Safety and Efficacy of Pazopanib in First-Line Metastatic Renal-Cell Carcinoma With or Without Renal Failure: CORE-URO-01 Study

Cristina Masini, Maria Giuseppa Vitale, Marco Maruzzo, Giuseppe Procopio, Ugo de Giorgi, Sebastiano Buti, Sabrina Rossetti, Roberto Iacovelli, Francesco Atzori, Laura Cosmai, Francesca Vignani, Giuseppe Prati, Sarah Scagliarini, Annalisa Guida, Annalisa Berselli, Carmine Pinto

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Pazopanib has been approved for first-line treatment of patients with metastatic renal-cell carcinoma on the basis of clinical trials that enrolled only patients with adequate renal function. Few data are available on the safety and efficacy of pazopanib in patients with renal insufficiency. This study investigated the effect of kidney function on treatment outcomes in such patients.

PATIENTS AND METHODS: We retrospectively analyzed data of metastatic renal-cell carcinoma patients treated with pazopanib from January 2010 to June 2016 with respect to renal function. Patients with Modification of Diet in Renal Disease ≤ 60 mL/min/1.73 m2 (group A) were compared to patients with Modification of Diet in Renal Disease > 60 mL/min/1.73 m2 (group B) in terms of progression-free survival, toxicities, response rates, and overall survival.

RESULTS: A total of 229 patients were included: 128 in group A and 101 in group B. Median progression-free survival was 14 months (95% confidence interval [CI], 9.4-18.5) and 17 months (95% CI, 11.4-22.8), and overall survival was 30.5 months (95% CI, 8-53) and 41.4 months (95% CI, 21-62) for group A and group B, respectively, with no significant difference (P = .6). No significant difference between the 2 groups was reported in the incidence of adverse events. Dose reductions were more frequent in group A patients (66% vs. 36%; P = .04).

CONCLUSION: Although the dose of pazopanib was reduced more frequently in patients with renal impairment, kidney function at therapy initiation does not adversely affect the safety and efficacy of pazopanib.

Original languageEnglish
Pages (from-to)e150-e155
JournalClinical Genitourinary Cancer
Volume17
Issue number1
DOIs
Publication statusPublished - Feb 2019

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Renal Cell Carcinoma
Renal Insufficiency
Safety
Kidney
Confidence Intervals
Diet Therapy
Disease-Free Survival
pazopanib
Survival Rate
Clinical Trials
Survival
Incidence
Therapeutics

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Safety and Efficacy of Pazopanib in First-Line Metastatic Renal-Cell Carcinoma With or Without Renal Failure : CORE-URO-01 Study. / Masini, Cristina; Vitale, Maria Giuseppa; Maruzzo, Marco; Procopio, Giuseppe; de Giorgi, Ugo; Buti, Sebastiano; Rossetti, Sabrina; Iacovelli, Roberto; Atzori, Francesco; Cosmai, Laura; Vignani, Francesca; Prati, Giuseppe; Scagliarini, Sarah; Guida, Annalisa; Berselli, Annalisa; Pinto, Carmine.

In: Clinical Genitourinary Cancer, Vol. 17, No. 1, 02.2019, p. e150-e155.

Research output: Contribution to journalArticle

Masini, Cristina ; Vitale, Maria Giuseppa ; Maruzzo, Marco ; Procopio, Giuseppe ; de Giorgi, Ugo ; Buti, Sebastiano ; Rossetti, Sabrina ; Iacovelli, Roberto ; Atzori, Francesco ; Cosmai, Laura ; Vignani, Francesca ; Prati, Giuseppe ; Scagliarini, Sarah ; Guida, Annalisa ; Berselli, Annalisa ; Pinto, Carmine. / Safety and Efficacy of Pazopanib in First-Line Metastatic Renal-Cell Carcinoma With or Without Renal Failure : CORE-URO-01 Study. In: Clinical Genitourinary Cancer. 2019 ; Vol. 17, No. 1. pp. e150-e155.
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abstract = "BACKGROUND: Pazopanib has been approved for first-line treatment of patients with metastatic renal-cell carcinoma on the basis of clinical trials that enrolled only patients with adequate renal function. Few data are available on the safety and efficacy of pazopanib in patients with renal insufficiency. This study investigated the effect of kidney function on treatment outcomes in such patients.PATIENTS AND METHODS: We retrospectively analyzed data of metastatic renal-cell carcinoma patients treated with pazopanib from January 2010 to June 2016 with respect to renal function. Patients with Modification of Diet in Renal Disease ≤ 60 mL/min/1.73 m2 (group A) were compared to patients with Modification of Diet in Renal Disease > 60 mL/min/1.73 m2 (group B) in terms of progression-free survival, toxicities, response rates, and overall survival.RESULTS: A total of 229 patients were included: 128 in group A and 101 in group B. Median progression-free survival was 14 months (95{\%} confidence interval [CI], 9.4-18.5) and 17 months (95{\%} CI, 11.4-22.8), and overall survival was 30.5 months (95{\%} CI, 8-53) and 41.4 months (95{\%} CI, 21-62) for group A and group B, respectively, with no significant difference (P = .6). No significant difference between the 2 groups was reported in the incidence of adverse events. Dose reductions were more frequent in group A patients (66{\%} vs. 36{\%}; P = .04).CONCLUSION: Although the dose of pazopanib was reduced more frequently in patients with renal impairment, kidney function at therapy initiation does not adversely affect the safety and efficacy of pazopanib.",
author = "Cristina Masini and Vitale, {Maria Giuseppa} and Marco Maruzzo and Giuseppe Procopio and {de Giorgi}, Ugo and Sebastiano Buti and Sabrina Rossetti and Roberto Iacovelli and Francesco Atzori and Laura Cosmai and Francesca Vignani and Giuseppe Prati and Sarah Scagliarini and Annalisa Guida and Annalisa Berselli and Carmine Pinto",
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year = "2019",
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TY - JOUR

