内容紹介
Gemcitabine in Combination with Cisplatin in Patients with Unresectable Advanced or Recurrent Biliary Tract Cancer―A Multicenter Prospective Observational Study in Fukuoka
Summary
The standard chemotherapy for the treatment of unresectable advanced and recurrent biliary tract cancers is considered gemcitabine plus cisplatin(GC)on the basis of favorable results reported in the ABC-02 study from the UK and the BT22 study from Japan. However, the GC cohort of the BT22 study consisted of only 42 patients, and we considered it necessary to confirm the effectiveness and safety of GC chemotherapy in a multicenter prospective observational study in Fukuoka. Thirty-seven patients were enrolled in this study, including two patients with recurrent disease. The median patient age was 67.5 years(range, 43-84 years). Twelve patients had intrahepatic cholangiocarcinoma, 13 patients had extrahepatic cholangiocarcinoma, and 12 patients had gallbladder cancer. The median survival time(MST)was 14.9 months, the 1-year survival rate was 54.5%, and the median progression free survival(PFS)was 7.7 months. No chemotherapy-related deaths occurred, and Grade 3/4 adverse events were mainly hematological events including leucopenia in 13(35.1%)patients and neutropenia in 12(32.4%). The MST, 1-year survival rate, median PFS, and rate of Grade 3/4 adverse events in our study were similar to those of the BT22 study. In conclusion, this multicenter prospective observational study confirms the effectiveness and safety of GC chemotherapy for the treatment of unresectable advanced and recurrent biliary tract cancers.
要旨
切除不能進行・再発胆道癌に対する標準化学療法は,英国のABC-02試験と日本のBT22試験の良好な結果から,ゲムシタビン+シスプラチン(GC療法)とされるが,BT22試験のGC群は42例にすぎず,さらに症例を重ねて有効性と安全性を検討する必要があると考えられた。そこで,福岡・北九州地区においてGC療法の安全性・有効性を多施設前向き観察研究にて確認した。登録症例は再発例2例を含む37例。年齢の中央値は67.5(43～84)歳,肝内胆管癌12例,肝外胆管癌13例,胆嚢癌12例であった。生存期間中央値(median survival time: MST)は14.9か月,1年生存率は54.5%であり,無増悪生存期間(progression free survival: PFS)の中央値は7.7か月であった。治療関連死亡は認めず,Grade 3以上の有害事象は白血球減少13例(35.1%),好中球減少12例(32.4%)など血液毒性が主であった。MST,1年生存率,PFS,有害事象発生状況などはBT22試験と同様であり,本多施設前向き観察研究により,切除不能進行・再発胆道癌に対するGC療法の有効性と安全性が確認された。
目次
Summary
The standard chemotherapy for the treatment of unresectable advanced and recurrent biliary tract cancers is considered gemcitabine plus cisplatin(GC)on the basis of favorable results reported in the ABC-02 study from the UK and the BT22 study from Japan. However, the GC cohort of the BT22 study consisted of only 42 patients, and we considered it necessary to confirm the effectiveness and safety of GC chemotherapy in a multicenter prospective observational study in Fukuoka. Thirty-seven patients were enrolled in this study, including two patients with recurrent disease. The median patient age was 67.5 years(range, 43-84 years). Twelve patients had intrahepatic cholangiocarcinoma, 13 patients had extrahepatic cholangiocarcinoma, and 12 patients had gallbladder cancer. The median survival time(MST)was 14.9 months, the 1-year survival rate was 54.5%, and the median progression free survival(PFS)was 7.7 months. No chemotherapy-related deaths occurred, and Grade 3/4 adverse events were mainly hematological events including leucopenia in 13(35.1%)patients and neutropenia in 12(32.4%). The MST, 1-year survival rate, median PFS, and rate of Grade 3/4 adverse events in our study were similar to those of the BT22 study. In conclusion, this multicenter prospective observational study confirms the effectiveness and safety of GC chemotherapy for the treatment of unresectable advanced and recurrent biliary tract cancers.
要旨
切除不能進行・再発胆道癌に対する標準化学療法は,英国のABC-02試験と日本のBT22試験の良好な結果から,ゲムシタビン+シスプラチン(GC療法)とされるが,BT22試験のGC群は42例にすぎず,さらに症例を重ねて有効性と安全性を検討する必要があると考えられた。そこで,福岡・北九州地区においてGC療法の安全性・有効性を多施設前向き観察研究にて確認した。登録症例は再発例2例を含む37例。年齢の中央値は67.5(43～84)歳,肝内胆管癌12例,肝外胆管癌13例,胆嚢癌12例であった。生存期間中央値(median survival time: MST)は14.9か月,1年生存率は54.5%であり,無増悪生存期間(progression free survival: PFS)の中央値は7.7か月であった。治療関連死亡は認めず,Grade 3以上の有害事象は白血球減少13例(35.1%),好中球減少12例(32.4%)など血液毒性が主であった。MST,1年生存率,PFS,有害事象発生状況などはBT22試験と同様であり,本多施設前向き観察研究により,切除不能進行・再発胆道癌に対するGC療法の有効性と安全性が確認された。