Endocrinological and clinical evaluation of two doses of formestane in advanced breast cancer

Bajetta, Emilio; Zilembo, Nicoletta; Buzzoni, Roberto; Noberasco, Cristina; Leo, Angelo Di; Bartoli, Cesare; Merson, M.; Sacchini, Virgilio; Moglia, Daniele; Celio, Luigi

doi:10.1038/bjc.1994.265

Cited by 24 publications

(6 citation statements)

References 25 publications

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“…2). [19,22] Plasma estrone and estrone sulfate levels fell in parallel with estradiol levels during treatment with intramuscular formestane[2I,27] (by 64, 68.S and 61 %, respectively, in one study [27]). …”

Section: Studies In Women With Breast Cancermentioning

confidence: 99%

“…Soft tissue metastases generally responded best to formestane, whereas visceral metastases, particularly those in the liver, were the least respon-siveJ19,39) In a large study, (19) 16 of 48 (33%) and 32 of 56 (57%) soft tissue metastases (skin, lymph nodes and breast) responded to treatment with formestane 250 and 500mg, respectively. Corresponding mean response rates in visceral metastases (liver, lung and pleural effusion) were 30 and 31%, respectively, and in bone, rates were 18 and 37% ( fig.…”

Section: 1 Efficacy As Second-or Thlrd-une Endocrine Therapymentioning

confidence: 99%

“…Corresponding mean response rates in visceral metastases (liver, lung and pleural effusion) were 30 and 31%, respectively, and in bone, rates were 18 and 37% ( fig. Patients whose tumours expressed the estrogen receptor were more likely to respond to formestane therapy than those with estrogen receptor-negative tumoursJ19,22,25) Bajetta et al [19) observed the highest responses in patients whose tumours expressed both estrogen and progesterone receptors [18 of31 patients (58%) responded] or had Other predictors of good response to formestane therapy included age (>70 years) [19,57) and previous response to endocrine therapy. Patients whose tumours expressed the estrogen receptor were more likely to respond to formestane therapy than those with estrogen receptor-negative tumoursJ19,22,25) Bajetta et al [19) observed the highest responses in patients whose tumours expressed both estrogen and progesterone receptors [18 of31 patients (58%) responded] or had Other predictors of good response to formestane therapy included age (>70 years) [19,57) and previous response to endocrine therapy.…”

Section: 1 Efficacy As Second-or Thlrd-une Endocrine Therapymentioning

confidence: 99%

“…3). [19,20,22,25) However, Bowman et aU 54 ) recently reported responses to formestane in 14% of patients (3 of 21) who had failed to respond to tamoxifen and in 21 % of patients (3 of 14) who had responded to prior tamoxifen treatment. [19,20,22,25) However, Bowman et aU 54 ) recently reported responses to formestane in 14% of patients (3 of 21) who had failed to respond to tamoxifen and in 21 % of patients (3 of 14) who had responded to prior tamoxifen treatment.…”

Section: 1 Efficacy As Second-or Thlrd-une Endocrine Therapymentioning

confidence: 99%

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Formestane

Wiseman¹,

Goa²

1996

Drugs & Aging

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Formestane (4-hydroxyandrostenedione) is an aromatase inhibitor which significantly reduces plasma levels of estrogen and has shown antitumour activity in postmenopausal women with breast cancer. Objective response rates in heavily pretreated patients with advanced breast cancer generally range between 20 and 30% during treatment with intramuscular formestone 250 or 500mg once every 2 weeks, and a further 20 to 30% of patients experience disease stabilisation. The median duration of response is between 8 and 14 months. Highest response rates are observed in soft tissue metastases, in patients with estrogen-responsive tumours and in those showing a response to previous endocrine therapy. Furthermore, there is some evidence to suggest that higher response rates are achieved with formestane 500 versus 250mg once every 2 weeks. In comparative studies, the clinical efficacy of intramuscular formestane 250mg did not differ significantly from that of oral megestrol when administered as second-line endocrine therapy to patients with advanced disease in whom previous tamoxifen therapy had failed. In addition, formestane produced a response rate, duration of response and overall survival rate that was not significantly different from that of oral tamoxifen when administered as first-line endocrine therapy to patients with advanced disease, but tamoxifen was superior in some measures. Further investigation of these 2 agents, including the higher dosage of formestane (500mg), is necessary to confirm their relative efficacies. Formestane is well tolerated by the majority of patients; adverse events rarely necessitate cessation of therapy. The most common adverse events are local reactions at the injection site and systemic events usually related to the effect of the drug on the hormonal milieu. The systemic tolerability of formestane is similar to that of tamoxifen but better than that of megestrol. Thus, formestane is effective and well tolerated as first-line endocrine therapy for advanced disease. However, at present, it is unlikely to challenge tamoxifen in this indication, based on recent findings from a large comparative study and the fact that formestane requires intramuscular administration. Nonetheless, formestane, which appears to have a better tolerability profile than other currently available second-line agents (including megestrol and the aromatase inhibitor aminoglutethimide), is a valuable drug for the second-line treatment of postmenopausal women with advanced breast cancer.

