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

To confirm the safety and efficacy of everolimus in patients with unresectable or metastatic RCC.

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.

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%.

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.

Japanese journal of clinical oncology. 2019 May 28 [Epub ahead of print]

Hideyuki Akaza, Ryohei Kurihara, Aiko Katsura, Miki Harumiya, Naoko Ushida

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., Biostatistics Oncology Group, Clinical Development & Analytics Japan Integrated Biostatistics Japan Department, Novartis Pharma K.K., Tokyo, Japan., Cell & Gene Safety Group, PVO Japan, Novartis Pharma K.K., Tokyo, Japan., Solid Tumor Clinical Development Department, Clinical Development & Analytics Japan, Novartis Pharma K.K., Tokyo, Japan., Oncology Re-Examination Group, Re-Examination Department, Novartis Pharma K.K., Tokyo, Japan.

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