Exposure-response relationship of T-DM1: Insight into dose optimization for patients with HER2-positive metastatic breast cancer

Clinical Pharmacology and Therapeutics

Volumn 95, Issue 5, 2014, Pages 558-564

  Wang, J ^a   Song, P ^a   Schrieber, S ^a   Liu, Q ^a   Xu, Q ^a   Blumenthal, G ^a   Amiri Kordestani, L ^a   Cortazar, P ^a   Ibrahim, A ^a   Justice, R ^a   Wang, Y ^a   Tang, S ^a   Booth, B ^a   Mehrotra, N ^a   Rahman, A ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; TRASTUZUMAB EMTANSINE;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BREAST CANCER; BREAST METASTASIS; CANCER CHEMOTHERAPY; CANCER SURVIVAL; DRUG EFFICACY; DRUG EXPOSURE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; LIVER TOXICITY; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROCESS OPTIMIZATION; PROGRESSION FREE SURVIVAL; RISK FACTOR; THROMBOCYTOPENIA; TUMOR VOLUME;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FLUOROURACIL; HUMANS; KAPLAN-MEIER ESTIMATE; MAYTANSINE; MIDDLE AGED; NEOPLASM METASTASIS; QUINAZOLINES; RECEPTOR, ERBB-2; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 84899437672     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2014.24     Document Type: Article

References (31)

