Efficacy and safety of apatinib monotherapy in metastatic renal cell carcinoma (mRCC) patients: A single-arm observational study

Urol Oncol. 2020 Dec;38(12):936.e1-936.e6. doi: 10.1016/j.urolonc.2020.07.023. Epub 2020 Aug 22.

Abstract

Background: Antiangiogenic treatments play an important role in the therapeutic strategy for metastatic renal cell carcinoma. Apatinib is an oral tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor-2. We aimed to assess the efficacy and safety of apatinib therapy in metastatic renal cell carcinoma patients.

Methods: Between January 2018 and November 2018, we enrolled 53 metastatic renal cell carcinoma patients. Apatinib was administered at an initial dose of 500 mg once daily. The disease control rate, objective response rate, progression-free survival, and adverse events were reviewed and evaluated.

Findings: Among the 53 patients, 14 achieved partial response and 31 achieved stable disease. Thus, the disease control rate was 84.9% and the objective response rate was 26.4%. The median progression-free survival was 11.2 months (95% confidence interval: 9.884-12.574). Most of the adverse events (AEs) were at grade 1 or 2, and the main grade 3 AEs were hypertension (5.7%), anemia (3.8%), and thrombocytopenia (3.8%).

Interpretation: Apatinib showed promising efficacy and manageable toxicity in metastatic renal cell carcinoma patients, giving potent evidence to conduct further clinical trials.

Keywords: Apatinib; Efficacy; Metastatic renal cell carcinoma; Safety; Targeted therapy.

Publication types

  • Observational Study

MeSH terms

  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / secondary
  • Female
  • Humans
  • Kidney Neoplasms / drug therapy*
  • Kidney Neoplasms / pathology*
  • Male
  • Middle Aged
  • Progression-Free Survival
  • Pyridines / adverse effects
  • Pyridines / therapeutic use*
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Pyridines
  • apatinib