Clinical and pharmacokinetic study of sunitinib and docetaxel in women with advanced breast cancer

Breast

Volumn 21, Issue 4, 2012, Pages 507-513

  Bergh, Jonas ^a,b   Mariani, Gabriella ^c   Cardoso, Fatima ^d   Liljegren, Annelie ^a   Awada, Ahmad ^d   Viganò, Lucia ^c   Huang, Xin ^e   Verkh, Lev ^e   Kern, Kenneth A ^e   Giorgetti, Carla ^e   Gianni, Luca ^c  

^a KAROLINSKA INSTITUTE   (Sweden)

^b UNIVERSITY OF MANCHESTER   (United Kingdom)

^c NATIONAL CANCER INSTITUTE   (Italy)

^d JULES BORDET INSTITUTE   (Belgium)

^e PFIZER INC   (United States)

Author keywords

Advanced breast cancer; Docetaxel; Sunitinib; Tyrosine kinase inhibitor

Indexed keywords

ANTHRACYCLINE; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR 2; N DEETHYLSUNITINIB; SUNITINIB;

ADULT; AGED; ALOPECIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; ASTHENIA; BLOOD TOXICITY; BRADYCARDIA; BRAIN HEMORRHAGE; BREAST CANCER; CANCER ADJUVANT THERAPY; CLINICAL ARTICLE; DEEP VEIN THROMBOSIS; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG FEVER; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPEPSIA; DYSPNEA; EDEMA; EPISTAXIS; EXPLORATORY RESEARCH; FACE EDEMA; FATIGUE; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; GENERALIZED EDEMA; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; LEUKOPENIA; LIVER METASTASIS; LUNG METASTASIS; LYMPHOCYTOPENIA; MAXIMUM PLASMA CONCENTRATION; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; QT PROLONGATION; RHINOPHARYNGITIS; SENSORY NEUROPATHY; SKIN TOXICITY; SORE THROAT; STOMATITIS; THORAX PAIN; THROMBOCYTOPENIA; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TREATMENT RESPONSE; UPPER ABDOMINAL PAIN; VOMITING;

EID: 84863874195     PISSN: 09609776     EISSN: 15323080     Source Type: Journal    
DOI: 10.1016/j.breast.2012.01.012     Document Type: Article

References (35)

