Growing opportunities for adjuvant therapy of renal cell carcinoma: targeted drugs and vaccines

• JEMAL A, SIEGEL R, WARD E et al.: Cancer statistics, 2006. CA Cancer J. Clin. (2006) 56:106-130.
   PubMed Web of Science ®Google Scholar
• PARKIN DM, BRAY F, FERLAY J et al.: Global cancer statistics, 2002. CA Cancer J. Clin. (2005) 55:74-108.
   PubMed Web of Science ®Google Scholar
• PATARD JJ, LECHEVALLIER E, CONGREGADO B et al.: New research on kidney cancer: highlights from urologic and oncologic congresses in 2006. Eur. Urol. (2007) 6:396-403.
   Google Scholar
• RODRIGUEZ A, SEXTON WJ: Management of locally advanced renal cell carcinoma. Cancer Control. (2006) 13:199-210.
   PubMedGoogle Scholar
• JANZEN NK, KIM HL, FIGLIN RA et al.: Surveillance after radical or partial nephrectomy for localized renal cell carcinoma and management of recurrent disease. Urol. Clin. North Am. (2003) 30:843-852.
   PubMed Web of Science ®Google Scholar
• AJCC Cancer Staging Manual. 6th Edition, Springer-Verlag, New York (2002).
   Google Scholar
• COONEY MM, REMICK SC, VOGELZANG NJ: Promising systemic therapy for renal cell carcinoma. Curr. Treat. Options Oncol. (2005) 6:357-365.
   PubMedGoogle Scholar
• MEKHAIL TM, ABOU-JAWDE RM, BOUMERHI G et al.: Validation and extension of the memorial Sloan-Kettering prognostic factors model for survival in patients with previously untreated metastatic renal cell carcinoma. J. Clin. Oncol. (2005) 23:832-841.
   PubMed Web of Science ®Google Scholar
• LAM JS, SHVARTS O, LEPPERT JT et al.: Renal cell carcinoma 2005: new frontiers in staging, prognostication and targeted molecular therapy. J. Urol. (2005) 173:1853-1862.
   PubMed Web of Science ®Google Scholar
• ELSON PJ, WITTE RS, TRUMP DL: Prognostic factors for survival in patients with recurrent or metastatic renal cell carcinoma. Cancer Res. (1988) 48:7310-7313.
   PubMed Web of Science ®Google Scholar
• MOTZER RJ, BACIK J, MURPHY BA et al.: Interferon-α as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J. Clin. Oncol. (2002) 20:289-296.
   PubMed Web of Science ®Google Scholar
• KATTAN MW, REUTER V, MOTZER RJ et al.: A postoperative prognostic nomogram for renal cell carcinoma. J. Urol. (2001) 166:63-67.
   PubMed Web of Science ®Google Scholar
• FRANK I, BLUTE ML, CHEVILLE JC et al.: An outcome prediction model for patients with clear cell renal cell carcinoma treated with radical nephrectomy based on tumor stage, size, grade, and necrosis: SSIGN score. J. Urol. (2002) 168:2395-2400.
   PubMed Web of Science ®Google Scholar
• ZISMAN A, PANTUCK AJ, DOREY F et al.: Mathematical model to predict individual survival for patients with renal cell carcinoma. J. Clin. Oncol. (2002) 20:1368-1374.
   PubMedGoogle Scholar
• ZISMAN A, PANTUCK AJ, WIEDER J et al.: Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J. Clin. Oncol. (2002) 20:4559-4566.
   PubMed Web of Science ®Google Scholar
• CINDOLO L, DE LA TAILLE A, MESSINA G et al.: A preoperative clinical prognostic model for non-metastatic renal cell carcinoma. BJU Int. (2003) 92:901-905.
   PubMed Web of Science ®Google Scholar
• YAYCIOGLU O, ROBERTS WW, CHAN T et al.: Prognostic assessment of nonmetastatic renal cell carcinoma: a clinically based model. Urology (2001) 58:141-145.
   PubMed Web of Science ®Google Scholar
• FICARRA V, NOVARA G, IAFRATE M et al.: Proposal for reclassification of the TNM staging system in patients with locally advanced (pT3-4) renal cell carcinoma according to the cancer-related outcome. Eur. Urol. (2007) 51:722-731.
   PubMed Web of Science ®Google Scholar
• BUI MH, SELIGSON D, HAN KR et al.: Carbonic anydrase IX is an independent predictor of survival in advance renal clear cell carcinoma: implications for prognosis and therapy. Clin. Cancer Res. (2003) 9:802-811.
