메뉴 건너뛰기




Volumn 19, Issue 7, 2014, Pages 766-773

The European medicines agency review of pertuzumab for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer: Summary of the scientific assessment of the committee for medicinal products for human use

Author keywords

Breast cancer; EMA; European medicines agency; Perjeta; Pertuzumab

Indexed keywords

DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GRANULOCYTE COLONY STIMULATING FACTOR; PERTUZUMAB; PLACEBO; RO 4368451; TRASTUZUMAB; UNCLASSIFIED DRUG; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

EID: 84903641743     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2013-0348     Document Type: Article
Times cited : (19)

References (19)
  • 1
    • 78049485263 scopus 로고    scopus 로고
    • Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008
    • Ferlay J, Shin HR, Bray F et al. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer 2010;127:2893-2917.
    • (2010) Int J Cancer , vol.127 , pp. 2893-2917
    • Ferlay, J.1    Shin, H.R.2    Bray, F.3
  • 2
    • 84874566782 scopus 로고    scopus 로고
    • European cancer mortality predictions for the year 2013
    • Malvezzi M, Bertuccio P, Levi F et al. European cancer mortality predictions for the year 2013. Ann Oncol 2013;24:792-800.
    • (2013) Ann Oncol , vol.24 , pp. 792-800
    • Malvezzi, M.1    Bertuccio, P.2    Levi, F.3
  • 3
    • 33644600485 scopus 로고    scopus 로고
    • Humanizationofarecombinantmonoclonalantibodytoproduce a therapeutic HER dimerization inhibitor, pertuzumab
    • Adams CW, Allison DE, Flagella K et al. Humanizationofarecombinantmonoclonalantibodytoproduce a therapeutic HER dimerization inhibitor, pertuzumab. Cancer Immunol Immunother 2006;55:717-727.
    • (2006) Cancer Immunol Immunother , vol.55 , pp. 717-727
    • Adams, C.W.1    Allison, D.E.2    Flagella, K.3
  • 4
    • 1842605531 scopus 로고    scopus 로고
    • Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex
    • Franklin MC, Carey KD, Vajdos FF et al. Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell 2004;5:317-328.
    • (2004) Cancer Cell , vol.5 , pp. 317-328
    • Franklin, M.C.1    Carey, K.D.2    Vajdos, F.F.3
  • 5
    • 1942474587 scopus 로고    scopus 로고
    • The HER-2-targeting antibodies trastuzumab and pertuzumab synergistically inhibit the survival of breast cancer cells
    • 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;64:2343-2346.
    • (2004) Cancer Res , vol.64 , pp. 2343-2346
    • Nahta, R.1    Hung, M.C.2    Esteva, F.J.3
  • 6
    • 73649149433 scopus 로고    scopus 로고
    • Strongly enhanced antitumor activity of trastuzumab and pertuzumab combination treatment on HER2-positive human xenograft tumor models
    • 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;69:9330-9336.
    • (2009) Cancer Res , vol.69 , pp. 9330-9336
    • Scheuer, W.1    Friess, T.2    Burtscher, H.3
  • 7
    • 33644591261 scopus 로고    scopus 로고
    • Dose-response studies of recombinant humanized monoclonal antibody 2C4 in tumor xenograft models [abstract 773]
    • Malik S, Totpal K, Balter I et al. Dose-response studies of recombinant humanized monoclonal antibody 2C4 in tumor xenograft models [abstract 773]. Proc Am Assoc Cancer Res 2003;44:150.
    • (2003) Proc Am Assoc Cancer Res , vol.44 , pp. 150
    • Malik, S.1    Totpal, K.2    Balter, I.3
  • 8
    • 36148966170 scopus 로고    scopus 로고
    • A phase Ib study of pertuzumab, a recombinant humanised antibody to HER2, and docetaxel in patients with advanced solid tumours
    • Attard G, Kitzen J, Blagden SP et al. 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: 1338-1343.
    • (2007) Br J Cancer , vol.97 , pp. 1338-1343
    • Attard, G.1    Kitzen, J.2    Blagden, S.P.3
  • 9
    • 77949900758 scopus 로고    scopus 로고
    • Clinical activity of gemcitabine plus pertuzumab in platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
    • Makhija S, Amler LC, Glenn D et al. Clinical activity of gemcitabine plus pertuzumab in platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. J Clin Oncol 2010;28:1215-1223.
    • (2010) J Clin Oncol , vol.28 , pp. 1215-1223
    • Makhija, S.1    Amler, L.C.2    Glenn, D.3
  • 10
    • 84867502679 scopus 로고    scopus 로고
    • A phase Ib, dose-finding study of erlotinib in combination with a fixed dose of pertuzumab in patients with advanced non-small-cell lung cancer
