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Volumn 6, Issue 5, 2013, Pages 541-555

Preclinical and clinical pharmacokinetic/pharmacodynamic considerations for antibody–drug conjugates

Author keywords

antibody drug conjugates; calicheamicin; clinical pharmacokinetics; pharmacokinetic pharmacodynamic modeling; tubulin inhibitors

Indexed keywords

ANTIBODY CONJUGATE; ANTINEOPLASTIC AGENT; CAC10-VCMMAE; MAYTANSINE; MONOCLONAL ANTIBODY; TRASTUZUMAB EMTANSINE;

EID: 84893848111     PISSN: 17512433     EISSN: 17512441     Source Type: Journal    
DOI: 10.1586/17512433.2013.827405     Document Type: Review
Times cited : (33)

References (52)
  • 1
    • 84877580407 scopus 로고    scopus 로고
    • Monoclonal antibody-based therapies in cancer: Advances and challenges
    • Sapra P, Shor B. Monoclonal antibody-based therapies in cancer: Advances and challenges. Pharmacol. Ther. 138 (3), 452–469 (2013).
    • (2013) Pharmacol. Ther , vol.138 , Issue.3 , pp. 452-469
    • Sapra, P.1    Shor, B.2
  • 2
    • 0027093080 scopus 로고
    • Natural products which interact with tubulin in the vinca domain: maytansine, rhizoxin, phomopsin A, dolastatins 10 and 15 and halichondrin B
    • Hamel E. Natural products which interact with tubulin in the vinca domain: maytansine, rhizoxin, phomopsin A, dolastatins 10 and 15 and halichondrin B. Pharmacol. Ther. 55 (1), 31–51 (1992).
    • (1992) Pharmacol. Ther , vol.55 , Issue.1 , pp. 31-51
    • Hamel, E.1
  • 3
    • 77957711298 scopus 로고    scopus 로고
    • Preliminary results of southwest oncology group study S0106: An international intergroup phase 3 randomized trial comparing the addition of gemtuzumab ozogamicin to standard induction therapy versus standard induction therapy followed by a second randomization to post-consolidation gemtuzumab ozogamicin versus no additional therapy for previously untreated acute myeloid leukemia
    • abstract nr 790
    • Petersdorf S, Kopecky K, Stuart RK et al. Preliminary results of southwest oncology group study S0106: An international intergroup phase 3 randomized trial comparing the addition of gemtuzumab ozogamicin to standard induction therapy versus standard induction therapy followed by a second randomization to post-consolidation gemtuzumab ozogamicin versus no additional therapy for previously untreated acute myeloid leukemia. Blood (ASH Annual Meeting Abstracts) 114, abstract nr 790 (2009).
    • (2009) Blood (ASH Annual Meeting Abstracts) , vol.114
    • Petersdorf, S.1    Kopecky, K.2    Stuart, R.K.3
  • 4
    • 85027916323 scopus 로고    scopus 로고
    • Press Release, American Society of Hematology. FDA Announcement of Pfizer Voluntary Withdrawal of Cancer Treatment Mylotarg From U.S. Market. June 21
    • Press Release, American Society of Hematology. FDA Announcement of Pfizer Voluntary Withdrawal of Cancer Treatment Mylotarg From U.S. Market. June 21, 2010. [ http://www.hematology.org/News/2010/5381.aspx ]
    • (2010)
  • 5
    • 84859911350 scopus 로고    scopus 로고
    • Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study
    • Castaigne S, Pautas C, Terre C et al. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet 379 (9825), 1508–1516 (2012).
    • (2012) Lancet , vol.379 , Issue.9825 , pp. 1508-1516
    • Castaigne, S.1    Pautas, C.2    Terre, C.3
  • 6
    • 0035874504 scopus 로고    scopus 로고
    • Targeting of the CD33-calicheamicin immunoconjugate Mylotarg (CMA-676) in acute myeloid leukemia: in vivo and in vitro saturation and internalization by leukemic and normal myeloid cells
    • Van Der Velden VH, Te Marvelde JG, Hoogeveen PG et al. Targeting of the CD33-calicheamicin immunoconjugate Mylotarg (CMA-676) in acute myeloid leukemia: in vivo and in vitro saturation and internalization by leukemic and normal myeloid cells. Blood 97 (10), 3197–3204 (2001).
