Sorafenib Shows Moderate Activity in Metastatic Castration-Resistant Prostate Cancer Study

Strategic Insights -

According to recent research from the National Cancer Institute, a phase II trial using sorafenib for metastatic castration-resistant prostate cancer has shown moderate activity as a second-line treatment. The trial, which involved 46 patients, found that sorafenib was associated with a median progression-free survival of 3.7 months and a median overall survival of 18.0 months. However, the most frequent toxicities included hand-foot skin reaction, rash, abnormalities in liver function tests, and fatigue.

Key Takeaways:

  • The phase II trial used sorafenib at a dose of 400 mg orally twice daily in 28-day cycles, and clinical and laboratory assessments were done every 4 weeks, with radiographic scans obtained every 8 weeks.
  • The study found that 10 patients had stable disease, with a median duration of 18 weeks, while one patient had a partial response.
  • The median progression-free survival was 3.7 months, and the median overall survival was 18.0 months, with a total of 18.3 months for the whole trial of 46 patients.
  • The most frequent toxicities included hand-foot skin reaction (9 patients grade 2, 3 patients grade 3), rash, abnormalities in liver function tests, and fatigue.
  • The researchers concluded that sorafenib has moderate activity as a second-line treatment for metastatic castration-resistant prostate cancer.

Statistics:

  • 46 patients were enrolled in the phase II trial.
  • 21 patients had previous chemotherapy with docetaxel.
  • 11 patients had bony metastases alone, while 13 patients had bony and soft-tissue disease.
  • The median age of patients was 66 years (range 49-85).
  • The median prostate-specific antigen level was 68.45 ng/mL (range 5.8-995).
  • The Gleason score was 8 (range 6-9), and the Eastern Cooperative Oncology Group status was 1 (in 17 patients).
  • The median potential follow-up was 27.2 months.

Sources:

  • Aragon-Ching et al. (2009). Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer. Bju International, 103(12), 1636-1640.
  • National Cancer Institute.
  • Prostate Cancer Therapy.
  • Cancer Weekly.