Shared Decision-Making for Advanced Renal Cell Carcinoma: Focus on Adverse Event Management of Axitinib Plus IO: A Vodcast

Abstract

Shared decision-making is essential to the care of patients with advanced renal carcinoma which can empower patients and help the healthcare team understand the patient’s goals of care. An important topic during the shared-decision making process is identification and management of treatment-related adverse events. A patient author and two healthcare professionals with real-world experience provide insight into the importance of shared decision-making and its utility in the management of treatment-related adverse events in patients with renal cell carcinoma who are receiving axitinib in combination with an immunotherapy agent.

Supplementary Information

The online version contains supplementary material available at 10.1007/s40487-025-00330-w.

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Key Summary Points

Shared decision-making (SDM) is an important part of healthcare during the treatment of advanced renal cell carcinoma (aRCC), empowering the patient participate in decision-making and reduce anxiety.

Axitinib plus pembrolizumab represents one of several new standards of care in the treatment of aRCC; however, potential adverse events must be effectively managed to help patients remain on their treatment and optimize the clinical benefit.

Discussing the potential adverse events that may be associated with axitinib plus pembrolizumab treatment and how these can be managed is a vital part of the SDM process.

Ongoing effective communication between the patient and healthcare team, including the prompt reporting of adverse events, is an essential part of ongoing care and optimizing treatment duration.

Introduction (00:00–02:21)

Dharanija Rao:

Hello everybody. My name is Dharanija Rao. I’m a senior medical director at Pfizer Oncology, supporting kidney cancer. I’m here today with Dr Posadas, with Nancy Moldawer, and Greg to discuss about advanced renal cell carcinoma in the context of therapy management, focused on shared decision-making, which is becoming increasingly important in terms of treatment decision-making as well as AE (adverse event) management throughout the course of the patient journey. So, I’ll just maybe ask Dr Posadas, Nancy, and Greg to briefly introduce themselves.

Dr Edwin Posadas:

So, hello everyone. My name is Dr Edwin Posadas. I am the Co-Director of the Cancer Therapeutics Program and the Medical Director of the Center for Uro-Oncology Research Excellence at Cedars-Sinai Cancer.

Nancy Moldawer:

Hi, my name is Nancy Moldawer and I have a dual position at Cedars-Sinai Cancer Center in that I am a clinical research nurse and also have a role as a practice nurse in the Cancer Center.

Greg Biddulph:

Hi, I’m Greg. I’ve had renal carcinoma for over 4 years now and I’ve been dealing with this disease with my care team and looking forward to discussing some of that with you.

Dharanija Rao:

So the overview of the topics to be covered today include an introduction to shared decision-making within the context of advanced renal cell carcinoma (RCC) and why shared decision-making is important and relevant to, in this case, advanced RCC.

We’re going to focus [the] majority of our time on [the] axitinib plus pembrolizumab combination, which is approved as a first-line indication for advanced RCC [and] the role of early communication with all of the members of the shared decision-making treatment in the context of advanced RCC. And also before we kick this off, I want to let everybody know this podcast is sponsored by Pfizer.

So with that, I’ll pass it on to Dr Posadas to kick it off and let us know a little bit about what shared decision-making is, who’s involved, and how and why this is becoming increasingly important.

What is Shared Decision-Making and Who is Involved? (02:22–03:26)

Dr Edwin Posadas:

So, thank you. Let’s begin by a brief discussion of shared decision-making. This is a process—a joint process—by which [the] patient engages with his multidisciplinary team to work together to reach decisions about treatment and care [1].

This is really a critical part of optimal treatment and therapy management and helps us to understand our choices as well as empowering patients to make decisions they feel that are right for them and really align strongly with their personal preferences and goals. This process involves the entire healthcare team that touch onto the patient’s goals and aspects of the therapy which are important to the patient. Shared decision-making allows patients the opportunity to choose the extent to which they’re engaged in this decision-making and can alleviate anxiety that may be associated with the treatment and management decisions that are made during the course of the patient’s journey [2, 3].

