Sorafenib for metastatic renal cancer: the Princess Margaret experience

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Sorafenib, an oral multikinase inhibitor, previously showed efficacy in prolonging progression-free survival for metastatic renal carcinoma (MRC).
• Expanded access programs provide treatment options for patients not included in clinical trials.

Purpose of the Study:

• To evaluate the efficacy and safety of sorafenib in a broader, less selected patient population with MRC.
• To assess real-world outcomes and toxicity profiles in an expanded access program setting.

Main Methods:

• Patients with MRC received sorafenib 400 mg twice daily until disease progression.
• Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST).
• Adverse events were graded using National Cancer Institute Common Toxicity Criteria.

Main Results:

• The median progression-free survival was 7.5 months in 58 enrolled patients.
• Grade 3/4 adverse events occurred in 64% of patients, notably skin rash (29%) and hand-foot syndrome (15%).
• Dose reductions or interruptions were required in 62% of patients.

Conclusions:

• Sorafenib is effective in a diverse patient population with metastatic renal carcinoma.
• Treatment with sorafenib in this expanded access program was associated with a higher incidence of toxicity than previously reported.