肺腺癌術後再発症例に対するDocetaxel (TXT), Carboplatin (CBDCA) 併用化学療法の早期II相試験
作者： Takayuki Kori , Enjyo Hata , Hirozou Sakaguchi , Shingo Ikeda , Ryouji Kawano
DOI: 10.2482/HAIGAN.42.85
关键词: Medicine 、 Gastroenterology 、 Internal medicine
摘要: 目的. 肺腺癌術後再発例に対するDocetaxel, Carboplatin併用化学療法の早期II相試験を実施し効果と安全性を検討した. 方法. 70歳以下, PS 0～2を対象にDocetaxel (60mg/m2), Carbopiatin (5 area under the concentrationtime curve) を3週間隔で2コース投与後効果判定を行い, PD以外は2ヶ月間隔で治療を継続した. 結果. Fleming法による中間解析で有効と判定し, 15例で試験を早期終了した. 総投与数66回, 中央値4回 (range 2～9), 観察期間は10.6～23.1ヶ月 (中央値20.3ヶ月).CR; 1例, PR; 3例, NC; 9例, PD; 2例で, 全奏効率は26.7%(95% CI: 4.2～49.0%) であった. 効果発現までの期間は中央値4週 (3.6～8週), 全奏効期間は中央値43.6週 (9.4～68.7週). Grade 3以上の主な副作用は貧血2例 (13.3%), 白血球減少7例 (46.7%), 好中球減少10例 (66.7%), 血小板減少2例 (13.3%) で, 治療関連死を1例 (6.7%) 認めた. 化学療法後の1年生存率は51.9%(95% 25.9～77.8%), 生存期間中央値は19.8ヶ月であった. 結論. 本療法は安全に実施可能で, 抗腫瘍効果の得られる可能性が示唆された.
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