   PubMed Web of Science ®Google Scholar
• ATKINS M, REGAN M, MCDERMOTT D et al.: Carbonic anhydrase IX expression predicts outcome of interleukin 2 therapy for renal cancer. Clin. Cancer Res. (2005) 11:3714-3721.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• YANG JC, SHERRY RM, STEINBERG SM et al.: Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J. Clin. Oncol. (2003) 21:3127-3132.
   PubMed Web of Science ®Google Scholar
• CLARK JI, ATKINS MB, URBA WJ et al.: Adjuvant high-dose bolus interleukin-2 for patients with high-risk renal cell carcinoma: a cytokine working group randomized trial. J. Clin. Oncol. (2003) 21:3133-3140.
   PubMed Web of Science ®Google Scholar
• MEDICAL RESEARCH COUNCIL RENAL CANCER COLLABORATORS: Interferon-α and survival in metastatic renal carcinoma: early results of a randomized controlled trial. Lancet (1999) 353:14-17.
   PubMed Web of Science ®Google Scholar
• COPPIN C, PORZSOLT F, AWA A et al.: Immunotherapy for advanced renal cell cancer. Cochrane Database Syst. Rev. (2005):CD001425.
   Google Scholar
• MESSING EM, MANOLA J, WILDING G et al.: Phase III study of interferon α-NL as adjuvant treatment for resectable renal cell carcinoma: an Eastern cooperative oncology group/intergroup trial. J. Clin. Oncol. (2003) 21:1214-1222.
   PubMed Web of Science ®Google Scholar
• PIZZOCARO G, PIVA L, COLAVITA et al.: Interferon adjuvant to radical nephrectomy in Robson stages II and III renal cell carcinoma: a multicentric randomized study. J. Clin. Oncol. (2001) 19:425-431.
   PubMed Web of Science ®Google Scholar
• ATZPODIEN J, SCHMITT E, GERTENBACH U et al.: Adjuvant treatment with interleukin-2- and interferon-α2a-based chemoimmunotherapy in renal cell carcinoma post tumour nephrectomy: results of a prospectively randomized trial of the German cooperative renal carcinoma chemoimmunotherapy group (DGCIN). Br. J. Cancer (2005) 92:843-846.
   PubMed Web of Science ®Google Scholar
• PASSALACQUA R, BUZIO C, BUTI S et al.: Adjuvant low-dose interleukin-2 (IL2) plus interferon-α (IFN) in operable renal cell cancer (RCC). A Phase III, randomized, multicenter, independent trial of the Italian oncology group for clinical research (GOIRC). J. Clin Oncol. (2007) 25(S18):LBA5028.
   Google Scholar
• MOTZER RJ, BACIK J, SCHWARTZ LH et al.: Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J. Clin. Oncol. (2004) 22:454-463.
   PubMed Web of Science ®Google Scholar
• MERTENS WC, EISENHAUER EA, MOORE M et al.: Gemcitabine in advanced renal cell carcinoma. A Phase II study of the National cancer institute of Canada clinical trials group. Ann. Oncol. (1993) 4:331-332.
   PubMed Web of Science ®Google Scholar
• OEVERMANN K, BUER J, HOFFMAN R et al.: Capecitabine in the treatment of metastatic renal cell carcinoma. Br. J. Cancer (2000) 83:583-587.
   PubMedGoogle Scholar
• RINI BI, VOGELZANG NJ, DUMAS MC et al.: Phase II trial of weekly intravenous gemcitabine with continuous infusion fluorouracil in patients with metastatic renal cell cancer. J. Clin. Oncol. (2000) 163:408-417.
   Google Scholar
• KJAER M, IVERSEN P, HVIDT V et al.: A randomized trial of postoperative radiotherapy versus observation in stage II and III renal adenocarcinoma. A study by the copenhagen renal cancer study group. Scand. J. Urol. Nephrol. (1987) 21:285-289.
   PubMed Web of Science ®Google Scholar
• PIZZOCARO G, PIVA L, DI FG et al.: Adjuvant medroxyprogesterone acetate to radical nephrectomy in renal cancer: 5-year results of a prospective randomized study. J. Urol. (1987) 138:1379-1381.
   PubMed Web of Science ®Google Scholar
• ADLER A, GILLON G, LURIE H et al.: Active specific immunotherapy of renal cell carcinoma patients: a prospective randomized study of hormone-immuno-versus hormonotherapy. Preliminary report of immunological and clinical aspects. J. Biol. Response Mod. (1987) 6:610-624.
   PubMedGoogle Scholar
• GALLIGIONI E, QUAIA M, MERLO A et al.: Adjuvant immunotherapy treatment of renal carcinoma patients with autologous tumor cells and bacillus Calmette-Guerin: five-year results of a prospective randomized study. Cancer (1996) 77:2560-2566.
