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Neoadjuvant Nivolumab in Patients with High-risk Nonmetastatic Renal Cell Carcinoma.
Gorin, Michael A; Patel, Hiten D; Rowe, Steven P; Hahn, Noah M; Hammers, Hans J; Pons, Alice; Trock, Bruce J; Pierorazio, Phillip M; Nirschl, Thomas R; Salles, Daniela C; Stein, Julie E; Lotan, Tamara L; Taube, Janis M; Drake, Charles G; Allaf, Mohamad E.
  • Gorin MA; The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Oncology, T
  • Patel HD; The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Rowe SP; The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; The Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Hahn NM; The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Hammers HJ; Division of Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
  • Pons A; Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Bloomberg~Kimmel Institute for Cancer Immunotherapy and The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, U
  • Trock BJ; The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Pierorazio PM; The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Nirschl TR; Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Bloomberg~Kimmel Institute for Cancer Immunotherapy and The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, U
  • Salles DC; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Stein JE; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Lotan TL; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Taube JM; Bloomberg~Kimmel Institute for Cancer Immunotherapy and The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
  • Drake CG; Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, USA.
  • Allaf ME; The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: mallaf
Eur Urol Oncol ; 5(1): 113-117, 2022 02.
Article en En | MEDLINE | ID: mdl-34049847
ABSTRACT
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. Nonprimary 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.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Carcinoma de Células Renales / Neoplasias Renales Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Female / Humans / Male Idioma: En Año: 2022 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Carcinoma de Células Renales / Neoplasias Renales Tipo de estudio: Etiology_studies / Risk_factors_studies Límite: Female / Humans / Male Idioma: En Año: 2022 Tipo del documento: Article