start-ver=1.4 cd-journal=joma no-vol= cd-vols= no-issue= article-no= start-page= end-page= dt-received= dt-revised= dt-accepted= dt-pub-year=2020 dt-pub=20200306 dt-online= en-article= kn-article= en-subject= kn-subject= en-title= kn-title=Sunitinib Versus Sorafenib as Initial Targeted Therapy for mCC-RCC With Favorable/Intermediate Risk: Multicenter Randomized Trial CROSS-J-RCC en-subtitle= kn-subtitle= en-abstract= kn-abstract=Purpose: The present study compared the efficacy of sunitinib and sorafenib as first-line treatment of metastatic clear cell renal cell carcinoma (mCC-RCC) with favorable or intermediate Memorial Sloan Kettering Cancer Center (MSKCC) risk.
Patients and methods: Treatment-naive patients with mCC-RCC were randomized to receive open-label sunitinib followed by sorafenib (SU/SO) or sorafenib followed by sunitinib (SO/SU). The primary endpoint was first-line progression-free survival (PFS). The secondary endpoints were total PFS and overall survival (OS).
Results: Of the 124 patients enrolled at 39 institutions from February 2010 to July 2012, 120 were evaluated. The median first-line PFS duration was 8.7 and 7.0 months in the SU/SO and SO/SU groups, respectively (hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.42-1.08). The total PFS and OS were not significantly different between the SU/SO and SO/SU groups (27.8 and 22.6 months; HR, 0.73; 95% CI, 0.428-1.246; and 38.4 and 30.9 months; HR, 0.934; 95% CI, 0.588-1.485, respectively). The subgroup analysis revealed that the total PFS with SU/SO was superior to the total PFS with SO/SU in the patients with favorable MSKCC risk and those with < 5 metastatic sites). SO/SU was superior to SU/SO for patients without previous nephrectomy.
Conclusions: No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870). en-copyright= kn-copyright= en-aut-name=TomitaYoshihiko en-aut-sei=Tomita en-aut-mei=Yoshihiko kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=1 ORCID= en-aut-name=NaitoSei en-aut-sei=Naito en-aut-mei=Sei kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=2 ORCID= en-aut-name=SassaNaoto en-aut-sei=Sassa en-aut-mei=Naoto kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=3 ORCID= en-aut-name=TakahashiAtsushi en-aut-sei=Takahashi en-aut-mei=Atsushi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=4 ORCID= en-aut-name=KondoTsunenori en-aut-sei=Kondo en-aut-mei=Tsunenori kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=5 ORCID= en-aut-name=KoieTakuya en-aut-sei=Koie en-aut-mei=Takuya kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=6 ORCID= en-aut-name=ObaraWataru en-aut-sei=Obara en-aut-mei=Wataru kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=7 ORCID= en-aut-name=KobayashiYasuyuki en-aut-sei=Kobayashi en-aut-mei=Yasuyuki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=8 ORCID= en-aut-name=TeishimaJun en-aut-sei=Teishima en-aut-mei=Jun kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=9 ORCID= en-aut-name=TakahashiMasayuki en-aut-sei=Takahashi en-aut-mei=Masayuki kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=10 ORCID= en-aut-name=MatsuyamaHideyasu en-aut-sei=Matsuyama en-aut-mei=Hideyasu kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=11 ORCID= en-aut-name=UedaTakeshi en-aut-sei=Ueda en-aut-mei=Takeshi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=12 ORCID= en-aut-name=YamaguchiKenya en-aut-sei=Yamaguchi en-aut-mei=Kenya kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=13 ORCID= en-aut-name=KishidaTakeshi en-aut-sei=Kishida en-aut-mei=Takeshi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=14 ORCID= en-aut-name=ShirokiRyoichi en-aut-sei=Shiroki en-aut-mei=Ryoichi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=15 ORCID= en-aut-name=SaikaTakashi en-aut-sei=Saika en-aut-mei=Takashi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=16 ORCID= en-aut-name=ShinoharaNobuo en-aut-sei=Shinohara en-aut-mei=Nobuo kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=17 ORCID= en-aut-name=OyaMototsugu en-aut-sei=Oya en-aut-mei=Mototsugu kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=18 ORCID= en-aut-name=KanayamaHiro-omi en-aut-sei=Kanayama en-aut-mei=Hiro-omi kn-aut-name= kn-aut-sei= kn-aut-mei= aut-affil-num=19 ORCID= affil-num=1 en-affil=Department of Urology, Niigata University Graduate School of Medical and Dental Sciences kn-affil= affil-num=2 en-affil=Department of Urology, Yamagata University Faculty of Medicine kn-affil= affil-num=3 en-affil=Department of Urology, Nagoya University Graduate School of Medicine kn-affil= affil-num=4 en-affil=Department of Urology, Hakodate Goryoukaku Hospital kn-affil= affil-num=5 en-affil=Department of Urology, Tokyo Women's Medical University Medical Center East kn-affil= affil-num=6 en-affil=Department of Urology, Hirosaki University Graduate School of Medicine kn-affil= affil-num=7 en-affil=Department of Urology, Iwate Medical University kn-affil= affil-num=8 en-affil=Department of Urology, Okayama University Graduate School of Medicine kn-affil= affil-num=9 en-affil=Department of Urology, Graduate School of Biomedical Health Science, Hiroshima University kn-affil= affil-num=10 en-affil= Department of Urology, Tokushima University Graduate School of Biomedical Sciences kn-affil= affil-num=11 en-affil=Department of Urology, Yamaguchi University Graduate School of Medicine kn-affil= affil-num=12 en-affil= Department of Urology, Chiba Cancer Center kn-affil= affil-num=13 en-affil= Department of Urology, Nihon University School of Medicine kn-affil= affil-num=14 en-affil=Department of Urology, Kanagawa Cancer Center kn-affil= affil-num=15 en-affil=Department of Urology, Fujita Health University School of Medicine kn-affil= affil-num=16 en-affil= Department of Urology, Ehime University kn-affil= affil-num=17 en-affil=Department of Urology, Hokkaido University Graduate School of Medicine kn-affil= affil-num=18 en-affil=Department of Urology, Keio University School of Medicine kn-affil= affil-num=19 en-affil=Department of Urology, Tokushima University Graduate School of Biomedical Sciences kn-affil= en-keyword=PFS kn-keyword=PFS en-keyword=RCT kn-keyword=RCT en-keyword=Renal cell carcinoma kn-keyword=Renal cell carcinoma en-keyword=SO/SU kn-keyword=SO/SU en-keyword=SU/SO. kn-keyword=SU/SO. END