دورية أكاديمية
A Study of Pazopanib Safety and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma and ECOG Performance Status 2 (Pazo2): An Open label, Multicentre, Single Arm, Phase II Trial.
| العنوان: | A Study of Pazopanib Safety and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma and ECOG Performance Status 2 (Pazo2): An Open label, Multicentre, Single Arm, Phase II Trial. |
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| المؤلفون: | Zarkar A; Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom., Pirrie S; Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, United Kingdom. Electronic address: s.j.pirrie@bham.ac.uk., Stubbs C; Birmingham Clinical Trials Unit (BCTU), University of Birmingham, Birmingham, United Kingdom., Hodgkins AM; Cancer Research UK Clinical Trials Unit (CRCTU), University of Birmingham, Birmingham, United Kingdom., Farrugia D; Cheltenham General Hospital, Cheltenham, United Kingdom., Fife K; Addenbrooke's Hospital, Cambridge, United Kingdom., MacDonald-Smith C; Glan Clwyd Hospital, Rhyl, United Kingdom., Vasudev N; St James's University Hospital, Leeds, United Kingdom., Porfiri E; Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, United Kingdom; Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom. |
| مؤلفون مشاركون: | Pazo2 Investigators |
| المصدر: | Clinical genitourinary cancer [Clin Genitourin Cancer] 2022 Oct; Vol. 20 (5), pp. 473-481. Date of Electronic Publication: 2022 Jun 14. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101260955 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1938-0682 (Electronic) Linking ISSN: 15587673 NLM ISO Abbreviation: Clin Genitourin Cancer Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2009-> : [New York] : Elsevier Original Publication: Dallas, Tex. : Cancer Information Group, c2005- |
| مواضيع طبية MeSH: | Carcinoma, Renal Cell*/pathology , Kidney Neoplasms*/drug therapy , Kidney Neoplasms*/pathology, Adolescent ; Adult ; Aged ; Humans ; Immune Checkpoint Inhibitors ; Indazoles/therapeutic use ; Prospective Studies ; Pyrimidines ; Sulfonamides |
| مستخلص: | Aim: Patients with advanced renal cell carcinoma and poor performance status (PS≥2) are often deemed unsuitable for treatment. The Pazo2 trial aimed to assess tolerability and efficacy of pazopanib as first-line treatment in renal cancer patients with ECOG PS2. Methods: Pazo2 was a prospective, single arm, open label, multicentre, phase II trial, conducted in 26 UK centres. Eligible patients were aged ≥18 years, with advanced or metastatic renal cancer and a clear cell component (aRCC), measurable disease as per RECIST Criteria 1.1, and ECOG PS2. Co-primary outcomes, assessed at 6-months after patients entered the trial, were tolerability, defined as the proportion of patients who did not develop "intolerable" adverse events, and efficacy, defined as the proportion of all patients who were progression-free and alive. Results: Between February 21, 2013 and August 12, 2016, 75 patients were registered. Median age was 68.6 years (IQR 64.6-76.0), 100% ECOG PS2, 62.7% 'poor risk' (International Metastatic Renal-Cell Carcinoma Database Consortium). Of the 65 evaluable patients, 70.8% (95% CI: 58.8, 80.4) did not develop "intolerable" adverse events and 56.9% (95% CI: 44.8, 68.2) were still alive and progression-free 6 months after starting pazopanib. Twenty-seven patients developed serious adverse events deemed to be related to pazopanib. Conclusion: These data suggests that pazopanib is tolerated and effective in aRCC patients with PS2 and represents a treatment option for patients who cannot receive or tolerate immune checkpoint inhibitors. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.) |
| معلومات مُعتمدة: | 25354 United Kingdom CRUK_ Cancer Research UK; C22436/A25354 United Kingdom CRUK_ Cancer Research UK; C11225/A12402 United Kingdom CRUK_ Cancer Research UK |
| فهرسة مساهمة: | Keywords: Advanced clear cell renal cell carcinoma; Clinical trial; Pazopanib; Poor performance status |
| المشرفين على المادة: | 0 (Immune Checkpoint Inhibitors) 0 (Indazoles) 0 (Pyrimidines) 0 (Sulfonamides) 7RN5DR86CK (pazopanib) |
| SCR Disease Name: | Clear-cell metastatic renal cell carcinoma |
| تواريخ الأحداث: | Date Created: 20220708 Date Completed: 20220928 Latest Revision: 20240210 |
| رمز التحديث: | 20240210 |
| DOI: | 10.1016/j.clgc.2022.06.012 |
| PMID: | 35803859 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1938-0682 |
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| DOI: | 10.1016/j.clgc.2022.06.012 |