Abstract
This study investigated the impact of relative dose intensity (RDI) on the effectiveness and safety of immuno-oncology plus tyrosine kinase inhibitor (IO-TKI) therapy in Japanese patients with renal cell carcinoma (RCC). A total of 145 patients receiving first-line treatment were analyzed: 55 received IO-TKI therapy and 90 received immuno-oncology combination (IO-IO) therapy. Patients in the IO-TKI group were divided based on an RDI threshold of 80% into high- and low-RDI groups. Median progression-free survival (mPFS) was significantly longer in the IO-TKI group compared to the IO-IO group (P < 0.05), while no significant difference in median overall survival (mOS) was observed (P = 0.53). Interestingly, the mOS tended to be shorter in the IO-TKI high-RDI group than in the IO-TKI low-RDI (P = 0.05) and IO-IO groups (P = 0.13). Moreover, treatment discontinuation due to adverse effects occurred earlier in the IO-TKI high-RDI group (P < 0.05). An association was found between RDI ≥ 80% in IO-TKI therapy, discontinuation due to adverse events, and poor prognosis. Careful dose adjustment of TKIs may be necessary to optimize outcomes in Japanese patients with RCC receiving IO-TKI combination therapy.
Data availability
The datasets analyzed during the current study available from the first and corresponding author (Yoshihiko Tasaki and Shuzo Hamamoto) on reasonable request.
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Funding
This study was supported by the JSPS KAKENHI Grant Number 25K18657 (Y. Tasaki).Japan Society for the Promotion of Science,25K18657
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Yoshihiko Tasaki and Shuzo Hamamoto designed and directed the study. Yoshihiko Tasaki analyzd the majority of the data. Yoshihiko Tasaki, Shuzo Hamamoto, Hiroaki Ikoma, Misato Tomita, Takuya Sakata, Hiroko Suzuki, Yusuke Noda, Masayuki Usami, Yohei Tsubouchi, Toshiharu Morikawa, Yoshihisa Mimura, Yosuke Sugiyama, Takashi Nagai, Rei Unno, Toshiki Etani, Taku Naiki, Yoko Furukawa-Hibi, and Takahiro Yasui acquired the data. Yosuke Sugiyama conducted the statistical analyses. Yoshihiko Tasaki and Shuzo Hamamoto prepared the manuscript. All authors discussed the results and commented on the manuscript.
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Tasaki, Y., Hamamoto, S., Ikoma, H. et al. Impact of high relative dose intensity on effectiveness and treatment continuity of IO-TKI therapy in Japanese advanced renal cell carcinoma. Sci Rep (2026). https://doi.org/10.1038/s41598-026-43607-4
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DOI: https://doi.org/10.1038/s41598-026-43607-4
