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DR QUINN: The ARISER trial is a very interesting trial because it looked at giving an antibody directed at G250, which is a hypoxia-derived molecule, in the adjuvant setting compared to placebo in patients with poor-risk renal cell cancer that had surgery.

The particular antibody that was produced was designed and in the lab produced antibody-dependent cytotoxicity. So this is a little different than some other antibodies that we’ve seen. But it’s actually meant to kill cancer cells and also set off some sort of immune reaction and a bystander effect. In this study, they accrued and randomized 1 to 1 to getting either placebo, which would be the standard, and being observed with scans, et cetera, to a loading dose of this antibody in week 1 and then 23 subsequent injections of the antibody given over basically 6 months and then observation.

These data were presented at ASCO by Dr Belldegrun. There were no particular toxicity issues. It was relatively well tolerated, and all of the toxicities were less than Grade 1 or 2. If we look at the cohorts overall, there was no significant difference for disease-free survival nor for overall survival with the agent. So it did not meet its primary endpoint.

But what was interesting is some post hoc analysis. Within this study, where we had a directed therapy, patients that had a higher carbonic anhydrase score by immunohistochemistry did better, both for disease-free survival and overall survival. So it does seem that there’s some predictive effect of the expression. In order for us to move forward with this, we would have to do another study and stratify for that and actually do a biomarker-driven study in the patients that have a high carbonic anhydrase score.

DR LOVE: Bob, where are things heading in terms of adjuvant therapy — in terms of what are the trials out there? When do you think we might start seeing some answers?

DR MOTZER: The first study was the ASSURE trial, which is the cooperative group trial — sorafenib, sunitinib and placebo. There’s been several other industry-supported trials. The S-TRAC trial accrued about 600 patients, and it was sunitinib versus placebo. That’s completed accrual. Just this week, the screening was stopped for the PROTECT trial, which is the 1,500-patient study — pazopanib versus placebo.

There’s another trial that’s ongoing in the United States — a cooperative group trial, the EVEREST trial, which is everolimus versus placebo — and a study in Europe for sorafenib. And one other trial that’s accruing patients in Asia with axitinib versus placebo. So there’s a number of these different trials with virtually all the approved targeted therapies.

It’s not really clear to me when we’ll get an answer. I would estimate somewhere in 2016, 2017, that we’ll probably begin to get information regarding these trials and whether VEGF TKIs and mTORs have some utility in adjuvant.