Sunitinib (SUTENT^®) for the treatment of metastatic renal cell carcinoma

References

• Lipworth L, Tarone RE, McLaughlin JK. The epidemiology of renal cell carcinoma. J. Urol.176(6 Pt 1), 2353–2358 (2006).
   PubMed Web of Science ®Google Scholar
• Hutson TE. Renal cell carcinoma: diagnosis and treatment, 1994–2003. Proc. Bayl. Univ. Med. Cent.18(4), 337–340 (2005).
   PubMedGoogle Scholar
• Ljungberg B, Hanbury DC, Kuczyk MA et al. Renal cell carcinoma guideline. Eur. Urol.511(6), 1502–1510 (2007).
   Google Scholar
• National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: kidney cancer (2008).
   Google Scholar
• Motzer RJ, Bacik J, Murphy BA, Russo P, Mazumdar M. Interferon-α as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J. Clin. Oncol.20(1), 289–296 (2002).
   PubMed Web of Science ®Google Scholar
• van Spronsen DJ, Mulders PF, De Mulder PH. Novel treatments for metastatic renal cell carcinoma. Crit. Rev. Oncol. Hematol.55(7), 177–191 (2005).
   PubMed Web of Science ®Google Scholar
• Potti A, George DJ. Tyrosine kinase inhibitors in renal cell carcinoma. Clin. Cancer Res.10(Suppl. 18 Pt 2), 6371S–6376S (2004).
   PubMed Web of Science ®Google Scholar
• Gollob JA, Wilhelm S, Carter C, Kelley SL. Role of Raf kinase in cancer: therapeutic potential of targeting the Raf/MEK/ERK signal transduction pathway. Semin. Oncol.33(4), 392–406 (2006).
   PubMed Web of Science ®Google Scholar
• Sridhar SS, Hedley D, Siu LL. Raf kinase as a target for anticancer therapeutics. Mol. Cancer Ther.4(4), 677–685 (2005).
   PubMed Web of Science ®Google Scholar
• Deeks ED, Keating GM. Sunitinib. Drugs66(17), 2255–2266 (2006).
   PubMed Web of Science ®Google Scholar
• Chow LQ, Eckhardt SG. Sunitinib: from rational design to clinical efficacy. J. Clin. Oncol.25(7), 884–896 (2007).
   PubMed Web of Science ®Google Scholar
• Roskoski R Jr. Sunitinib: a VEGF and PDGF receptor protein kinase and angiogenesis inhibitor. Biochem. Biophys. Res Commun.356(2), 323–328 (2007).
   PubMed Web of Science ®Google Scholar
• Bergers G, Song S, Meyer-Morse N, Bergsland E, Hanahan D. Benefits of targeting both pericytes and endothelial cells in the tumor vasculature with kinase inhibitors. J. Clin. Invest.111(9), 1287–1295 (2003).
   PubMed Web of Science ®Google Scholar
• Pietras K, Pahler J, Bergers G, Hanahan D. Functions of paracrine PDGF signaling in the proangiogenic tumor stroma revealed by pharmacological targeting. PLoS Med.5(1), e19 (2008).
   PubMed Web of Science ®Google Scholar
• Abrams TJ, Lee LB, Murray LJ, Pryer NK, Cherrington JM. SU11248 inhibits KIT and platelet-derived growth factor receptor β in preclinical models of human small cell lung cancer. Mol. Cancer Ther.2(5), 471–478 (2003).
   PubMed Web of Science ®Google Scholar
• Osusky KL, Hallahan DE, Fu A, Ye F, Shyr Y, Geng L. The receptor tyrosine kinase inhibitor SU11248 impedes endothelial cell migration, tubule formation, and blood vessel formation in vivo, but has little effect on existing tumor vessels. Angiogenesis7(3), 225–233 (2004).
   PubMedGoogle Scholar
• Potapova O, Laird AD, Nannini MA et al. Contribution of individual targets to the antitumor efficacy of the multitargeted receptor tyrosine kinase inhibitor SU11248. Mol. Cancer Ther.5(5), 1280–1289 (2006).