1. O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist 2005, 10(Suppl 3):20-29.
2. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005, 365:1687-1717. Early Breast Cancer Trialists' Collaborative Group (EBCTCG).
3. Nakopoulou L., Stefanaki K., Panayotopoulou E., Giannopoulou I., Athanassiadou P., Gakiopoulou-Givalou H., et al. Expression of the vascular endothelial growth factor receptor-2/Flk-1 in breast carcinomas: correlation with proliferation. Hum Pathol 2002, 33:863-870.
4. Seymour L., Bezwoda W.R. Positive immunostaining for platelet derived growth factor (PDGF) is an adverse prognostic factor in patients with advanced breast cancer. Breast Cancer Res Treat 1994, 32:229-233.
5. Relf M., LeJeune S., Scott P.A., Fox S., Smith K., Leek R., et al. Expression of the angiogenic factors vascular endothelial cell growth factor, acidic and basic fibroblast growth factor, tumor growth factor beta-1, platelet-derived endothelial cell growth factor, placenta growth factor, and pleiotrophin in human primary breast cancer and its relation to angiogenesis. Cancer Res 1997, 57:963-969.
6. Schmidt M., Voelker H.U., Kapp M., Dietl J., Kammerer U. Expression of VEGFR-1 (Flt-1) in breast cancer is associated with VEGF expression and with node-negative tumour stage. Anticancer Res 2008, 28:1719-1724.
7. Wang X.B., Yang Q.X., Pei X.J. Expression of angiogenesis-related factors in invasive breast cancer and its clinical significance. Nan Fang Yi Ke Da Xue Xue Bao 2006, 26:860-863.
8. Carvalho I., Milanezi F., Martins A., Reis R.M., Schmitt F. Overexpression of platelet-derived growth factor receptor alpha in breast cancer is associated with tumour progression. Breast Cancer Res 2005, 7:788-795.
9. Foekens J.A., Peters H.A., Grebenchtchikov N., Look M.P., Meijer-van Gelder M.E., Geurts-Moespot A., et al. High tumor levels of vascular endothelial growth factor predict poor response to systemic therapy in advanced breast cancer. Cancer Res 2001, 61:5407-5414.
10. Miles D., Chan A., Dirix L.Y., Cortés J., Pivot X., Tomczak P., et al. Phase III Study of Bevacizumab Plus Docetaxel Compared With Placebo Plus Docetaxel for the First-Line Treatment of Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol 2010, 28:3239-3247.
11. Miller K., Wang M., Gralow J., Dickler M., Cobleigh M., Perez E.A., et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med 2007, 357:2666-2676.
12. Robert N.J., Dieras V., Glaspy J., Brufsky A., Bondarenko I., Lipatov O., et al. RIBBON-1: Randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab (B) for first-line treatment of HER2-negative locally recurrent or metastatic breast cancer (MBC). J Clin Oncol 2009, 27(suppl). abstr.1005.
13. Miller K.D., Chap L.I., Holmes F.A., Cobleigh M.A., Marcom P.K., Fehrenbacher L., et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005, 23:792-799.
14. Mendel D.B., Laird A.D., Xin X., Louie S.G., Christensen J.G., Li G., et al. In vivo antitumor activity of SU11248, a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor and platelet-derived growth factor receptors: determination of a pharmacokinetic/pharmacodynamic relationship. Clin Cancer Res 2003, 9. 327-327.
15. Abrams T.J., Lee L.B., Murray L.J., Pryer N.K., Cherrington J.M. SU11248 inhibits KIT and platelet-derived growth factor receptor beta in preclinical models of human small cell lung cancer. Mol Cancer Ther 2003, 2:471-478.
16. O'Farrell A.M., Abrams T.J., Yuen H.A., Ngai T.J., Louie S.G., Yee K.W., et al. SU11248 is a novel FLT3 tyrosine kinase inhibitor with potent activity in vitro and in vivo. Blood 2003, 101:3597-3605.
17. Murray L.J., Abrams T.J., Long K.R., Ngai T.J., Olson L.M., Hong W., et al. SU11248 inhibits tumor growth and CSF-1R-dependent osteolysis in an experimental breast cancer bone metastasis model. Clin Exp Metastasis 2003, 20:757-766.
18. Kim D.W., Jo Y.S., Jung H.S., Chung H.K., Song J.H., Park K.C., et al. An orally administered multitarget tyrosine kinase inhibitor, SU11248, is a novel potent inhibitor of thyroid oncogenic RET/papillary thyroid cancer kinases. J Clin Endocrinol Metab 2006, 91:4070-4076.
19. Burstein H.J., Elias A.D., Rugo H.S., Cobleigh M.A., Wolff A.C., Eisenberg P.D., et al. Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2008, 26:1810-1816.
20. Sanofi-aventis: Taxotere (docetaxel) prescribing information 2009, Sanofi-aventis, New York.
21. Schueneman A.J., Himmelfarb E., Geng L., Tan J., Donnelly E., Mendel D., et al. SU11248 maintenance therapy prevents tumor regrowth after fractionated irradiation of murine tumor models. Cancer Res 2003, 63:4009-4016.
22. Abrams T.J., Murray L.J., Pesenti E., Holway V.W., Colombo T., Lee L.B., et al. Preclinical evaluation of the tyrosine kinase inhibitor SU11248 as a single agent and in combination with ' standard of care' therapeutic agents for the treatment of breast cancer. Mol Cancer Ther 2003, 2:1011-1021.
23. Hu-Lowe D.D., Grazzini M.L. Significant enhancements of anti-tumor efficacy of VEGF/PDGF RTKI AG-013736 in combination with docetaxel in chemo-refractory and/or orthotopic xenograft tumor models in mice. Proc Amer Assoc Cancer Res 2005, 46(suppl). abstr. 2032.
24. Robert F., Sandler A., Schiller J.H., Liu G., Harper K., Verkh L., et al. Sunitinib in combination with docetaxel in patients with advanced solid tumors: a phase I dose-escalation study. Cancer Chemother Pharmacol 2010, 66:669-680.
25. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000, 92:205-216.
26. Trotti A., Colevas A.D., Setser A., Rusch V., Jaques D., Budach V., et al. CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 2003, 13:176-181.
27. Fossella F.V., DeVore R., Kerr R.N., Crawford J., Natale R.R., Dunphy F., et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol 2000, 18:2354-2362.
28. Harvey V., Mouridsen H., Semiglazov V., Jakobsen E., Voznyi E., Robinson B.A., et al. Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol 2006, 24:4963-4970.
29. Liljegren A., Bergh J., Castany R. Early experience with sunitinib, combined with docetaxel, in patients with metastatic breast cancer. Breast 2009, 18:259-262.
30. Nabholtz J.M., Tonkin K., Smylie M., Au H.J., Lindsay M.A., Mackey J. Chemotherapy of breast cancer: are the taxanes going to change the natural history of breast cancer?. Expert Opin Pharmacother 2000, 1:187-206.
31. Kozloff M., Chuang E., Starr A., Gowland P.A., Cataruozolo P.E., Collier M., et al. An exploratory study of sunitinib plus paclitaxel as first-line treatment for patients with advanced breast cancer. Annals Oncol 2010, 21:1436-1441.
32. Chan S., Friedrichs K., Noel D., Pintér T., Van Belle S., Vorobiof D., et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol 1999, 17:2341-2354.
33. Bergh J., Bondarenko I.M., Lichinitser M.R., Hatschek T., Greil R., Voytko N.L., et al. First-Line treatment of advanced breast cancer with sunitinib in combination with docetaxel versus docetaxel alone - Results of a prospective, randomized phase III study. J Clin Oncol 2011, In press.
34. Bergh J. Quo vadis with targeted drugs in the 21st century?. J Clin Oncol 2009, 27:2-5.
35. Lindström L.S., Giorgetti C., Smeds J., Borg A.-L., Skoog L., Liljegren A., et al. Ways to understand mechanism of action for targeted drugs? Gene expression analyses from paired biopsies in patients with advanced breast cancer in a substudy from the randomized study docetaxel +/- sunitinib A6181064 December 8-12, 2010, Poster presentation at the 33rd Annual San Antonio Breast Cancer Symposium, San Antonio, TX, abstr P6-12-05.