Toshikazu Tanaka1, Shingo Hatakeyama2, Kazuyuki Numakura3, Koichi Kido1, Daisuke Noro4, Masaaki Oikawa5, Shogo Hosogoe6, Noriko Tokui7, Hayato Yamamoto1, Shintaro Narita3, Hiroyuki Ito8, Takahiro Yoneyama9, Yasuhiro Hashimoto1, Toshiaki Kawaguchi10, Tomonori Habuchi3, Chikara Ohyama1,2,9. 1. Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. 2. Department of Advanced Blood Purification Therapy, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. 3. Department of Urology, Akita University Graduate School of Medicine, Akita, Japan. 4. Department of Urology, Mutsu General Hospital, Mutsu, Japan. 5. Department of Urology, Hakodate Municipal Hospital, Hakodate, Japan. 6. Department of Urology, Aomori City Hospital, Aomori, Japan. 7. Department of Urology, Odate Municipal Hospital, Odate, Japan. 8. Department of Urology, Aomori Rosai Hospital, Hachinohe, Japan. 9. Department of Advanced Transplant Regenerative Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. 10. Department of Urology, Aomori Prefectural Central Hospital, Aomori, Japan.
Abstract
OBJECTIVES: To investigate the efficacy and safety of first-line nivolumab plus ipilimumab for patients treated with metastatic renal cell carcinoma. METHODS: We retrospectively evaluated 52 metastatic renal cell carcinoma patients who were treated with nivolumab plus ipilimumab between August 2015 and January 2020. Data on patient characteristics, treatment parameters and adverse events were obtained. Oncological outcomes were assessed according to the International Metastatic Renal Cell Carcinoma Database Consortium prognostic model. Furthermore, differences in treatment parameters between patients with objective response (responders) and non-responders were compared. RESULTS: The median age and follow-up periods were 69 years and 8.2 months, respectively. The 1-year progression-free survival and overall survival rates were 55% and 75%, respectively. The objective response rate was 39%, and it was significantly different between the International Metastatic Renal Cell Carcinoma Database Consortium intermediate- and poor-risk groups (52% vs 24%). We observed 36 (69%) any immune-related adverse events, and 19 (37%) severe immune-related adverse events (grades III-V). The International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group and higher value of initial C-reactive protein (≥1.0 mg/dL) were significantly associated with non-responders. Patients with two factors (the International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group plus C-reactive protein ≥1.0 mg/dL) had a significantly poor overall survival than those with none or a single factor. CONCLUSIONS: In our experience, treatment response to nivolumab plus ipilimumab is comparable with that of the CheckMate 214 clinical trial, but the incidence of treatment-related adverse events is lower. The International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group and initial C-reactive protein value might have a prognostic value for poor survival.
OBJECTIVES: To investigate the efficacy and safety of first-line nivolumab plus ipilimumab for patients treated with metastatic renal cell carcinoma. METHODS: We retrospectively evaluated 52 metastatic renal cell carcinomapatients who were treated with nivolumab plus ipilimumab between August 2015 and January 2020. Data on patient characteristics, treatment parameters and adverse events were obtained. Oncological outcomes were assessed according to the International Metastatic Renal Cell Carcinoma Database Consortium prognostic model. Furthermore, differences in treatment parameters between patients with objective response (responders) and non-responders were compared. RESULTS: The median age and follow-up periods were 69 years and 8.2 months, respectively. The 1-year progression-free survival and overall survival rates were 55% and 75%, respectively. The objective response rate was 39%, and it was significantly different between the International Metastatic Renal Cell Carcinoma Database Consortium intermediate- and poor-risk groups (52% vs 24%). We observed 36 (69%) any immune-related adverse events, and 19 (37%) severe immune-related adverse events (grades III-V). The International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group and higher value of initial C-reactive protein (≥1.0 mg/dL) were significantly associated with non-responders. Patients with two factors (the International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group plus C-reactive protein ≥1.0 mg/dL) had a significantly poor overall survival than those with none or a single factor. CONCLUSIONS: In our experience, treatment response to nivolumab plus ipilimumab is comparable with that of the CheckMate 214 clinical trial, but the incidence of treatment-related adverse events is lower. The International Metastatic Renal Cell Carcinoma Database Consortium poor-risk group and initial C-reactive protein value might have a prognostic value for poor survival.