Ralph Clayman: Hi, I'm Dr. Ralph Clayman. I am a professor of Urology at the University of California, Irvine, and I'm going to be speaking with Dr. Jaime Landman, who is a professor and chair of the Department of Urology at the University of California, Irvine, and my boss. There you go. Okay. So, why are you biopsying renal masses? Why would you do that?

Jaime Landman: What you're referring to is the three-centimeter renal mass panel that we did today at the plenary session at the AUA, which I thought was a really eye-opening meeting. We had Costas Lallas, who was our host, introduce the topic, give a little summary. Dr. Lane then proceeded to talk a bit about partial nephrectomy, which is touted as the gold standard, which is when a little switch went off in my mind, and we'll talk about that. Lee Ponsky did a really nice job on ablation and radiotherapy, which is fascinating and some new material was presented. That was great, and my job was to talk about active surveillance. But largely, aside from a little review of the global literature, which as you know, Sora Abalee is doing with our team, we then proceed to talk about what we think is a little better standard, which is BIAS. The Biopsy Informed Active Surveillance.

Jaime Landman: The truth is, whether we talk about active surveillance or any aspect of the renal mass guidelines, the data is quite poor. I think what was really bothering me as I sat there was that we have a non-data-based structure that gives guidelines. This isn't just the US guidelines, it's the European guidelines and the Asian guidelines as well. For the most part, because the data's relatively poor, they're culture-based guidelines and when that happens, what I think we're seeing is a perpetuation of some patterns that aren't serving our patients as well as they could. As you are probably the guy most responsible for the minimally invasive standard of cancer therapy in Urology with the introduction of the lap nephrectomy, it bothers me that we're now talking about a gold standard that is partial nephrectomy, and it is nice that that's evolved from open to laparoscopic and then robotic.

Jaime Landman: The problem is when you start talking about a gold standard treatment for a not well-defined entity, that's really bad. So the small renal mass, as we all know, has a wide biologic spectrum, and there's a very rare few that are quite aggressive and can be life-threatening that are oncologically challenging. While the spectrum is real, we all know that the vast majority sit on the very indolent side. In fact, there's pretty decent data out there that 25% to 30% of these that we're treating with partial nephrectomy are in fact, benign tumors, thus making the surgery largely or entirely unnecessary. So when we talk about a biopsy-driven standard, people do look at me like I have two heads and it is a little bit disturbing at this point, because if you want to step out of the Urology culture and our cultural perspective on this issue, every other surgeon and every other discipline and every other organ with every other tumor has a biopsy-driven standard.

Jaime Landman: So when people say I'm going to do a partial nephrectomy, it's the gold standard for a renal mass that's three centimeters, it really bothers me because everybody else would biopsy it. When we do biopsy it and we presented these results, what happens? People say, "Oh, I'm not sure it's going to change management." It dramatically changes management, but that's really not where we should go. It doesn't change management, it dramatically improves management. So in this panel, I focused largely on active surveillance. What we showed is that we have 40% or so of our patients on active surveillance, which is dramatically higher than everyone else. Everyone else has about 80% of their patients going to partial nephrectomy and the other 20%, a smattering of active surveillance and perhaps ablation. We have the largest proportion of our patients going to active surveillance. Now, we call that the BIAS, the Biopsy Informed Active Surveillance.

Jaime Landman: If you look globally at active surveillance data, it's great. Very few of these patients end up going to surgery and even fewer end up going on to metastasis and death, sub 1%. But with BIAS, what we found is only 3% of our patients ended up going to surgery and our mean growth rate was half of what everyone else's is. Most people report three millimeters per year on the whole, ours was one and a half and they did great. Then with this biopsy-informed standard, our partial nephrectomies had a 4% rate of benign tumors. So a 4% unnecessary surgery rate and I think we can do even better than that.

Ralph Clayman: Versus how much?


Jaime Landman: Nationally, that's 25% to 30%. So we are literally a factor less.

Ralph Clayman: Fivefold.

Jaime Landman: Yeah, it's impressive. So you asked me, and I think your question was largely to wind me up, why are we-

Ralph Clayman: Didn't take much.

Jaime Landman: Yeah, no, it's pretty easy.

Ralph Clayman: It really was a yes or no question, but anyway, go ahead.

Jaime Landman: But the bottom line is, I biopsy because it's a standard for every tumor in every surgeon, every organ and I just don't see... There's no biologic reason this should be different.

Ralph Clayman: You mean you don't have anyone on the faculty who takes the prostate out without a biopsy, or does hysterectomy without a biopsy?

Jaime Landman: They would go to jail because it's not culturally accepted and in fact, I remember back when I was taking psych, the definition of a delusion was a false fixed belief that's not culturally shared. The only reason that the non-biopsy standard is not a delusion is because it's a culturally shared bias that you don't need to biopsy. That's the only thing I learned in psychiatry during my medical school time.

Ralph Clayman: I feel a lot better now.

Jaime Landman: So the binary question was answered in a very long way.

Ralph Clayman: Right.

Jaime Landman: Thanks.

Ralph Clayman: Thank you. I take that was a no?

Jaime Landman: Correct.