内容紹介
PhaseⅡ Clinical Trial of High-Dose Toremifene as Primary Hormone Therapy in Aromatase Inhibitor-Resistant Breast Cancer
Summary
Background: Third-generation aromatase inhibitors(AIs)are now common in adjuvant hormone therapy for breast cancer in postmenopausal women. However, a suitable treatment has yet to be established for patients who develop cancer recurrence during or after adjuvant AI therapy. Patients and methods: This prospective study evaluated the efficacy and safety of 120 mg/day toremifene citrate(TOR-120)administered orally to 23 patients with recurrent breast cancer who were receiving or had received adjuvant AI therapy. Primary therapy for recurrence was TOR-120 monotherapy. Results: The response rate was 13.0%(partial response: three patients), the clinical benefit rate was 78.3%(partial response: three patients; long-term stable disease: 15 patients), and median time to progression was 8.1 months. Grade 1 adverse events such as loss of appetite, sweating, flushing and edema face were observed. Conclusion: TOR-120 monotherapy was effective and safe as a primary hormone therapy for recurrent breast cancer unresponsive to AIs.
要旨
背景: 第三世代アロマターゼインヒビター(AIs)は閉経後乳癌に対するホルモン療法薬として広く用いられているが,AI投与中または投与後に再発を来した症例に対する治療法は未だ確立しておらず明確な指針はない。方法: AI投与中または投与後の閉経後再発乳癌症例23例に対し初期治療としてトレミフェン120 mg/日の経口投与を行い,その効果と安全性を前向き試験にて評価した。結果: 奏効率13.0%(partial response 3例),臨床的有用率78.3%(partial response 3例,long stable disease 15例),無増悪期間中央値8.1か月であった。Grade 1有害事象として食欲不振,多汗症,皮膚潮紅と顔面浮腫を認めた。結論: トレミフェン120 mg/日の経口投与はAI耐性再発乳癌に対する一次治療として有効かつ安全であった。
目次
Summary
Background: Third-generation aromatase inhibitors(AIs)are now common in adjuvant hormone therapy for breast cancer in postmenopausal women. However, a suitable treatment has yet to be established for patients who develop cancer recurrence during or after adjuvant AI therapy. Patients and methods: This prospective study evaluated the efficacy and safety of 120 mg/day toremifene citrate(TOR-120)administered orally to 23 patients with recurrent breast cancer who were receiving or had received adjuvant AI therapy. Primary therapy for recurrence was TOR-120 monotherapy. Results: The response rate was 13.0%(partial response: three patients), the clinical benefit rate was 78.3%(partial response: three patients; long-term stable disease: 15 patients), and median time to progression was 8.1 months. Grade 1 adverse events such as loss of appetite, sweating, flushing and edema face were observed. Conclusion: TOR-120 monotherapy was effective and safe as a primary hormone therapy for recurrent breast cancer unresponsive to AIs.
要旨
背景: 第三世代アロマターゼインヒビター(AIs)は閉経後乳癌に対するホルモン療法薬として広く用いられているが,AI投与中または投与後に再発を来した症例に対する治療法は未だ確立しておらず明確な指針はない。方法: AI投与中または投与後の閉経後再発乳癌症例23例に対し初期治療としてトレミフェン120 mg/日の経口投与を行い,その効果と安全性を前向き試験にて評価した。結果: 奏効率13.0%(partial response 3例),臨床的有用率78.3%(partial response 3例,long stable disease 15例),無増悪期間中央値8.1か月であった。Grade 1有害事象として食欲不振,多汗症,皮膚潮紅と顔面浮腫を認めた。結論: トレミフェン120 mg/日の経口投与はAI耐性再発乳癌に対する一次治療として有効かつ安全であった。