Overview
Eligibility criteria in clinical trials often limit enrollment to patients who are “fit” enough to participate on the basis of baseline organ function. However, these criteria are rarely driven by evidence and can limit the applicability of trial findings to real-world settings. Specifically, clinical trials for first-line (1L) therapies in metastatic renal cell carcinoma (mRCC) often use strict kidney function requirements to select participants, however, these criteria may not represent the broader population of patients seen in everyday clinical practice.
This study examined how these trial-based kidney function criteria affect real-world outcomes for patients with mRCC who started 1L systemic therapy between 2011 and 2023. Almost 7,000 patients were grouped based on whether they met all, some, or none of the typical trial renal function criteria, comparing progression-free survival and overall survival. Researchers found that patients who met all renal function criteria had better survival outcomes than those who did not, suggesting that clinical trial results for mRCC may not be fully generalizable to real-world patients.
Why this matters
The findings reveal that clinical trial results may not be generalizable to the overall population of mRCC patients receiving these treatments in practice, especially among patients with poor renal function. By highlighting these differences, the study underscores the importance of considering real-world patient diversity when interpreting trial results and making treatment decisions for mRCC.