    • (2001) Blood , vol.97 , Issue.10 , pp. 3197-3204
    • Van Der Velden, V.H.1    Te Marvelde, J.G.2    Hoogeveen, P.G.3
  • 7
    • 13544266555 scopus 로고    scopus 로고
    • CD33-directed therapy with gemtuzumab ozogamicin in acute myeloid leukemia: progress in understanding cytotoxicity and potential mechanisms of drug resistance
    • Linenberger ML. CD33-directed therapy with gemtuzumab ozogamicin in acute myeloid leukemia: progress in understanding cytotoxicity and potential mechanisms of drug resistance. Leukemia 19 (2), 176–182 (2005).
    • (2005) Leukemia , vol.19 , Issue.2 , pp. 176-182
    • Linenberger, M.L.1
  • 8
    • 84863522871 scopus 로고    scopus 로고
    • Addition of gemtuzumab ozogamicin to induction chemotherapy improves survival in older patients with acute myeloid leukemia
    • Burnett AK, Russell NH, Hills RK et al. Addition of gemtuzumab ozogamicin to induction chemotherapy improves survival in older patients with acute myeloid leukemia. J. Clin. Oncol 30 (32), 3924–3931 (2012).
    • (2012) J. Clin. Oncol , vol.30 , Issue.32 , pp. 3924-3931
    • Burnett, A.K.1    Russell, N.H.2    Hills, R.K.3
  • 9
    • 79952099282 scopus 로고    scopus 로고
    • Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab ozogamicin: results of the MRC AML15 trial
    • Burnett AK, Hills RK, Milligan D et al. Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab ozogamicin: results of the MRC AML15 trial. J. Clin. Oncol. 29 (4), 369–377 (2011).
    • (2011) J. Clin. Oncol , vol.29 , Issue.4 , pp. 369-377
    • Burnett, A.K.1    Hills, R.K.2    Milligan, D.3
  • 10
    • 0035397980 scopus 로고    scopus 로고
    • Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse
    • Sievers EL, Larson RA, Stadtmauer EA et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J. Clin. Oncol. 19 (13), 3244–3254 (2001).
    • (2001) J. Clin. Oncol , vol.19 , Issue.13 , pp. 3244-3254
    • Sievers, E.L.1    Larson, R.A.2    Stadtmauer, E.A.3
  • 11
    • 0034770328 scopus 로고    scopus 로고
    • Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse
    • Dowell JA, Korth-Bradley J, Liu H, King SP, Berger MS. Pharmacokinetics of gemtuzumab ozogamicin, an antibody-targeted chemotherapy agent for the treatment of patients with acute myeloid leukemia in first relapse. J. Clin. Pharm. 41 (11), 1206–1214 (2001).
    • (2001) J. Clin. Pharm , vol.41 , Issue.11 , pp. 1206-1214
    • Dowell, J.A.1    Korth-Bradley, J.2    Liu, H.3    King, S.P.4    Berger, M.S.5
  • 12
    • 0034785696 scopus 로고    scopus 로고
    • Impact of age and gender on the pharmacokinetics of gemtuzumab ozogamicin
    • Korth-Bradley JM, Dowell JA, King SP, Liu H, Berger MS, Mylotarg Study G. Impact of age and gender on the pharmacokinetics of gemtuzumab ozogamicin. Pharmacotherapy 21 (10), 1175–1180 (2001).
    • (2001) Pharmacotherapy , vol.21 , Issue.10 , pp. 1175-1180
    • Korth-Bradley, J.M.1    Dowell, J.A.2    King, S.P.3    Liu, H.4    Berger, M.S.5
  • 13
    • 67449127005 scopus 로고    scopus 로고
    • Phase I/II study of humanized anti-CD33 antibody conjugated with calicheamicin, gemtuzumab ozogamicin, in relapsed or refractory acute myeloid leukemia: final results of Japanese multicenter cooperative study
    • Kobayashi Y, Tobinai K, Takeshita A et al. Phase I/II study of humanized anti-CD33 antibody conjugated with calicheamicin, gemtuzumab ozogamicin, in relapsed or refractory acute myeloid leukemia: final results of Japanese multicenter cooperative study. Int. J. Hematol. 89 (4), 460–469 (2009).
