
• Herceptin (trastuzumab) Label- Access data FDA. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/.../103792s5256lbl.pdf
   Google Scholar
• Slamon D, Eiermann W, Robert N, Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med 2011;365(14):1273-83
   PubMed Web of Science ®Google Scholar
• Vogel CL, Cobleigh MA, Tripathy D, 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
   PubMed Web of Science ®Google Scholar
• Marty M, Cognetti F, Maraninchi D, 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
• Nahta R, Yu D, Hung MC, Mechanisms of disease: understanding resistance to HER2-targeted therapy in human breast cancer. Nat Clin Pract Oncol 2006;3(5):269-80
   PubMedGoogle Scholar
• Tsang RY, Finn RS. Beyond trastuzumab: novel therapeutic strategies in HER2-positive metastatic breast cancer. Br J Cancer 2012;106(1):6-13
   PubMed Web of Science ®Google Scholar
• Cortes J, Fumoleau P, Bianchi GV, 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(14):1594-600
   PubMed Web of Science ®Google Scholar
• Baselga J, Cortes J, Kim SB, Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012;366(2):109-19
   PubMed Web of Science ®Google Scholar
• Franklin MC, Carey KD, Vajdos FF, Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell 2004;5(4):317-28
   PubMed Web of Science ®Google Scholar
• Agus DB, Gordon MS, Taylor C, Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer. J Clin Oncol 2005;23(11):2534-43
   PubMed Web of Science ®Google Scholar
• Adams CW, Allison DE, Flagella K, Humanization of a recombinant monoclonal antibody to produce a therapeutic HER dimerization inhibitor, pertuzumab. Cancer Immunol Immunother 2006;55(6):717-27
   PubMed Web of Science ®Google Scholar
• Burgess AW, Cho HS, Eigenbrot C, An open-and-shut case? Recent insights into the activation of EGF/ErbB receptors. Mol Cell 2003;12(3):541-52
   PubMed Web of Science ®Google Scholar
• Scheuer W, Friess T, Burtscher H, Strongly enhanced antitumor activity of trastuzumab and pertuzumab combination treatment on HER2-positive human xenograft tumor models. Cancer Res 2009;69(24):9330-6
   PubMed Web of Science ®Google Scholar
• Park S, Jiang Z, Mortenson ED, The therapeutic effect of anti-HER2/neu antibody depends on both innate and adaptive immunity. Cancer Cell 2010;18(2):160-70
   PubMed Web of Science ®Google Scholar
• Herbst RS, Davies AM, Natale RB, Efficacy and safety of single-agent pertuzumab, a human receptor dimerization inhibitor, in patients with non-small cell lung cancer. Clin Cancer Res 2007;13:6175-81
   PubMed Web of Science ®Google Scholar
• Gordon MS, Matei D, Aghajanian C, Clinical activity of pertuzumab (rhuMAb 2C4), a HER dimerization inhibitor, in advanced ovarian cancer: potential predictive relationship with tumor HER2 activation status. J Clin Oncol 2006;24(26):4324-32
   PubMed Web of Science ®Google Scholar
• Crawford A, Nahta R. Targeting Bcl-2 in herceptin-resistant breast cancer cell lines. Curr Pharmacogenomics Person Med 2011;9(3):184-90
   PubMedGoogle Scholar
• Nahta R, Hung MC, Esteva FJ. The HER-2-targeting antibodies trastuzumab and pertuzumab synergistically inhibit the survival of breast cancer cells. Cancer Res 2004;64(7):2343-6
   PubMed Web of Science ®Google Scholar
• Crone SA, Zhao YY, Fan L, ErbB2 is essential in the prevention of dilated cardiomyopathy. Nat Med 2002;8(5):459-65
   PubMed Web of Science ®Google Scholar
• Allison DE, Ng C, Derynck K, Pharmacokinetics (PK) of pertuzumab (rhuMAb 2C4) in phase II studies of ovarian, breast, prostate and lung cancers. J Clin Oncol (2005 ASCO Annual Meeting) 2005;23(16S Suppl):2532
   Google Scholar
• Malik MA, Totpal K, Balter I, Dose-response studies of recombinant humanized monoclonal antibody 2C4 in tumor xenograft models [abstract 773]. Proc Am Assoc Cancer Res 2003;44:150
   Google Scholar
• Cortes J, Swain S, Kudaba I, Pharmacokinetics of pertuzumab with trastuzumab and docetaxel in HER2-positive first line metastatic breast cancer. Results from the phase III trial CLEOPATRA (poster-344P). Proceedings of the 35th san antonio breast cancer Symposium; San Antonio, Texas; 2012. p. 4-8
   Google Scholar
