An integrated multiple-analyte pharmacokinetic model to characterize trastuzumab emtansine (T-DM1) clearance pathways and to evaluate reduced pharmacokinetic sampling in patients with HER2-positive metastatic breast cancer

Clinical Pharmacokinetics

Volumn 52, Issue 8, 2013, Pages 657-672

  Lu, Dan ^a   Joshi, Amita ^a   Wang, Bei ^a   Olsen, Steve ^a   Yi, Joo Hee ^a   Krop, Ian E ^b   Burris, Howard A ^c   Girish, Sandhya ^a  

^a GENENTECH INC   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c SARAH CANNON RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB EMTANSINE;

ARTICLE; BREAST CANCER; CATABOLISM; COMPARTMENT MODEL; DISTRIBUTION VOLUME; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG CONJUGATION; HUMAN; METASTASIS; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROTEIN DEGRADATION;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; FEMALE; HUMANS; MAYTANSINE; MODELS, BIOLOGICAL; RECEPTOR, ERBB-2; REPRODUCIBILITY OF RESULTS;

EID: 84877300886     PISSN: 03125963     EISSN: 11791926     Source Type: Journal    
DOI: 10.1007/s40262-013-0060-y     Document Type: Article

References (40)

1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin. 2012; 62(1):10-29.
2. Sjögren S, Inganäs M, Lindgren A, et al. Prognostic and predictive value of c-erbB-2 overexpression in primary breast cancer, alone and in combination with other prognostic markers. J Clin Oncol. 1998;16(2):462-9.
3. 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(4):320-68.
4. 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(1):92-8.
5. 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(4785):177-82.
6. Seshadri R, Firgaira FA, Horsfall DJ, et al. Clinical significance of HER-2/neu oncogene amplification in primary breast cancer. The South Australian Breast Cancer Study Group. J Clin Oncol. 1993;11(10):1936-42.
7. Gabos Z, Sinha R, Hanson J, et al. Prognostic significance of human epidermal growth factor receptor positivity for the development of brain metastases after newly diagnosed breast cancer. J Clin Oncol. 2006;24(36):5658-63.
8. 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):9280-90.
9. 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(2):347-56.
10. Barok M, Tanner M, Köninki K, et al. Trastuzumab-DM1 is highly effective in preclinical models of HER2-positive gastric cancer. Cancer Lett. 2011;306(2):171-9.
11. 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(4):398-405.
12. Krop I, 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):3234-41.
13. Hurvitz SA, Dirix L, Kocsis J, et al. A phase 2 randomized study of trastuzumab emtansine (T-DM1) versus trastuzumab + docetaxel in patients with HER2-positive metastatic breast cancer. J Clin Oncol. 2013;31(9):1157-63.
14. Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783-91.
15. Leipold D, Bender B, Xu K, et al. (2009). Understanding the de-conjugation of Trastuzumab-MCC-DM1 through application of a multi-compartmental model of individual drug:antibody species in cynomolgus monkey [abstract no. 2914]. American Association for Cancer Research (AACR) Meeting; 2009 Apr 18; Denver (CO).
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):1229-40.
17. Gupta M, LoRusso PM, Wang B, et al. Clinical implications of pathophysiological and demographic covariates on the population pharmacokinetics of trastuzumab-emtansine, a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer. J Clin Pharmacol. 2012;52(5):691-703.
18. Bruno R, Washington CB, Lu JF, et al. Population pharmacokinetics of trastuzumab in patients with HER2 + metastatic breast cancer. Cancer Chemother Pharmacol. 2005;56(4):361-9.
