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.
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).
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.
No statistically significant differences were found in first-line PFS, total PFS, or OS between the 2 treatment arms (ClinicalTrials.gov identifier, NCT01481870).
Clinical genitourinary cancer. 2020 Mar 06 [Epub ahead of print]
Yoshihiko Tomita, Sei Naito, Naoto Sassa, Atsushi Takahashi, Tsunenori Kondo, Takuya Koie, Wataru Obara, Yasuyuki Kobayashi, Jun Teishima, Masayuki Takahashi, Hideyasu Matsuyama, Takeshi Ueda, Kenya Yamaguchi, Takeshi Kishida, Ryoichi Shiroki, Takashi Saika, Nobuo Shinohara, Mototsugu Oya, Hiro-Omi Kanayama
Department of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. Electronic address: ., Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan., Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan., Department of Urology, Hakodate Goryoukaku Hospital, Hokkaido, Japan., Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan., Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan; Department of Urology, Gifu University School of Medicine, Seki, Japan., Department of Urology, Iwate Medical University, Morioka, Japan., Department of Urology, Okayama University Graduate School of Medicine, Okayama, Japan., Department of Urology, Graduate School of Biomedical Health Science, Hiroshima University, Hiroshima, Japan., Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan., Department of Urology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan., Department of Urology, Chiba Cancer Center, Chiba, Japan., Department of Urology, Nihon University School of Medicine, Tokyo, Japan., Department of Urology, Kanagawa Cancer Center, Yokohama, Japan., Department of Urology, Fujita Health University School of Medicine, Toyoake, Japan., Department of Urology, Ehime University, Matsuyama, Japan., Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan., Department of Urology, Keio University School of Medicine, Tokyo, Japan.