Sasaki T, Ota K, Taguchi T, Ogawa N, Kurihara M, Akazawa S, Ogawa M, Tominaga T, Konishi T, Kumai K
Dept. of Chemotherapy, Tokyo Metropolitan Komagome Hospital.
Gan To Kagaku Ryoho. 1995 Mar;22(4):521-9.
A randomized early phase II study using l-leucovorin (l-LV) and 5-fluorouracil (5-FU) in gastric cancer was conducted. The administration schedules: Arm A was 250 mg/m2 of l-LV and 600 mg/m2 of 5-FU weekly, arm B was 100 mg/m2 of l-LV and 370 mg/m2 of 5-FU for 5 consecutive days, and arm C was 10 mg/m2 of l-LV and 370 mg/m2 of 5-FU for 5 consecutive days. PR was obtained in 10/28 (35.7%) of arm A, 7/28 (25.0%) of arm B and 0/17 (0%) of arm C, in complete cases. In eligible cases, 30.3%, 21.9% and 0%, respectively. Because there was no responder in arm C, the entry to arm C was stopped by controller at the point where 17 patients were treated with arm C. Median survival time was 9.6 months in arm A, 8.0 months in arm B and 5.9 months in arm C. Major toxicities were stomatitis, diarrhea and neutropenia. Stomatitis was seen more in arm B and C than in arm A. These data suggest that the high dose of l-LV and 5-FU seems to be a very promising combination, but there was no responder using low-dose l-LV schedule against gastric cancer. We thus selected arm A for the next late phase II study against gastric cancer.
开展了一项使用左亚叶酸（l-LV）和5-氟尿嘧啶（5-FU）治疗胃癌的随机II期早期研究。给药方案如下：A组为每周给予250mg/m²的l-LV和600mg/m²的5-FU；B组为连续5天给予100mg/m²的l-LV和370mg/m²的5-FU；C组为连续5天给予10mg/m²的l-LV和370mg/m²的5-FU。在完全可评估病例中，A组28例中有10例（35.7%）获得部分缓解（PR），B组28例中有7例（25.0%）获得PR，C组17例中无1例获得PR。在符合条件的病例中，分别为30.3%、21.9%和0%。由于C组无缓解者，在17例患者接受C组治疗时，研究负责人停止了C组入组。A组的中位生存时间为9.6个月，B组为8.0个月，C组为5.9个月。主要毒性反应为口腔炎、腹泻和中性粒细胞减少。B组和C组的口腔炎比A组更常见。这些数据表明，高剂量的l-LV和5-FU似乎是一种非常有前景的联合用药方案，但低剂量l-LV方案治疗胃癌无缓解者。因此，我们选择A组进行下一项针对胃癌的II期后期研究。