    • (2009) Int. J. Hematol , vol.89 , Issue.4 , pp. 460-469
    • Kobayashi, Y.1    Tobinai, K.2    Takeshita, A.3
  • 14
    • 3242749618 scopus 로고    scopus 로고
    • Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia
    • Buckwalter M, Dowell JA, Korth-Bradley J, Gorovits B, Mayer PR. Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia. J. Clin. Pharmacol. 44 (8), 873–880 (2004).
    • (2004) J. Clin. Pharmacol , vol.44 , Issue.8 , pp. 873-880
    • Buckwalter, M.1    Dowell, J.A.2    Korth-Bradley, J.3    Gorovits, B.4    Mayer, P.R.5
  • 15
    • 0033151526 scopus 로고    scopus 로고
    • Selective ablation of acute myeloid leukemia using antibody-targeted chemotherapy: a phase I study of an anti-CD33 calicheamicin immunoconjugate
    • Sievers EL, Appelbaum FR, Spielberger RT et al. Selective ablation of acute myeloid leukemia using antibody-targeted chemotherapy: a phase I study of an anti-CD33 calicheamicin immunoconjugate. Blood 93 (11), 3678–3684 (1999).
    • (1999) Blood , vol.93 , Issue.11 , pp. 3678-3684
    • Sievers, E.L.1    Appelbaum, F.R.2    Spielberger, R.T.3
  • 16
    • 77951648118 scopus 로고    scopus 로고
    • Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin’s lymphoma: results of a phase I study
    • Advani A, Coiffier B, Czuczman MS et al. Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin’s lymphoma: results of a phase I study. J. Clin. Oncol. 28 (12), 2085–2093 (2010).
    • (2010) J. Clin. Oncol , vol.28 , Issue.12 , pp. 2085-2093
    • Advani, A.1    Coiffier, B.2    Czuczman, M.S.3
  • 17
    • 84875434050 scopus 로고    scopus 로고
    • Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab
    • Fayad L, Offner F, Smith MR et al. Safety and clinical activity of a combination therapy comprising two antibody-based targeting agents for the treatment of non-Hodgkin lymphoma: results of a phase I/II study evaluating the immunoconjugate inotuzumab ozogamicin with rituximab. J. Clin. Oncol. 31 (5), 573–583 (2013).
    • (2013) J. Clin. Oncol , vol.31 , Issue.5 , pp. 573-583
    • Fayad, L.1    Offner, F.2    Smith, M.R.3
  • 18
    • 0035730322 scopus 로고    scopus 로고
    • General pharmacokinetic model for drugs exhibiting target-mediated drug disposition
    • Mager DE, Jusko WJ. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J. Oharmacokinet. Pharmacodyn. 28 (6), 507–532 (2001).
    • (2001) J. Oharmacokinet. Pharmacodyn , vol.28 , Issue.6 , pp. 507-532
    • Mager, D.E.1    Jusko, W.J.2
  • 19
    • 0036137093 scopus 로고    scopus 로고
    • Pharmacokinetics of murine anti-human CD3 antibodies in man are determined by the disappearance of target antigen
    • Meijer RT, Koopmans RP, Ten Berge IJ, Schellekens PT. Pharmacokinetics of murine anti-human CD3 antibodies in man are determined by the disappearance of target antigen. J. Pharmacol. Exp. Ther. 300 (1), 346–353 (2002).
    • (2002) J. Pharmacol. Exp. Ther , vol.300 , Issue.1 , pp. 346-353
    • Meijer, R.T.1    Koopmans, R.P.2    Ten Berge, I.J.3    Schellekens, P.T.4
  • 20
    • 0037115430 scopus 로고    scopus 로고
    • Model of chemotherapy-induced myelosuppression with parameter consistency across drugs
    • Friberg LE, Henningsson A, Maas H, Nguyen L, Karlsson MO. Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. J. Clin. Oncol. 20 (24), 4713–4721 (2002).
