Asthenia, the most common severe adverse event, was seen more often with IFN-α Dr. Hudes reported. Mild-to-moderate rash, peripheral edema, and stomatitis were more common with temsirolimus. Anemia, neutropenia, and thrombocytopenia were more common with the combination.
"Hyperglycemia and hyperlipidemia were greater in the temsirolimus-alone and combination arms, probably reflecting inhibition of mTOR-regulated glucose and lipid metabolism," Dr. Hudes said. He pointed out that significantly fewer patients in the temsirolimus-alone arm had any grade 3-4 adverse event69% vs 85% of IFN-α patients and 87% of combination patients.
Dr. Hudes noted that in this study, responses were seen in a population "whose cancer was so advanced that they would not qualify for most other clinical trials." Given that the current trial has shown mTOR to be "an important therapeutic target in renal cell carcinoma," he said, future trials "may further benefit patients with metastatic RCC by using temsirolimus in combination with agents that target VEGF and its receptor."