Evaluation of the Safety and Tolerability of Oral TAS-108 in Postmenopausal Patients with Metastatic Breast Cancer

Strategic Insights -

In a groundbreaking study published in the Annals of Oncology, researchers from Saitama Medical University in Japan have made significant findings on the safety and tolerability of oral TAS-108 in postmenopausal patients with metastatic breast cancer. The study involved 15 patients who received TAS-108 treatment, with five patients receiving each of the three dose levels (40, 80, and 120 mg) for a scheduled 8 weeks. The results showed that orally administered TAS-108 was well tolerated at doses up to 120 mg, with no notable changes in hormone levels or bone metabolism markers. The study also demonstrated a steady state was achieved by 2 weeks at all dose levels, suggesting no marked accumulation.

Key Takeaways:

  • Repeated oral administration of TAS-108 at doses up to 120 mg was well tolerated in postmenopausal patients with metastatic breast cancer.
  • No notable changes were observed in hormone levels or bone metabolism markers following TAS-108 treatment.
  • The plasma level of TAS-108 and its metabolites increased dose-dependently.
  • Clinical benefits were confirmed in 5 of 15 patients who received TAS-108 treatment.
  • The study involved 15 patients who received TAS-108 treatment, with five patients receiving each of the three dose levels (40, 80, and 120 mg).
  • A steady state was achieved by 2 weeks at all dose levels, suggesting no marked accumulation.
  • The researchers concluded that TAS-108 has shown potential for the treatment of breast cancer in preclinical studies.

Statistics:

  • 15 patients received TAS-108 treatment.
  • 5 patients received each of the three dose levels (40, 80, and 120 mg).
  • 5 of 15 patients demonstrated clinical benefits following TAS-108 treatment.
  • 120 mg was the highest dose level administered in the study.
  • 2 weeks was the time required to achieve a steady state at all dose levels.
  • 40, 80, and 120 mg were the three dose levels used in the study.

Sources:

  • Saeki, T., et al. (2009). Evaluation of the safety and tolerability of oral TAS-108 in postmenopausal patients with metastatic breast cancer. Annals of Oncology, 20(5), 868-73.