    • (2002) J. Clin. Oncol , vol.20 , Issue.24 , pp. 4713-4721
    • Friberg, L.E.1    Henningsson, A.2    Maas, H.3    Nguyen, L.4    Karlsson, M.O.5
  • 21
    • 85027916106 scopus 로고    scopus 로고
    • Use of pharmacokinetic-pharmacodynamic modeling to characterize platelet response following inotuzumab ozogamicin treatment in patients with follicular or diffuse large B-cell non-Hodgkin’s lymphoma
    • abstract nr 3767
    • Mugundu G, Vandendries E, Boni J. Use of pharmacokinetic-pharmacodynamic modeling to characterize platelet response following inotuzumab ozogamicin treatment in patients with follicular or diffuse large B-cell non-Hodgkin’s lymphoma. Cancer Res. 72 (Suppl. 8), abstract nr 3767 (2012).
    • (2012) Cancer Res , vol.72
    • Mugundu, G.1    Vandendries, E.2    Boni, J.3
  • 22
    • 85027916299 scopus 로고    scopus 로고
    • Antitumor response to inotuzumab ozogamicin (INO) in patients with refractory or relapsed indolent B-cell non-Hodgkin’s lymphomas (NHL): Pharmacokinetic-pharmacodynamic (PK-PD) modeling and interim results from a phase II study
    • abstract nr 3776
    • Luu K, Vandendries E, Volkert A, Ogura M, Goy A, Boni J. Antitumor response to inotuzumab ozogamicin (INO) in patients with refractory or relapsed indolent B-cell non-Hodgkin’s lymphomas (NHL): Pharmacokinetic-pharmacodynamic (PK-PD) modeling and interim results from a phase II study. Cancer Res. 72 (Suppl. 8), abstract nr 3776 (2012).
    • (2012) Cancer Res , vol.72
    • Luu, K.1    Vandendries, E.2    Volkert, A.3    Ogura, M.4    Goy, A.5    Boni, J.6
  • 23
    • 84862786326 scopus 로고    scopus 로고
    • Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study
    • Kantarjian H, Thomas D, Jorgensen J et al. Inotuzumab ozogamicin, an anti-CD22-calecheamicin conjugate, for refractory and relapsed acute lymphocytic leukaemia: a phase 2 study. Lancet Oncol. 13 (4), 403–411 (2012).
    • (2012) Lancet Oncol , vol.13 , Issue.4 , pp. 403-411
    • Kantarjian, H.1    Thomas, D.2    Jorgensen, J.3
  • 24
    • 84880849517 scopus 로고    scopus 로고
    • Experience with 2 dose schedules of inotuzumab ozogamicin, single dose, and weekly, in refractory-relapsed Acute Lymphocytic Leukemia (ALL)
    • O’Brien S, Thomas DA, Jorgensen JL et al. Experience with 2 dose schedules of inotuzumab ozogamicin, single dose, and weekly, in refractory-relapsed Acute Lymphocytic Leukemia (ALL). ASH Ann. Meet. Abstr. 120 (21), 671 (2012).
    • (2012) ASH Ann. Meet. Abstr , vol.120 , Issue.21 , pp. 671
    • O’Brien, S.1    Thomas, D.A.2    Jorgensen, J.L.3
  • 25
    • 80054018330 scopus 로고    scopus 로고
    • + rituximab in relapsed DLBCL patients followed by stem cell transplantation: Preliminary safety and efficacy
    • + rituximab in relapsed DLBCL patients followed by stem cell transplantation: Preliminary safety and efficacy. ASH Ann. Meet. Abstr. 116 (21), 2883 - (2010).
    • (2010) ASH Ann. Meet. Abstr , vol.116 , Issue.21 , pp. 2883
    • Wagner-Johnston, N.1    Goy, A.2    Feldman, T.3
  • 26
    • 84875956517 scopus 로고    scopus 로고
    • An Open-Label, Phase I study of R-CVP in combination with inotuzumab ozogamicin in patients with relapsed/refractory CD22-positive B-cell non-hodgkin lymphoma
    • Ogura M, Uchida T, Macdonald DA et al. An Open-Label, Phase I study of R-CVP in combination with inotuzumab ozogamicin in patients with relapsed/refractory CD22-positive B-cell non-hodgkin lymphoma. ASH Ann. Meet. Abstr. 118 (21), 3715 - (2011).
