Inuyama Y, Hiroto I, Taketa C, Horiuchi M, Mashino S, Fujii M, Matsuura S, Satake B, Takeoda S, Nishijima W, Okuda M, Sakaguchi K, Tanigaito Y, Imakirei M, Konno T, Hirokawa T, Takada K, Ono I, Saitoh H, Takemiya S, Shimada F, Omura K, Miyake H, Fujii K, Kawabe Y, Kondoh T, Komiyama S, Yanagida T, Matsumura Y, Hirano M, Araki S
Gan To Kagaku Ryoho. 1982 Dec;9(12):2193-200.
A clinical trial of moderate dose methotrexate (MTX)-CF rescue was conducted in 12 institutions. Thirty-seven patients with head and neck carcinoma entered this trial, of which 32 were evaluable. MTX was administered 350 mg/m2 (500 mg/body) by i.v. drip over 6 hours. Three hours after completion of MTX infusion, CF rescue was started. There was no complete response in 32 patients. Nine patients showed partial response with the response rate of 28%. The response rates were 21% for the group of patients treated previously, and 75% for the group untreated previously. MTX concentration in plasma was determined at 6, 24, 48 and 72 hours after the initiation of MTX infusion, and the assay results revealed a safe range. GI disturbances were seen at the rates of 11 to 38%. Bone marrow suppression was mild and no renal toxicity was observed. We concluded that the moderate dose MTX-CF rescue therapy was useful for head and neck carcinoma. As a next step, we are planning to conduct a clinical trial of high-dose MTX.
在12家机构开展了一项中等剂量甲氨蝶呤(MTX)-亚叶酸钙(CF)解救的临床试验。37例头颈癌患者进入该试验,其中32例可评估。MTX以350mg/m²(500mg/体)通过静脉滴注6小时给药。MTX输注完成3小时后开始CF解救。32例患者中无完全缓解者。9例患者出现部分缓解,缓解率为28%。既往接受过治疗的患者组缓解率为21%,既往未接受过治疗的患者组缓解率为75%。在MTX输注开始后6、24、48和72小时测定血浆MTX浓度,测定结果显示在安全范围内。胃肠道紊乱发生率为11%至38%。骨髓抑制较轻,未观察到肾毒性。我们得出结论,中等剂量MTX-CF解救疗法对头颈癌有用。下一步,我们计划开展高剂量MTX的临床试验。