   PubMed Web of Science ®Google Scholar
• JOCHAM D, RICHTER A, HOFFMANN L et al.: Adjuvant autologous renal tumour cell vaccine and risk of tumour progression in patients with renal cell carcinoma after radical nephrectomy: Phase III, randomized controlled trial. Lancet (2004) 363:594-599.
   PubMed Web of Science ®Google Scholar
• FISHMAN M, ANTONIA S: Specific antitumor vaccine for renal cancer. Lancet (2004) 363:583-584.
   PubMedGoogle Scholar
• RINI BI, SMALL EJ: Biology and clinical development of vascular endothelial growth factor-targeted therapy in renal cell carcinoma. J. Clin. Oncol. (2005) 23:1028-1043.
   PubMed Web of Science ®Google Scholar
• MAXWELL PH, WIESENER MS, CHANG GW et al.: The tumour suppressor protein VHL targets hypoxia-inducible factors for oxygen-dependent proteolysis. Nature (1999) 399:271-275.
   PubMed Web of Science ®Google Scholar
• KAELIN WG Jr: Molecular basis of the VHL hereditary cancer syndrome. Nat. Rev. Cancer (2002) 2:673-682.
   PubMed Web of Science ®Google Scholar
• BERGERS G, SONG S, MEYER-MORSE N et al.: Benefits of targeting both pericytes and endothelial cells in the tumor vasculature with kinase inhibitors. J. Clin. Invest. (2003) 111:1287-1295.
   PubMed Web of Science ®Google Scholar
• DE PAULSEN N, BRYCHZY A, FOURNIER MC et al.: Role of transforming growth factor-α in von Hippel-Lindau (VHL)(-/-) clear cell renal carcinoma cell proliferation: a possible mechanism coupling VHL tumor suppressor inactivation and tumorigenesis. Proc. Natl. Acad. Sci. USA (2001) 98:1387-1392.
   PubMedGoogle Scholar
• ARTEAGA CL: Epidermal growth factor receptor dependence in human tumors: more than just expression? Oncologist (2002) 7:31-39.
   PubMed Web of Science ®Google Scholar
• SALOMON DS, BRANDT R, CIARDIELLO F et al.: Epidermal growth factor-related peptides and their receptors in human malignancies. Crit. Rev. Oncol. Hematol. (1995) 19:183-232.
   PubMed Web of Science ®Google Scholar
• GOLLOB JA, WILHELM S, CARTER C et al.: Role of Raf kinase in cancer: therapeutic potential of targeting the Raf/MEK/ERK signal transduction pathway. Semin. Oncol. (2006) 33: 392-406.
   PubMed Web of Science ®Google Scholar
• YANG JC, HAWORTH L, SHERRY RM et al.: A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N. Engl. J. Med. (2003) 349:427-434.
   PubMed Web of Science ®Google Scholar
• ESCUDIER B, KORALEWSKI P, PLUZANSKA A et al.: A randomized, controlled, double-blind Phase III study (AVOREN) of bevacizumab/interferon-α2a vs placebo/interferon-α2a as first-line therapy in metastatic renal cell carcinoma. J. Clin. Oncol. (2007) 25(S18):(Abstract 3).
   PubMedGoogle Scholar
• MOTZER RJ, AMATO R, TODD M et al.: Phase II trial of antiepidermal growth factor receptor antibody C225 in patients with advanced renal cell carcinoma. Invest. New Drugs (2003) 21:99-101.
   PubMed Web of Science ®Google Scholar
• SCHWARTZ G, DUTCHER JP, VOGELZANG NJ et al.: Phase II clinical trial evaluating the safety and effectiveness of ABX-EGF in renal cell cancer. Proc. Am. Soc. Clin. Oncol. (2002) 21:A24.
   Google Scholar
• RAYAUD A, GARDNER J, HAWKINS R et al.: Efficacy of lapatinib in patients with high tumor EGFR expression: results of a Phase III trial in advanced renal cell carcinoma (RCC). J. Clin. Oncol. (2006) 24:S217.
   PubMedGoogle Scholar
• DRUCKER B, BACIK J, GINSBERG M et al.: Phase II trial of ZD1839 (IRESSA) in patients with advanced renal cell carcinoma. Invest. New Drugs (2003) 21:341-345.
   PubMed Web of Science ®Google Scholar
• ESCUDIER B, EISEN T, STADLER WM et al.: Sorafenib in advanced clear-cell renal-cell carcinoma. N. Engl. J. Med. (2007) 356:125-134.
   PubMed Web of Science ®Google Scholar
• MOTZER RJ, MICHAELSON MD, REDMAN BG et al.: Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J. Clin. Oncol. (2006) 24:16-24.
   PubMed Web of Science ®Google Scholar
• MOTZER RJ, RININ BI, BUKOWSKI RM et al.: Sunitinib in patients with metastatic renal cell carcinoma. JAMA (2006) 295:2516-2524.
