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

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.

• Authors: 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
• Journal: Clinical genitourinary cancer (Clin Genitourin Cancer) Vol. 17 Issue 1 Pg. e150-e155 (Feb 2019) ISSN: 1938-0682 [Electronic] United States
• PMID: 30396828 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2018 Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Indazoles
• Pyrimidines
• Sulfonamides
• pazopanib

Topics

• Adult
• Aged
• Aged, 80 and over
• Angiogenesis Inhibitors (therapeutic use)
• Carcinoma, Renal Cell (drug therapy, etiology, secondary)
• Female
• Follow-Up Studies
• Humans
• Indazoles
• Kidney Neoplasms (drug therapy, etiology, pathology)
• Male
• Middle Aged
• Patient Safety
• Pyrimidines (therapeutic use)
• Renal Insufficiency (complications)
• Retrospective Studies
• Sulfonamides (therapeutic use)
• Survival Rate
• Treatment Outcome