TY - JOUR
T1 - A Study of Pazopanib Safety and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma and ECOG Performance Status 2 (Pazo2)
T2 - An Open label, Multicentre, Single Arm, Phase II Trial
AU - Pazo2 Investigators
AU - Zarkar, Anjali
AU - Pirrie, Sarah
AU - Stubbs, Clive
AU - Hodgkins, Anne-Marie
AU - Farrugia, David
AU - Fife, Kathryn
AU - MacDonald-Smith, Carey
AU - Vasudev, Naveen
AU - Porfiri, Emilio
N1 - Copyright © 2022 The Authors.
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
KW - Adolescent
KW - Adult
KW - Aged
KW - Carcinoma, Renal Cell/pathology
KW - Humans
KW - Immune Checkpoint Inhibitors
KW - Indazoles/therapeutic use
KW - Kidney Neoplasms/drug therapy
KW - Prospective Studies
KW - Pyrimidines
KW - Sulfonamides
UR - http://www.scopus.com/inward/record.url?scp=85133837882&partnerID=8YFLogxK
U2 - 10.1016/j.clgc.2022.06.012
DO - 10.1016/j.clgc.2022.06.012
M3 - Article
C2 - 35803859
SN - 1558-7673
VL - 20
SP - 473
EP - 481
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
IS - 5
ER -