SAN FRANCISCO, CA USA (UroToday.com) - Dr. Elisabeth Heath presented the results of two phase III trials in the context of a 68-year-old healthy male who presented with a large renal mass without evidence of metastasis.
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He underwent nephrectomy but developed pulmonary metastases 16 months later. Combination therapy for metastatic renal cell carcinoma has generated much interest after the demonstration of activity for Interferon-alfa/bevacizumab. The INTORACT trial compared this regimen to Interferon-alfa/temsirolimus in 791 patients, and, unfortunately, showed no difference in the primary endpoint (progression free survival) or overall survival. Additional subgroup analysis did not show that any particular groups benefited from either arm. However, the Interferon-alfa/temsirolimus arm had a significantly higher rate of toxicity. Based on the result of this trial, the patient received Interferon-alfa/bevacizumab. Nine months later the patient had radiographic progression, which prompted a treatment change. In this setting, one might wonder if treatment with another antiangiogenic agent is useful if the patient failed prior antiangiogenic therapy. The INTERSECT trial sought to help answer this debate by comparing temsirolimus and sorafenib in 512 patients who progressed on first-line sunitinib. Again, no difference in the primary outcome (progression-free survival) was demonstrated. However, overall survival was increased in patients receiving sorafenib, and subgroup analysis showed that clear cell renal cell carcinoma, cytoreductive nephrectomy, and a longer interval on sunitinib prior to progression benefitted as well. INTERSECT also showed that there was higher toxicity with temsirolimus.
Highlights of a presentation by Elisabeth Heath, MD at the 2014 Genitourinary Cancers Symposium - January 30 - February 1, 2014 - San Francisco Marriott Marquis - San Francisco, California USA
Karmanos Cancer Center, Detroit, MI USA