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

Clin Genitourin Cancer. 2019 Feb;17(1):e150-e155. doi: 10.1016/j.clgc.2018.10.001. Epub 2018 Oct 10.

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.

Keywords: Renal insufficiency; Tyrosine kinase inhibitors; mRCC.

Publication types

  • Multicenter Study

MeSH terms

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

Substances

  • Angiogenesis Inhibitors
  • Indazoles
  • Pyrimidines
  • Sulfonamides
  • pazopanib