Yoshihiko Tomita1, Sei Naito2, Naoto Sassa3, Atsushi Takahashi4, Tsunenori Kondo5, Takuya Koie6, Wataru Obara7, Yasuyuki Kobayashi8, Jun Teishima9, Masayuki Takahashi10, Hideyasu Matsuyama11, Takeshi Ueda12, Kenya Yamaguchi13, Takeshi Kishida14, Ryoichi Shiroki15, Takashi Saika16, Nobuo Shinohara17, Mototsugu Oya18, Hiro-Omi Kanayama10. 1. Department of Urology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan. Electronic address: ytomita@med.niigata-u.ac.jp. 2. Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan. 3. Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan. 4. Department of Urology, Hakodate Goryoukaku Hospital, Hokkaido, Japan. 5. Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo, Japan. 6. Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan; Department of Urology, Gifu University School of Medicine, Seki, Japan. 7. Department of Urology, Iwate Medical University, Morioka, Japan. 8. Department of Urology, Okayama University Graduate School of Medicine, Okayama, Japan. 9. Department of Urology, Graduate School of Biomedical Health Science, Hiroshima University, Hiroshima, Japan. 10. Department of Urology, Tokushima University Graduate School of Biomedical Sciences, Tokushima, Japan. 11. Department of Urology, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan. 12. Department of Urology, Chiba Cancer Center, Chiba, Japan. 13. Department of Urology, Nihon University School of Medicine, Tokyo, Japan. 14. Department of Urology, Kanagawa Cancer Center, Yokohama, Japan. 15. Department of Urology, Fujita Health University School of Medicine, Toyoake, Japan. 16. Department of Urology, Ehime University, Matsuyama, Japan. 17. Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan. 18. Department of Urology, Keio University School of Medicine, Tokyo, Japan.
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).
RCT Entities:
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).
Authors: Jakob Michaelis; Markus Grabbert; August Sigle; Mehmet Yilmaz; Daniel Schlager; Christian Gratzke; Arkadiusz Miernik; Dominik Stefan Schoeb Journal: Cancers (Basel) Date: 2022-08-03 Impact factor: 6.575