Researchers involved in a U.S. multicenter trial (Cytokine Working Group) have reported that high-dose Proleukin® (aldesleukin, interleukin-2, IL-2) results in a higher response rate in patients with metastatic renal cell carcinoma (MRCC) than historically reported. The details of this study were presented at the 2010 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, March 5-7, in San Francisco.[1]

For more than two decades, the main treatment of MRCC has been Il-2 and alfa interferon. These two agents can produce complete remissions (CR) in a small fraction of patients. More recently, several targeted agents such as Tarceva® (erlotinib), Avastin® (bevacizumab), Nexavar® (sorafinib), Sutent® (sunitinib), and Votrient™ (pazopamib) have been found to be effective for treating MRCC. There have been no recent reports of high-dose Proleukin therapy.  

The current study included 120 patients with MRCC treated with high-dose Proleukin between 2007 and 2009.

• There were two treatment-related deaths.
• The response rate was 28%, with six complete responses and 28 partial responses.
• Stable disease was observed in 44 patients.
• The response rate for patients with clear cell MRCC was 30%.
• No responses were observed in “patients with non-clear histology and adverse risk UCLA SANI (survival after nephrectomy and immunotherapy) scores.”

These authors conclude: “The response rate for HD IL-2 in this trial was significantly better than the historical experience.”

Comments: This study suggests that high-dose Proleukin therapy maybe the treatment of choice for patients with clear cell MRCC.

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