    • (2011) ASH Ann. Meet. Abstr , vol.118 , Issue.21 , pp. 3715
    • Ogura, M.1    Uchida, T.2    Macdonald, D.A.3
  • 27
    • 84868561570 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymphoma
    • De Claro RA, Mcginn K, Kwitkowski V et al. U.S. Food and Drug Administration approval summary: brentuximab vedotin for the treatment of relapsed Hodgkin lymphoma or relapsed systemic anaplastic large-cell lymphoma. Clin. Cancer Res. 18 (21), 5845–5849 (2012).
    • (2012) Clin. Cancer Res , vol.18 , Issue.21 , pp. 5845-5849
    • De Claro, R.A.1    Mcginn, K.2    Kwitkowski, V.3
  • 28
    • 78049515807 scopus 로고    scopus 로고
    • Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas
    • Younes A, Bartlett NL, Leonard JP et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N. Engl. J. Med. 363 (19), 1812–1821 (2010).
    • (2010) N. Engl. J. Med , vol.363 , Issue.19 , pp. 1812-1821
    • Younes, A.1    Bartlett, N.L.2    Leonard, J.P.3
  • 29
    • 84855465227 scopus 로고    scopus 로고
    • A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies
    • Fanale MA, Forero-Torres A, Rosenblatt JD et al. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin. Cancer Res. 18 (1), 248–255 (2012).
    • (2012) Clin. Cancer Res , vol.18 , Issue.1 , pp. 248-255
    • Fanale, M.A.1    Forero-Torres, A.2    Rosenblatt, J.D.3
  • 30
    • 84863676500 scopus 로고    scopus 로고
    • Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin’s lymphoma
    • Younes A, Gopal AK, Smith SE et al. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin’s lymphoma. J. Clin. Oncol. 30 (18), 2183–2189 (2012).
    • (2012) J. Clin. Oncol , vol.30 , Issue.18 , pp. 2183-2189
    • Younes, A.1    Gopal, A.K.2    Smith, S.E.3
  • 31
    • 84863678237 scopus 로고    scopus 로고
    • Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study
    • Pro B, Advani R, Brice P et al. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J. Clin. Oncol. 30 (18), 2190–2196 (2012).
    • (2012) J. Clin. Oncol , vol.30 , Issue.18 , pp. 2190-2196
    • Pro, B.1    Advani, R.2    Brice, P.3
  • 32
    • 84861478656 scopus 로고    scopus 로고
    • Frontline therapy with brentuximab vedotin combined with ABVD or AVD in patients with newly diagnosed advanced stage Hodgkin lymphoma
    • abstract 955
    • Younes A, Connors JM, Park SI, Hunder NNH, Ansell SM. Frontline therapy with brentuximab vedotin combined with ABVD or AVD in patients with newly diagnosed advanced stage Hodgkin lymphoma. Blood (ASH Annual Meeting Abstracts) 118, abstract 955 (2011).
    • (2011) Blood (ASH Annual Meeting Abstracts) , pp. 118
    • Younes, A.1    Connors, J.M.2    Park, S.I.3    Hunder, N.N.H.4    Ansell, S.M.5
  • 33
    • 84863522501 scopus 로고    scopus 로고
    • Brentuximab vedotin enables successful reduced-intensity allogeneic hematopoietic cell transplantation in patients with relapsed or refractory Hodgkin lymphoma
    • Chen R, Palmer JM, Thomas SH et al. Brentuximab vedotin enables successful reduced-intensity allogeneic hematopoietic cell transplantation in patients with relapsed or refractory Hodgkin lymphoma. Blood 119 (26), 6379–6381 (2012).
    • (2012) Blood , vol.119 , Issue.26 , pp. 6379-6381
    • Chen, R.1    Palmer, J.M.2    Thomas, S.H.3
  • 34
    • 33645736326 scopus 로고    scopus 로고
    • Peripheral neuropathy induced by microtubule-stabilizing agents
    • Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule-stabilizing agents. J. Clin. Oncol. 24 (10), 1633–1642 (2006).