T1 - Safety and Efficacy of Pazopanib in First-Line Metastatic Renal-Cell Carcinoma With or Without Renal Failure

T2 - CORE-URO-01 Study

AU - Masini, Cristina

AU - Vitale, Maria Giuseppa

AU - Maruzzo, Marco

AU - Procopio, Giuseppe

AU - de Giorgi, Ugo

AU - Buti, Sebastiano

AU - Rossetti, Sabrina

AU - Iacovelli, Roberto

AU - Atzori, Francesco

AU - Cosmai, Laura

AU - Vignani, Francesca

AU - Prati, Giuseppe

AU - Scagliarini, Sarah

AU - Guida, Annalisa

AU - Berselli, Annalisa

AU - Pinto, Carmine

N1 - Copyright © 2018 Elsevier Inc. All rights reserved.

PY - 2019/2

Y1 - 2019/2

N2 - BACKGROUND: Pazopanib has been approved for first-line treatment of patients with metastatic renal-cell carcinoma on the basis of clinical trials that enrolled only patients with adequate renal function. Few data are available on the safety and efficacy of pazopanib in patients with renal insufficiency. This study investigated the effect of kidney function on treatment outcomes in such patients.PATIENTS AND METHODS: We retrospectively analyzed data of metastatic renal-cell carcinoma patients treated with pazopanib from January 2010 to June 2016 with respect to renal function. Patients with Modification of Diet in Renal Disease ≤ 60 mL/min/1.73 m2 (group A) were compared to patients with Modification of Diet in Renal Disease > 60 mL/min/1.73 m2 (group B) in terms of progression-free survival, toxicities, response rates, and overall survival.RESULTS: A total of 229 patients were included: 128 in group A and 101 in group B. Median progression-free survival was 14 months (95% confidence interval [CI], 9.4-18.5) and 17 months (95% CI, 11.4-22.8), and overall survival was 30.5 months (95% CI, 8-53) and 41.4 months (95% CI, 21-62) for group A and group B, respectively, with no significant difference (P = .6). No significant difference between the 2 groups was reported in the incidence of adverse events. Dose reductions were more frequent in group A patients (66% vs. 36%; P = .04).CONCLUSION: Although the dose of pazopanib was reduced more frequently in patients with renal impairment, kidney function at therapy initiation does not adversely affect the safety and efficacy of pazopanib.

AB - BACKGROUND: Pazopanib has been approved for first-line treatment of patients with metastatic renal-cell carcinoma on the basis of clinical trials that enrolled only patients with adequate renal function. Few data are available on the safety and efficacy of pazopanib in patients with renal insufficiency. This study investigated the effect of kidney function on treatment outcomes in such patients.PATIENTS AND METHODS: We retrospectively analyzed data of metastatic renal-cell carcinoma patients treated with pazopanib from January 2010 to June 2016 with respect to renal function. Patients with Modification of Diet in Renal Disease ≤ 60 mL/min/1.73 m2 (group A) were compared to patients with Modification of Diet in Renal Disease > 60 mL/min/1.73 m2 (group B) in terms of progression-free survival, toxicities, response rates, and overall survival.RESULTS: A total of 229 patients were included: 128 in group A and 101 in group B. Median progression-free survival was 14 months (95% confidence interval [CI], 9.4-18.5) and 17 months (95% CI, 11.4-22.8), and overall survival was 30.5 months (95% CI, 8-53) and 41.4 months (95% CI, 21-62) for group A and group B, respectively, with no significant difference (P = .6). No significant difference between the 2 groups was reported in the incidence of adverse events. Dose reductions were more frequent in group A patients (66% vs. 36%; P = .04).CONCLUSION: Although the dose of pazopanib was reduced more frequently in patients with renal impairment, kidney function at therapy initiation does not adversely affect the safety and efficacy of pazopanib.

U2 - 10.1016/j.clgc.2018.10.001

DO - 10.1016/j.clgc.2018.10.001

M3 - Article

C2 - 30396828

VL - 17

SP - e150-e155

JO - Clinical Genitourinary Cancer

JF - Clinical Genitourinary Cancer

SN - 1558-7673

IS - 1

ER -