President and Patient Advocate at KidneyCAN in Philadelphia, Pennsylvania.

Bryan Lewis

Speaking of advocacy, Mr. Lewis, you run KidneyCAN. You have been instrumental in getting all of this funding for kidney cancer research. Talk a little about resources and the challenges that are coming up for the field.

 First of all, thank you, Dr. Lee. Meryl, your story is so inspirational and moving. We need to cut that section out and make it a motivational speech to send around. It was awesome to hear that. I have a couple of other thoughts on that before we talk about advocacy a little.

Ms. Virdee, what you pointed out about communication is so important. It’s hard to communicate in the medical environment. Sometimes people are intimidated. But if you create an environment where there’s collaboration, discussion, or shared decision-making, and there’s a sense that people can be comfortable talking with you, with their medical providers, that’s huge. That’s a huge barrier that a lot of people don’t realize. They come into a hospital setting and it’s off-putting at times, or it can be scary. Breaking down that barrier of communication and allowing for communication is so important. Especially because many of us have been on Google looking for information and have misinformation.

Another point I want to touch on is that we talk about side effect management a lot these days because it’s so important. I’m not sure where this goes exactly, but the medical profession talks about grades 1 through 5. We don’t even want to talk about grade 5 most of the time. I’m wondering if we can’t dive down a little further, because it’s hard to distinguish as a patient the differences between grades 1 and 2 and between 2 and 3. We don’t have time to go into that right now, but that’s something we need to work on as a community.

Quality-of-life measurements are gaining importance in clinical trial design and development. We all applaud that. Now it’s up to us to try to figure out how we approach quality-of-life measures as a standard across society. One of the things someone told me recently is, “When you think about measuring quality of life, what you’re not taking into account is that you had a different quality of life prior to having cancer. You now have a new standard of what your quality of life is because you have cancer.” You have to keep that in mind.

Thank you for this opportunity to hear Meryl’s story—that was awesome—and the latest on personalizing medicine. That’s very inspiring for the patient community to hear. Quickly on the front with advocacy, as Meryl pointed out, kidney cancer has been underfunded for many years. As you said, Dr. Lee, we’re sixth or eighth or ninth, depending on the year and gender, but we’re in the top 10 of cancer diagnoses. We need to have more funding to find out what’s going on in this space.

KidneyCAN and eight or nine other organizations partner to do advocacy on Capitol Hill in Washington, D.C. Yesterday, we finished about 180 meetings with 39 states represented. I have to give a shout-out to our wonderful leader, Debra Beyhan, from Atlanta, who’s organizing most of this. We have doctors, researchers, and patients talking to our elected representatives and saying, “Thank you for this investment in kidney cancer research, but we need more.” We need more at the NIH [National Institutes of Health]. We need more through the KCRP [Kidney Cancer Research Program] and others. And I think our voice is being heard.

We’re louder these days than we have been in the past, and we continue to march forward, but we’ve got a lot of ways to go. The reason that came front and center yesterday was because I was on a call with one of the Senate offices, and one of our patient advocates told her story about being diagnosed with kidney cancer, but then during treatment being subsequently diagnosed with breast cancer early on. She compared her treatment for breast cancer early on with her treatment for kidney cancer, and it’s unfortunately night and day. The amount of research and knowledge that they have around breast cancer these days is off the charts compared with the knowledge and information on kidney cancer. We have to change that. That’s what we’re doing. With people like you and others who are doing the research to help advance cures, that’s what we’re all in this together to do.

We’ve been very fortunate to have some champions in Congress. We’re continuing to march forward. We asked yesterday for $60 million for the KCRP. I got cautiously optimistic, but we heard this morning that the omnibus bill that came out for this fiscal year includes our $50 million for kidney cancer research. We locked it in for another year. Now we have to get some more, and efforts like from everybody on this call is making a difference. Thank you for this opportunity.

Yes, the work that you do is fantastic. The ability to have a unified voice from the patient, advocate, researcher, and clinician front is necessary to think about how we can move the field forward. The ability to have all of these scientific advancements unfortunately isn’t free. These types of investments that we’re all making are critical for thinking about how we can advance the field and change outcomes for patients.