Advanced Renal Cell Carcinoma (03:27–05:21)

Dr Edwin Posadas:

So, today’s topic will really focus on the subject of advanced renal cell carcinoma (RCC). And I’ll set the background by saying that this term, advanced renal cell carcinoma, refers to a kidney cancer that has grown into nearby tissues or lymph nodes or blood vessels, or that has already spread to other parts of the body [4].

We’re very glad to acknowledge that in recent years there have been a number of very important advances in the care of patients who have been affected by kidney cancer in particular for advanced RCC. The approval of the first-line immuno-oncology agents, drugs like nivolumab [5, 6], ipilimumab [5, 6], and pembrolizumab [7, 8], and avelumab [9, 10], have really revolutionized the way that we care for patients, and with further studies, we’ve really seen that combinations of these immuno-oncologics, along with tyrosine kinase inhibitors such as axitinib [7–10], cabozantinib [11], and lenvatinib [12], have made substantial differences in survival and outcomes for these patients who are affected by advanced RCC [13]. Amongst those combinations that are available are the combination of axitnib and pembrolizumab, which we’re going to talk more about today.

The problem though, when starting to combine these oncologics—these oncologic agents—together is an increased risk of adverse events [14] that counterbalances the benefit that may be had, and so thinking about how to do this thoughtfully and to a patient’s best advantage [15] really becomes an important part of optimizing care and then a patient really needs to be involved in this process that we really have begun to call shared decision-making [16, 17].

The Axitinib Plus IO Combination (05:22–06:06)

Dr Edwin Posadas:

So, this particular combination of axitnib and pembrolizumab was approved in 2019. It’s been an incredibly effective means of treating patients as demonstrated by a clinical trial known as KEYNOTE-426. Despite the benefits that were seen with improved overall survival and progression-free survival, there was an increase of adverse events even over single-agent axitinib alone that required some consideration about how to manage patients. This combination can involve a number of adverse events that range from fatigue and diarrhea to hypertension and other complications that can really impact a patient’s quality of life [7].

Early Communication and SDM in Treatment with Axitinib Plus Pembrolizumab (06:05–09:32)

Dr Edwin Posadas:

So, I’m fortunate to have with me today Nancy and Greg, both who have tremendous amounts of personal experience working in this field.

So Nancy, you’ve worked in the area of kidney cancer for quite some time and have seen the field evolve. Let’s talk a little bit about how you use shared decision-making in your care of patients now that these newer treatments are available. And what does shared decision-making mean to you?

Nancy Moldawer:

Thank you, Dr Posadas. Well, I would like to start by just kind of going back to kind of defining more a picture of shared decision-making and start by saying what it’s not. Long ago in my practice, you know, patients would, we didn’t have many choices for treatment; patients wanted to be treated yesterday. And what shared decision-making again is not, is giving a prescription to a patient, having them fill it and say, come back in 6 weeks, I’ll see how you’re doing. That picture is not part of our landscape at all today, not only in taking care of kidney cancer patients, but I’d like to think in all areas of oncology.

So, it really starts with the patient and the treating physician and it’s really a very, it’s a bird’s eye view of their medical situation, and when we first meet the patient for the first time, there’s a lot going on at that meeting and patients are anxious. Patients want answers as to, you know, how they’re going to be treated. But we need more information many times and that takes time. I would say that we see patients at least three visits before they actually start their therapy. And during that time, we exchange information, we build trust, we build communication. And by alleviating anxiety during that time, it really feels okay for the patient to, let’s say, start within 3 to 4 weeks of their diagnosis. There’s always going to be exceptions to this where a patient may need to be treated a little bit sooner. But during that time, we talk about what type of treatment they will receive. We say it’s going to be an IV (intravenous) infusion; it will probably be a pill. We tend not to give names at that first visit because it could change once we get more information about results of CAT (computed tomography) scans, blood work, and then also start talking about side effects, and, when we do, that is a time when we really learn about the patient’s preferences, their goals, do they want to go back to work? Do they want to travel?

