タカギ　トシオ   Takagi Toshio   高木　敏男    所属   医学部 医学科（東京女子医科大学病院）    職種   教授・基幹分野長
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Prognostic impact of trial-eligibility criteria in patients with metastatic renal cell carcinoma
掲載誌名	正式名：Urologia internationalis 略　 称：Urol Int ISSNコード：00421138/14230399
掲載区分	国外
巻・号・頁	26,pp.1-8
著者・共著者	ISHIHARA Hiroki†, TACHIBANA Hidekazu, FUKUDA Hironori, YOSHIDA Kazuhiko, KOBAYASHI Hirohito, TAKAGI Toshio, IIZUKA Junpei, ISHIDA Hideki, KONDO Tsunenori, TANABE Kazunari
発行年月	2021/08
概要	OBJECTIVE:The aim of the study was to evaluate the prognostic impact of trial-eligibility criteria on outcome in real-world metastatic renal cell carcinoma (mRCC) patients treated with tyrosine kinase inhibitors (TKIs).PATIENTS AND METHODS:mRCC patients treated with TKIs as first-line systemic therapy were retrospectively evaluated. The patients were determined as trial-ineligible when they met at least 1 following trial-ineligible criteria; Karnofsky performance status score <70, hemoglobin <9.0 g/dL, creatinine >2.4 mg/dL (male) or >2.0 mg/dL (female), calcium >12.0 mg/dL, platelet <100,000 /μL, neutrophil <1,500 /μL, nonclear-cell histology, and brain metastasis.RESULTS:Of 238 patients, 101 patients (42%) were determined as trial-ineligible. Progression-free survival (PFS) and overall survival (OS) after the TKI initiation were significantly shorter in the trial-ineligible patients than in the trial-eligible patients (median PFS: 5.53 vs. 15.8 months, p < 0.0001; OS: 13.8 vs. 43.4 months, p < 0.0001). Objective response rate was also significantly lower in the trial-ineligible patients (15% vs. 37%, p = 0.0003). Multivariate analysis further showed that the trial-eligibility was an independent factor for PFS (hazard ratio [HR]: 2.46, p < 0.0001) and OS (HR: 2.39, p < 0.0001). In addition, the number of trial-ineligible factors were negatively correlated with PFS and OS.CONCLUSIONS:In real-word, the substantial number of mRCC patients did not meet the trial-eligibility criteria, and their outcome was worse than that in the trial-eligible patients. Further studies focusing on the outcome in real-world trial-ineligible patients in the immune checkpoint inhibitor era are warranted.
DOI	10.1159/000518162
PMID	34515259