Immunotherapy

Interferon α-2b
Interferon (IFN) α-2b 5 million IU/m2 sc tiw

Flanigan, RC et al. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med 2001; 345:1655 (link to the article).

Mickisch, GH et al. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet 2001; 358:966 (link to the article).

High-dose Interleukin-2
Interleukin-2 (IL-2) 600,000- 720,000 IU/kg iv over 15 min q8h for up to 14 doses in 5 days, repeat the treatment following 5-9 days of rest (one course). Courses repeated every 6-12 weeks

Fyfe, G et al. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol 1995; 13:688 (link to the article).

Yang, JC et al. Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol 2003; 21:3127 (link to the article).

Low-dose Interleukin-2
Interleukin-2 (IL-2) 72,000 IU/kg iv bolus q8h up to 14 doses in 5 days, repeat the treatment following 7-10 days of rest (one course). Courses repeated every 8 weeks

Yang, JC et al. Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol 2003; 21:3127 (link to the article).

SC Interleukin-2
Interleukin-2 (IL-2) 250,000 IU/kg sc qd x 5 days in the first week, followed by 125,000 IU/kg sc qd x 5 days/w for 5 weeks. Courses repeated every 8 week

Yang, JC et al. Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol 2003; 21:3127 (link to the article).

Interleukin-2 + Interferon α-2a
Induction Interleukin-2 (IL-2) 18 million IU/m2/d civi x 5 days, repeat the treatment following 6 days of rest (one course) , course repeated once after 3 weeks rest
Maintenance IL-2 18 million IU/m2/d civi x 5 days (one course), courses repeated 3 times with a 3  weeks rest between courses
Interferon (IFN) α-2a 6 million IU sc tiw

Negrier, S et al. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie. N Engl J Med 1998; 338:1272 (link to the article).

 
Molecular targeting therapy (back to top)

Bevacizumab
Bevacizumab (Avastin) 10 mg/kg iv q2w

Bukowski RM et al. Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. J Clin Oncol 2007; 25:4536 (link to the article). 

Yang, JC 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 (link to the article).

Bevacizumab + Interferon α-2a
Bevacizumab (Avastin) 10 mg/kg iv q2w until disease progression
Interferon (IFN) α-2a 9 million IU sc tiw for 1 yr

Escudier B 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 (link to the article).   

Sorafenib
Sorafenib (Nexavar) 400 mg po bid

Approved by FDA on 12/20/2005 

Choueiri TK et al. Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma. J Clin Oncol 2008; 26:127 (link to the article). 

Sablin MP et al. Sequential use of sorafenib and sunitinib in renal cancer: retrospective analysis in 90 patients. 2007 ASCO annual meeting. Abstract 5038 (link to the abstract). 

Amato RJ et al. A phase II trial of intra-patient dose-escalated sorafenib in patients (pts) with metastatic renal cell cancer (MRCC). 2007 ASCO annual meeting. Abstract 5026 (link to the abstract). 

Szczylik C et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon in patients with advanced renal cell carcinoma: final results. 2007 ASCO annual meeting. Abstract 5025 (link to the abstract). 

Escudier B et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Eng J Med 2007; 356:125 (link to the article).

Ratain MJ et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic  renal cell carcinoma. J Clin Oncol 2006; 24:2505 (link  to the article).

Sunitinib
Sunitinib (Sutent) 50 mg po qd x 4 wks, repeat after 2 wks rest

Approved by FDA on 2/2/07 (link to FDA file). 

Rini BI et al. Antitumor activity and biomarker analysis of sunitinib in patients with bevacizumab-refractory metastatic renal cell carcinoma. J Clin Oncol 2008; 26:3743 (link to the article). 

Cella D et al. Quality of life in patients with metastatic renal cell carcinoma treated with sunitinib or interferon alfa: results from a phase III randomized trial. J Clin Oncol 2008; 26:3763 (link to the article). 

Choueiri TK et al. Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma. J Clin Oncol 2008; 26:127 (link to the article).

Sablin MP et al. Sequential use of sorafenib and sunitinib in renal cancer: retrospective analysis in 90 patients. 2007 ASCO annual meeting. Abstract 5038 (link to the abstract).

Motzer RJ et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Eng J Med 2007; 356:115 (link to the article).

Motzer RJ et al. Activity of SU 11248, 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 (link  to the article).

Motzer RJ et al. Sunitinib in patients with metastatic renal cell carcinoma. JAMA 2006; 295:2516 (link to the article).

Temsirolimus
Temsirolimus (Torisel) 25 mg iv over 30 min qw

Approved by FDA on 5/30/07 (link to the FDA file). 

Hudes G et al. Temsirolimus, interferon alpha, or both for advanced renal-cell carcinoma. N Eng J Med 2007; 356-2271 (link to the article).

Everolimus
Everolimus (RAD001) 10 mg (two 5 mg tablets) po qd until progression or unacceptable toxicity

Motzer RJ et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomized, placebo-controlled phase III trial. Lancet 2008; 372:449 (link to the article).