• Pegram MD, Pienkowski T, Northfelt DW, Results of two open-label, multicenter phase II studies of docetaxel, platinum salts, and trastuzumab in HER2-positive advanced breast cancer. J Natl Cancer Inst 2004;96(10):759-69
   PubMed Web of Science ®Google Scholar
• Hudis CA. Trastuzumab–mechanism of action and use in clinical practice. N Engl J Med 2007;357(1):39-51
   PubMed Web of Science ®Google Scholar
• Attard G, Kitzen J, Blagden SP, A phase Ib study of pertuzumab, a recombinant humanised antibody to HER2, and docetaxel in patients with advanced solid tumours. Br J Cancer 2007;97(10):1338-43
   PubMed Web of Science ®Google Scholar
• de Bono JS, Bellmunt J, Attard G, Open-label phase II study evaluating the efficacy and safety of two doses of pertuzumab in castrate chemotherapy-naive patients with hormone-refractory prostate cancer. J Clin Oncol 2007;25(3):257-62
   PubMed Web of Science ®Google Scholar
• Kaye SB, Poole CJ, Danska-Bidzinska A, A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer. Ann Oncol 2013;24(1):145-52
   PubMed Web of Science ®Google Scholar
• Portera CC, Walshe JM, Rosing DR, 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(9):2710-16
   PubMed Web of Science ®Google Scholar
• Baselga J, Gelmon KA, Verma S, 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(7):1138-44
   PubMed Web of Science ®Google Scholar
• Gianni L, Llado A, Bianchi G, 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(7):1131-7
   PubMed Web of Science ®Google Scholar
• Datko FM, D'Andrea G, Dickler MN, Phase II Study of pertuzumab, trastuzumab and weekly paclitaxel in patients with HER2-overexpressing metastatic breast cancer. Thirty-Fifth Annual CTRC-AACR San Antonio Breast Cancer Symposium; 4 - 8 December 2012; San Antonio, TX
   Google Scholar
• A study of pertuzumab in combination with trastuzumab and chemotherapy in patients with HER2-positive advanced gastric cancer. Available from: www.clinicaltrials.gov; NCT01461057
   Google Scholar
• Combination of bevacizumab, pertuzumab and sandostatin for advanced neuroendocrine cancers. Available from: www.clinicaltrials.gov; NCT01121939
   Google Scholar
• A Study of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer and low HER3 mRNA expression. Available from: www.clinicaltrials.gov; NCT01684878
   Google Scholar
• Pertuzumab and cetuximab in treating patients with previously treated locally advanced or metastatic colorectal cancer. Available from: www.clinicaltrials.gov;NCT00551421
   Google Scholar
• Gianni L, Pienkowski T, Im YH, 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(1):25-32
   PubMed Web of Science ®Google Scholar
• Schneeweiss A, Chia S, Hickish T, S5-6: 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 2012;71(24 Suppl):S5-6
   Google Scholar
• A Study of Neoadjuvant Myocet,Paclitaxel, Pertuzumab and Trastuzumab in HER2-Positive Breast Cancer. Available from: www.clinicaltrials.gov.NCT01669239
   Google Scholar
• Swain SM, Sung-Bae K, Cortes J, Confirmatory overall survival analysis of CLEOPATRA: A randomized, double-blind, placebo-controlled phase III study with pertuzumab, trastuzumab and docetaxel in patients with HER2-positive first line MBC (poster;P5-18-26). Proceedings of the 35th San Antonio Breast Cancer Symposium; 4 - 8 December 2012; San Antonio Texas
   Google Scholar
• Miles D, Baselga J, Young HI, Pertuzumab in combination with trastuzumab and docetaxel in elderly patients with HER2-positive breast cancer in the CLEOPATRA study (poster P5-18-01). Proceedings of the 35th San Antonio Breast Cancer Symposium; 4 - 8 December 2012; San Antonio, Texas
   Google Scholar
• Cortes J, Baselga J, Young HI, Quality of life assessment in CLEOPATRA,a phase II study combining pertuzumab with trastuzumab and docetaxel in metastatic breast cancer.ASCO annual meeting 2012. J Clin Oncol 2012;30(Suppl):abstract 598
   Google Scholar
• A Randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast Cancer. APHINITY trial. Aavilable from www.clinical trials.gov; NCT01358877
   Google Scholar
• Verma S, Miles D, Gianni L, EMILIA Study Group. Trastuzumab emtansine for HER2-positive advancedbreast cancer. N Engl J Med 2012;367(19):1783-91
   PubMed Web of Science ®Google Scholar