Do they want to just spend time with their families? We find out what’s important to them and then we’re able to work with the patient to develop the trust and let them know what their care and what their journey will be like. So it’s a bird’s eye view that we narrow down and we get more information for them so that they feel confident and secure in their decisions.

Shared Decision-Making in the Ongoing Management of Advanced Renal Cell Carcinoma (aRCC) Treatment with Axitinib Plus Pembrolizumab (9:33–14:03)

Dr Edwin Posadas:

Nancy, how does that process evolve beyond the first visit that you described where you meet a patient, try to point out this or point towards a landscape of what could happen to them and why we’re going to go on this journey together as a team? What happens at subsequent visits? Does it now, you know, now that you’ve had that decision, the patient has made their statement, you know, does it end there or is this an ongoing process?

Nancy Moldawer:

It is absolutely an ongoing process. And, you know, once we know, for us, we need to know the extent of their disease. We need to know the tissue type. We need to know blood work. And then we can propose treatment plans to the patient based on, you know, evidence that we know is going to be effective for their cancer. That’s the first thing.

Dr Edwin Posadas:

Are there particular tools that you utilize when you engage in this process with your patients that are particularly helpful?

Nancy Moldawer:

The best tool that we have, I think, is really good communication. We encourage patients to tape-record if they want because usually this is a very long visit. And we’d rather have them listen than, you know, writing things down and missing things that we’re saying. But certainly, if they want to write things down, they can. So, the use of video recording, we have the patients, and their families listen to the conversations so that they can take this recording home and really listen to it again and come back with questions. There is a lot of information that is explained and exchanged during this first visit. And again, without getting too much into the names of drugs, we talk about kidney cancer. We talk about stage. We talk about outcomes. And we talk about the changing landscape in kidney cancer today that we did not have, you know, 10, 20 years ago.

So, [at] their first meeting with the team, our goal is to really allay a lot of anxiety and to know that there’s a treatment plan for them when they leave the visit. We just may need to do a few more things, order a few more tests. But knowing that there’s treatment out there that’s been highly effective in kidney cancer really changes when they leave the door and go home.

Dr Edwin Posadas:

And Nancy, you know, in that dialogue, that ongoing dialogue, you’ve seen these treatments evolve over time. I mean, with combining drugs like pembrolizumab with drugs like axitinib, which we used to use as a single agent many years ago. How has shared decision-making improved outcomes from patients from your perspective as a nurse who’s accompanied patients and educated them and their families through this journey?

Nancy Moldawer:

Well, I like to think that my availability and presence with the patient during this time really helps to decrease a lot of their anxieties and fears, and then to educate patients about the medications, that’s the first thing. And we’re a team, so, patients know that there are many ways of getting in touch with us if they’re having any type of issue with the medications. So, my experience is really that by educating the patient, letting them know the team is available, letting them know the success of these combinations that we’re using really helps them to formulate their team and getting started on these treatment regimens.

Dr Edwin Posadas:

That’s great, Nancy. And I think as a physician that’s worked with you and other nurses, I think having nursing professionals who understand the side effects, the benefits, but still take the time and use their experience to educate patients is really an invaluable part of a partnership.

Patient Experience with Treatment Management (14:04–23:37)

Dr Edwin Posadas:

But these partnerships ultimately come down to the star of our show and that’s the patient, and we’re fortunate to have Greg with us who’s walked, who’s walked that journey, who’s walked a mile in those shoes.

Greg, you know, you’ve experienced, or you’ve been part of this change in renal cell carcinoma with new treatments. I want you to tell us a little bit about your journey with kidney cancer. And then we’ll get into a little bit about how the shared decision-making and its impact on your treatment outcomes. So, let’s start with your kidney cancer. How did you, how did all this come to pass where you were told you needed to have treatment?