    • (2006) J. Clin. Oncol , vol.24 , Issue.10 , pp. 1633-1642
    • Lee, J.J.1    Swain, S.M.2
  • 35
    • 52949122818 scopus 로고    scopus 로고
    • Neuropathy associated with microtubule inhibitors: diagnosis, incidence, and management
    • Swain SM, Arezzo JC. Neuropathy associated with microtubule inhibitors: diagnosis, incidence, and management. Clin. Adv. Hematol. Oncol. 6 (6), 455–467 (2008).
    • (2008) Clin. Adv. Hematol. Oncol , vol.6 , Issue.6 , pp. 455-467
    • Swain, S.M.1    Arezzo, J.C.2
  • 36
    • 77954031486 scopus 로고    scopus 로고
    • Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer
    • 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. 28 (16), 2698–2704 (2010).
    • (2010) J. Clin. Oncol , vol.28 , Issue.16 , pp. 2698-2704
    • Krop, I.E.1    Beeram, M.2    Modi, S.3
  • 37
    • 84869508508 scopus 로고    scopus 로고
    • A phase 1 study of weekly dosing of trastuzumab emtansine (T-DM1) in patients with advanced human epidermal growth factor 2-positive breast cancer
    • 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 118 (23), 5733–5740. (2012).
    • (2012) Cancer , vol.118 , Issue.23 , pp. 5733-5740
    • Beeram, M.1    Krop, I.E.2    Burris, H.A.3
  • 38
    • 79952092706 scopus 로고    scopus 로고
    • 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
    • Burris HA, 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. 29 (4), 398–405 (2011).
    • (2011) J. Clin. Oncol , vol.29 , Issue.4 , pp. 398-405
    • Burris, H.A.1    Rugo, H.S.2    Vukelja, S.J.3
  • 39
    • 84863688392 scopus 로고    scopus 로고
    • 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
    • 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. 30 (26), 3234–3241 (2012).
    • (2012) J. Clin. Oncol , vol.30 , Issue.26 , pp. 3234-3241
    • Krop, I.E.1    Lorusso, P.2    Miller, K.D.3
  • 40
    • 84876011018 scopus 로고    scopus 로고
    • Phase II randomized study of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer
    • 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. 31 (9), 1157–1163 (2013).
    • (2013) J. Clin. Oncol , vol.31 , Issue.9 , pp. 1157-1163
    • Hurvitz, S.A.1    Dirix, L.2    Kocsis, J.3
  • 41
    • 84868520609 scopus 로고    scopus 로고
    • Trastuzumab emtansine for HER2-positive advanced breast cancer
    • Verma S, Miles D, Gianni L et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N. Engl. J. Med. 367 (19), 1783–1791 (2012).
    • (2012) N. Engl. J. Med , vol.367 , Issue.19 , pp. 1783-1791
    • Verma, S.1    Miles, D.2    Gianni, L.3
  • 42
    • 84867571080 scopus 로고    scopus 로고
    • A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer
    • Bender BC, Schaedeli-Stark F, Koch R et al. A population pharmacokinetic/pharmacodynamic model of thrombocytopenia characterizing the effect of trastuzumab emtansine (T-DM1) on platelet counts in patients with HER2-positive metastatic breast cancer. Cancer Chemother. Pharm. 70 (4), 591–601 (2012).
    • (2012) Cancer Chemother. Pharm , vol.70 , Issue.4 , pp. 591-601
    • Bender, B.C.1    Schaedeli-Stark, F.2    Koch, R.3
  • 43
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat. Rev. Drug Discov. 3 (8), 711–715 (2004).
    • (2004) Nat. Rev. Drug Discov , vol.3 , Issue.8 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 44
    • 79955601786 scopus 로고    scopus 로고
    • Trial watch: Phase II failures: 2008–2010
    • Arrowsmith J. Trial watch: Phase II failures: 2008–2010. Nat. Rev. Drug Discov. 10 (5), 328–329 (2011).
