Orta ila yüksek tekrarlama riski olan berrak hücreli renal hücreli karsinomun küratif cerrahi tedavisinden sonra adjuvan pembrolizumab için hasta seçim kriterlerinin etkinliği nasıldır? Tek kurumsal deneyimden gerçek yaşam veri analizi


Erdem S., Tantekin S. A., Özervarlı M. F., Ergül R. B., Pazır Y., Hürdoğan Ö., ...More

European Urology Open Science, vol.69, pp.262-263, 2024 (Conference Book)

  • Publication Type: Article / Abstract
  • Volume: 69
  • Publication Date: 2024
  • Journal Name: European Urology Open Science
  • Page Numbers: pp.262-263
  • Istanbul University Affiliated: Yes

Abstract

Introduction & Objectives

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.

Materials & Methods

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.

Results

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.

Conclusions

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.