PMID- 35915038 OWN - NLM STAT- MEDLINE DCOM- 20230214 LR - 20230228 IS - 2405-4569 (Electronic) IS - 2405-4569 (Linking) VI - 9 IP - 1 DP - 2023 Jan TI - Adverse Events of Axitinib plus Pembrolizumab Versus Lenvatinib plus Pembrolizumab: A Pharmacovigilance Study in Food and Drug Administration Adverse Event Reporting System. PG - 141-144 LID - S2405-4569(22)00164-X [pii] LID - 10.1016/j.euf.2022.07.003 [doi] AB - No head-to-head postmarket surveillance study has compared the differences in adverse events (AEs) between two combination therapies, axitinib (AXI) + pembrolizumab (PEMBRO) and lenvatinib (LEN) + PEMBRO, against metastatic renal cell carcinoma. This study aims to highlight the comprehensive differences in AEs between these two therapies based on the real-world big data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. In total, 28 937 records were extracted from the FAERS database, and 139 AEs grouped into the System Organ Class according to the Medical Dictionary for Regulatory Activities were analysed. Logistic regression analyses were performed, and the reporting odds ratio with a 95% confidence interval was determined. We found that the incidences of cardiac and hepatobiliary disorders for AXI + PEMBRO, and blood and lymphatic system, metabolism and nutrition, and vascular disorders for LEN + PEMBRO, all of which were associated with serious AEs, were higher than those for LEN + PEMBRO and AXI + PEMBRO, respectively. The differences in the AEs between AXI + PEMBRO and LEN + PEMBRO were not derived merely from those between AXI and LEN monotherapies. Furthermore, remarkable AE potentiation was observed for AXI + PEMBRO. As FAERS is a spontaneous reporting system comprising partially limited information, analysing more detailed relationships between AEs and patient or treatment characteristics was challenging in this study. The present study is the first to show the overall real-world postmarketing differences in AEs between AXI + PEMBRO and LEN + PEMBRO. Our novel findings will substantially improve clinical practice; we recommend comparing patients' conditions associated with the above AEs when selecting between these two therapies. PATIENT SUMMARY: Herein, we highlight the differences in adverse events (AEs) between axitinib + pembrolizumab and lenvatinib + pembrolizumab therapies using data from the real-world Food and Drug Administration Adverse Event Reporting System database aimed at patients with metastatic renal cell carcinoma. We identified AEs that needed attention in each combination. We recommend the differences in AEs to be considered when selecting these two therapies. CI - Copyright (c) 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved. FAU - Matsumoto, Jun AU - Matsumoto J AD - Department of Personalized Medicine and Preventive Healthcare Sciences, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Kita-ku, Okayama, Japan; Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan. FAU - Iwata, Naohiro AU - Iwata N AD - Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan. FAU - Watari, Shogo AU - Watari S AD - Department of Urology, National Hospital Organization Okayama Medical Centre, Kita-ku, Okayama, Japan. FAU - Ushio, Soichiro AU - Ushio S AD - Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan. Electronic address: s-ushio@okayama-u.ac.jp. FAU - Shiromizu, Shoya AU - Shiromizu S AD - Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan. FAU - Takeda, Tatsuaki AU - Takeda T AD - Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan. FAU - Hamano, Hirofumi AU - Hamano H AD - Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan. FAU - Kajizono, Makoto AU - Kajizono M AD - Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan. FAU - Araki, Motoo AU - Araki M AD - Department of Urology, Faculty of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Kita-ku, Okayama, Japan. FAU - Nasu, Yasutomo AU - Nasu Y AD - Department of Urology, Faculty of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University, Kita-ku, Okayama, Japan. FAU - Ariyoshi, Noritaka AU - Ariyoshi N AD - Department of Personalized Medicine and Preventive Healthcare Sciences, Faculty of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Kita-ku, Okayama, Japan. FAU - Zamami, Yoshito AU - Zamami Y AD - Department of Pharmacy, Okayama University Hospital, Kita-ku, Okayama, Japan. LA - eng PT - Journal Article DEP - 20220729 PL - Netherlands TA - Eur Urol Focus JT - European urology focus JID - 101665661 RN - DPT0O3T46P (pembrolizumab) RN - EE083865G2 (lenvatinib) RN - C9LVQ0YUXG (Axitinib) SB - IM MH - United States MH - Humans MH - Pharmacovigilance MH - *Carcinoma, Renal Cell/drug therapy MH - Axitinib/adverse effects MH - United States Food and Drug Administration MH - Adverse Drug Reaction Reporting Systems MH - *Drug-Related Side Effects and Adverse Reactions/epidemiology MH - *Kidney Neoplasms/drug therapy OTO - NOTNLM OT - Adverse event OT - Food and Drug Administration Adverse Event Reporting System OT - Immune-checkpoint inhibitor OT - Renal cell carcinoma OT - Tyrosine kinase inhibitor EDAT- 2022/08/02 06:00 MHDA- 2023/02/15 06:00 CRDT- 2022/08/01 22:06 PHST- 2022/05/17 00:00 [received] PHST- 2022/06/23 00:00 [revised] PHST- 2022/07/19 00:00 [accepted] PHST- 2022/08/02 06:00 [pubmed] PHST- 2023/02/15 06:00 [medline] PHST- 2022/08/01 22:06 [entrez] AID - S2405-4569(22)00164-X [pii] AID - 10.1016/j.euf.2022.07.003 [doi] PST - ppublish SO - Eur Urol Focus. 2023 Jan;9(1):141-144. doi: 10.1016/j.euf.2022.07.003. Epub 2022 Jul 29.