Eligibility for Adjuvant Pembrolizumab in RCC: Real-World Vs KEYNOTE-564

Giuseppe Fallaro, MD of Vita‐Salute San Raffaele University, discusses research comparing baseline characteristics of patients with renal cell carcinoma treated with adjuvant pembrolizumab (Keytruda) in the real-world setting compared with those treatment treated in the KEYNOTE-564 (NCT03142334).

Transcript:

0:07 | So of course, with surprise we found that real-world patients are very different from those involved in the clinical trials. This is something that is already known. Because, of course, patients in clinical trial are well selected. What we found is that our patients were most frequently high stage compared to KEYNOTE-564. We had much more pN plus patients, so patients with a positive nod invasion. And this is a very peculiar data because the difference was 15% in our off-trial data set compared to data 6% in the KEYNOTE-564 study.

1:05 | We also had much more patients with metastasis, of course that has been resected. So, they were without disease at the moment of our analysis but were frequent enough in the real-world setting compared to the trial setting.

1:24 | Another important point apart from the tumor characteristics is that patient in real life are less fit. And again, this is not something new. For example, in our in our patients, more than 60% that had an ECOG score performance status of 1 compared to just the 15% of the KEYNOTE-564 population. This is another big difference. Of course, it should not have any impact on disease recurrence, but the performance of the patient is an important feature to consider when you have to wonder about if the patient is fit or not for chemoimmunotherapy, also in a different setting.