内容紹介
Efficacy and Safety of Cisplatin plus Pemetrexed as a First-Line Treatment for Japanese Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer―A Retrospective Analysis
Summary
Background: Cisplatin plus pemetrexed is considered the standard of care for the first-line treatment of patients with advanced non-squamous non-small-cell lung cancer(NSCLC). However, little is known about the efficacy and safety of this regimen in Japanese patients in a daily clinical setting. Methods: We retrospectively analyzed 40 patients who received cisplatin(75 mg/m2)and pemetrexed(500 mg/m2)as a first-line treatment for advanced non-squamous NSCLC. Results: Recorded Grade 3 or 4 hematological toxicities included neutropenia in 7 cases(17.5%), leukopenia in 5 cases(12.5%), anemia in 1 case(2.5%), thrombocytopenia in 1 case(2.5%), and febrile neutropenia in 1 case(2.5%). Grade 3 or 4 non-hematological toxicities included anorexia in 3 cases(7.5%), infection in 1 case(2.5%), rash in 1 case(2.5%), and increased transaminase expression in 1 case(2.5%). Therefore, the adverse events were mostly mild. There were no treatment-related deaths. The overall response rate was 37.5%, median progression free survival was 5.6 months, and median overall survival(OS)was 18.8 months. In an epidermal growth factor receptor(EGFR)mutation status subgroup analysis, the median OS of patients with wild-type EGFR or unknown status(n=28)was 16.8 months. Conclusion: Cisplatin plus pemetrexed was well tolerated as a first-line treatment and effective in Japanese patients with advanced non-squamous NSCLC.
要旨
cisplatin(CDDP)+pemetrexed(PEM)併用療法は未治療進行非扁平上皮非小細胞肺癌(NSCLC)に対する標準治療の一つと考えられるが,本邦における同治療の報告は第Ⅱ相試験の報告1報にとどまり,日常臨床における安全性および有効性は明らかでない。今回われわれは,未治療進行非扁平上皮NSCLCの初回化学療法としてCDDP+PEM併用療法を行った40例を対象に後方視的に解析を行った。治療に関連する有害事象は,Grade 3以上の血液毒性は好中球減少7例(17.5%),白血球減少5例(12.5%),貧血,血小板減少,発熱性好中球減少を1例(2.5%)ずつ認めた。Grade 3以上の非血液毒性は食欲不振3例(7.5%),感染,皮疹,トランスアミナーゼ上昇を1例(2.5%)ずつ認めた。治療に関連する死亡は認めなかった。奏効率37.5%,無増悪生存期間中央値5.6か月,全生存期間中央値は18.8か月であった。EGFR遺伝子変異陰性または不明例(n=28)に関しても,全生存期間中央値16.8か月と長期生存を認めていた。未治療進行非扁平上皮NSCLCに対するCDDP+PEM併用療法は既存の報告と同様に安全性が高く,良好な生存成績が期待できる治療法と考えられた。
目次
Summary
Background: Cisplatin plus pemetrexed is considered the standard of care for the first-line treatment of patients with advanced non-squamous non-small-cell lung cancer(NSCLC). However, little is known about the efficacy and safety of this regimen in Japanese patients in a daily clinical setting. Methods: We retrospectively analyzed 40 patients who received cisplatin(75 mg/m2)and pemetrexed(500 mg/m2)as a first-line treatment for advanced non-squamous NSCLC. Results: Recorded Grade 3 or 4 hematological toxicities included neutropenia in 7 cases(17.5%), leukopenia in 5 cases(12.5%), anemia in 1 case(2.5%), thrombocytopenia in 1 case(2.5%), and febrile neutropenia in 1 case(2.5%). Grade 3 or 4 non-hematological toxicities included anorexia in 3 cases(7.5%), infection in 1 case(2.5%), rash in 1 case(2.5%), and increased transaminase expression in 1 case(2.5%). Therefore, the adverse events were mostly mild. There were no treatment-related deaths. The overall response rate was 37.5%, median progression free survival was 5.6 months, and median overall survival(OS)was 18.8 months. In an epidermal growth factor receptor(EGFR)mutation status subgroup analysis, the median OS of patients with wild-type EGFR or unknown status(n=28)was 16.8 months. Conclusion: Cisplatin plus pemetrexed was well tolerated as a first-line treatment and effective in Japanese patients with advanced non-squamous NSCLC.
要旨
cisplatin(CDDP)+pemetrexed(PEM)併用療法は未治療進行非扁平上皮非小細胞肺癌(NSCLC)に対する標準治療の一つと考えられるが,本邦における同治療の報告は第Ⅱ相試験の報告1報にとどまり,日常臨床における安全性および有効性は明らかでない。今回われわれは,未治療進行非扁平上皮NSCLCの初回化学療法としてCDDP+PEM併用療法を行った40例を対象に後方視的に解析を行った。治療に関連する有害事象は,Grade 3以上の血液毒性は好中球減少7例(17.5%),白血球減少5例(12.5%),貧血,血小板減少,発熱性好中球減少を1例(2.5%)ずつ認めた。Grade 3以上の非血液毒性は食欲不振3例(7.5%),感染,皮疹,トランスアミナーゼ上昇を1例(2.5%)ずつ認めた。治療に関連する死亡は認めなかった。奏効率37.5%,無増悪生存期間中央値5.6か月,全生存期間中央値は18.8か月であった。EGFR遺伝子変異陰性または不明例(n=28)に関しても,全生存期間中央値16.8か月と長期生存を認めていた。未治療進行非扁平上皮NSCLCに対するCDDP+PEM併用療法は既存の報告と同様に安全性が高く,良好な生存成績が期待できる治療法と考えられた。