Overcoming Access and Treatment Hurdles in Community and Academic RCC Care

In the fifth part of this roundtable series, Dr. Michael Atkins moderates a discussion on the real-world challenges and barriers to starting patients on ipi-nivo therapy for advanced kidney cancer. The panelists, including Dr. Chandler Park and Dr. Mike Lattanzi, discuss issues related to coordination with urologists, insurance delays, and challenges faced by community oncologists. The session also covers the importance of proper patient selection and the impact of ongoing clinical trials such as the PDIGREE study in refining treatment strategies.

Watch the final segment of this series: Advancing RCC Treatment: Trials to Watch and Promising Novel Approaches

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Dr. Atkins:
So moving on. So what are the common real-world challenges that you face in initiating patients on Nivo-Ipi and how do you navigate those barriers, Chandler? 

Dr. Park:
Yeah. I think for me, in a community practice, I think one of the things that I’m thinking about is working together with a urologist. Even though there’s some data about not doing a subtle reducting of nephrectomy, I still actually consider that for some of my patients where they’re symptomatic but intermediate risk. So I think that’s a barrier there. But typically where I’m working at, we can get the urologist on board right away. But I know some of my colleagues in the other areas of Kentucky, they might not have access to urologists for that. Now, in terms of the medications, I haven’t had any problems at all. I think we’re very fortunate in Louisville, whichever regimen that we want is readily available. 

Dr. Atkins:
And Mike? 

Dr. Lattanzi:
In terms of barriers, the biggest barrier is simply getting into the office, I think. And our value proposition is we get patients in quickly. I see patients same day or next day, I’m in clinic five days a week. And so once the patient’s in the office, it’s relatively straightforward from there. Oftentimes the patient’s insurance company will require a referral from an outside provider, which can slow down the process a bit. Sometimes the insurance may reject the treatment for whatever reason, there’s some sort of appeal process around that. But I’m fortunate enough to work in a large practice that has a team dedicated to pushing back on those things and getting the patients the treatments they need. 

Dr. Atkins:
And any issues with Medicare at all? 

Dr. Lattanzi:
No, I seldom have issues with Medicare. 

Dr. Atkins:
Right. Okay. Alan, anything there? 

Dr. Tan:
Well, I think CheckMate 214 was a large registration study. But what actually do we see in the real world? I think that’s what I want to know. And the study that I’m really anticipating is the PDIGREE study led by my friend and colleague, Tian Zhang. Basically this was a real-world study looking at upfront Ipi-Nivo, and then they get an adaptive approach of intensification or deescalation. But being part of this team, I think we’re going to see a wide variety of patients that have primary progressive disease and they don’t even make it to the Nivo-Cabo arm because maybe patient selection was the issue. I think in the community, we all see RCC every week. We are pretty much experts and we are very comfortable selecting these patients. But for community oncologists, I think there’s a struggle. If you only see two RCC patients a year, you may not know if a patient that has a poor performance status that with pleural fusions ascites is a good candidate. Maybe they’re trying to do the Ipi-Nivo, and unfortunately these patients don’t make it past three months. So I think that’s probably the barrier for the widespread community. 

Dr. Atkins:
You brought up the PDIGREE trial. Do you feel comfortable in patients who have a partial response on their twelve-week scan adding Cabo to their treatment? 

Dr. Tan:
That’s a great question. Personally, I think three months of Iodoblid is probably not enough. As we know from the melanoma studies, CheckMate 067, responses will deepen. And just because you have a partial response does not mean that you’re not clinically in a complete response. We have long-term data from the melanoma studies where even with a partial response, you live just as long as the patients that have a complete response. So I think we don’t want to offend the study chairs of this study, but in hindsight, I think that’s possibly a flaw. 

Dr. Atkins:
And Laurence in France, what barriers do you face? 

Dr. Albiges:
I’m going to take another angle. I think one situation I like to stress is patients that are elderly. Initially, people thought that it would be hard to have IO/IO strategy in elderly. I actually consider it’s very manageable and has less side effect than an IO/TKI in elderly or frail patients. But what the cushion I’m taking here is that I try always to meet the family and make sure that they’re really aware on the need of coming back to the hospital in case of side effect or new symptoms that they don’t understand. Because I think that the IO/IO approach is now well endorsed by the community doctors and so on, but it’s about making sure that the patient and the family will actually report side effect that they don’t understand. And that’s one thing that we still need to be careful around, making sure that if something happens they call, so that we can have the blood work, we can double check it’s not acute immuno-related activity side effect. I think this is really something that I’m very cautious around. 

Dr. Atkins:
And do you have someone who works with you who’s available to be contacted all the time? A nurse practitioner or anything? 

Dr. Albiges:
Yeah, so I guess every hospital has a different organization. But yes, the short answer is yes. We don’t have nurse practitioner for instance, but we have junior faculty, so we find a way. 

Dr. Park:
It’s a good learning experience. 

Dr. Atkins:
So no one here talked about the IMDC categories. I know you mentioned that as a barrier in France.. But you all, if you wanted to give Ipi-Nivo to a favorable risk patient, are you able to do that? 

Dr. Park:
Yeah, I have. I’ve had patients that were favorable risk that had the sarcomatoid features, and I’ve had no problems at all providing that treatment. So I don’t see that. I think that IMDC risk classification is becoming less and less useful. I think you have to… Especially with the updated study here with 214, we have to look at the totality and always be mindful of the updated data. 

Dr. Tan:
Yeah, I agree. The IMDC is not meant to be predictive. I don’t think Danny Heng would say it’s meant to be predictive, it’s a prognostic. And I think for… Once again, going back to community practice, if you only see two or three RCCs a year, do you actually score those patients appropriately? I think treatment within a year of diagnosis, I think in most patients in community would treat them right away because you have one or two lung lesions, “Well, this is stage four cancer. We should treat this right away.” But I think maybe those patients are actually a good risk and you don’t have long enough follow up. So I think there is some flaws in the IMDC that we don’t know. 

Dr. Atkins:
Is it an issue for you, Mike? 

Dr. Lattanzi: 
The one thing I’ll add my practice, like many practices across the United States use value-based pathways. And while certainly the value-based pathways will make a recommendation when you classify your patient as IMDC good risk, they’ll make a recommendation for IO/TKI. Our value pathways are strong recommendations, they don’t dictate absolutely patient care. And while we try to adhere to those pathways, part of our value proposition is we provide care at a relatively low cost to patients and providers alike. We ultimately are able to do what’s in the best interest of the patient.