• A study of trastuzumab-dm1 plus pertuzumab versus trastuzumab [Herceptin] plus a taxane in patients with metastatic breast cancer. MARIANNE trial. Available from: www.clinicaltrials.gov; NCT01120184
   Google Scholar
• Ellis PA, Barrios CH, Im Y, 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). ASCO Annual Meeting 2011. J Clin Oncol 2011;29(Suppl):abstract TPS102
   Google Scholar
• Martin M, Garcia-Saenz JA, Dewar JA, Interim results from a phase 1b/2a study of trastuzumab emtansine and docetaxel, with and without pertuzumab, in patients with HER2-positive locally advanced or metastatic breast cancer. San Antonio Breast Cancer Symposium - 35th Annual Meeting; 2012
   Google Scholar
• Modi S, Elias A, LoRusso PM, Results from a phase 1b study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab. American Society of Clinical Oncology - 48th Annual Meeting; 2012
   Google Scholar
• Schaller G, Fuchs I, Gonsch T, Phase II study of capecitabine plus trastuzumab in human epidermal growth factor receptor-2 overexpressing metastatic breast cance pretreated with anthracyclines and taxanes. J Clin Oncol 2007;25(22):3246-50
   PubMed Web of Science ®Google Scholar
• Munoz-Mateu M, Urruticoechea A, Separovic R, Trastuzumab plus capecitabine with or without pertuzumab in patients with HER2-positive MBC whose disease has progressed during or following trastuzumab-based therapy for first-line metastatic disease: A multicenter, randomized, two-arm, phase II study (PHEREXA). ASCO Meeting Abstracts 2011;29(15 Suppl):TPS118
   Google Scholar
• Kaufman B, Mackey JR, Clemens MR, Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor-2 positive,hormone receptor positive metastatic breast cancer: results from the randomized phase III TAnDEM study. J Clin Oncol 2009;27(33):5529-37
   PubMed Web of Science ®Google Scholar
• Arpino G, Poole C, Ferrero J-M, Treatment of patients with hormone receptor (HR)-positive and HER2-positive locally advanced or metastatic breast cancer with a combination of pertuzumab and trastuzumab plus an aromatase inhibitor (AI): an open-label, randomised Phase II study (PERTAIN). European Society for Medical Oncology 37th Congress - ESMO 2012; 2012
   Google Scholar
• Perez EA, Lopez-Vega JM, Mastro LD, A combination of pertuzumab,trastuzumab, and vinorelbine for first-line treatment of patients with HER2-positive metastatic breast cancer: An open-label, two-cohort, phase II study(VELVET). 2012 ASCO Annual Meeting. J Clin Oncol 2012;30(Suppl):abstract TPS653
   Google Scholar
• Bachelot T, Ciruelos E, Peretz-Yablonski T, A single-arm phase IIIb study of pertuzumab and trastuzumab with a taxane as first-line therapy for patients with HER2-positive advanced breast cancer (PERUSE). San Antonio Breast Cancer Symposium - 35th Annual Meeting; 2012
   Google Scholar
• Drucker AM, Wu S, Dang CT, Risk of rash with the anti-HER2 dimerization antibody pertuzumab: a meta-analysis. Breast Cancer Res Treat 2012;135(2):347-54
   PubMed Web of Science ®Google Scholar
• Lenihan D, Suter T, Brammer M, Pooled analysis of cardiac safety in patients with cancer treated with pertuzumab. Ann Oncol 2012;23(3):791-800
   PubMed Web of Science ®Google Scholar
• Ewer M, Baselga J, Clark E, Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in the CLEOPATRA study. ASCO Meeting Abstracts 2012;30(15 Suppl):533
   Google Scholar
• Makhija S, Amler LC, Glenn D, Clinical activity of gemcitabine plus pertuzumab in platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. J Clin Oncol 2010;28:1215-23
   PubMed Web of Science ®Google Scholar
• Nagumo Y, Faratian D, Mullen P, Modulation of HER3 is a marker of dynamic cell signaling in ovarian cancer. Mol Cancer Res 2009;7(9):1563-71
   PubMed Web of Science ®Google Scholar
• Baselga J, Cortes J, Im S-A, Biomarker analysis in CLEOPATRA: a phase III, placebo controlled study of pertuzumab in HER2-positive, first line metastatic breast cancer (oral presentation). Proceedings of the 35th San Antonio Breast Cancer Symposium; 4 - 8 December 2012; San Antonio, Texas
   Google Scholar
• Perjeta. European Medicines Agency. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002547/smops/Positive/human_smop_000457.jsp&mid=WC0b01ac058001d127
