Outcome change in patients with advanced renal cell carcinoma outside of clinical trials from the tyrosine-kinase inhibitor era to the immune checkpoint inhibitor era

You have accessJournal of UrologyCME1 Apr 2023MP28-08 OUTCOME CHANGE IN PATIENTS WITH ADVANCED RENAL CELL CARCINOMA OUTSIDE OF CLINICAL TRIALS FROM THE TYROSINE-KINASE INHIBITOR ERA TO THE IMMUNE CHECKPOINT INHIBITOR ERA Hiroki Ishihara, Yuki Nemoto, kazutaka Nakamura, Hidekazu Tachibana, Hironori Fukuda, Kazuhiko Yoshida, Hirohito Kobayashi, Junpei Iizuka, Hiroaki Shimmura, Yasunobu Hashimoto, Tsunenori Kondo, and Toshio Takagi Hiroki IshiharaHiroki Ishihara More articles by this author , Yuki NemotoYuki Nemoto More articles by this author , kazutaka Nakamurakazutaka Nakamura More articles by this author , Hidekazu TachibanaHidekazu Tachibana More articles by this author , Hironori FukudaHironori Fukuda More articles by this author , Kazuhiko YoshidaKazuhiko Yoshida More articles by this author , Hirohito KobayashiHirohito Kobayashi More articles by this author , Junpei IizukaJunpei Iizuka More articles by this author , Hiroaki ShimmuraHiroaki Shimmura More articles by this author , Yasunobu HashimotoYasunobu Hashimoto More articles by this author , Tsunenori KondoTsunenori Kondo More articles by this author , and Toshio TakagiToshio Takagi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003256.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Clinical trials have demonstrated the superior efficacy of immune checkpoint inhibitor (ICI)-based combination therapy over sunitinib, a multi-target tyrosine kinase inhibitor (TKI), in patients with advanced renal cell carcinoma (RCC). However, such benefit has not been elucidated in populations outside of clinical trials. METHODS: We retrospectively evaluated data of 331 patients with advanced RCC receiving ICI-based combination therapy or TKIs as first-line therapy. Patients were determined as trial-ineligible when at least one of following factors was present: KPS score <70%, hemoglobin level <9.0 g/dL, eGFR <40 mL/min/1.73 m2, platelet count <100,000/µL, neutrophil count <1500/µL, non-clear cell histology, or brain metastasis. The outcome change from the previous TKIs to the current ICI-based combination therapy was analyzed in both trial-eligible and trial-ineligible populations. RESULTS: This study included 48/93 (52%) and 101/238 (42%) patients receiving TKI and ICI-based combination therapy outside of clinical trials, respectively. Among the TKI-treated patients, the trial-ineligible patients had significantly lower progression-free survival (PFS) (p<0.0001) and overall survival (OS) (p<0.0001) than the trial-eligible patients. In contrast, among ICI-based combination therapy-treated patients, no significant difference in PFS (p=0.393) or OS (p=0.634) was found between them. On analyzing each population based on trial eligibility throughout the TKI and ICI-based combination therapy, in the trial-eligible population, no significant difference in PFS (p=0.236) or OS (p=0.333) was found between TKI and ICI-based combination therapy (Figure a and b). However, in the trial-ineligible population, PFS (p=0.0037) and OS (p<0.0001) were significantly higher for the ICI-based combination therapy than for the TKIs (Figure c and d). CONCLUSIONS: Using real-world data, this study indicated the substantial rate of patients with advanced RCC treated with systemic therapy outside of clinical trials. ICI-based combination therapy helped improve outcomes of advanced RCC, and the therapeutic benefit was more prominent in the trial-ineligible population than in the trial-eligible population. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e373 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hiroki Ishihara More articles by this author Yuki Nemoto More articles by this author kazutaka Nakamura More articles by this author Hidekazu Tachibana More articles by this author Hironori Fukuda More articles by this author Kazuhiko Yoshida More articles by this author Hirohito Kobayashi More articles by this author Junpei Iizuka More articles by this author Hiroaki Shimmura More articles by this author Yasunobu Hashimoto More articles by this author Tsunenori Kondo More articles by this author Toshio Takagi More articles by this author Expand All Advertisement PDF downloadLoading ...