Real-world use of sorafenib for advanced renal cell carcinoma patients with cardiovascular disease: nationwide survey in Japan

Expert Rev Anticancer Ther. 2020 Jul;20(7):615-623. doi: 10.1080/14737140.2020.1773805. Epub 2020 Jun 16.


Objectives: To assess whether the clinical outcome of advanced/metastatic renal cell carcinoma (mRCC) treated with sorafenib, in real-world conditions, differs in patients with cardiovascular disease (CVD).

Methods: mRCC patients (n = 2256 before matching) were matched by propensity score into CVD (n = 560) and non-CVD groups (n = 560), followed by safety and effectiveness analyzes.

Results: After matching, patients' features used for matching were balanced between the CVD and non-CVD groups, except for age (p = 0.0049). Renal comorbidity occurred more frequently in the CVD group. Exposure to sorafenib and objective response rate (25.4% [CVD], 28.5% [non-CVD]) were comparable in both groups. Median progression-free survival (PFS; 7.1 months, 95% CI: 6.4-8.6 [CVD]; 6.7 months, 6.3-8.3 [non-CVD]), and hazard ratios for PFS (0.954, 0.821-1.108) and overall survival (0.889, 0.683-1.156), were similar in the matched population. The incidences of adverse drug reactions (ADR, ≥10%) were generally similar between groups, although hypertension (42.1% vs 34.5%), diarrhea (26.3% vs 19.6%), decreased appetite (11.3% vs 7.5%), and non-serious and serious renal failure/dysfunction (3.6% vs 1.4% and 1.8% vs 0.4%), occurred more frequently in the CVD group.

Conclusion: This analyzes suggests that sorafenib has clinical benefit for mRCC patients regardless of baseline CVD. Serious ADRs increased for renal dysfunction.

Clinical trial registration: identifier is NCT01411423.

Keywords: Cardiovascular disease; prognosis; renal cell carcinoma; sorafenib.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Carcinoma, Renal Cell / drug therapy*
  • Cardiovascular Diseases / physiopathology*
  • Disease-Free Survival
  • Female
  • Humans
  • Japan
  • Kidney Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Sorafenib / administration & dosage*
  • Sorafenib / adverse effects
  • Surveys and Questionnaires
  • Survival Rate
  • Treatment Outcome


  • Antineoplastic Agents
  • Sorafenib

Associated data