Formestane: an effective first-line endocrine treatment for advanced breast cancer

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 d...

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Published inJournal of cancer research and clinical oncology Vol. 121; no. 6; p. 378
Main Authors Zilembo, N, Bajetta, E, Noberasco, C, Buzzoni, R, Vicario, G, Bono, A, Laffranchi, A, Biasi, G, Dolci, S, Bichisao, E
Format Journal Article
LanguageEnglish
Published Germany 01.06.1995
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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.
AbstractList 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.
Author Bichisao, E
Buzzoni, R
Biasi, G
Zilembo, N
Bono, A
Laffranchi, A
Bajetta, E
Dolci, S
Vicario, G
Noberasco, C
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PublicationTitle Journal of cancer research and clinical oncology
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Snippet Formestane, a new selective aromatase inhibitor devoid of severe side-effects, has been shown to be active in patients with advanced breast cancer. To...
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StartPage 378
SubjectTerms 17-Hydroxycorticosteroids - urine
Aged
Androstenedione - administration & dosage
Androstenedione - analogs & derivatives
Androstenedione - therapeutic use
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - therapeutic use
Aromatase Inhibitors
Breast Neoplasms - drug therapy
Breast Neoplasms - metabolism
Breast Neoplasms - pathology
Drug Administration Schedule
Estradiol - blood
Female
Humans
Injections, Intramuscular
Middle Aged
Postmenopause
Prognosis
Risk Factors
Survival Analysis
Treatment Outcome
Title Formestane: an effective first-line endocrine treatment for advanced breast cancer
URI https://www.ncbi.nlm.nih.gov/pubmed/7797604
Volume 121
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