ISHIDA Hideki
   Department   School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine
   Position   Professor
Article types Original article
Language English
Peer review Peer reviewed
Title Prognostic impact of trial-eligibility criteria in patients with metastatic renal cell carcinoma
Journal Formal name：Urologia internationalis
Abbreviation：Urol Int
ISSN code：00421138/14230399
Domestic / ForeginForegin
Volume, Issue, Page 26,pp.1-8
Author and coauthor ISHIHARA Hiroki†, TACHIBANA Hidekazu, FUKUDA Hironori, YOSHIDA Kazuhiko, KOBAYASHI Hirohito, TAKAGI Toshio, IIZUKA Junpei, ISHIDA Hideki, KONDO Tsunenori, TANABE Kazunari
Publication date 2021/08
Summary 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