AROMASIN Shows Promising Results in Phase II Study for Advanced Breast Cancer

Strategic Insights -

Preliminary results from a Phase II study indicate that AROMASIN (exemestane tablets) may extend the time postmenopausal women with advanced breast cancer remain free of tumor growth when compared to tamoxifen, currently the standard hormonal therapy for first-line treatment. The study, conducted by the European Organization for Research and Treatment of Cancer (EORTC), compared the efficacy and safety of AROMASIN with tamoxifen in 97 patients with advanced breast cancer. AROMASIN is an oral inactivator therapy that targets the aromatase enzyme, required for estrogen production, which some breast cancer cells rely on for survival.

Key Takeaways:

  • The median time to tumor progression in patients treated with AROMASIN was 8.9 months, compared to 5.2 months in patients treated with tamoxifen.
  • 63 patients had available data on response, and 76 had data on toxicity, out of 97 randomized patients.
  • AROMASIN showed a favorable side effect profile compared to tamoxifen, with lower rates of grade 2/3 fatigue (5% vs. 13%), pain (11% vs. 18%), and hot flushes (3% vs. 15%).
  • A large Phase III trial of identical design was initiated based on the initial results, and a National Surgical Breast and Bowel Project (NSABP) study of AROMASIN will be initiated in mid-2000.
  • AROMASIN is the first in a new class of oral hormonal inactivator therapies, designed to selectively target and irreversibly bind to the aromatase enzyme.

Statistics:

  • 97 patients were randomized to receive either AROMASIN (25 mg/day) or tamoxifen (20 mg/day).
  • Mean age of patients was 63 years (range: 47-72 years).
  • 63 patients had available data on response, and 76 had data on toxicity.
  • Median time to tumor progression in AROMASIN-treated patients was 8.9 months, while in tamoxifen-treated patients it was 5.2 months.

Sources:

  • PRNewswire, May 22.
  • American Society of Clinical Oncology (ASCO) Annual Meeting.
  • European Organization for Research and Treatment of Cancer (EORTC).
  • European Organization for Research and Treatment of Cancer (EORTC) - Phase II Study of AROMASIN in Advanced Breast Cancer.