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Section: Studies In Women With Breast Cancermentioning

confidence: 99%

Section: 1 Efficacy As Second-or Thlrd-une Endocrine Therapymentioning

confidence: 99%

Section: 1 Efficacy As Second-or Thlrd-une Endocrine Therapymentioning

confidence: 99%

Section: 1 Efficacy As Second-or Thlrd-une Endocrine Therapymentioning

confidence: 99%

See 2 more Smart Citations

Formestane

Wiseman¹,

Goa²

1996

Drugs & Aging

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“…Formestane (4-hydroxyandrostenedione) is a se lective aromatase inhibitor that is capable of reducing plasma estrogen levels by blocking the peripheral conver sion of androgens to estrogens without interfering with adrenal steroidogenesis [3]. The good clinical efficacy of formestane has been demonstrated in a large number of studies [4,5] and, in a previous experiment with the drug, we found a certain activity in postmenopausal advanced breast cancer patients who had already received TMX treatment [6], Given these data, and the fact that only TMX relapse patients are generally considered for sec ond-line endocrine therapy, we decided to test the activity of formestane in de novo resistant patients.…”

Section: Introductionmentioning

confidence: 99%

Activity of Formestane in de novo Tamoxifen–Resistant Patients with Metastatic Breast Cancer

Noberasco¹,

Bajetta²,

Zilembo³

et al. 1995

Oncology

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In order to assess the feasibility of a sequential hormonal treatment after tamoxifen failure, 24 postmenopausal advanced breast cancer patients (median age 60 years; ECOG PS ≤ 1) were treated with formestane (4-hydroxyan-drostenedione) 250 mg i.m. fortnightly; 19 patients were estrogen receptor-positive. The sites of metastatic disease were soft tissue in 22 patients, viscera in 9 and bone in 18. The patients were considered evaluable for tumor response after four doses of formestane. Objective responses were observed in 8/24 patients (33%) with one complete and seven partial responses. The median response duration was 9.5 months. The complete response was obtained on skin. We conclude that although the number of complete responses appears to be unsatisfactory, de novo tamoxifen-resistant breast cancer patients are suitable for further hormonal treatment with formestane.

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Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women

Gibson

Dawson

Lawrence

et al. 2007

Cochrane Database of Systematic Reviews

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Background Hormonal treatments for advanced or metastatic breast cancer, such as tamoxifen and the progestins megestrol acetate and medroxyprogesterone acetate, have been in use for many years. Aromatase inhibitors (AIs) are a class of compounds that systemically inhibit oestrogen synthesis in the peripheral tissues. Aminoglutethimide was the first AI in clinical use (first generation) and had a similar tumour-regressing effect to other endocrine treatments, which showed the potential of this alternative type of therapy. Other AIs have since been developed and the third generation AIs anastrozole, exemestane and letrozole are in current use. Randomised evidence on response rates and side effects of these drugs is still limited. Objectives To compare aromatase inhibitors to other endocrine therapy in the treatment of advanced breast cancer in postmenopausal women. Search strategy The Cochrane Breast Cancer Group Specialised Register was first searched on 3 December 2004 using the codes for "advanced" and "endocrine therapy". Details of the search strategy applied to create the Register and the procedure used to code references are described in the Cochrane Breast Cancer Group module on The Cochrane Library. The search was updated to 30 September 2005 and additional publications were included. Experts were consulted to determine that no relevant studies had been excluded. Selection criteria Randomised trials comparing the effects of any aromatase inhibitor versus other endocrine therapy, no endocrine therapy or a different aromatase inhibitor in the treatment of advanced (metastatic) breast cancer. Data collection and analysis Data from published trials were extracted by two independent review authors. A third independent author then carried out a further cross check for accuracy and consistency. Hazard ratios (HR) were derived for analysis of time-to-event outcomes (overall and progressionfree). Odds ratios (OR) were derived for objective response and clinical benefit (both analysed as dichotomous variables). Toxicity data were extracted where present and treatments were compared using odds ratios. All but one of the studies included data on one or more of the following outcomes: overall survival, progression-free survival, clinical benefit and objective response.

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Endocrinological and clinical evaluation of two doses of formestane in advanced breast cancer

Cited by 24 publications

References 25 publications

Formestane

Formestane

Activity of Formestane in de novo Tamoxifen–Resistant Patients with Metastatic Breast Cancer

Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women

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