title: Formestane: an effective first-line endocrine treatment for advanced breast cancer.
abstract: Formestane, a new selective aromatase inhibitor devoid of severe side-effects, has been shown to be active in patients with advanced breast cancer. To investigate the clinical activity and endocrinological effects of formestane as a first-line treatment, 52 patients were administered two different doses: 24 received 250 mg formestane and 28 received 500 mg formestane i.m. fortnightly. All of the patients had a performance status of 2 or less (ECOG scale), 34 (65%) had a disease-free interval of at least 2 years and 21 (40%) were both oestrogen-receptor- and progesterone-receptor-positive; 20 patients received hormone and 13, received chemotherapeutical adjuvant treatment. Objective responses were obtained in 8 patients in the 250-mg group (33%; 95% CI: 14%-52%) and in 13 patients in the 500-mg group (46%; 95% CI: 28%-64%). The median response duration in the two groups was respectively 11 and 12 months. E2 serum levels of oestradiol had significantly (P < 0.001) decreased to more than 40% below the baseline value in both groups after 15 days of treatment, and remained unchanged thereafter. Local and systemic tolerability was satisfactory. We conclude that formestane is an effective and well-tolerated agent in previously untreated patients, and that these results should be confirmed by further studies.
authors.affiliation: Division of Medical Oncology B, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Zilembo
authors.forename: E
authors.initials: E
authors.lastname: Bajetta
authors.forename: C
authors.initials: C
authors.lastname: Noberasco
authors.forename: R
authors.initials: R
authors.lastname: Buzzoni
authors.forename: G
authors.initials: G
authors.lastname: Vicario
authors.forename: A
authors.initials: A
authors.lastname: Bono
authors.forename: A
authors.initials: A
authors.lastname: Laffranchi
authors.forename: G
authors.initials: G
authors.lastname: Biasi
authors.forename: S
authors.initials: S
authors.lastname: Dolci
authors.forename: E
authors.initials: E
authors.lastname: Bichisao
mesh_terms: D015065:17-Hydroxycorticosteroids / Q000652:urine; D000368:Aged; D000735:Androstenedione / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D047072:Aromatase Inhibitors; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D004334:Drug Administration Schedule; D004958:Estradiol / Q000097:blood; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008875:Middle Aged; D017698:Postmenopause; D011379:Prognosis; D012307:Risk Factors; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D015065:17-Hydroxycorticosteroids; D000970:Antineoplastic Agents; D047072:Aromatase Inhibitors; D000735:Androstenedione; D004958:Estradiol; C014594:formestane