FORMESTANE AS TREATMENT OF ADVANCED BREAST-CANCER IN ELDERLY WOMEN

Aims and background: The number of elderly people is increasing, and t he proportion of breast cancer in female cancer patients older than 65 years is 26%. in elderly patients, hormone therapy is widely accepted as the treatment of choice, because of its efficacy and good tolerabi lity compared to chemotherapy. The aim of this study was to evaluate t he endocrinologic and clinical activity of formestane (4-hydroxyandros tenedione), a selective aromatase inhibitor, in elderly patients with advanced breast cancer. Methods: Thirty-five patients older than 65 ye ars, selected from a larger group, were given formestane (250 mg or 50 0 mg i.m. fortnightly). Patients were evaluable for tumor response aft er 4 doses of formestane. Blood samples were collected to evaluate E(2 ), FSH, LH, SHBG and DHEAS serum levels at baseline and after 2, 4, 8, 12 and 24 weeks. Results: Thirty patients had PS less than or equal t o 1 (ECOG) and only 5 patients had PS = 2. Twenty-six patients were ER positive. Previous hormonal treatment for metastatic disease had been given to 17 patients; only 1 case had received chemotherapy. The over all response rate was 51% (95% C.I. 35-67%) and the median response du ration was 9.5 months. Three complete responses were observed on visce ra. The best responses were obtained on soft tissues (59%); on bone an d viscera the response was respectively 45% and 47%. Local and systemi c tolerability was highly satisfactory. Formestane induced prolonged s uppression of E(2) levels in all of the patients, and a significant re duction in SHBG levels was also observed from month 2 onward. A statis tically significant (P = 0.0001) rise in serum FSH was also observed d uring the therapy. Conclusions: The study showed that formestane induc ed a long-lasting suppression of E2 levels and a satisfactory overall response. In our opinion, the drug is an effective and well-tolerated approach in the management of advanced breast cancer in elderly patien ts.