   PubMed Web of Science ®Google Scholar
• Erber R, Thurnher A, Katsen AD et al. Combined inhibition of VEGF and PDGF signaling enforces tumor vessel regression by interfering with pericyte-mediated endothelial cell survival mechanisms. FASEB J.18(2), 338–340 (2004).
   PubMed Web of Science ®Google Scholar
• Grimaldi AM, Guida T, D’Attino R et al. Sunitinib: bridging present and future cancer treatment. Ann. Oncol.18(Suppl. 6), vi31–vi34 (2007).
   PubMedGoogle Scholar
• O’Brien MF, Russo P, Motzer RJ. Sunitinib therapy in renal cell carcinoma. BJU Int.101(11), 1339–1342 (2008).
   PubMed Web of Science ®Google Scholar
• Mendel DB, Laird AD, Xin X 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.9(1), 327–337 (2003).
   PubMed Web of Science ®Google Scholar
• Faivre S, Delbaldo C, Vera K et al. Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J. Clin. Oncol.24(1), 25–35 (2006).
   PubMed Web of Science ®Google Scholar
• Houk BE, Bello CL, Michaelson MD et al. Exposure-response of sunitinib in metastatic renal cell carcinoma (mRCC): a population pharmacokinetic/pharmacodynamic (PKPD) approach. J. Clin. Oncol.25(Suppl. 18), 5027 (2007).
   Google Scholar
• Sutent®. Prescribing information. 2008. Pfizer Labs. Division of Pfizer Inc. New York, NY, USA.
   Google Scholar
• Meyer AJ, Hernandez A, Florl AR et al. Novel mutations of the von hippel-lindau tumor-suppressor gene and rare DNA hypermethylation in renal-cell carcinoma cell lines of the clear-cell type. Int. J. Cancer87, 650–653 (2000).
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Hutson TE, Tomczak P et al. Sunitinib vs. interferon α in metastatic renal-cell carcinoma. N. Engl. J. Med.356(2), 115–124 (2007).
   PubMed Web of Science ®Google Scholar
• Figlin RA, Hutson TE, Tomczak P et al. Overall survival with sunitinib vs. interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC). J. Clin. Oncol.26(Suppl.), 5024 (2008).
   Web of Science ®Google Scholar
• Bukowski RM, Eisen T, Szczylik C et al. Final results of the randomized Phase III trial of sorafenib in advanced renal cell carcinoma: survival and biomarker analysis. J. Clin. Oncol.25(Suppl.), 5023 (2007).
   Web of Science ®Google Scholar
• Kollmannsberger CK, Heng DY, Murray N, Chi KN. A population-based study evaluating metastatic renal cell cancer (mRCC) patients treated with interferon (IFN) alone, first-line IFN then second-line sunitinib, or sunitinib alone. J. Clin. Oncol.25(Suppl. 18), 15572 (2007).
   Google Scholar
• Heng DY, Chi KN, Murray N et al. A population-based study evaluating the impact of sunitinib on overall survival in the treatment of patients with metastatic renal cell cancer (mRCC). Presented at: 2008 Genitourinary Cancers Symposium. San Francisco, CA, USA, 14–16 February 2008.
   Google Scholar
• Remak E, Mullins CD, Akobundu E, Charbonneau C, Woodruff K. Economic evaluations of sunitinib vs. interferon-α (IFN-α) in first-line metastatic renal cell carcinoma (mRCC). J. Clin. Oncol.25(Suppl. 18), 6607 (2007).
   Google Scholar
• Remak E, Charbonneau C, Négrier S, Kim ST, Motzer RJ. Economic evaluation of sunitinib malate for the first-line treatment of metastatic renal cell carcinoma. J. Clin. Oncol.26, 3995–4000 (2008).
   PubMed Web of Science ®Google Scholar
• Benedict A, Charbonneau C, Hidi J, Kim ST, Negrier S. Economic evaluation of sunitinib, sorafenib, bevacizumab/interferon-α or temsirolimus in 1st-line treatment of metastatic renal cell carcinoma (mRCC): an indirect comparison. J. Clin. Oncol.26(Suppl.), 5048 (2008).
