In selected metastatic Renal Cell Carcinoma (mRCC) patients, radical metastasectomy followed by observation is a strategy. The integration of surgery and systemic treatments in mRCC is an unmet medical need. Our objective was to assess the clinical outcome after radical metastasectomy of the selected population of RESORT trial.
RESORT was a randomized, open-label, phase II study conducted between November 2012 and November 2017. Eligible patients were those with clear-cell mRCC pre-treated with nephrectomy and undergoing radical metastasectomy (≤ 3 lesions). 76 patients were screened and 69 were randomized: 33 were assigned to sorafenib and 36 to observation. Patients were randomized (1:1) within 12 weeks from metastasectomy to sorafenib (standard dose 400 mg twice daily) or observation for maximum 52 weeks. Stratification factors were interval from nephrectomy, site and number of lesions. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints were overall survival and safety profile.
RFS curves were estimated with the Kaplan-Meier method and the log-rank test was used to statistically compare the curves.
Median RFS was 37 months (95% CI 20-NA) versus 21 months (95% CI 11-NA) in observation and sorafenib arms respectively (log rank test p=0.404), with a 12-months, 24- months and 36-months RFS probability of 74%, 59% and 50,7% respectively, in the observation arm.
In our study the majority of patients (53% in observation arm) had no relapse after metastasectomy at a median follow-up of 38 months. Thus, this prospective study suggests that radical metastasectomy could improve the clinical outcome of selected patients with mRCC.