Greg Biddulph:

I originally was diagnosed with stage 3 kidney cancer. And during that process it metastasized, and I found out that I was going to have to go on treatment. That is a very difficult diagnosis to take on. Understanding that you have stage 4, it can be overwhelming. And you have a lot of different emotions that go with that particular time. It makes it very difficult to really process all that information initially to the point where maybe after that first visit you’re going out and you’re looking at “Dr Google” or you’re looking at Facebook, you know, and seeing what people are saying. And really what you have to learn over time is trust your care team. And that was the early part of what I had to do is learn to trust my care team that what they’re telling me is what’s going to be best for my future.

Dr Edwin Posadas:

And Greg, you were recommended to have treatment with the axitinib and pembrolizumab combination. Tell us a little bit about what that was like to get started on that. And how did you and your health team, your healthcare team manage the side effects that you experienced?

Greg Biddulph:

So, when we first got started with it, they gave me a general list of some things that could be possible adverse effects that I was going to face. So those were things that I watched out for. But I also had a background working in an industry that was adjacent to breast cancer and breast cancer lymphedema. And in doing so, I also had access to other types of people in my business world who kind of directed me to other things to do to help mitigate these adverse effects like exercise and diet and nutrition and how these other things can also help. So these oncology rehab professionals or exercise oncology specialists or nutritionists that I have in my professional social network, they provided invaluable information to me to help me, also, not just wait for an adverse effect to happen to actually try to prevent it.

Dr Edwin Posadas:

Outstanding.

Which of these, I had mentioned earlier in this podcast some of the side effects like fatigue and diarrhea and hypertension. But you touched, I think there were a couple others that you’ve experienced along the way. Can you tell us a little bit how things like your thyroid, the fatigue, the muscle aches, how did they impact your quality of life, Greg?

Greg Biddulph:

I learned through the different… some things I can manage on my own. When it comes to fatigue, you know, exercise is a huge, huge benefit for me. I kind of refer to it as jump-starting my metabolism so I get on, and I can get myself a good exercise. I get re-energized. I’ve also had diarrhea. Some of that was being managed pharmaceutically, but then what I started to learn is there’s things I could change that were trigger foods in my diet that I could change and eliminate.

And those trigger foods, by eliminating them, was helping to mitigate that problem as well. I also had hypothyroidism so that also was things that pharmaceuticals had to help benefit. Hypertension, same thing, I had to take some different medicines for that.

But as far as the muscle aches and pains..., that sometimes was just a matter of stretching and moving. Generally speaking, when you have a diagnosis like this, the people around you want to say, just relax, just stay tight. And I found the exact opposite is better for me: to get up and move around and get my muscles moving and get my blood flowing was very beneficial for me.

Dr Edwin Posadas:

Greg, you raise a really good point. Everyone, everyone reacts to things a little bit differently. The laundry list of complications that we can go through can be a little bit intimidating. How did you—you and your team engage in shared decision-making: (a) you know, as a patient who is starting to address your concerns and (b) as someone actually experiencing some of these side effects? Because from the way you’re describing them, it sounds like, you know, while it may... alarm a patient who’s about to get started on treatment that, wow this guy had had a lot of things. I’m seeing you on my screen. I’m talking to you [and] I’m thinking you’ve had pretty good outcomes on the whole [since] you started your treatment. Is it about 3 years ago at this point?

Greg Biddulph:

Correct, I’ve been on treatment for 3 years. During that time, ...I experienced 26 months of being NED (no evidence of disease). But at that point shared decision-making was a big part of that. Even as you’re going through the NED, my doctor, we constantly had communication that if we go to this point what are we going to do, what are we going to do after 2 years? Are we going to continue on treatment, are we not? And we went back and forth and when it was a constant, where my doctor was looking at the data and making a decision of what was the risk versus reward of me going on, or maybe [pausing] treatment for a while which we did. We stop treatment for a while and unfortunately it didn’t work, and we had to go back on. And then it was [a] matter [of], do we go the same path we’re on currently? Or do we try [one]... we were previously on? Or do we try a different path? And ultimately, we decided to stay with what worked and it seems to be working again which is, you know, has me very excited.

Dr Edwin Posadas:

Do you think that shared decision-making allowed you to personalize the approach to you and your kidney cancer management in a way that impacted your outcomes.