   PubMed Web of Science ®Google Scholar
• MOTZER RJ, HUTSON TE, TOMCZAC P et al.: Phase III randomized trial of sunitinib malate (SU11248) versus interferon-α (IFN-α) as first line systemic therapy for patients with metastatic renal cell carcinoma (mRCC). J. Clin. Oncol. (2006) 24:S2.
   Google Scholar
• HURWITZ H, DOWLATI A, SAVAGE S et al.: Safety, tolerability and pharmacokinetics of oral administration of GW786034 in patients with solid tumors. J. Clin. Oncol. (2005) 23:S195.
   Google Scholar
• RINI BI, WILDING GT, HUDES G et al.: Axitinib (AG-013736;AG) in patients (pts) with metastatic renal cell cancer (RCC) refractory to sorafenib. J. Clin. Oncol. (2007) 23(18S):5032.
   Google Scholar
• FAIVRE S, KROENER G, RAYMOND E: Current development of mTOR inhibitors as anticancer agents. Nat. Rev. Drug Discov. (2006) 5:671-688.
   PubMed Web of Science ®Google Scholar
• HUDES G, CARDUCCI M, TOMCZAK P et al.: Temsirolimus, interferon-α, or both for advanced renal-cell carcinoma. N. Engl. J. Med. (2007) 356:2272-2281.
   Google Scholar
• AMATO RJ, MISELLATI A, KHAN M et al.: A Phase II trial of RAD001 in patients (pts) with metastatic renal cell carcinoma (mRCC). J. Clin. Oncol. (2006) 24:S224.
   Google Scholar

Websites

• http://www.uroweb.nl/files/uploaded_files/guidelines/08%20Renal%20Cell%20Carcinoma.pdf LJUNGBERG B, HANBURY DC, KUCZYK MA et al.: European Association of Urology guidelines on renal cell carcinoma (2006). (Accessed 1 April 2007).
   Google Scholar
• http://www.egms.de//en/meetings/dkk2006/06dkk395.shtml DOEHN C, RICHTER A, THEODOR RA, LEHMACHER W, JOCHAM D: Prolongation of progression-free and overall survival following an adjuvant vaccination with Reniale® in patients with non-metastatic renal cell carcinoma: Secondary analysis of a multicenter phase-III trial (Meeting abstract). (Accessed 25 October 2007)
   Google Scholar
• http://www.urotoday.com/287/conference_reports/aua_2007 DOEHN C, RICHTER A, THEODOR RA: Prolongation of progression-free and overall survival following an adjuvant vaccination with Reniale in patients with non-metastatic renal cell carcinoma: secondary analysis of a multicenter Phase-III trial. (Accessed 10 July 2007).
   Google Scholar
• http:/www.abstracts2view.com/aua/authorindex.php?num=22&page=2&start=40&stop=40. WOOD CG, ESCUDIER B, LACOMBE L et al.: A multicenter, randomized, phase 3 trial of a novel autologous therapeutic vaccine (vitespen) vs. observation as adjuvant therapy in patients at high risk of recurrence after nephrectomy for renal cell carcinoma. (Accessed 25 October 2007).
   Google Scholar
• www.clinicaltrials.gov www.clinicaltrials.gov/ct/search?term=Renal+cancer (Accessed 2 April 2007).
   Google Scholar
• http://www.sutent.com Sutent: a treatment option for patients with advanced renal cell carcinoma (RCC). (Accessed 25 October 2007).
   Google Scholar
• http://www.nexavar.com Nexavar: proven efficacy and saftety in the largest phase 3 study for advanced renal cell carcinoma. (Accessed 25 October 2007)
   Google Scholar
• http://www.emea.eu.int/humandocs/Humans/EPAR/nexavar/nexavar.htm Nexavar summary of product characteristics. (Accessed 7 December 2006).
   Google Scholar
• www.clinicaltrials.gov/ct/show/NCT00326898?order=1 ClinicalTrial.gov. Sunitinib or sorafenib in treating patients with kidney cancer that was removed by surgery. (Accessed 29 March 2006).
   Google Scholar
• www.clinicaltrials.gov/ct/show/NCT00375674?order=4 ClinicalTrials.gov. A clinical trial comparing efficacy and safety of sunitinib and placebo in high risk renal cell cancer. (Accessed 29 March 2006).
   Google Scholar
• www.ctu.mrc.ac.uk/studies/RE05.asp Clinical Trials Unit. RE05/SORCE: a Phase III randomized controlled study comparing sorafenib with placebo in patients with resected primary renal cell carcinoma at high or intermediate risk of relapse. (Accessed 27 November 2006).
   Google Scholar