アブストラクト | INTRODUCTION: Recently, many agents and combinations for metastatic and advanced renal cell carcinoma have been approved. This study aims to highlight the comprehensive differences in adverse events (AEs) between cabozantinib (CAB) plus nivolumab (NIVO) and ipilimumab (IPI) plus NIVO based on a real-world big dataset. MATERIAL AND METHODS: We downloaded AE datasets of IPI + NIVO and CAB + NIVO from the Food and Drug Administration Adverse Event Reporting System database. We used the Medical Dictionary for Regulatory Activities to treat each AE as a preferred term and grouped it into the System Organ Class (SOC). We performed logistic regression analyses to compare IPI + NIVO and CAB + NIVO. RESULTS: The incidence rates of 7 types of toxicities were higher for CAB + NIVO than for IPI + NIVO. On the other hand, the incidence rates of 3 types of toxicities were higher for IPI + NIVO than for CAB + NIVO. Serious AEs were higher in patients receiving IPI + NIVO. CONCLUSION: Our findings suggest that both combination therapies presented a disproportionate distribution of toxicities in several SOC. These findings may help clinicians select suitable therapy for the individual and improve the safety profile in patients with advanced renal cell carcinoma receiving NIVO + IPI and NIVO + CAB in a real-world setting. |
ジャーナル名 | Clinical genitourinary cancer |
Pubmed追加日 | 2023/10/10 |
投稿者 | Blas, Leandro; Shiota, Masaki; Tsukahara, Shigehiro; Nagakawa, Shohei; Matsumoto, Takashi; Eto, Masatoshi |
組織名 | Department of Urology, Graduate School of Medical Sciences, Kyushu University,;Fukuoka, Japan.;Fukuoka, Japan. Electronic address: shiota.masaki.101@m.kyushu-u.ac.jp. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37813699/ |