European Urology Open Science, vol.69, pp.262-263, 2024 (Conference Book)
Adjuvant pembrolizumab (adjPemb) is recommended for reducing recurrence risk after curative surgical treatment of intermediate to high risk non-metastatic clear cell renal cell carcinoma (ccRCC). This study investigated the natural course of non-metastatic ccRCC after curative surgery in patients classified by the KEYNOTE-564 patient selection criteria.
A total of 531 curative and cytoreductive nephrectomies were performed between January 2015-March 2023 in a tertiary single institution. After exclusion of 235 patients (n=201 non-ccRCC, n=20 incomplete follow-up, n=14 cytoreductive nephrectomy for metastatic renal tumor), a total of 296 non-metastatic ccRCC patients were included into this study. The clinical, histopathological and survival parameters were retrospectively documented from prospectively collected real life database. Chi-square and Mann-Whitney U tests were used for the comparisons of parameters. Kaplan-Meier Analysis was used for survival outcomes.
Overall, 76 (25.7%) patients were defined as eligible for adjPemb (n=66, 86.8%; intermediate-high risk, n=10, 13.2%; high risk). The eligible patients had larger median tumor size in clinical (7.5 vs. 3.9 cm, p<0.001) and pathological (7.8 vs. 3.65 cm, p<0.001) assessments, and underwent more often radical nephrectomy (95.9 vs 27.7%, p<0.001). Two-year recurrence free survival (RFS) was lower (58.6 vs. 94.6%, p<0.001) in eligible patients. A total of 44 (14.9%) patients recurred in overall cohort at median follow-up of 18 months, 25 (32.9%) in eligible group and 19 (8.6%) in non-eligible group. Median pathologic tumor size were larger (9 vs 5 cm, p<0.001) and median time to recurrence were earlier (8 vs. 32 months, p<0.001) in eligible group. Fifty-one (67.1%) patients in eligible group did not experience any recurrence at a median follow-up of 15 months.
This real-life data showed that ccRCC recurred after curative surgery in 32.9% of patients defined eligible for adjPemb, and in 8.5% of patients defined non-eligible. The remaining 67.1% of eligible patients did not recur at median follow-up of 15 months. These results suggested that selection criteria defined in KEYNOTE-564 needs to be improved to optimize individualized treatment strategies.