Expert discusses pooled analysis of cytoreductive nephrectomy

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“We may be tempted to conclude a causal relationship based on the results of this analysis; however, we should avoid making statements implying a causal relationship,” says Jaleh Fallah, MD.

In this video, Jaleh Fallah, MD, discusses findings from the Journal of the National Cancer Institute paper, “Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a U.S. FDA pooled analysis.” Fallah is a medical oncologist with the FDA.

Transcription:

How do the treatments in the study compare to patients with metastatic kidney cancer today?

As I mentioned earlier, we did not include the trial of ipilimumab and nivolumab in this analysis, and the combination of atezolizumab and bevacizumab that we included in the pool has not been approved for treatment of RCC. However, the other 4 trials that were included in this pooled analysis led to FDA approval of the investigative combinations of immune checkpoint inhibitor and VEGF TKI.

Within the confines of the limitations, are there certain patients for whom the study suggests would benefit most from CN over others?

We may be tempted to conclude a causal relationship based on the results of this analysis; however, we should avoid making statements implying a causal relationship. For example, we cannot say that cytoreductive nephrectomy improves patient outcomes, and we cannot conclude it provides any benefit in this setting. Our analysis only demonstrated an association, which may be due to the effects of nephrectomy or confounding factors associated with patient selection for nephrectomy, or both. And to answer this question, we need a randomized trial.

This transcription was edited for clarity.

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