Absence of pharmacokinetic drug-drug interaction of pertuzumab with trastuzumab and docetaxel

Anti-Cancer Drugs

Volumn 24, Issue 10, 2013, Pages 1084-1092

  Cortés, Javier ^a   Swain, Sandra M ^b   Kudaba, Iveta ^f   Hauschild, Maik ^h   Patel, Taral ^c   Grincuka, Elza ^g   Masuda, Norikazu ⁱ   McNally, Virginia ^j   Ross, Graham ^j   Brewster, Mike ^j   Marier, Jean François ^k   Trinh, My My ^k   Garg, Amit ^d   Nijem, Ihsan ^d   Visich, Jennifer ^d   Lum, Bert L ^d   Baselga, José ^e  

^a VALL D HEBRON UNIVERSITY HOSPITAL   (Spain)

^b WASHINGTON CANCER INSTITUTE   (United States)

^c Mid Ohio Oncology Hematology   (United States)

^d GENENTECH INC   (United States)

^e MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^f RIGA EAST UNIVERSITY HOSPITAL   (Latvia)

^g Daugavpils Reǵionala Slimnica ^*  (Latvia)

^h Gesundheitszentrum Fricktal   (Switzerland)

ⁱ OSAKA NATIONAL HOSPITAL   (Japan)

^j ROCHE PRODUCTS LTD   (United Kingdom)

^k Pharsight   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; PERTUZUMAB; PLACEBO; TRASTUZUMAB;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; BODY HEIGHT; BODY WEIGHT; BREAST METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CLINICAL ARTICLE; CONTINUOUS INFUSION; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG DRUG INTERACTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG INTERACTION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HUMAN; LIMIT OF QUANTITATION; MAINTENANCE DRUG DOSE; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SENSITIVITY ANALYSIS; STEADY STATE;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; FEMALE; HUMANS; MIDDLE AGED; MODELS, BIOLOGICAL; NEOPLASM METASTASIS; RECEPTOR, ERBB-2; TAXOIDS;

EID: 84885390952     PISSN: 09594973     EISSN: 14735741     Source Type: Journal    
DOI: 10.1097/CAD.0000000000000016     Document Type: Article

References (31)