First of all, let me thank all of you for joining me today and sharing your valuable perspectives. And to our viewing audience, thank you for joining us. We hope that you found this episode of the 

Videos

Bryan Lewis, president of KidneyCAN, and Chung-Han Lee, MD, describe unmet needs and future perspectives in the treatment of renal cell carcinoma.

Unmet Needs and Future Perspectives in the Treatment of RCC

Ms. Uranga, do want to talk a little more about your journey as a patient, where you are now, and where you see things going?

 The beginning was crazy. It was a whirlwind of not knowing what was going on, being told what to do, going through the motions, and shock. I was in my mid-50s. I never expected my life to take that turn. I went through a lot of anxiety and depression. I was really lost and felt like I didn’t have much ahead of me. That has dramatically changed for me. I know the fact that I’m doing well physically has helped, but the psychological side of getting involved in my care and in the community in a support arena, and more than anything, as an advocate [has helped immensely].

Since my diagnosis, I have seen the funding for research go from $0 the year before I was diagnosed to the $60 million that we’re asking to have for the next year. Because of that, I’ve also seen FDA-approved treatments, with one after the other coming out, like was mentioned earlier. It was just a few several years ago. When I was diagnosed, there were a couple more on board. Now we’re talking double digits, 14 or 16, with triplets coming down the road, like you said.

My mental world has improved so dramatically because of the knowledge and empowerment that I have from getting involved, understanding this, and doing my part to make it happen. It’s a small part, a drop in the bucket, but I do whatever I can do. It has changed my whole outlook on my life, my future, and my day-to-day existence. I’m extremely active. I hiked this past weekend. In fact, one of my kids reminded me, “Mom, we went to this place nine years ago and you couldn’t do the hike. And here you are after cancer and 60-plus years old, and you did the hike.”

That’s basically how I see my life now. I don’t take anything for granted. I feel like I’m [helping move things along]. Because of the work that I do with KidneyCAN, I see that’s a reality, that we can keep [making advancements], with new treatments becoming available and the level of research and education.

I was fortunate to be privy to the Kidney Cancer Research Summit this past year, which is hosted by KidneyCAN. That was such a boost as well because there are brilliant minds working on this. There was a day where I’d just sit around thinking, “It’s just not fair. I want to see my grandkids be born,” and now I have two on the way. That actually looks like it’s going to happen. It’s become a totally different world by getting involved. That’s what I’ll share with people who want to hear my story, especially newly diagnosed people who are feeling lost and in that state of mind. Get involved and make things happen. It makes a world of difference on a personal level and in helping the general cause that we’re working toward.

It’s absolutely fantastic how much you’ve gotten involved with this diagnosis. We truly appreciate all your efforts in being an advocate and trying to do all that you can to not only improve your own life but the lives of people in the United States and around the world in terms of advancing the research. The work that you do is truly fundamental in being able to do that.

 Circumstances worked out where I was able to retire from my professional career a couple of years ago, so I have the time and the skills. That’s what I’ve said to the people I work with at KidneyCAN and everything. I was a project management professional. I have the skills to help. I was also in media for many years. That’s another thing that I can contribute. I’m [available]. I have the time and the desire to do it because I’m giving back [and expressing] how much this has helped me in my own perspective in living my life. I couldn’t have seen this a few years ago. I was just sitting around waiting for things to go bad, and now I have the opposite view of my life, and I think it’s going to get better.

From a quality-of-life standpoint, as a medical oncologist, this is what we strive for in terms of helping you maintain quality of life and allowing you to do the things that you find important. One of the things that patients sometimes think at the beginning before they’ve started on treatment is that the treatment isn’t working unless they get sick. That’s not what we want for you. There’s often a lot more pushback from the patients about potentially dose reducing and making those modifications to improve their quality of life. I tell my own patients, “I can’t predict how much time I can give you, but whatever I can do to make that time better is incredibly valuable.” How about for you in terms of your own health care team? How frequently are you seeing them now? Who else on the team besides your oncologist is involved in your care when you have questions?