Greg Biddulph:

I think what it really allows you to have [is] that voice to advocacy for yourself. And that’s something that you see a lot where people are recommending people should advocate for themselves, and having a voice in there allows you to have that trust in your care team that you’re working together to formulate the best solution that’s going to make you have the best outcome.

Dr Edwin Posadas:

And Greg, you know as the patient, Nancy and I are here representing the physician’s voice and a nurse’s voice, which we like to think are important. We like what it is that we do. But who else was on that team, Greg? It sounds like you had a lot of other voices that helped you, to help guide you. You had some background that maybe some other folks don’t but everyone comes to this, comes to this journey, with different pieces of intellectual and historical experience with them. But how did you utilize what you had versus you know what you needed that you didn’t already have in your armamentarium? Who did you put on your team?

Greg Biddulph:

So, my nurse and my doctor were the key, most instrumental people... I kind of have different roles for everybody in my participant [list], right; ...my doctor, he manages my treatment, he manages my scans and give you those results, and we identify courses of action. Whereas my nurse, she’s a little bit more of my confidant, she’s easier to talk to, a little less intimidating for me. Our meetings when I’m meeting with my nurse were a little bit more relaxed because we don’t have stress of scans over [the] top of our heads. So, you know, ...these are things what makes the conversation with her a little bit easier to go about.

But then outside of that, then that’s why I formulated... my informal [team]. My informal [team] is the people that I have in my social network, my professional social network, who are oncology rehab professionals. Who are exercise oncology professionals. These are people I was very, very, very fortunate over the years of my professional employment that I was able to come to know, and they have been very instrumental, even though they probably don’t even know it, but the research and the best practices they post online are things that I read and I look at those things, I actually include them as part of my care team because they provide so much valuable information to help me manage this process and getting through this.

Dr Edwin Posadas:

And Greg as a patient… Well first, I apologize on behalf of physicians because I know that there’s a certain different dynamic in the room. I have been alerted by this by Nancy and others that sometimes it’s just easier to talk to someone else, but I can actually assure you one of the great things about this process is that as a team, when we manage a patient, as much as your nurses are your confidant, they try to filter things to the distracted physician to make sure that we’re paying attention to issues that are important or in their experience will make a difference now. Nancy, is that... fair to say? You’ve worked with several of us.

Nancy Moldawer:

Absolutely, I agree.

What Does a Successful Outcome Look Like? (23:38–27:46)

Dr Edwin Posadas:

So, so Greg as a patient, maybe in your words, can you tell me: What does a successful outcome look like? Because you just said 3 years, you’ve had intermittent therapies. You’ve dealt with progression and response. It sounds like you’re pretty engaged. What does success in management look like from the patient’s perspective?

Greg Biddulph:

I think the biggest thing when you first get started with this, you have two questions: one question is, well, am I going to live? That’s the biggest question you probably have. And the second thing is, ...how’s my life going to be impacted? How’s my life going to be impacted? I’m going to be going on these drugs and they’re kind of scary because they start telling you about the adverse effects that they can have and you get... a little bit, almost: is my life going to change? So, what do I consider successful? [It] is having a good quality of life and through what I’ve been able to accomplish through my team is I feel I have a good quality of life, I still work a full-time job, I can still be involved with my child’s life. There’s a lot of different things I can still do, and my life has a minimal impact of the medications that I’m on.

Dr Edwin Posadas:

That’s great. And that really does sound successful.

Nancy, you, like I said, you’re experiencing this, particularly with kidney cancer which not enough oncology professionals have experience with—especially given this evolving landscape; and... what do you see [as] a success and how is this going to change? When we go to meetings, we hear about all these new treatments that are coming. But we also hear about potential new adverse effects, things we hadn’t seen before. And with your experience, even not just with dealing with what we have available.

You mentioned early on in our podcast that you’ve been a research nurse, and you hadn’t told everyone that you’ve been a research nurse; that really helped to navigate a lot of patients who were on some of these landmark clinical trials that defined where we are. So, you know, what does that look like and how do you... point towards that future when you deal with the patients to say, there’s still hope?

