Koichi Kido1, Shingo Hatakeyama2,3, Kazuyuki Numakura4, Toshikazu Tanaka5, Masaaki Oikawa6, Daisuke Noro7, Shogo Hosogoe8, Shintaro Narita4, Takamitsu Inoue4, Takahiro Yoneyama9, Hiroyuki Ito10, Shoji Nishimura6, Yasuhiro Hashimoto1, Toshiaki Kawaguchi5, Tomonori Habuchi4, Chikara Ohyama1,11. 1. Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. 2. Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. shingoh@hirosaki-u.ac.jp. 3. Department of Advanced Blood Purification Therapy, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. shingoh@hirosaki-u.ac.jp. 4. Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. 5. Department of Urology, Aomori Prefectural Central Hospital, Aomori, Japan. 6. Department of Urology, Hakodate Municipal Hospital, Hakodate, Japan. 7. Department of Urology, Mutsu General Hospital, Mutsu, Japan. 8. Department of Urology, Aomori City Hospital, Aomori, Japan. 9. Department of Advanced Transplant Regenerative Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. 10. Department of Urology, Aomori Rosai Hospital, Hachinohe, Japan. 11. Department of Advanced Blood Purification Therapy, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Abstract
BACKGROUND: This study compared real-world outcomes of metastatic renal-cell carcinoma (mRCC) patients treated with tyrosine kinase inhibitors or nivolumab plus ipilimumab. METHODS: Using the International mRCC Database Consortium (IMDC), we retrospectively evaluated intermediate- and poor-risk mRCC patients who were treated with nivolumab plus ipilimumab (Nivo-Ipi), tyrosine kinase inhibitors (TKIs) as the first-line therapy between August 2015 and January 2020. We compared oncological outcomes between the Nivo-Ipi group and TKIs group using multivariate logistic regression analysis with the inverse probability of treatment weighting (IPTW) method. RESULTS: In this study 278 patients were included. There were 52 and 226 patients in the Nivo-Ipi and TKIs groups (sunitinib 97, axitinib 118, sorafenib 9, pazopanib 2), respectively. The median age in the Nivo-Ipi and TKIs groups were 69 and 67 years, respectively. There was no significant difference in age, performance status, history of nephrectomy, and the IMDC risk group distribution between the groups. The objective response rate was significantly higher in the Nivo-Ipi group (38%) than in the TKIs group (23%, P = 0.018). The IPTW-adjusted Cox regression analysis showed that a significantly longer progression-free survival (hazard ratio 0.60, P = 0.039) and overall survival (hazard ratio 0.51, P = 0.037) rates in the Nivo-Ipi group than those in the TKIs group. CONCLUSIONS: The oncological outcomes of patients receiving the first-line therapy of nivolumab plus ipilimumab in real-world practice were significantly improved in comparison with first-line TKIs therapy.
BACKGROUND: This study compared real-world outcomes of metastatic renal-cell carcinoma (mRCC) patients treated with tyrosine kinase inhibitors or nivolumab plus ipilimumab. METHODS: Using the International mRCC Database Consortium (IMDC), we retrospectively evaluated intermediate- and poor-risk mRCC patients who were treated with nivolumab plus ipilimumab (Nivo-Ipi), tyrosine kinase inhibitors (TKIs) as the first-line therapy between August 2015 and January 2020. We compared oncological outcomes between the Nivo-Ipi group and TKIs group using multivariate logistic regression analysis with the inverse probability of treatment weighting (IPTW) method. RESULTS: In this study 278 patients were included. There were 52 and 226 patients in the Nivo-Ipi and TKIs groups (sunitinib 97, axitinib 118, sorafenib 9, pazopanib 2), respectively. The median age in the Nivo-Ipi and TKIs groups were 69 and 67 years, respectively. There was no significant difference in age, performance status, history of nephrectomy, and the IMDC risk group distribution between the groups. The objective response rate was significantly higher in the Nivo-Ipi group (38%) than in the TKIs group (23%, P = 0.018). The IPTW-adjusted Cox regression analysis showed that a significantly longer progression-free survival (hazard ratio 0.60, P = 0.039) and overall survival (hazard ratio 0.51, P = 0.037) rates in the Nivo-Ipi group than those in the TKIs group. CONCLUSIONS: The oncological outcomes of patients receiving the first-line therapy of nivolumab plus ipilimumab in real-world practice were significantly improved in comparison with first-line TKIs therapy.
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