Efficacy of anti‑PD‑1 antibody nivolumab in Japanese patients with metastatic renal cell carcinoma: A retrospective multicenter analysis

Abstract

To evaluate the efficacy and safety of anti-PD1 therapy (nivolumab) in advanced renal cell carcinoma (RCC) in a clinical setting. Between March 2013 and January 2018, 33 patients with RCC (27 men and 6 women) were treated with nivolumab. Before anti-PD1 treatment, 12, 9 and 12 patients received one, two, and three or more therapies, respectively. Objective response, survival rate, and clinical adverse events were evaluated by the revised RECIST criteria (version 1.1). The median patient age was 68 years (range: 37-79). In total, 14 (42%) patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 while 17 (52%) and two (6%) had an ECOG PS of 1 and 2 or higher, respectively. One (3%), 24 (73%) and eight (24%) were classified as having favorable, intermediate, and poor risk, respectively. The median follow-up duration after nivolumab initiation was 26 months (range: 1-131). The median progression-free and overall survival were 10.3 months and 45.9 months, respectively. Nivolumab was associated with a disease control rate of 58%, with an objective response of 24% (complete response, 1; partial response, 7; stable disease, 11; progressive disease, 10; not assessed, 4). A total of 15 (46%) patients experienced adverse events, of which six were severe (grade 3 or more) and 10 were immunotherapy-related. This study examined the initial experience of nivolumab administration in Japanese patients with advanced RCC. Our results suggest that nivolumab can achieve acceptable outcomes in a real clinical setting, with outcomes that are comparable to those of clinical trials. Patients and methods Eligibility criteria. The present study included patients who were diagnosed with advanced RCC and treated with nivolumab from two institutes between March 2013 and January 2018. All patients with histologically-proven mRCC, regardless of Eastern Cooperative Oncology Group (ECOG) performance status (PS), were eligible for inclusion. All patients received at least two cycles of nivolumab and were assessed for treatment efficacy and toxicity. This study was approved by both institutional review boards, The Research

Efficacy and safety of subsequent molecular targeted therapy after immuno-checkpoint therapy, retrospective study of Japanese patients with metastatic renal cell carcinoma (AFTER I-O study)

“…In the similar setting, Numakura et al. reported PR for 3 patients, and SD for 6 patients out of 13 patients who failed NIVO ( 28 ). And Ishihara et al.…”

“…TTs are recommended as subsequent therapy after discontinuation of NIVO and NIVO+IPI ( 16 , 17 ). Reported efficacy and safety data of TTs after ICIs are generally favorable without new safety signals ( 19–29 ), but most of the reports were analyzed among several ICI regimens except for few reports ( 22 , 28 , 29 ), the impact of TTs after NIVO and NIVO+IPI remains unclear. Aim of this study is to clarify the benefit of TTs after discontinuation of NIVO or NIVO+IPI independently, by evaluating the efficacy and safety of first TT, after discontinuation of NIVO or NIVO+IPI, in patients with mRCC.…”

Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with renal cell carcinoma

“… 45 , 46 , 47 , 48 , 49 , 50 The applicability of these agents to the treatment of Asian patients with mRCC has also been investigated and confirmed. 9 , 51 , 52 , 53 , 54 , 55 , 56 Currently, doublet combinations of these agents and single-agent therapy form the backbone of the first- and second-line systemic therapy approaches, respectively, for patients with RCC ( Table 1 and Figure 1 ). Single-agent therapy with VEGF pathway tyrosine kinase inhibitors (TKIs) is a first-line treatment option in patients where immune therapy is contraindicated or not available.…”

Nivolumab-induced hypophysitis followed by acute-onset type 1 diabetes with renal cell carcinoma: a case report

“…Although nivolumab caused unique AEs, the AEs were treated promptly, and all except one was reversible. A recent study suggested that nivolumab is a reasonable therapeutic option for patients with mRCC after multiple lines of treatment [ 7 ]. However, future prospective studies with larger sample sizes are required to better understand the appropriate indications for nivolumab treatment in patients with RCC.…”