Nancy Moldawer:

Oh, my conversations with patients have evolved a lot during my career as a kidney cancer nurse. As one can imagine, when I first started out our conversations were somewhat dismal. We did not have approved therapies for kidney cancer patients and I’m talking a long time ago, when really the standard of care was probably going on a clinical trial. Well, that has changed tremendously. And now there are many options, including clinical trials today for patients, and their outcomes are just extraordinarily different and much more positive. And even for the more advanced cases that we see today, we can get patients absolutely into control of their disease, getting back to their activities, the daily living, their family, their jobs, their community, and maintaining patients on these medications. Even if they have to have changes in their dosages. It’s… the drugs work, we see responses, and patients have a good quality of life and that’s important to the patient. It’s important to us. And we forge forward for a long time that patients are on these medications. And so it’s the knowledge that we have today based on the research that we’ve had in the past that makes outcomes for kidney cancer patients really tremendous today.

Dr Edwin Posadas:

I wholeheartedly agree.

Closing Summary (27:47–30:27)

Dr Edwin Posadas:

So, if I can sum things up, I would say shared decision-making is really an important part of healthcare—of good healthcare—during the treatment of advanced renal cell carcinoma, empowering a patient like Greg. And in his words, [this] really empowers them to participate in the treatment process and the decision-making that not only reduces anxiety but really gives them back some control of their life and their journey, improves quality of life and satisfaction with where they’re at, even when dealing with an advanced cancer, like advanced renal cell carcinoma.

The axitinib/pembrolizumab combination represents one of several new standards of care in advanced RCC, but... it does come [with], as you heard from Greg’s own words, and then Nancy’s perspective, a lot of potential adverse events that are manageable and manageable requires some help. It’s not right for a patient to just kind of white knuckle it through all of this. And certainly, as oncology professionals we’re dedicated to getting patients through this. Discussing these adverse potential events that can be associated with combinations like axitinib/pembrolizumab or with other combinations can really be vital to optimizing outcomes and for someone to lead their best life, as Greg explained. And so we really want to emphasize the importance of communication.

I want to thank Nancy and Greg for both their, their knowledge, their openness, their frankness about what’s happened to them.

And we hope that this podcast helps us with patients, nurses, healthcare providers, and most importantly in patients to feel comfortable that this is a manageable journey, and we wish you well.

Dharanija Rao:

Thanks everybody. Thanks, Dr Posadas, for sharing your insights, Nancy for sharing, you know, the entire patient journey and the importance of shared decision-making and the evolution of the shared decision-making during, you know, the last several years.

And more than anything, thank you very much Greg for participating in this, for sharing your journey and your experience and valuable insights, which have... been helpful to you and hopefully will be helpful to other patients who listen to this.

Thanks everybody and, last but not the least, thank you to the Envision team for this podcast.

Author Contributions

Edwin M Posadas, Nancy Moldawer, Greg Biddulph, and Dharanija Rao contributed equally to all aspects of the development of this podcast, including concept and design, drafting of the outline and interpretation of the data discussed.

Funding

This vodcast, including the journal’s publication fees, was sponsored by Pfizer.

Data Availability

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Declarations

Conflict of Interest

The authors declare that this study received funding from Pfizer Inc. Dharanija Rao is an employee of Pfizer and has stock in Pfizer. The funder had the following involvement with the study: Pfizer-affiliated authors were involved in the review and feedback for current manuscript and budget from Pfizer Publication Team. Nancy Moldawer served on speaker’s bureaus for Exelixis; has received reimbursement for travel to International Kidney Cancer Symposium. Edwin Posadas received consulting fees from Bayer and Janssen, served on speaker’s bureaus for Bayer, received support for travel from Bayer, and is vice-president of the Catholic Medical Association-LA Guild. Greg Biddulph is a patient author and has no conflicts of interest to declare.

Ethical Approval

This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.