内容紹介
Efficacy and Safety of the Selective Estrogen Receptor Down-Regulator“Fulvestrant”in Japanese Patients with Advanced, Recurrent, ER-Positive Postmenopausal Breast Cancer
Summary
Fulvestrant is a novel endocrine therapy for breast cancer that exerts both anti-estrogenic and down-regulatory effects by binding to and degrading estrogen receptors(ERs). In the present study, the safety and effectiveness of 500 mg fulvestrant in 69 patients with advanced, recurrent, ER-positive postmenopausal breast cancer were investigated retrospectively. Outcomes were favorable for fulvestrant. The objective response rate was 24.6%, the clinical benefit rate was 49.2%, the median progression-free survival(PFS)was 203 days, and the median overall survival was 794 days. PFS tended to be longer in patients without a history of previous treatment or visceral metastasis. The main adverse events included injection site reactions and hot flushes; however, the majority of these events were mild to moderate. The present findings suggest that, among Japanese patients with advanced, recurrent, ER-positive postmenopausal breast cancer, 500 mg fulvestrant is effective and safe in those without metastasis and a minimal history of receipt of previous treatment regimens.
要旨
フルベストラントは,エストロゲン受容体(ER)に結合して抗エストロゲン作用を示すだけでなく,ERを分解してダウンレギュレートする作用を併せもつ新規ホルモン療法剤である。今回,閉経後ER陽性進行・再発乳癌69例を対象に,フルベストラント500 mgの有効性と安全性をレトロスペクティブに検討した。その結果,奏効率は24.6%,臨床的有用率49.2%,無増悪生存期間(PFS)中央値203日,全生存期間中央値794日と良好な成績であった。また,PFSは前治療歴や臓器転移のないサブグループで延長傾向が認められた。主な有害事象は,注射部位反応,ほてりなどであり,ほとんどは軽度～中等度であった。フルベストラント500 mgは,日本人閉経後ER陽性進行・再発乳癌患者に対しても良好な効果と安全性を有することに加え,特に前治療レジメン数が少なく臓器転移なしの症例で,より有用である可能性が示唆された。
目次
Summary
Fulvestrant is a novel endocrine therapy for breast cancer that exerts both anti-estrogenic and down-regulatory effects by binding to and degrading estrogen receptors(ERs). In the present study, the safety and effectiveness of 500 mg fulvestrant in 69 patients with advanced, recurrent, ER-positive postmenopausal breast cancer were investigated retrospectively. Outcomes were favorable for fulvestrant. The objective response rate was 24.6%, the clinical benefit rate was 49.2%, the median progression-free survival(PFS)was 203 days, and the median overall survival was 794 days. PFS tended to be longer in patients without a history of previous treatment or visceral metastasis. The main adverse events included injection site reactions and hot flushes; however, the majority of these events were mild to moderate. The present findings suggest that, among Japanese patients with advanced, recurrent, ER-positive postmenopausal breast cancer, 500 mg fulvestrant is effective and safe in those without metastasis and a minimal history of receipt of previous treatment regimens.
要旨
フルベストラントは,エストロゲン受容体(ER)に結合して抗エストロゲン作用を示すだけでなく,ERを分解してダウンレギュレートする作用を併せもつ新規ホルモン療法剤である。今回,閉経後ER陽性進行・再発乳癌69例を対象に,フルベストラント500 mgの有効性と安全性をレトロスペクティブに検討した。その結果,奏効率は24.6%,臨床的有用率49.2%,無増悪生存期間(PFS)中央値203日,全生存期間中央値794日と良好な成績であった。また,PFSは前治療歴や臓器転移のないサブグループで延長傾向が認められた。主な有害事象は,注射部位反応,ほてりなどであり,ほとんどは軽度～中等度であった。フルベストラント500 mgは,日本人閉経後ER陽性進行・再発乳癌患者に対しても良好な効果と安全性を有することに加え,特に前治療レジメン数が少なく臓器転移なしの症例で,より有用である可能性が示唆された。