19. Kuester K, Kloft C. Pharmacokinetics of monoclonal antibodies. In: Meibohm B, editor. Pharmacokinetics and pharmacodynamics of biotech drugs. 1st ed. Weinheim (Germany): Wiley-VCH GmbH & Co. KGaA; 2006. p. 45-91.
20. 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):2698-704.
21. Gupta M, Wang B, Carrothers TJ, et al. Effects of trastuzumab emtansine (T-DM1) on QT interval and safety of pertuzumab plus T-DM1 in patients with previously treated human epidermal growth factor receptor 2-positive metastatic breast cancer. Clin Pharmacol Drug Devel. 2013 Feb 26 (E-pub)
22. Bonate PL. Pharmacokinetic-pharmacodynamic modeling and simulation. 2nd ed. New York: Springer; 2005.
23. Boeckman AJ, Beal SL, Sheiner LB, Beal. NONMEM User's Guide - Part IV (online). San Francisco (CA): NONMEM Project Group, University of California at San Francisco, 1992. Available from URL: ftp://nonmem.iconplc.com/Public/ nonmem720/guides/iv.pdf. Accessed 2012 Jul 18.
24. Rowland M, Tozer TN. Clinical pharmacokinetics: concepts and applications. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 1995.
25. Hooker AC, Staatz CE, Karlsson MO. Conditional weighted residuals (CWRES): a model diagnostic for the FOCE method. Pharm Res. 2007;24(12):2187-97.
26. Karlsson MO, Savic RM. Diagnosing model diagnostics. Clin Pharmacol Ther. 2007;82(1):17-20.
27. Raemer DB, Buschman A, Varvel JR, et al. The prospective use of population pharmacokinetics in a computer-driven infusion system for alfentanil. Anesthesiology. 1990;73(1):66-72.
28. Varvel JR, Donoho DL, Shafer SL. Measuring the predictive performance of computer-controlled infusion pumps. J Pharmacokinet Biopharm. 1992;20(1):63-94.
29. Savic RM, Karlsson MO. Importance of shrinkage in empirical bayes estimates for diagnostics: problems and solutions. AAPS J. 2009;11(3):558-69.
30. Fukushima Y, Charoin J-E. Report No. 1034069. Population pharmacokinetic analysis of combined Phase II/III studies: BO15899, BO15935, WO16229, M77004 and MO16982. Basel: Hoffman-La Roche, Inc.;2009. Data on file.
31. Meibohm B, editor. Pharmacokinetics and pharmacodynamics of biotech drugs: Principles and case studies in drug development. San Francisco: Wiley-VCH GmbH & Co.;2006.
32. Erickson HK, Widdison WC, Mayo MF, et al. Tumor delivery and in vivo processing of disulfide-linked and thioether-linked antibody-maytansinoid conjugates. Bioconjug Chem. 2010;21(1):84-92.
33. Shen BQ, Xu K, Liu L, et al. Conjugation site modulates the in vivo stability and therapeutic activity of antibody-drug conjugates. Nat Biotechnol. 2012;30(2):184-9.
34. Xie H, Audette C, Hoffee M, et al. Pharmacokinetics and biodistribution of the antitumor immunoconjugate, cantuzumab mertansine (huC242-DM1), and its two components in mice. J Pharmacol Exp Ther. 2004;308(3):1073-82.
35. Lu JF, Bruno R, Eppler S, et al. Clinical pharmacokinetics of bevacizumab in patients with solid tumors. Cancer Chemother Pharmacol. 2008;62(5):779-86.
36. 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(6):1275-84.
37. Li J, Zhi J, Wenger M, et al. Population pharmacokinetics of rituximab in patients with chronic lymphocytic leukemia. J Clin Pharmacol. 2012;52(12):1918-26.
38. Lobo ED, Hansen RJ, Blathasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93(11):2645-68.
39. Garzone PD, Atkinson AJ Jr. In search of physiologically based distribution volume estimates for macromolecules. Clin Pharmacol Ther. 2012;92(4):419-21.
40. Chudasama VL, Schaedeli Stark F, Harrold JM, et al. Semi-mechanistic population pharmacokinetic model of multivalent trastuzumab emtansine in patients with metastatic breast cancer. Clin Pharmacol Ther. 2012;92(4):520-7.