Posts Tagged ‘metastatic renal cancer’

Proleukin (Interleukin-2) Therapy for Renal Cell Carcinoma: Treatment Option for Select Patients

August 6, 2009

Therapy options for patients with metastatic renal cell carcinoma has expanded significantly, with the FDA approval of sunitinib (Sutent), sorafenib (Nexavar), everolimus (Affinitor), temsirolimus (Torisel), and bevacizumab (Avastin).  These drugs have significant anti-tumor and anti-angiogenic effects.  Progression-free survival (PFS) is improved when compared to placebo or alpha-interferon (Intron-A) therapy.  Many patients will respond to more than one of these agents, and therefore overall outcomes for patients receiving sequential treatments may be improved.   These therapies have expected and manageable toxicities and risks, and are delivered on an outpatient basis.  Nonetheless, these new therapies do not offer curative potential to any patient when used in patients with established metastatic disease.   Patients with reduced overall health and function (performance status) can be treated with these agents.

Interleukin-2 (IL-2, Proleukin) is an FDA approved therapy for metastatic renal cancer.   It is a potent immune stimulator, and it may have anti-angiogenic activity.  Since its clinical development nearly two decades ago, it remains the only therapy with a known curative potential for patients with metastatic renal carcinoma.  Treatment with IL-2 has substantial toxicity, priniciply secondary to capillary leak syndrome and vasodilation, which can result in serious hypotension, fluid accumulation, edema, pulmonary congestion, renal dysfunction, or other organ failure.  Patient selection for this form of therapy is critical.  Only patients with good performance status and adequate kidney, heart, and lung function are potential candidates for IL-2 treatment.  Treatment is delivered on an inpatient basis, under carefully-monitored circumstances, usually in the intensive care unit.  Treatment is delivered by a specialized team of oncologists and nurses, who are familiar with the specific program of IL-2 therapy, and have experience in management and prevention of toxicities.   A critical care physician (ICU physician) is also engaged in management.  Therapy lasts for 5 days, with several additional days potentially required for resolution of treatment-related lab or clinical changes.  Most of the treatment-related side effects abate rapidly after the therapy is completed.  A second cycle of inpatient IL-2 therapy is given after the patient has had a brief period of outpatient recovery.   In studies of IL-2 in metastatic kidney cancer, the overall response rate (out of 255 patients) = 15% (7% complete, 8% partial). That is not higher than other recently-approved medications.  However, the median duration of complete response (CR*) is 6.7+ years (range 7 months – 10+ years).  Those long-term results are not achieved by other treatments for metastatic renal cancer.

Additional information about IL-2 therapy is available at www.Proleukin.com.  CORT is a provider for IL-2 therapy in the North Texas area.  Our patients are treated in Medical City Dallas Hospital.

For information about CORT, or to schedule a consultation about treatment of renal cancer, call 972-566-5588 to speak with a Patient Care Coordinator.  Additional information about CORT and directions are available at www.CORTPA.com.

Study Testing Anti-Angiogenic Drug Therapy for Metastatic Renal Cancer

December 25, 2008

CORT has initiated the SWOG S0717 Study for treatment of metastatic renal cancer that has progressed after prior sunitinib (Sutent) or sorafenib (Nexavar) therapy.   These treatments are standard first-line treatments.  After failure of sunitinib or sorafenib, currently, there is no standard therapy for this disease.  The study will evaluate anti-angiogenic drug therapy. 

Bevacizumab (Avastin) is a monoclonal antibody against VEGF (vascular endothelial growth factor).  VEGF is a key protein that stimulates angiogenesis (new blood vessel growth), when binding to endothelial cell VEGF-receptors (VEGF-R).  Inhibition of VEGF by bevacizumab has proven successful in metastatic breast, lung, and colon cancer, settings where bevacizumab has already been FDA-approved for use.   MEDI-522 (Etaracizumab, Abegrin) is a monoclonal antibody against integrin molecules (av,b3).  Intregins are structural signaling molecules that direct cell movement and attachment, and these are required for new blood vessel growth.  Early phase studies have shown that disruption of vascular growth by anti-integrin molecules results in tumor growth arrest. 

In the S0717 study, patients with metastatic renal cancer will receive either bevacizumab in combination with a placeo MEDI-522 (inactive), or bevacizuamb in combination with active MEDI-522.  All patients will receive active bevacizumab.   This study evaluates whether the combination of anti-angiogenic drug therapy is more active than anti-angiogenic therapy with bevacizumab alone.

For more information about this study, call a CORT Research Coordinator at 972-566-5588, or visit our website at www.CORTPA.com.

Sunitinib (Sutent) for Metastatic Renal (Kidney) Cancer

September 28, 2007

Recent studies of sunitinib (Sutent) in patients with metastatic renal cell carcinoma have demonstrated it is effective in prolonging disease control and survival. The FDA-approved dosing regimen for Sutent is 50 mg per day orally for four weeks, followed by a 2-week rest period off of medication (the 4/2 regimen). CORT is conducting a study comparing a continuous dosing regimen of Sutent (37.5 mg per day orally, without treatment interruption) compared to standard dosing with the 4/2 regimen. The study will determine which regimen has superior outcomes and which has the least toxicity (side effects).

The risks of treatment on this study are fatigue, anemia, nausea, vomiting, diarrhea, proteinuria (protein in the urine), delayed wound healing, bleeding, or thrombosis.

For more information on our research studies, visit www.CORTPA.com, or speak with a Study Coordinator at 972-566-5588.