   Google Scholar
• An observational study of pregnancy and pregnancy outcomes in women with breast cancer treated with herceptin or perjeta in combination with herceptin during pregnancy or within 6 months prior to conception (MotHER). Available from: www.clinicaltrials.gov;NCT00833963
   Google Scholar
• Emens LA, Machiels JP, Reilly RT, Chemotherapy: friend or foe to cancer vaccines? Curr Opin Mol Ther 2001;3(1):77-84
   PubMed Web of Science ®Google Scholar
• Apetoh L, Ghiringhelli F, Tesniere A, Toll-like receptor 4-dependent contribution of the immune system to anticancer chemotherapy and radiotherapy. Nat Med 2007;13(9):1050-9
   PubMed Web of Science ®Google Scholar
• Sears AK, Perez SA, Clifton GT, AE37: a novel T-cell-eliciting vaccine for breast cancer. Expert Opin Biol Ther 2011;11(11):1543-50
   PubMed Web of Science ®Google Scholar
• Okines AF, Cunningham D. Trastuzumab: a novel standard option for patients with HER-2-positive advanced gastric or gastro-oesophageal junction cancer. Ther Adv Gastroenterol 2012;5(5):301-18
   PubMedGoogle Scholar
• Burris HA, Hurwitz HI, Dees EC, 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(23):5305-13
   PubMed Web of Science ®Google Scholar
• Geyer CE, Forster J, Lindquist D, Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355(26):2733-43
   PubMed Web of Science ®Google Scholar
• A randomised, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer - ALLTO trial. Available from: www.clinicaltrials.gov;NCT00490139
   Google Scholar
• Carter PJ, Senter PD. Antibody-drug conjugates for cancer therapy. Cancer J 2008;114(3):154-69
   Google Scholar
• A Randomized, multicenter, phase III open-label study of the efficacy and safety of trastuzumab-MCC-DM1 vs. capecitabine + lapatinib in patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy. EMILIA trial. Available from: www.clinicaltrials.gov; NCT00829166
   Google Scholar
• Martin M, Bonneterre J, Geyer CE, S5-7: a phase 2, randomized, open-label, study of neratinib (HKI-272) vs lapatinib plus capecitabine for 2nd/3rd-Line treatment of HER2+ locally advanced or metastatic breast cancer. Cancer Res 2012;2012;71(24 Suppl):S5-7
   Google Scholar
• Investigation of serial studies to predict your therapeutic response with imaging and MOLECULAR analysis 2: I SPY 2 trial. Available from: www.clinical trials.gov; NCT01042379
   Google Scholar
• Lin NU, Winer EP, Wheatley D, 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(3):1057-65
   PubMed Web of Science ®Google Scholar
• Baselga J, Cortes J, Fumoleau P, Pertuzumab and trastuzumab: re-responses to 2 biological agents in patients with HER2-positive breast cancer which previously progressed during therapy with each agent given separately: a new biological and clinical observation. Cancer Res 2009;69(24 Suppl) abstract 5114
   Web of Science ®Google Scholar
• A Study of trastuzumab-MCC-DM1 (T-DM1) in combination with pertuzumab administered to patients with HER2-positive locally advanced or metastatic breast cancer who have previously received trastuzumab. Available from: www.clinicaltrials.gov; NCT00875979
   Google Scholar
• Burris HA. T-DM1: Hitching a Ride on a Therapeutic Antibody. ASCO Educational Book. 2012. Available from: http://www.asco.org/ASCOv2/Home/Education%20&%20Training/Educational%20Book/PDF%20Files/2012/zds00112000159.PDF
   Google Scholar
• A Multicenter Randomized Study to Compare the Combination Trastuzumab and Capecitabine With or Without Pertuzumab, as 2nd-line Treatment in Patients With HER2-positive Metastatic Breast Cancer That Has Progressed After Previous Treatment With Trastuzumab. PHEREXA trial, NCT01026142
   Google Scholar
• Rimawi MF, Poole CJ, Ferrero JM, Pertuzumab in combination with trastuzumab plus an aromatase inhibitor in patients with hormone receptor positive, HER2-positive metastatic breast cancer: A randomized phase II study (PERTAIN). 2012 ASCO Annual Meeting. J Clin Oncol 2012;30(Suppl):TPS654
   Google Scholar
• Sundaresan S, Roberts PE, King KL, Biological response to ErbB ligands in nontransformed cell lines correlates with a specific pattern of receptor expression. Endocrinology 1998;139(12):4756-64
   PubMed Web of Science ®Google Scholar