KEY TAKEAWAYS
- The Phase 3 study assessed RESORT (Sorafenib+SBRT) and the RAPPORT (Pembrolizumab+SBRT) approaches to find the approach that yields the best outcomes for oligometastatic ccRCC.
- The study supported using surgery and Pembrolizumab for oligometastatic ccRCC.
Based on the limited number of randomized control studies (RCTs) conducted, oligometastatic renal cell carcinoma still poses a challenge for clinicians. However, two Phase I/II trials on this issue have been published over the past few years, namely the RESORT (Sorafenib+SBRT) and the RAPPORT (Pembrolizumab+SBRT). Moreover, the Kaplan Meier curves of the KEYNOTE-564 (surgery on metastases+Pembro) group were presented at ASCO23. In this study, researchers aimed to assess which of these approaches yields the best outcomes.
A thorough search was conducted in PubMed, EMBASE, Web of Science, and Scopus databases up to 10/2022 to gather all published trials that contained survival data on treatment for oligometastatic RCC. Researchers reconstructed the survival data from published Kaplan-Meier curves on overall survival (OS) and compared Pembrolizumab+SBRT versus Sorafenib+SBRT versus surgery Pembro through meta-analysis. The effectiveness of these treatments was evaluated using differences in restricted mean survival time (ΔRMST) at different time points and Cox regression.
The study included three trials (RESORT, RAPPORT and KEYNOTE-564) and a total of 91 patients were analyzed. All the patients had histologically confirmed clear cell RCC with ECOG≤2 and one to five sites of metastatic disease. Unfortunately, the small sample size and incomplete data reporting prevented a statistical comparison of the studies. However, Pembrolizumab+NED showed the highest OS benefit (HR: 0.37 compared to Sorafenib+SBRT and 0.33 compared to Pembro+SBRT, all p<0.05) with a ΔRMST at 24 months of 1.4 months (1.0-1.8) compared with Sorafenib+SBRT and of 1.2 months (0.9-1.3) compared to Pembro+SBRT.
This hypothesis generating meta-analysis supported the combination of surgery and Pembro for oligometastatic ccRCC, despite the lack of baseline differences and power and the presence of confounding.
Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003302.03
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03142334
Fallara, Giuseppe; Rosiello, Giuseppe; Martini, Alberto; Musso, Giacomo; Cei, Francesco; Re, Chiara; Belladelli, Federico; Necchi, Andrea; Raggi, Daniele; Marandino, Laura; Bertini, Roberto; Karakiewicz, Pierre I.; Mottrie, Alexandre; Briganti, Alberto; Salonia, Andrea; Montorsi, Francesco; Larcher, Alessandro; Capitanio, Umberto PD24-03 BEST TREATMENT FOR OLIGOMETASTATIC RENAL CANCER: A QUASI-INDIVIDUAL PATIENT DATA ANALYSIS, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4 doi: 10.1097/JU.0000000000003302.03