    • (2011) Nat. Rev. Drug Discov , vol.10 , Issue.5 , pp. 328-329
    • Arrowsmith, J.1
  • 45
    • 41549136895 scopus 로고    scopus 로고
    • PK/PD modelling and simulations: utility in drug development
    • Rajman I. PK/PD modelling and simulations: utility in drug development. Drug Discov. Today 13 (7–8), 341–346 (2008).
    • (2008) Drug Discov. Today , vol.13 , Issue.7-8 , pp. 341-346
    • Rajman, I.1
  • 46
    • 65249191379 scopus 로고    scopus 로고
    • Quantitative disease, drug, and trial models
    • Gobburu JV, Lesko LJ. Quantitative disease, drug, and trial models. Ann. Rev. Pharm. Toxicol. 49, 291–301 (2009).
    • (2009) Ann. Rev. Pharm. Toxicol , vol.49 , pp. 291-301
    • Gobburu, J.V.1    Lesko, L.J.2
  • 47
    • 77950535995 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic reasoning in drug discovery and early development
    • Van Der Graaf PH, Gabrielsson J. Pharmacokinetic-pharmacodynamic reasoning in drug discovery and early development. Fut. Med. Chem. 1 (8), 1371–1374 (2009).
    • (2009) Fut. Med. Chem , vol.1 , Issue.8 , pp. 1371-1374
    • Van Der Graaf, P.H.1    Gabrielsson, J.2
  • 48
    • 36549073194 scopus 로고    scopus 로고
    • The role of mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modelling in translational research of biologics
    • Agoram BM, Martin SW, Van Der Graaf PH. The role of mechanism-based pharmacokinetic-pharmacodynamic (PK-PD) modelling in translational research of biologics. Drug Discov. Today 12 (23–24), 1018–1024 (2007).
    • (2007) Drug Discov. Today , vol.12 , Issue.23-24 , pp. 1018-1024
    • Agoram, B.M.1    Martin, S.W.2    Van Der Graaf, P.H.3
  • 49
    • 77956759089 scopus 로고    scopus 로고
    • Modeling the efficacy of trastuzumab-DM1, an antibody drug conjugate, in mice
    • Jumbe NL, Xin Y, Leipold DD et al. Modeling the efficacy of trastuzumab-DM1, an antibody drug conjugate, in mice. J. Pharm. Pharm. 37 (3), 221–242 (2010).
    • (2010) J. Pharm. Pharm , vol.37 , Issue.3 , pp. 221-242
    • Jumbe, N.L.1    Xin, Y.2    Leipold, D.D.3
  • 50
    • 0842282616 scopus 로고    scopus 로고
    • Predictive pharmacokinetic-pharmacodynamic modeling of tumor growth kinetics in xenograft models after administration of anticancer agents
    • Simeoni M, Magni P, Cammia C et al. Predictive pharmacokinetic-pharmacodynamic modeling of tumor growth kinetics in xenograft models after administration of anticancer agents. Cancer Res. 64 (3), 1094–1101 (2004).
    • (2004) Cancer Res , vol.64 , Issue.3 , pp. 1094-1101
    • Simeoni, M.1    Magni, P.2    Cammia, C.3
  • 51
    • 84885643512 scopus 로고    scopus 로고
    • On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: a PK/PD approach
    • (In Press).
    • Haddish-Berhane N, Shah DK, Ma D et al. On translation of antibody drug conjugates efficacy from mouse experimental tumors to the clinic: a PK/PD approach. J. Pharm. Pharm. (2013) (In Press).
    • (2013) J. Pharm. Pharm
    • Haddish-Berhane, N.1    Shah, D.K.2    Ma, D.3
  • 52
    • 84880733804 scopus 로고    scopus 로고
    • Bench to bedside translation of antibody drug conjugates using a multiscale mechanistic PK/PD model: a case study with brentuximab-vedotin
    • Shah DK, Haddish-Berhane N, Betts A. Bench to bedside translation of antibody drug conjugates using a multiscale mechanistic PK/PD model: a case study with brentuximab-vedotin. J. Pharm. Pharm. 39 (6), 643–659 (2012).
    • (2012) J. Pharm. Pharm , vol.39 , Issue.6 , pp. 643-659
    • Shah, D.K.1    Haddish-Berhane, N.2    Betts, A.3


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