PMID- 31135920
OWN - NLM
STAT- MEDLINE
DCOM- 20200207
LR  - 20200207
IS  - 1465-3621 (Electronic)
IS  - 0368-2811 (Linking)
VI  - 49
IP  - 10
DP  - 2019 Oct 1
TI  - Post-marketing observational study of everolimus in patients with unresectable or 
      metastatic renal cell carcinoma in Japan.
PG  - 956-964
LID - 10.1093/jjco/hyz081 [doi]
AB  - OBJECTIVE: To confirm the safety and efficacy of everolimus in patients with 
      unresectable or metastatic RCC. METHODS: Patients with unresectable or metastatic 
      RCC were included and were followed for up to 1 year from the start of 
      everolimus. The study was conducted at 618 investigational sites in Japan from 
      March 2010 through January 2018. Safety endpoints include adverse events (AEs), 
      and efficacy endpoints were presence/absence of tumor response, progression-free 
      survival (PFS), and overall survival (OS) rate. RESULTS: Of 1694 patients, 
      majority were male (76.33%). Overall, 97.64% of patients experienced AEs and 49% 
      reported serious AEs. The most common serious AEs (incidence of >/= 5%) include 
      malignant neoplasm progression (21.13%) and interstitial lung disease (10.86%). 
      The incidences of adverse reactions of priority investigation items are as 
      follows: interstitial lung disease (27.74%), infections (11.57%), stomatitis 
      (45.45%), increased in serum creatinine (5.61%), hyperglycemia (14.23%), 
      exacerbation of renal impairment (26.14%), and exacerbation of hepatic impairment 
      (1.15%). The overall tumor response rate was 6.81% with 0.08% CR, and 6.73% PR. 
      The SD was reported in 68.74% of patients. The median PFS was 196 days (95% CI: 
      181-216 days). The 365-day cumulative OS rate was 82.42%. CONCLUSIONS: The 
      acceptable safety and efficacy findings in patients with unresectable or 
      metastatic RCC were confirmed in this study, and are similar to those of pivotal 
      study, which led to the approval, and no new issues were detected. There were no 
      safety or efficacy issues in special populations including elderly and patients 
      with renal/hepatic impairment.
CI  - (c) The Author(s) 2019. Published by Oxford University Press. All rights reserved. 
      For permissions, please e-mail: journals.permissions@oup.com.
FAU - Akaza, Hideyuki
AU  - Akaza H
AD  - Department of Strategic Investigation on Comprehensive Cancer Network, 
      Interfaculty Initiative in Information Studies/Graduate School of 
      Interdisciplinary Information Studies, The University of Tokyo, Tokyo, Japan.
FAU - Kurihara, Ryohei
AU  - Kurihara R
AD  - Biostatistics Oncology Group, Clinical Development & Analytics Japan Integrated 
      Biostatistics Japan Department, Novartis Pharma K.K., Tokyo, Japan.
FAU - Katsura, Aiko
AU  - Katsura A
AD  - Cell & Gene Safety Group, PVO Japan, Novartis Pharma K.K., Tokyo, Japan.
FAU - Harumiya, Miki
AU  - Harumiya M
AD  - Solid Tumor Clinical Development Department, Clinical Development & Analytics 
      Japan, Novartis Pharma K.K., Tokyo, Japan.
FAU - Ushida, Naoko
AU  - Ushida N
AD  - Oncology Re-Examination Group, Re-Examination Department, Novartis Pharma K.K., 
      Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PL  - England
TA  - Jpn J Clin Oncol
JT  - Japanese journal of clinical oncology
JID - 0313225
RN  - 0 (Antineoplastic Agents)
RN  - 9HW64Q8G6G (Everolimus)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/adverse effects/therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/*pathology
MH  - Disease-Free Survival
MH  - Dose-Response Relationship, Drug
MH  - Everolimus/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Japan
MH  - Kidney Neoplasms/*drug therapy/*pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - *Product Surveillance, Postmarketing
MH  - Progression-Free Survival
MH  - Survival Rate
MH  - Treatment Outcome
MH  - Withholding Treatment
MH  - Young Adult
OTO - NOTNLM
OT  - everolimus
OT  - post-marketing observational study
OT  - renal cell carcinoma
EDAT- 2019/05/29 06:00
MHDA- 2020/02/08 06:00
CRDT- 2019/05/29 06:00
PHST- 2018/12/21 00:00 [received]
PHST- 2019/04/08 00:00 [revised]
PHST- 2019/05/20 00:00 [accepted]
PHST- 2019/05/29 06:00 [pubmed]
PHST- 2020/02/08 06:00 [medline]
PHST- 2019/05/29 06:00 [entrez]
AID - 5499208 [pii]
AID - 10.1093/jjco/hyz081 [doi]
PST - ppublish
SO  - Jpn J Clin Oncol. 2019 Oct 1;49(10):956-964. doi: 10.1093/jjco/hyz081.