Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: A single-group phase 2 trial

The Lancet Oncology

Volumn 13, Issue 10, 2012, Pages 1055-1062

  Eisen, Tim ^a   Joensuu, Heikki ^b   Nathan, Paul D ^c   Harper, Peter G ^d   Wojtukiewicz, Marek Z ^e   Nicholson, Steve ^f   Bahl, Amit ^g   Tomczak, Piotr ^h   Pyrhonen, Seppo ⁱ   Fife, Kate ^a   Bono, Petri ^b   Boxall, Jane ^c   Wagner, Andrea ^j   Jeffers, Michael ^k   Lin, Tiffany ^k   Quinn, David I ^l  

^a St John s Innovation Centre   (United Kingdom)

^b HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^c MOUNT VERNON HOSPITAL   (United Kingdom)

^d GUY S HOSPITAL   (United Kingdom)

^e MEDICAL UNIVERSITY OF BIALYSTOK   (Poland)

^f UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST   (United Kingdom)

^g BRISTOL HAEMATOLOGY AND ONCOLOGY CENTRE   (United Kingdom)

^h Klinika Onkologii   (Poland)

ⁱ TURKU UNIVERSITY HOSPITAL   (Finland)

^j BAYER PHARMA AG   (Germany)

^k BAYER CORPORATION   (United States)

^l UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; REGORAFENIB;

ADULT; AGED; ALOPECIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CLINICAL ARTICLE; CONSTIPATION; DESQUAMATION; DIARRHEA; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG SAFETY; DYSPHONIA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; HYPERTENSION; HYPOMAGNESEMIA; HYPONATREMIA; IMMUNOASSAY; KIDNEY CARCINOMA; KIDNEY FAILURE; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TREATMENT RESPONSE; TRIACYLGLYCEROL LIPASE BLOOD LEVEL; VOMITING;

AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, RENAL CELL; FEMALE; HUMANS; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PHENYLUREA COMPOUNDS; PYRIDINES;

EID: 84866888498     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(12)70364-9     Document Type: Article

References (20)

1. Escudier B, Kataja V Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010, 21(suppl 5):v137-v139. ESMO Guidelines Working Group.
2. Bellmunt J, Guix M The medical management of metastatic renal cell carcinoma: integrating new guidelines and recommendations. BJU Int 2009, 103:572-577.
3. Lindblad P Epidemiology of renal cell carcinoma. Scand J Surg 2004, 93:88-96.
4. McDermott DF, Regan MM, Clark JI, et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol 2005, 23:133-141.
5. de Reijke TM, Bellmunt J, van Poppel H, et al. EORTC-GU group expert opinion on metastatic renal cell cancer. Eur J Cancer 2009, 45:765-773.
6. Reeves DJ, Liu CY Treatment of metastatic renal cell carcinoma. Cancer Chemother Pharmacol 2009, 64:11-25.
7. Wilhelm SM, Dumas J, Adnane L, et al. Regorafenib (BAY 73-4506): a new oral multikinase inhibitor of angiogenic, stromal and oncogenic receptor tyrosine kinases with potent preclinical antitumor activity. Int J Cancer 2011, 129:245-255.
8. Zopf D, Heinig R, Schütz G, et al. Regorafenib (BAY 73-4506): identification of clinically relevant metabolites and their preclinical pharmacology. 101st AACR Annual Meeting; Washington DC, USA; 17-21 April, 2010. abstr 1666.
9. Mross K, Frost A, Steinbild S, et al. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res 2012, 18:2658-2667.
10. Strumberg D, Scheulen ME, Frost A, et al. Phase I study of BAY 73-4506, an inhibitor of oncogenic and angiogenic kinases, in patients with advanced refractory colorectal carcinoma (CRC). Br J Cancer 2012, 106:1722-1727.
11. Shimizu T, Tolcher AW, Patnaik A, et al. Phase I dose-escalation study of continuously administered regorafenib (BAY 73-4506), an inhibitor of oncogenic and angiogenic kinases, in patients with advanced solid tumors. Proc Am Soc Clin Oncol 2010, 28(suppl). abstr 3035.
12. Kies MS, Blumenschein GR, Christensen O, et al. Phase I study of regorafenib (BAY 73-4506), an inhibitor of oncogenic and angiogenic kinases, administered continuously in patients (pts) with advanced refractory non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 2010, 28(suppl). abstr 7585.
13. Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007, 356:115-124.
14. Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase III trial. Lancet 2007, 370:2103-2111. AVOREN Trial investigators.
15. Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol 2010, 28:1061-1068.
16. Murukesh N, Dive C, Jayson GC Biomarkers of angiogenesis and their role in the development of VEGF inhibitors. Br J Cancer 2010, 102:8-18.
17. Greystoke A, O'Connor JP, Linton K, et al. Assessment of circulating biomarkers for potential pharmacodynamic utility in patients with lymphoma. Br J Cancer 2011, 104:719-725.
18. Bergers G, Hanahan D Modes of resistance to anti-angiogenic therapy. Nat Rev Cancer 2008, 8:592-603.
19. Ribatti D The paracrine role of Tie-2-expressing monocytes in tumor angiogenesis. Stem Cells Dev 2009, 18:703-706.
20. Augustin HG, Koh GY, Thurston G, et al. Control of vascular morphogenesis and homeostasis through the angiopoietin-Tie system. Nat Rev Mol Cell Biol 2009, 10:165-177.