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Post-marketing observational study of everolimus in patients with unresectable or metastatic renal cell carcinoma in Japan.

Abstract：

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.

journal_name

Jpn J Clin Oncol

journal_title

Japanese journal of clinical oncology

authors

Akaza H,Kurihara R,Katsura A,Harumiya M,Ushida N

doi

10.1093/jjco/hyz081

subject

Has Abstract

pub_date

2019-10-01 00:00:00

pages

956-964

issue

10

eissn

0368-2811

issn

1465-3621

pii

5499208

journal_volume

49

pub_type

杂志文章

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