KOBAYASHI Hirohito
   Department   School of Medicine(Tokyo Women's Medical University Adachi Medical Center), School of Medicine
   Position   Associate 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