内容紹介
Third- and Fourth-Line Chemotherapies including Paclitaxel and Bevacizumab for Metastatic Breast Cancer
Summary
The present study was designed to estimate the clinical efficacy of bevacizumab(BV)combined with paclitaxel(PTX)(BV-PTX)as third- and fourth-line therapies in 31 patients with metastatic breast cancer(MBC). Most patients were previously treated with docetaxel and/or epirubicin. Patients were intravenously treated with BV at 5-10 mg/kg and PTX at 3-5 mg/kg at 2-3 week intervals, and when the effect of BV-PTX was low, other chemotherapeutic agents(CTAs)and/or trastuzumab(Tr)were additionally administered. Twelve MBC patients were treated with BV-PTX alone and 19 MBC patients were treated with other CTAs and/or Tr in addition to BV-PTX. No serious adverse events were observed in any regimen. Three complete responses(9.7%), 4 partial responses(12.9%), 8 stable diseases(25.8%), and 16 progressive diseases(51.6%)were observed; the response rate was 22.6%, and the clinical benefit rate was 48.4%. The median progression-free survival(PFS)and median overall survival(OS)after the initiation of BV-PTX were 7.0 and 16.0 months, respectively. All 13 HER2-positive MBC patients were treated with Tr in addition to BV-PTX, and the OS and PFS were significantly higher in the BV-PTX+Tr+CTAs group than in the BV-PTX+Tr group. In 18 HER2-negative MBC patients, PFS and OS were better in the BV-PTX+CTAs group than in the BV-PTX alone group, though this difference was not significant. Multivariate analyses demonstrated that an additional CTAs was a variable for significantly better PFS, and additional CTAs, Tr, and endocrine therapy were significant variables for better OS. These results indicated that additional CTAs and Tr should be combined with BV-PTX for third- and fourth-line chemotherapies.
要旨
bevacizumab(BV)-paclitaxel(PTX)療法(BV-PTX)は転移性乳癌(MBC)に用いられ,奏効率(RR)と無増悪生存期間(PFS)を改善するが,全生存期間(OS)の改善が明確でなく,臨床的有用性が議論の対象である。今回,BV-PTXを含む化学療法(化療)を三次,四次治療として単独または他剤と併用投与したMBC 31例での効果と予後から,その有用性を検討した。平均年齢55.8(32～83)歳,転移部位(重複含む)は,脳8例,胸腹水6例,内臓23例,骨8例で,Luminal-A 9.7%,Luminal-B 32.3%,HER2 type 32.3%,triple-negative 25.8%で,大半がtaxaneまたはanthracycline既治療例であった。BVは5～10 mg/kg,PTXは3～5 mg/kgを2～3週ごとに点滴し進行確認まで継続し,効果が不十分な場合は他の化療を追加した。BVによる重篤な有害事象はなかった。完全奏効3例,部分奏効4例,安定8例,進行16例で,RR 22.6%,臨床的有用率48.4%であった。31例中21例が最終的にBV-PTXを中断し,その後他界している。PFS,OSの中間値は,7.0か月と16.0か月であった。HER2(+)13例では,全例がtrastuzumab(Tr)を投与されたが,Tr+他化療群のPFS,OSがTr群よりも有意に良好であった。HER2(-)18例では,BV-PTX単独群よりもBV-PTX+他化療群のPFS,OSが良好であったが有意差はなかった。多変量解析では,他化療の併用がPFS良好の,またestrogen receptor(+),他化療の併用,Tr併用,内分泌療法の併用がOS良好の有意因子であった。今回,三次,四次治療においてBV-PTX単独では効果が不十分で,他化療や分子標的療法との併用が必要であることが示唆された。
目次
Summary
The present study was designed to estimate the clinical efficacy of bevacizumab(BV)combined with paclitaxel(PTX)(BV-PTX)as third- and fourth-line therapies in 31 patients with metastatic breast cancer(MBC). Most patients were previously treated with docetaxel and/or epirubicin. Patients were intravenously treated with BV at 5-10 mg/kg and PTX at 3-5 mg/kg at 2-3 week intervals, and when the effect of BV-PTX was low, other chemotherapeutic agents(CTAs)and/or trastuzumab(Tr)were additionally administered. Twelve MBC patients were treated with BV-PTX alone and 19 MBC patients were treated with other CTAs and/or Tr in addition to BV-PTX. No serious adverse events were observed in any regimen. Three complete responses(9.7%), 4 partial responses(12.9%), 8 stable diseases(25.8%), and 16 progressive diseases(51.6%)were observed; the response rate was 22.6%, and the clinical benefit rate was 48.4%. The median progression-free survival(PFS)and median overall survival(OS)after the initiation of BV-PTX were 7.0 and 16.0 months, respectively. All 13 HER2-positive MBC patients were treated with Tr in addition to BV-PTX, and the OS and PFS were significantly higher in the BV-PTX+Tr+CTAs group than in the BV-PTX+Tr group. In 18 HER2-negative MBC patients, PFS and OS were better in the BV-PTX+CTAs group than in the BV-PTX alone group, though this difference was not significant. Multivariate analyses demonstrated that an additional CTAs was a variable for significantly better PFS, and additional CTAs, Tr, and endocrine therapy were significant variables for better OS. These results indicated that additional CTAs and Tr should be combined with BV-PTX for third- and fourth-line chemotherapies.
要旨
bevacizumab(BV)-paclitaxel(PTX)療法(BV-PTX)は転移性乳癌(MBC)に用いられ,奏効率(RR)と無増悪生存期間(PFS)を改善するが,全生存期間(OS)の改善が明確でなく,臨床的有用性が議論の対象である。今回,BV-PTXを含む化学療法(化療)を三次,四次治療として単独または他剤と併用投与したMBC 31例での効果と予後から,その有用性を検討した。平均年齢55.8(32～83)歳,転移部位(重複含む)は,脳8例,胸腹水6例,内臓23例,骨8例で,Luminal-A 9.7%,Luminal-B 32.3%,HER2 type 32.3%,triple-negative 25.8%で,大半がtaxaneまたはanthracycline既治療例であった。BVは5～10 mg/kg,PTXは3～5 mg/kgを2～3週ごとに点滴し進行確認まで継続し,効果が不十分な場合は他の化療を追加した。BVによる重篤な有害事象はなかった。完全奏効3例,部分奏効4例,安定8例,進行16例で,RR 22.6%,臨床的有用率48.4%であった。31例中21例が最終的にBV-PTXを中断し,その後他界している。PFS,OSの中間値は,7.0か月と16.0か月であった。HER2(+)13例では,全例がtrastuzumab(Tr)を投与されたが,Tr+他化療群のPFS,OSがTr群よりも有意に良好であった。HER2(-)18例では,BV-PTX単独群よりもBV-PTX+他化療群のPFS,OSが良好であったが有意差はなかった。多変量解析では,他化療の併用がPFS良好の,またestrogen receptor(+),他化療の併用,Tr併用,内分泌療法の併用がOS良好の有意因子であった。今回,三次,四次治療においてBV-PTX単独では効果が不十分で,他化療や分子標的療法との併用が必要であることが示唆された。