内容紹介
Efficacy and Safety of Pertuzumab for HER2-Positive Metastatic Breast Cancer
Summary
The CLEOPATRA trial showed a significant improvement in the progression-free survival(PFS)and overall survival of patients with HER2-positive first-line metastatic breast cancer(MBC)who were treated with pertuzumab(PER), trastuzumab(TRA), and docetaxel(DTX), compared to those treated with placebo, TRA, and DTX. PER was approved in 2013 for treating HER2-positive MBC in Japan. Herein, we present the retrospective review of data from 10 HER2-positive MBC patients who received PER in our hospital between September 2013 and August 2014. The median age was 52 years(range, 45-66 years), and 7 patients were positive for ER. Six patients had not received any previous chemotherapy for their metastatic disease, while the others had received comparatively heavy pretreatment doses of chemotherapy. Our patients received the PER, TRA, and DTX regimen, although 2 patients were treated without DTX. Four patients experienced a partial response, 6 patients experienced stable disease(SD), and 3 patients experienced SD for【>_】6 months. The response rate was 40%, and the clinical benefit rate was 70%. The median PFS was 7.3 months(range, 2.5-11.5 months). Grade 3 neutropenia and allergic reactions were observed in 1 and 2 patients, respectively; no Grade 4 adverse events were observed, and thus, the regimen was well tolerated. Further clinical research seems to be warranted for developing new treatment strategies involving PER for HER2-positive MBC.
要旨
ペルツズマブはトラスツズマブとドセタキセルとの併用療法によって,トラスツズマブとドセタキセルのみの対照群と比較して前治療歴のないHER2陽性転移・再発乳癌の無増悪生存期間(PFS)および全生存期間を有意に延長したことが報告され(CLEOPATRA試験),本邦でも2013年に使用が承認された。本稿では2013年9月～2014年8月までに当院でHER2陽性進行再発乳癌に対し,ペルツズマブの投与を受けた10例を対象にその有効性および安全性について報告する。年齢中央値は52(45～66)歳,ER(+)7例,ER(-)は3例であった。転移・再発乳癌に対して前治療歴のない症例は6例,他は比較的前治療歴の多い症例であった。8例はペルツズマブ,トラスツズマブとドセタキセルの併用で開始したが,2例はペルツズマブとトラスツズマブで開始した。部分奏効4例,安定(SD)6例,6か月以上のSD 3例,奏効率40%,臨床的有効率70%,PFS中央値は7.3(2.5～11.5)か月であった。有害事象はGrade 1～2がほとんどであったが,Grade 3の好中球減少1例,Grade 3の過敏症を2例認めた。いずれにおいてもGrade 4の有害事象は認めず,忍容性は良好であった。今後,さらなるデータの集積やペルツズマブの新たな治療戦略に期待する。
目次
Summary
The CLEOPATRA trial showed a significant improvement in the progression-free survival(PFS)and overall survival of patients with HER2-positive first-line metastatic breast cancer(MBC)who were treated with pertuzumab(PER), trastuzumab(TRA), and docetaxel(DTX), compared to those treated with placebo, TRA, and DTX. PER was approved in 2013 for treating HER2-positive MBC in Japan. Herein, we present the retrospective review of data from 10 HER2-positive MBC patients who received PER in our hospital between September 2013 and August 2014. The median age was 52 years(range, 45-66 years), and 7 patients were positive for ER. Six patients had not received any previous chemotherapy for their metastatic disease, while the others had received comparatively heavy pretreatment doses of chemotherapy. Our patients received the PER, TRA, and DTX regimen, although 2 patients were treated without DTX. Four patients experienced a partial response, 6 patients experienced stable disease(SD), and 3 patients experienced SD for【>_】6 months. The response rate was 40%, and the clinical benefit rate was 70%. The median PFS was 7.3 months(range, 2.5-11.5 months). Grade 3 neutropenia and allergic reactions were observed in 1 and 2 patients, respectively; no Grade 4 adverse events were observed, and thus, the regimen was well tolerated. Further clinical research seems to be warranted for developing new treatment strategies involving PER for HER2-positive MBC.
要旨
ペルツズマブはトラスツズマブとドセタキセルとの併用療法によって,トラスツズマブとドセタキセルのみの対照群と比較して前治療歴のないHER2陽性転移・再発乳癌の無増悪生存期間(PFS)および全生存期間を有意に延長したことが報告され(CLEOPATRA試験),本邦でも2013年に使用が承認された。本稿では2013年9月～2014年8月までに当院でHER2陽性進行再発乳癌に対し,ペルツズマブの投与を受けた10例を対象にその有効性および安全性について報告する。年齢中央値は52(45～66)歳,ER(+)7例,ER(-)は3例であった。転移・再発乳癌に対して前治療歴のない症例は6例,他は比較的前治療歴の多い症例であった。8例はペルツズマブ,トラスツズマブとドセタキセルの併用で開始したが,2例はペルツズマブとトラスツズマブで開始した。部分奏効4例,安定(SD)6例,6か月以上のSD 3例,奏効率40%,臨床的有効率70%,PFS中央値は7.3(2.5～11.5)か月であった。有害事象はGrade 1～2がほとんどであったが,Grade 3の好中球減少1例,Grade 3の過敏症を2例認めた。いずれにおいてもGrade 4の有害事象は認めず,忍容性は良好であった。今後,さらなるデータの集積やペルツズマブの新たな治療戦略に期待する。