   Web of Science ®Google Scholar
• Porta C, Szczylik D, Bracarda R et al. Short- and long-term safety with sunitinib in an expanded access trial in metastatic renal cell carcinoma (mRCC). J. Clin. Oncol.26(Suppl.), 5114 (2008).
   Web of Science ®Google Scholar
• Chu TF, Rupnick MA, Kerkela R et al. Cardiotoxicity associated with tyrosine kinase inhibitor sunitinib. Lancet370(9604), 2011–2019 (2007).
   PubMed Web of Science ®Google Scholar
• Khakoo AY, Kassiotis CM, Tannir N et al. Heart failure associated with sunitinib malate: a multitargeted receptor tyrosine kinase inhibitor. Cancer112(11), 2500–2508 (2008).
   PubMed Web of Science ®Google Scholar
• Telli ML, Witteles RM, Fisher GA, Srinivas S. Cardiotoxicity associated with the cancer therapeutic agent sunitinib malate. Ann. Oncol.19(9), 1613–1618 (2008).
   PubMed Web of Science ®Google Scholar
• Whitteles RM, Telli ML, Fisher GA, Srinivas S. Cardiotoxicity associated with the cancer therapeutic agent sunitinib malate. J. Clin. Oncol.26(Suppl.), 9597 (2008).
   Google Scholar
• Gore ME, Porta C, Oudard S et al. Sunitinib in metastatic renal cell carcinoma (mRCC): preliminary assessment of toxicity in an expanded access trial with subpopulation analysis. J. Clin. Oncol.25(Suppl. 18), 5010 (2007).
   Google Scholar
• Dallabrida SM, Ismail N, Pravda EA et al. Sunitinib-induced cardiotoxicity is mediated in part via direct effects on cardiac myocytes and smooth muscle cells. Circulation116(4), II–311 (2007).
   Google Scholar
• Desai J, Yassa L, Marqusee E et al. Hypothyroidism after sunitinib treatment for patients with gastrointestinal stromal tumors. Ann. Intern. Med.145(9), 660–664 (2006).
   PubMed Web of Science ®Google Scholar
• Wolter P, Stefan C, Decallonne B et al. The clinical implications of sunitinib-induced hypothyroidism: a prospective evaluation. Br. J. Cancer99, 448–454 (2008).
   PubMed Web of Science ®Google Scholar
• Shaheen PE, Tamaskar IR, Salas RN et al. Thyroid function tests (TFTs) abnormalities in patients (pts) with metastatic renal cell carcinoma (mRCC) treated with sunitinib. J. Clin. Oncol.24(Suppl.), 4605 (2006).
   Google Scholar
• Schoeffski P, Wolter P, Himpe U et al. Sunitinib-related thyroid dysfunction: a single-center retrospective and prospective evaluation. J. Clin. Oncol.24(Suppl.), 3092 (2006).
   Web of Science ®Google Scholar
• Rini BI, Tamaskar I, Shaheen P et al. Hypothyroidism in patients with metastatic renal cell carcinoma treated with sunitinib. J. Natl. Cancer Inst.99(1), 81–83 (2007).
   PubMed Web of Science ®Google Scholar
• Mannavola D, Coco P, Vannucchi G et al. A novel tyrosine-kinase selective inhibitor, sunitinib, induces transient hypothyroidism by blocking iodine uptake. J. Clin. Endocrinol. Metab.92(9), 3531–3534 (2007).
   PubMed Web of Science ®Google Scholar
• Wong E, Rosen LS, Mulay M et al. Sunitinib induces hypothyroidism in advanced cancer patients and may inhibit thyroid peroxidase activity. Thyroid17(4), 351–355 (2007).
   PubMed Web of Science ®Google Scholar
• Wolter P, Stefan C, Decallonne B et al. Evaluation of thyroid dysfunction as a candidate surrogate marker for efficacy of sunitinib in patients (pts) with advanced renal cell cancer (RCC). J. Clin. Oncol.26(Suppl.), 5126 (2008).
   PubMed Web of Science ®Google Scholar
• Feldman DR, Martorella AJ, Robbins RJ, Motzer RJ. Re: Hypothyroidism in patients with metastatic renal cell carcinoma treated with sunitinib. J. Natl Cancer Inst.99(12), 974–975 (2007).
