Neoadjuvant Nivolumab in Patients with High-risk Nonmetastatic Renal Cell Carcinoma

被引：53

作者：

Gorin, Michael A. ^{[1
,2
,3
,4
]}

Patel, Hiten D. ^{[1
,2
]}

Rowe, Steven P. ^{[1
,2
,3
]}

Hahn, Noah M. ^{[1
,2
,4
]}

Hammers, Hans J. ^{[5
]}

Pons, Alice ^{[4
,6
,7
]}

Trock, Bruce J. ^{[1
,2
]}

Pierorazio, Phillip M. ^{[1
,2
,4
]}

Nirschl, Thomas R. ^{[4
,6
,7
]}

Salles, Daniela C. ^{[8
]}

Stein, Julie E. ^{[8
]}

Lotan, Tamara L. ^{[8
]}

Taube, Janis M. ^{[6
,7
,8
]}

Drake, Charles G. ^{[9
]}

Allaf, Mohamad E. ^{[1
,2
,4
]}

机构：

[1] Johns Hopkins Univ, Sch Med, James Buchanan Brady Urol Inst, Baltimore, MD USA

[2] Johns Hopkins Univ, Sch Med, Dept Urol, Baltimore, MD 21205 USA

[3] Johns Hopkins Univ, Sch Med, Russell H Morgan Dept Radiol & Radiol Sci, Baltimore, MD USA

[4] Johns Hopkins Univ, Sch Med, Dept Oncol, Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD 21205 USA

[5] Univ Texas Southwestern Med Ctr Dallas, Div Hematol Oncol, Dallas, TX 75390 USA

[6] Johns Hopkins Univ, Sch Med, Bloomberg Kimmel Inst Canc Immunotherapy, Baltimore, MD USA

[7] Johns Hopkins Univ, Sch Med, Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA

[8] Johns Hopkins Univ, Sch Med, Dept Pathol, Baltimore, MD 21205 USA

[9] Columbia Univ, Med Ctr, Herbert Irving Comprehens Canc Ctr, Div Hematol & Oncol, New York, NY USA

来源：

EUROPEAN UROLOGY ONCOLOGY | 2022年 / 5卷 / 01期

关键词：

Renal cell carcinoma; Immunotherapy; Neoadjuvant therapy; Clinical trial;

D O I：

10.1016/j.euo.2021.04.002

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Neoadjuvant immune checkpoint blockade represents a novel approach for potentially decreasing the risk of recurrence in patients with nonmetastatic renal cell carcinoma (RCC). In this early phase clincal tiral, we evaluated the safety and tolerability of neoadjuvant treatment with the programmed cell death protein 1 (PD-1) inhibitor nivolumab in patients with nonmetastatic high-risk RCC. Non-primary endpoints included objective radiographic tumor response rate, immune-related pathologic response rate, quality of life alterations, and metastasis-free and overall survival. In total, 17 patients were enrolled in this study and underwent surgery without a delay after receiving three every-2-wk doses of neoadjuvant nivolumab. Adverse events (AEs) of any grade occurred in 14 (82.4%) patients, with two (11.8%) experiencing grade 3 events. Ten (58.8%) patients experienced an AE of any grade potentially attributable to nivolumab (all grade 1-2), and no grade 4-5 AEs occurred regardless of treatment attribution. The most common AEs were grade 1 fatigue (41.2%), grade 1 pruritis (29.4%), and grade 1 rash (29.4%). All evaluable patients had stable disease as per established radiographic criteria, with one (6.7%) demonstrating features of an immune-related pathologic response. Quality of life remained stable during treatment, with improvements relative to baseline noted at >= 6 mo postoperatively. Metastasis-free survival and overall survival were 85.1% and 100% at 2 yr, respectively. Patient summary: In this study, we evaluated the safety and tolerability of preoperative administration of three doses of the immune checkpoint inhibitor nivolumab in patients with clinically localized high-risk renal cell carcinoma. We demonstrated the safety of this approach and found that, although most patients will not experience a radiographic response to treatment, a subset may have features of an immune-related pathologic response. (C) 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.

引用

页码：113 / 117

页数：5

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