"I think the take-home message is that surgery is safe, even for these challenging surgical cases after this therapy," says Jason Scovell, MD.
In this video, Jason Scovell, MD, discusses the study “Safety of partial and radical nephrectomy for complex locally advanced renal cell carcinoma after neo-adjuvant immune checkpoint inhibition (durvalumab +/- tremelimumab),” which was presented at the 2023 Society of Urologic Oncology Annual Meeting in Washington DC. Scovell is a urology resident at the Cleveland Clinic Glickman Urological & Kidney Institute in Cleveland, Ohio.
In recent years, there's been a big explosion of immune checkpoint inhibitors for treatments of all types of cancer, but in this space for kidney cancer, the thought here was to look at a combination of durvalumab and tremelimumab for patients that are high risk of metastatic disease. These are patients that have locally advanced kidney cancer that were included in the trial. And it is a phase 1B trial, mostly looking at just the safety and efficacy of giving this combination.
What were some of the notable findings? Were any of them surprising to you and your coauthors?
Data analysis is ongoing from an outcome standpoint with the medical oncology team. There are a couple of different outcome measurements as part of this trial, and the primary outcome was looking at the safety and efficacy. And so what we report on here today is the safety of surgery for patients that have complex locally advanced kidney tumors after they have undergone neoadjuvant immune checkpoint inhibitors. And I think the take-home message is that surgery is safe, even for these challenging surgical cases after this therapy.
We looked at a couple of different measurements of complications. One is blood loss, [which] was within our standard expectation. There were 25 patients as part of this trial; a total of 4 units of blood were transfused postoperatively across all 25 patients. And I think that's pretty standard for the complexity of these types of tumors. When we look at Clavien grade complications, there were 5, but it's not that these were mostly due to drug-related events or completely unrelated events. There were 4 Clavien 2 and there was 1 Clavien 3B and that 3B was a surgical but a non surgical related to our treatment. It was something completely unrelated, but just happened within that 30-day period.
I think as we see an expansion of immune checkpoint inhibitor therapy in the neoadjuvant space, I think we're going to see more and more of that. It's important to know if there are considerations for surgical safety, is there a big reactive component that complicates the surgery or not? And I think that what we show here is that in general, even for these complex cases, it's a safe surgery, after immune checkpoint inhibitor therapy, but as different combinations come out, and as more people have experience with this out in the clinical world, I think we'll have to continue to assess this as we counsel patients, as we plan for surgery, because these things could contribute, but I think here, at least in this combination in this group of 25 patients, it seems to be a pretty safe situation.
This transcription was edited for clarity.