 For the last couple of years, it’s mostly been telemedicine. I have very rarely been in person other than the things I have to do in person, such as getting an infusion. They haven’t figured out how to do that from afar. I meet with either my oncologist or one of his nurse practitioners, and I do that about every other infusion. That would be about every six weeks. We check in and talk about future scheduling, how I’m doing, concerns, questions, side effects, etc. I reach out through the portal in between those visits if I need to. I also work with a radiation oncologist who basically manages my brain situation. My oncologist is aware of what’s going on, but my radiation oncologist manages it.

I received great news on that. Because I’ve been treatment-free for over two years with my brain, I’ve been switched over to six-month scans. That was a big celebration in this house because of what it indicated more than anything. I still get the other scans every three months, but the fact that they felt that it was OK to stretch it to twice a year is really good news. I have no medical basis on which to base this on, but it has been ever since I started immunotherapy that I’ve had no activity with the brain. I had five radiation treatments on very small 2- or 3-mm things in my brain that were treated with radiation, SRS [stereotactic radiosurgery] gamma knife. But since immunotherapy, I’ve had zero. I don’t know. It’s anecdotal, but that’s been my experience, and I’ll take it.

We’re very happy for you based on the response that you’ve had and all your contributions to the field in terms of advocacy.

Meryl Uranga describes her path with metastatic clear cell renal cell carcinoma after first treatment, and how it has affected her outlook on her life and future.

The Importance of Patients Advocating for Themselves During Their RCC Journey

Continuing on this trend of talking about side effects, a lot of these studies from the large phase 3 clinical trials have included quality-of-life data. What was your take on some of these quality-of-life data and how that weighs into how you approach patients?

 Thank you, Dr. Lee. When we look at clinical trials and either the TKI [tyrosine kinase inhibitor]-IO [immunotherapy] combination, such as the CLEAR trial, or the IO combination, as in CheckMate 214, quality-of-life data are collected from patient-reported outcomes, where patients quantify an assessment of how they feel. This entails from a disease standpoint as well as from toxicity related to the treatments that they’re on. These assessments come directly from the patients. There’s no clinician involvement. The patients themselves complete surveys to assess how they’re feeling.

When we do these quality-of-life assessments, there are a lot of caveats that can go into this. There may be certain information that might not necessarily be captured based on how these surveys are designed. The quality-of-life assessments talk about the average patient. It gives everyone an equal weight and might underestimate the quality of life for patients who experience rare events that could lead to other complications. In medicine and our practice, we tend to have a greater weight on those rare side effects, because we have seen firsthand the complications that can occur, such as adrenal insufficiency, which we talked about earlier, and other side effects.

In clinical practice, there’s an unpredictability in how patients will respond from a toxicity standpoint. The quality-of-life curves that we see in the trials may not be as meaningful because individuals are so unique in their response to treatment. We generally draw from our own personal experiences with patients and use that to help with their treatment and quality of life. One thing that we can say about the combination treatments themselves from the CLEAR and CheckMate 214 trials is that being on a combination treatment doesn’t necessarily mean that you’ll have worse or increased side effects. That’s one thing that we can identify.

A look at how to consider quality-of-life clinical trial and patient-reported data when treating clear cell renal cell carcinoma with combination therapies.

Quality-of-Life with Systemic Therapies in Metastatic Clear Cell RCC

 Ms. Uranga, you’ve been on both types of treatments. You’ve been on dual immunotherapy approaches and then a TKI [tyrosine kinase inhibitor] plus an immunotherapy. How would you compare them in terms of side effects and what you experienced?

 My experience was that I felt pretty good with the double immunotherapy. I didn’t have what I would call side effects on a daily basis. I did have some pretty intense itching overall that was manageable with a prescription steroid cream. But I had a major side effect, which was I believe grade 4 hypophysitis [inflammation of the pituitary gland]. My pituitary gland was impacted by the immunotherapy, and it left me in a state of permanent adrenal insufficiency. That isn’t going to get better. I have to manage that daily for the rest of my life. It’s not the end of the world. I look at it as a small price to pay for a great response. But I felt well on that.