   PubMedGoogle Scholar
• Hudes G, Carducci M, Tomczak P et al. A Phase 3, randomized, 3-arm study of temsirolimus (TEMSR) or interferon-α (IFN) or the combination of TEMSR + IFM in the treatment of first-line, poor-risk patients with advanced renal cell carcinoma (adv RCC). J. Clin. Oncol.24, LBA4 (2006).
   Google Scholar
• Escudier B, Pluzanska A, Koralewski P et al. Bevacizumab plus interferon α-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind Phase III trial. Lancet370, 2103–2111 (2007).
   PubMed Web of Science ®Google Scholar
• Haas NB, Uzzo RG. The ASSURE trial – adjuvant sunitinib vs. sorafenib vs. placebo in patients with resected renal cell carcinoma. US Renal Genito-Urinary Dis. 54–56 (2006).
   Google Scholar
• Michaelson M, Schwarzberg A, Ryan D et al. A Phase I study of sunitinib in combination with gemcitabine in advanced renal cell carcinoma and other solid tumors. Presented at: 2008 Genitourinary Cancers Symposium. San Francisco, CA, USA, 14–16 February 2008.
   Google Scholar
• Pandya SS, Mier JW, Cho D, McDermott D. The role of adding gemcitabine at time of sunitinib resistance in patients with metastatic renal cell cancer. Presented at: 2008 Genitourinary Cancers Symposium. San Francisco, CA, USA, 14–16 February 2008.
   Google Scholar
• Allerton JP, Ebrahimi B, Schreeder MT et al. Phase I report from a multicenter trial of perifosine (PERI) + sunitinib (SUT) in patients with advanced cancers including renal cell carcinoma (RCC). J. Clin. Oncol.26(Suppl.), 14565 (2008).
   Google Scholar
• Redman BG, Hudes GR, Kim ST, Chen I, Motzer RJ. Sunitinib in combination with gefitinib in patients (pts) with metastatic renal cell carcinoma (mRCC): updated results from a Phase I/II study. J. Clin. Oncol.26(Suppl.), 16014 (2008).
   Google Scholar
• Ryan CW, Curti BD, Pattee KJ, Besaw L, Beer TM, Fisher B. A dose-escalation Phase II study of sunitinib (S) plus erlotinib (E) in advanced renal carcinoma (RCC). Presented at: 2008 Genitourinary Cancers Symposium. San Francisco, CA, USA, 14–16 February 2008.
   Google Scholar
• Vance V, Amato RJ, Jac J, Saxena S, Willis JP, Chiang SB. A Phase I study of PEG-intron, sunitinib and tarceva in patients with metastatic renal cell cancer (MRCC). J. Clin. Oncol.26(Suppl.), 14659 (2008).
   Google Scholar
• Fischer P, Patel P, Carducci MA et al. Phase I study combining treatment with temsirolimus and sunitinib malate in patients with advanced renal cell carcinoma. J. Clin. Oncol.26(Suppl.), 16020 (2008).
   Web of Science ®Google Scholar
• Feldman DR, Ginsberg MS, Baum M et al. Phase I trial of bevacizumab plus sunitinib in patients with metastatic renal cell carcinoma. J. Clin. Oncol.26(Suppl.), 5100 (2008).
   Web of Science ®Google Scholar
• Schrader AJ, Olbert PJ, Hegele A, Varga Z, Hofmann R. Metastatic non-clear cell renal cell carcinoma: current therapeutic options. BJU Int.101(11), 1343–1345 (2008).
   PubMed Web of Science ®Google Scholar
• Choueiri TK, Plantade A, Elson P et al. Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma. J. Clin. Oncol.26(1), 127–131 (2008).
   PubMed Web of Science ®Google Scholar
• Plimack ER, Jonasch E, Bekele BN, Smith LA, Araujo JC, Tannir NM. Sunitinib in non-clear cell renal cell carcinoma (ncc-RCC): a Phase II study. J. Clin. Oncol.26(Suppl.), 5112 (2008).
   Web of Science ®Google Scholar