Cabozantinib in the First-Line Treatment of Patients With Metastatic Renal Cell Carcinoma, Real-World Data From the Czech Republic and Poland: ICARO-RC Project

Clin Genitourin Cancer. 2025 Aug;23(4):102382. doi: 10.1016/j.clgc.2025.102382. Epub 2025 Jun 3.

Abstract

Introduction: The treatment of metastatic renal cell carcinoma (RCC) has changed dramatically in the last few years, with different options being available, and with no data comparing these new systemic therapies. Therefore, the value of real-world outcomes (RWO) becomes of great interest to understand the effectiveness of these treatments. Here we analyze the outcome of metastatic RCC patients treated with first-line cabozantinib in a retrospective cohort from the Czech Republic and Poland METHODS: Patients with metastatic RCC treated with first-line cabozantinib in the Czech Republic and Poland were included in a retrospective fashion. Data were collected regarding progression-free survival (PFS), overall survival (OS), response rate and toxicity, with a focus in several subgroups of interest.

Results: We identified 146 patients, the majority of them (80.8%) with clear cell RCC (ccRCC). The median OS was 14.7 months, and the median PFS 8.2 months, with a response rate of 30.3%. CTCAE v3.0 grade 3+4 toxicity was presented in 34.2% of patients. The efficacy of Cabozantinib was maintained regardless of histologic subtype and the presence of sarcomatoid component, although PFS and OS data were numerically better for nonclear cell RCC. Bone and liver metastases were confirmed as independent factor for poor survival in the multivariate analysis.

Conclusions: In our series, Cabozantinib demonstrated its activity in RCC patients in a RWO setting. Our data can be considered comparable with what has been seen in randomised clinical trials, considering the inherent bias present in RWO studies.

Keywords: First-line therapy; Real world outcomes; Renal cancer; Tyrosine kinase inhibitors.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anilides* / administration & dosage
  • Anilides* / adverse effects
  • Anilides* / therapeutic use
  • Carcinoma, Renal Cell* / drug therapy
  • Carcinoma, Renal Cell* / mortality
  • Carcinoma, Renal Cell* / pathology
  • Czech Republic
  • Female
  • Humans
  • Kidney Neoplasms* / drug therapy
  • Kidney Neoplasms* / mortality
  • Kidney Neoplasms* / pathology
  • Male
  • Middle Aged
  • Poland
  • Progression-Free Survival
  • Protein Kinase Inhibitors* / adverse effects
  • Protein Kinase Inhibitors* / therapeutic use
  • Pyridines* / administration & dosage
  • Pyridines* / adverse effects
  • Pyridines* / therapeutic use
  • Retrospective Studies
  • Treatment Outcome

Substances

  • cabozantinib
  • Pyridines
  • Anilides
  • Protein Kinase Inhibitors