GRACE :: Kidney Cancer

The RECORD-3 Trial: What Can We Learn From It?

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For the past year, several pivotal trials have emerged that truly are giving us in the RCC community a better sense how to appropriately sequence therapies. One trial that I’d like to focus on is the so called RECORD-3 trial. The RECORD-3 trial asks a fundamentally important question — whether or not the sequence of a VEGF-TKI followed by a MTOR inhibitor is better than the sequence of an MTOR inhibitor followed by a VEGF-TKI. We are familiar with the treatment options for first and second line treatment of RCC in the metastatic setting. The RECORD-3 trial evaluates the sequence of sunitinib followed by everolimus, the standard, and compares it to everolimus followed by sunitinib in a one to one fashion. Patients cross over to the second treatment when their treatment progresses or worsens. The primary endpoint of this trial (i.e. the principal focus) was to determine whether or not everolimus or sunitinib led to a greater delay in tumor growth in the first-line setting. However, the trial also explored multiple secondary endpoints such as the combined delay in growth from the sequence of therapies. In addition to that, the study looked at response rate and overall survival.

In this trial, patients could have clear cell or non-clear cell histology. I will focus on that a bit later because I think there’s some important information that can be gleaned from the subpopulation of patients that did not have clear cell disease. In addition to this, patients in this clinical trial may or may not have had prior nephrectomy. Ultimately sunitinib resulted in a greater delay in tumor growth as compared to everolimus (10.7 months versus 7.8 months) in the first-line setting. I actually think one of the most interesting observations from the RECORD-3 trial has to do with what was seen in the breakdown based on clear cell and non clear cell histology. It’s always tricky for us to know what to do for patients with non-clear cell metastatic kidney cancer. We typically apply the treatments that have been developed for clear cell disease. In this trial, it seemed as though patients did a bit better with sunitinib, with median delay in tumor growth of 7.2 months versus 5.1 months with everolimus. The numbers here were very small — just over 60 patients within the subset of patients with non-clear cell disease — so it’s hard to make any definitive conclusions. However, this trial offers some suggestion and seems to indicate that patients may potentially do better with VEGF-TKI in the upfront setting whether or not they have clear cell disease or non-clear cell disease.

If we look at combined progression free survival, this data seems to suggest that there may be benefit with the sequence of sunitinib followed by everolimus as compared to everolimus followed by sunitinib. The total delay in tumor growth for sunitinib followed by everolimus was 25.8 months as compared to 21.1 for everolimus followed by sunitinib. One encouraging note from this study was the overall survival data. If we go back to the interferon era when we were quoting a median survival closer to just 1 year, we see that the results from RECORD-3 trial suggest a ray of hope. Specifically with a sequence of sunitinib followed by everolimus a median overall survival of 32 months was observed. Notably, this overall survival was substantially higher than with a sequence of everolimus followed by sunitinib. With that particular sequence, overall survival was 22 months.


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