Abstract
We prospectively validate the efficacy of the frailty discriminant score (FDS) in individuals with urological cancers, as there has been growing importance in evaluating frailty in clinical practice. A prospective, multicenter study was conducted from February 2017 to April 2019. We enrolled 258 patients with urological cancers and 301 community-dwelling participants who were assessed for frailty. Frailty was assessed using FDS that includes ten items, such as physical, mental, and blood biochemical tests. The primary outcome was the non-inferiority (margin 5%) of FDS in discriminating patients with urological cancers from controls (Ctrl). The sensitivity, specificity, and area under the receiver operating characteristic (AUROC) curve for each predictive test were calculated. The secondary endpoints included the prediction of overall survival between patients with urological cancer who have high and low FDS. FDS was significantly higher in patients with urological cancers than that in the Ctrl. The AUROC curves for individuals with non-prostate cancers (such as bladder cancer, upper tract urothelial carcinoma, and renal cell carcinoma; 0.942) and those with prostate cancer (0.943) were within the non-inferior margin. The overall survival values were significantly lower in patients with higher FDS score than in those with lower FDS score. The study met its primary and secondary endpoints. The FDS is a reliable and valid tool for assessing frailty and prognosis in patients with urological cancers.
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Acknowledgements
We thank Yusuke Ishibashi, Yuki Fujita, and Yukie Nishizawa for their invaluable help with the data collection.
Funding
This study was supported by Japan Society for the Promotion of Science (JSPS) KAENHI Grant Nos. of 15H02563, 17K11119, and 18K09157 and a research Grant from the 31st Japanese Society of Geriatric Urology.
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Conception and design: SH, CO. Acquisition of data: OS, TO, NF, IH, TT, MM, HY, AI, TY, YH, KY, and TK. Drafting of the manuscript: SH. Critical revision of the manuscript: CO. Statistical analysis: SH, TY, and AI. Funding: SH, CO, and SN. Administrative, technical, and material support: TY and SN.
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This multicenter prospective study was performed according to the ethical standards of the Declaration of Helsinki and was approved by the ethics review board of the Hirosaki University School of Medicine (authorization number: 2014-297), Mutsu General Hospital, Aomori Prefectural Central Hospital, and Oyokyo Kidney Research Institute Hirosaki Hospital. All participants provided a written informed consent.
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Soma, O., Hatakeyama, S., Okamoto, T. et al. Multicenter prospective study validating the efficacy of a quantitative assessment tool for frailty in patients with urological cancers. Med Oncol 36, 88 (2019). https://doi.org/10.1007/s12032-019-1313-x
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DOI: https://doi.org/10.1007/s12032-019-1313-x