1. Agus DB, Akita RW, Fox WD, Lewis GD, Higgins B, Pisacane PI, et al. Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell 2002; 2:127-137.
2. Adams CW, Allison De , Flagella K, Presta L, Clarke J, Dybdal N, et al. Humanization of a recombinant monoclonal antibody to produce a therapeutic HER dimerization inhibitor, pertuzumab. Cancer Immunol Immunother 2006; 55:717-727.
3. Scheuer W, Friess T, Burtscher H, Bossenmaier B, Endl J, Hasmann M. Strongly enhanced antitumor activity of trastuzumab and pertuzumab combination treatment on HER2-positive human xenograft tumor models. Cancer Res 2009; 69:9330-9336.
4. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology: breast cancer. Pennsylvania, USA: National Comprehensive Cancer Network (NCCN); 2012.
5. Molina MA, Codony-Servat J, Albanell J, Rojo F, Arribas J, Baselga J. Trastuzumab (herceptin), a humanized anti-Her2 receptor monoclonal antibody, inhibits basal and activated Her2 ectodomain cleavage in breast cancer cells. Cancer Res 2001; 61: 4744-4749.
6. Junttila TT, Akita RW, Parsons K, Fields C, Lewis Phillips GD, Friedman LS, et al. Ligand-independent HER2/HER3/PI3K complex is disrupted by trastuzumab and is effectively inhibited by the PI3K inhibitor GDC-0941. Cancer Cell 2009; 15:429-440.
7. Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012; 366:109-119.
8. Swain SM, Kim SB, Cortes J, Ro J, Semiglazov V, Campone M, et al. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA study): Overall survival results from a randomised, double-blind, placebo-controlled, phase study. Lancet Oncol 2013; 14:461-471.
9. Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, et al. 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 trial. Lancet Oncol 2012; 13:25-32.
10. Seitz K, Zhou H. Pharmacokinetic drug-drug interaction potentials for therapeutic monoclonal antibodies: Reality check. J Clin Pharmacol 2007; 47:1104-1118.
11. US Food and Drug Administration. Drug interaction studies-study De sign, data analysis, implications for dosing, and labeling recommendations (draft guidance), 2012. Maryland, USA: US Food and Drug Administration; 2012.
12. Cho HS, Mason K, Ramyar KX, Stanley AM, Gabelli SB, De nney DWJr, et al. Structure of the extracellular region of HER2 alone and in complex with the Herceptin Fab. Nature 2003; 421:756-760.
13. Franklin MC, Carey KD, Vajdos FF, Leahy DJ, Devos AM, Sliwkowski MX. Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell 2004; 5:317-328.
14. Royer I, Monsarrat B, Sonnier M, Wright M, Cresteil T. Metabolism of docetaxel by human cytochromes P450: Interactions with paclitaxel and other antineoplastic drugs. Cancer Res 1996; 56:58-65.
15. Baker SD, Sparreboom A, Verweij J. Clinical pharmacokinetics of docetaxel: Recent developments. Clin Pharmacokinet 2006; 45:235-252.
16. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 2010; 49:493-507.
17. Attard G, Kitzen J, Blagden SP, Fong PC, Pronk LC, Zugmaier G, 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.
18. Garg A, Li J, Clark E, Knott A, Carrothers TJ, Aeschliman D, et al. Exposureresponse (E-R) analysis of pertuzumab (Ptz) in patients with HER2-positive (HER2+) metastatic breast cancer (MBC): Effect on QTc prolongation and other ECG parameters. Clin Pharmacol Ther 2013; 1): S14-S48.
19. Gabrielsson J, Weiner D. Pharmacokinetic & pharmacodynamic data analysis: Concepts and applications. 4th ed. Stockholm: Swedish Pharmaceutical Press; 2006.
20. Ng CM, Lum BL, Gimenez V, Kelsey S, Allison D. Rationale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysis. Pharm Res 2006; 23:1275-1284.
21. Garg A, Li J, Jin J, Wada DR, Li H, Quartino A, et al. Population pharmacokinetic analysis of pertuzumab in patients with cancer: Rationale for fixed, non-weight-based dosing [in preparation].
22. Malik MA, Totpal K, Balter I, Sliwkowski MX, Pelletier N, Reich M, 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.
23. Bruno R, Vivier N, Vergniol JC, De Phillips SL, Montay G, Sheiner LB. A population pharmacokinetic model for docetaxel (Taxotere): Model building and validation. J Pharmacokinet Biopharm 1996; 24:153-172.
24. Clarke SJ, Rivory LP. Clinical pharmacokinetics of docetaxel. Clin Pharmacokinet 1999; 36:99-114.
25. McLeod HL. Clinically relevant drug-drug interactions in oncology. Br J Clin Pharmacol 1998; 45:539-544.
26. Zhou H, Mascelli MA. Mechanisms of monoclonal antibody-drug interactions. Annu Rev Pharmacol Toxicol 2011; 51:359-372.
27. Lu D, Burris HA III, Wang B, De es EC, Cortes J, Joshi A, et al. Drug interaction potential of trastuzumab emtansine (T-DM1) combined with pertuzumab in patients with HER2-positive metastatic breast cancer. Curr Drug Metab 2012; 13:911-922.
28. Huang SM, Zhao H, Lee JI, Reynolds K, Zhang L, Temple R, et al. Therapeutic protein-drug interactions and implications for drug development. Clin Pharmacol Ther 2010; 87:497-503.
29. Girish S, Martin SW, Peterson MC, Zhang LK, Zhao H, Balthasar J, et al. AAPS workshop report: Strategies to address therapeutic protein-drug interactions during clinical development. AAPS J 2011; 13:405-416.
30. Albanell J, Montagut C, Jones ET, Pronk L, Mellado B, Beech J, 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.
31. Baselga J, Cortes J, Im SA, Pivot X, Clark E, Knott A, et al. Adverse events with pertuzumab and trastuzumab: Evolution during treatment with and without docetaxel in CLEOPATRA. J Clin Oncol 2012; 30 (20 May Suppl):597.