1. Verma, S. et al.; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N. Engl. J. Med. 367, 1783-1791 (2012).
2. Girish, S. 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. 69, 1229-1240 (2012).
3. Alberts, S.R. et al. Gemcitabine and ISIS-2503 for patients with locally advanced or metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group phase II trial. J. Clin. Oncol. 22, 4944-4950 (2004). (Pubitemid 46638619)
4. Krop, I.E. 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, 2698-2704 (2010).
5. The FDA Guidance for Industry: Exposure-Response Relationships - Study Design, Data Analysis, and Regulatory Applications. 〈http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072109. pdf〉 (2003).
6. Berinstein, N.L. et al. Association of serum Rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Ann. Oncol. 9, 995-1001 (1998). (Pubitemid 28496709)
7. Delbaldo, C. et al. Pharmacokinetic-pharmacodynamic relationships of imatinib and its main metabolite in patients with advanced gastrointestinal stromal tumors. Clin. Cancer Res. 12, 6073-6078 (2006). (Pubitemid 44703771)
8. Fracasso, P.M. et al. A phase 1 escalating single-dose and weekly fxed-dose study of cetuximab: pharmacokinetic and pharmacodynamic rationale for dosing. Clin. Cancer Res. 13, 986-993 (2007). (Pubitemid 46340377)
9. Houk, B.E., Bello, C.L., Poland, B., Rosen, L.S., Demetri, G.D. & Motzer, R.J. Relationship between exposure to sunitinib and efcacy and tolerability endpoints in patients with cancer: results of a pharmacokinetic/pharmacodynamic meta-analysis. Cancer Chemother. Pharmacol. 66, 357-371 (2010).
10. Hudes, G. et al.; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N. Engl. J. Med. 356, 2271-2281 (2007). (Pubitemid 46849157)
11. Larson, R.A. et al. Population pharmacokinetic and exposure-response analysis of nilotinib in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase. Eur. J. Clin. Pharmacol. 68, 723-733 (2012).
12. Picard, S. et al. Trough imatinib plasma levels are associated with both cytogenetic and molecular responses to standard-dose imatinib in chronic myeloid leukemia. Blood 109, 3496-3499 (2007). (Pubitemid 46572540)
13. Soulieres, D., Senzer, N.N., Vokes, E.E., Hidalgo, M., Agarwala, S.S. & Siu, L.L. Multicenter phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J. Clin. Oncol. 22, 77-85 (2004). (Pubitemid 41095117)
14. Tabernero, J. et al. Dose-and schedule-dependent inhibition of the mammalian target of rapamycin pathway with everolimus: a phase I tumor pharmacodynamic study in patients with advanced solid tumors. J. Clin. Oncol. 26, 1603-1610 (2008).
15. Thornton, K. et al. Vandetanib for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease: U.S. Food and Drug Administration drug approval summary. Clin. Cancer Res. 18, 3722-3730 (2012).
16. Yang, J. et al. The combination of exposure-response and case-control analyses in regulatory decision making. J. Clin. Pharmacol. 53, 160-166 (2013).
17. The US FDA Clinical Pharmacology and Biopharmaceutics Review for KADCyLA (Ado-trastuzumab Emtansine, T-DM1). 〈http://www.accessdata.fda. gov/drugsatfda-docs/nda/2013/125427Orig1s000ClinPharmR.pdf〉 (2013).
18. Esteva, F.J. et al. Phase II study of weekly docetaxel and trastuzumab for patients with HER-2-overexpressing metastatic breast cancer. J. Clin. Oncol. 20, 1800-1808 (2002). (Pubitemid 34273269)
19. Finn, R.S., Gagnon, R., Di Leo, A., Press, M.F., Arbushites, M. & Koehler, M. Prognostic and predictive value of HER2 extracellular domain in metastatic breast cancer treated with lapatinib and paclitaxel in a randomized phase III study. J. Clin. Oncol. 27, 5552-5558 (2009).
20. Fornier, M.N. et al. Serum HER2 extracellular domain in metastatic breast cancer patients treated with weekly trastuzumab and paclitaxel: association with HER2 status by immunohistochemistry and fuorescence in situ hybridization and with response rate. Ann. Oncol. 16, 234-239 (2005). (Pubitemid 40309302)
21. Fridlyand, J., Kaiser, L.D. & Fyfe, G. Analysis of tumor burden versus progression-free survival for Phase II decision making. Contemp. Clin. Trials 32, 446-452 (2011).
22. Sørensen, J.B., Klee, M., Palshof, T. & Hansen, H.H. Performance status assessment in cancer patients. An inter-observer variability study. Br. J. Cancer 67, 773-775 (1993). (Pubitemid 23101557)
23. The US FDA Clinical Review for KADCyLA (Ado-trastuzumab Emtansine, T-DM1). 〈http://www.accessdata.fda.gov/drugsatfda-docs/nda/2013/ 125427Orig1s000MedR.pdf〉 (2013).
24. Gao, B., yeap, S., Clements, A., Balakrishnar, B., Wong, M. & Gurney, H. Evidence for therapeutic drug monitoring of targeted anticancer therapies. J. Clin. Oncol. 30, 4017-4025 (2012).
25. Beeram, M. 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, 5733-5740 (2012).
26. Sawyer, M. & Ratain, M.J. Body surface area as a determinant of pharmacokinetics and drug dosing. Invest. New Drugs 19, 171-177 (2001). (Pubitemid 32423722)
27. Wang, D.D., Zhang, S., Zhao, H., Men, A.y. & Parivar, K. Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J. Clin. Pharmacol. 49, 1012-1024 (2009).
28. Gupta, M. 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. 52, 691-703 (2012).
29. Roche, H.-L. A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With HER2-Positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-Directed Therapy (TH3RESA). 〈http://clinicaltrials.gov/ct2/show/NCT01419197〉 NLM Identifer: NCT01419197. (2013). Accessed 17 October 2013.
30. Kalbfeisch, J.D. & Prentice, R.L. The Statistical Analysis of Failure Time Data. 2nd edn. (John Wiley and Sons, New york, 2002).
31. Govindarajulu, U.S., Malloy, E.J., Ganguli, B., Spiegelman, D. & Eisen, E.A. The comparison of alternative smoothing methods for ftting non-linear exposure-response relationships with Cox models in a simulation study. Int. J. Biostat. 5, Article 2 (2009).