Once the TKI was introduced when I switched regimens, I had more of a daily side effect profile that I had to manage. It hasn’t been that bad, even with the dose increase. It’s very manageable. I’ve had bouts of gastrointestinal and blood pressure issues — the standard TKI side effects — but they’ve been very manageable. In some cases, they’ve settled down. I don’t know if my body got used to it, but it’s fine. I generally feel very well. I’m very active. I’m feeling great. That may have something to do with the fact that my performance level has always been good. Even when I was diagnosed with stage 4 and metastases, I never felt bad. I never even knew I was sick.

That’s the best way to describe the differences. With the TKI introduced, there’s a lot of daily management of side effects as opposed to the big events where a major organ system or whatever gets attacked by the overstimulation of the immune system and some very serious things could go on. I was fortunate. I guess permanent adrenal insufficiency would be serious, but it’s easily managed. The risk-reward scenario there was well worth it.

 When you had to go up on the dose on your axitinib [Inlyta], did you notice any difference in what you experienced from a side effect standpoint?

 I did at first. It was very noticeable. The diarrhea, blood pressure, everything kicked in again like it did at the beginning on the lower dose, but it didn’t last very long. It seems like I adjusted to it fairly quickly within the first couple of months. It now seems to be the way that it was when I was on the 5 mg dose. Hopefully that isn’t a problem. So far it doesn’t appear to be a problem with efficacy. I don’t know what the reality is, but there’s a lot of talk in the community about side effects equaling efficacy. I don’t think that’s always true because I was on the 5 mg dose with very clear scans for a couple of years and there were no issues. I just keep an eye on it. When things do kick in, they’re easy to manage overall.

 Good. Is there anything that you have to take on a daily basis to help manage the side effects?

 Not really. If my blood pressure is up, then yes. I have a low dose of lisinopril. If there’s some gastrointestinal, specifically intestinal, thing going on, I have things like over-the-counter Imodium. It works fine for me. I take hydrocortisone daily for my adrenal insufficiency, which is a physiologic replacement dose of cortisol. It’s meant to copy what the body does naturally. You get a large dose in the morning, a little in the afternoon, a microdose in the late afternoon, and that’s it. It isn’t a big deal. If you’re sick or have big stressful events going on or something, sometimes you have to bump that up, but it’s fairly easy to deal with once you get used to it. I take a thyroid pill as well, which is extremely common with both of the drugs in terms of having thyroid impact, but that has also been very well controlled.

 Your experience with the 2 medications mirrors what the clinical trials have shown from a toxicity perspective. For a lot of people who are on the dual immunotherapy approaches, most people from a day-to-day standpoint feel pretty well. We do hear people complain about the itching that can come about, and things like topical steroids can be very helpful for that. The concern is whether you’re going to fall into that uncommon circumstance in which the immune system gets too excited and then you have to make an intervention at that point. For the various different tyrosine kinase [inhibitor]/immunotherapy combinations, there’s that chronicity of toxicity that’s there. A lot of that comes from the chronic TKI use.

There are a lot of specific dose and class distinctions in terms of when you treat people on a medication that targets the blood vessels. It raises people’s blood pressure. It can give them diarrhea and make them tired. Regardless of which TKI you end up using, it’s often the case that you can experience those types of side effects related to it. Whether it’s lenvatinib [Lenvima] or axitinib, all of them have this chronic low-grade thing. This is where it’s important to talk with your oncologist about adjusting the dose and deciding whether we stay at the current dose and ride it out, like what you did when you went up on the dose and the side effects eventually settled, or if it’s time to go down on the dose. A lot of the side effects do improve by going down on the dose. That’s why we use that as a very common way of managing the toxicities after we’ve given you supportive medications.

Meryl Uranga describes her personal experience with managing the side effects of treatment for clear cell renal cell carcinoma.

Bryan Lewis

Unmet Needs and Future Perspectives in the Treatment of RCC

The Importance of Patients Advocating for Themselves During Their RCC Journey

Quality-of-Life with Systemic Therapies in Metastatic Clear Cell RCC

Patient Experience with Systemic Therapy-Related Toxicities in Metastatic RCC

Latest News