    • Felip E, Ranson M, Cedres S et al. A phase Ib, dose-finding study of erlotinib in combination with a fixed dose of pertuzumab in patients with advanced non-small-cell lung cancer. Clin Lung Cancer 2012;13:432-441.
    • (2012) Clin Lung Cancer , vol.13 , pp. 432-441
    • Felip, E.1    Ranson, M.2    Cedres, S.3
  • 11
    • 52049104951 scopus 로고    scopus 로고
    • A phase I study of the safety and pharmacokinetics of the combination of pertuzumab (rhuMab 2C4) and capecitabine in patients with advanced solid tumors
    • Albanell J, Montagut C, Jones ET et al. A phase I study of the safety and pharmacokinetics of the combination of pertuzumab (rhuMab 2C4) and capecitabine in patients with advanced solid tumors. Clin Cancer Res 2008;14:2726-2731.
    • (2008) Clin Cancer Res , vol.14 , pp. 2726-2731
    • Albanell, J.1    Montagut, C.2    Jones, E.T.3
  • 12
    • 20244378677 scopus 로고    scopus 로고
    • Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer
    • 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;23:2534-2543.
    • (2005) J Clin Oncol , vol.23 , pp. 2534-2543
    • Agus, D.B.1    Gordon, M.S.2    Taylor, C.3
  • 13
    • 33745343753 scopus 로고    scopus 로고
    • Rationale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysis
    • Ng CM, Lum BL, Gimenez V et al. Rationale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysis. Pharm Res 2006;23:1275-1284.
    • (2006) Pharm Res , vol.23 , pp. 1275-1284
    • Ng, C.M.1    Lum, B.L.2    Gimenez, V.3
  • 14
    • 33749003463 scopus 로고    scopus 로고
    • Clinical activity of pertuzumab (rhuMAb 2C4), a HER dimerization inhibitor, in advanced ovarian cancer: Potential predictive relationship with tumor HER2 activation status
    • Gordon MS, Matei D, Aghajanian C et al. 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: 4324-4332.
    • (2006) J Clin Oncol , vol.24 , pp. 4324-4332
    • Gordon, M.S.1    Matei, D.2    Aghajanian, C.3
  • 15
    • 33846927744 scopus 로고    scopus 로고
    • Openlabel phase II study evaluating the efficacy and safety of two doses of pertuzumab in castrate chemotherapy-naive patients with hormonerefractory prostate cancer
    • de Bono JS, Bellmunt J, Attard G et al. Openlabel phase II study evaluating the efficacy and safety of two doses of pertuzumab in castrate chemotherapy-naive patients with hormonerefractory prostate cancer. J Clin Oncol 2007;25: 257-262.
    • (2007) J Clin Oncol , vol.25 , pp. 257-262
    • de Bono, J.S.1    Bellmunt, J.2    Attard, G.3
  • 16
    • 84862914692 scopus 로고    scopus 로고
    • Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer
    • Baselga J, Cortes J, KimSB et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012;366: 109-119.
    • (2012) N Engl J Med , vol.366 , pp. 109-119
    • Baselga, J.1    Cortes, J.2    Kim, S.B.3
  • 17
    • 84882962589 scopus 로고    scopus 로고
    • Biomarker analyses in CLEOPATRA: A phase III, placebocontrolled study of pertuzumab in HER2-positive, first-linemetastaticbreastcancer (MBC)
    • Baselga J, Cortés J, Im SA et al. Biomarker analyses in CLEOPATRA: A phase III, placebocontrolled study of pertuzumab in HER2-positive, first-linemetastaticbreastcancer (MBC). Cancer Res 2012;72(suppl 3):S5-1.
    • (2012) Cancer Res , vol.72 , Issue.SUPPL. 3
    • Baselga, J.1    Cortés, J.2    Im, S.A.3
  • 18
    • 77954335295 scopus 로고    scopus 로고
    • Hematopoietic growth factors: ESMO Clinical Practice Guidelines for the applications
    • Crawford J, Caserta C, Roila F. Hematopoietic growth factors: ESMO Clinical Practice Guidelines for the applications. Ann Oncol 2010;21(suppl 5): v248-v251.
    • (2010) Ann Oncol , vol.21 , Issue.SUPPL. 5
    • Crawford, J.1    Caserta, C.2    Roila, F.3
  • 19
    • 84876970810 scopus 로고    scopus 로고
    • Pertuzumab, trastuzumab, anddocetaxel forHER2-positivemetastatic breastcancer(CLEOPATRAstudy):Overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study
    • Swain SM, Kim SB, Cortés J et al. Pertuzumab, trastuzumab, anddocetaxel forHER2-positivemetastatic breastcancer(CLEOPATRAstudy):Overall survival results from a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Oncol 2013;14:461-471.
    • (2013) Lancet Oncol , vol.14 , pp. 461-471
    • Swain, S.M.1    Kim, S.B.2    Cortés, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.