A Mennitto1, E Verzoni1, F Cognetti2, R Miceli3, M Milella4, A Mosca5, V E Chiuri6, A Bearz7, F Morelli8, C Ortega9, F Atzori10, M Donini11, M Claps1, V Guadalupi1, P Sepe1, V Cappelletti12, F G de Braud1,13, G Procopio1. 1. Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 2. Medical Oncology Department, Istituto Nazionale Tumori Regina Elena, Rome, Italy. 3. Department of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 4. Department of Medicine, Medical Oncology, University and Hospital Trust of Verona, Verona, Italy. 5. Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy. 6. Medical Oncology Department, Ospedale Vito Fazzi, Lecce, Italy. 7. Medical Oncology Department, National Cancer Institute, Aviano, Italy. 8. Medical Oncology Department, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy. 9. Department of Medical Oncology, Ospedale S. Lazzaro ASL CN2 Alba-Bra, Cuneo, Italy. 10. Medical Oncology Department, University Hospital, University of Cagliari, Cagliari, Italy. 11. Medical Oncology Department, Ospedale di Cremona, Cremona, Italy. 12. Biomarker Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy. 13. Oncology and Hemato-Oncology Department, University of Milan, Milan, Italy.
Abstract
Background: The RESORT trial showed no longer relapse free survival (RFS) with sorafenib following radical metastasectomy in metastatic renal cell carcinoma. We present the updated 42-month follow-up data. Methods: The phase II RESORT trial randomized patients to sorafenibor observation within 12 weeks from surgery. RFS was the primary endpoint. Results: We analyzed 68 patients (32 in sorafenib and 36 in the observation arm), randomized between November 2012 and November 2017. Eighty-one percent in the sorafenib arm and 80% in the observation arm had one metastasis . At a median follow-up of 42 months (interquartile range 31-58), in the observation arm the median RFS was 35 months, RFS probability was 57% (95% CI 42-76%) at 24 and 44% (95% CI 30-65%) at 48 months. In the sorafenib arm, median RFS was 21 months, RFS probability was 50% (95% CI 34-71%) at 24 and 32% (95% CI 18-57%) at 48 months (p = 0.342;HR 1.35;95% CI 0.72-2.54). Forty-seven percent and 37.5% of the patients in the two arms, respectively, are disease free. The site of relapses was independent of the previous metastasectomy site.Expert commentary: Sorafenib after metastasectomy did not improve RFS, but surgery in selected patients should be considered in order to potentially improve survival.Clinical trial registration: www.clinicaltrials.gov identifier is NCT0144480.
RCT Entities:
Background: The RESORT trial showed no longer relapse free survival (RFS) with sorafenib following radical metastasectomy in metastatic renal cell carcinoma. We present the updated 42-month follow-up data. Methods: The phase II RESORT trial randomized patients to sorafenib or observation within 12 weeks from surgery. RFS was the primary endpoint. Results: We analyzed 68 patients (32 in sorafenib and 36 in the observation arm), randomized between November 2012 and November 2017. Eighty-one percent in the sorafenib arm and 80% in the observation arm had one metastasis . At a median follow-up of 42 months (interquartile range 31-58), in the observation arm the median RFS was 35 months, RFS probability was 57% (95% CI 42-76%) at 24 and 44% (95% CI 30-65%) at 48 months. In the sorafenib arm, median RFS was 21 months, RFS probability was 50% (95% CI 34-71%) at 24 and 32% (95% CI 18-57%) at 48 months (p = 0.342;HR 1.35;95% CI 0.72-2.54). Forty-seven percent and 37.5% of the patients in the two arms, respectively, are disease free. The site of relapses was independent of the previous metastasectomy site.Expert commentary: Sorafenib after metastasectomy did not improve RFS, but surgery in selected patients should be considered in order to potentially improve survival.Clinical trial registration: www.clinicaltrials.gov identifier is NCT0144480.