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[甲氨蝶呤(MTX)、5-氟尿嘧啶(5-FU)和吡柔比星(THP)与单纯5-氟尿嘧啶治疗晚期或复发性胃癌的随机对照试验。东海北陆THP研究组]

[A randomized controlled trial with methotrexate (MTX), 5-fluorouracil (5-FU) and pirarubicin (THP) vs 5-FU alone in advanced or recurrent gastric carcinoma. Tokai Hokuriku THP Study Group].

作者信息

Yamamura Y, Miyazaki I, Ogawa M, Yonemura Y, Tanemura H, Kito T, Hamajima N, Saji S, Kosaka T

机构信息

Dept. of Gastroenterological Surgery, Aichi Cancer Center Hospital.

出版信息

Gan To Kagaku Ryoho. 1998 Aug;25(10):1543-8.

PMID:9725047
Abstract

A randomized controlled trial was designed to investigate the therapeutic benefit of a combination chemotherapy consisting of MTX, 5-FU and THP in patients with advanced or recurrent gastric carcinoma. The patients were randomized into two groups; Group A patients (n = 37) underwent our combined chemotherapy, whereas Group B (n = 34) underwent chemotherapy with 5-FU alone as a control. There were no significant differences in various background factors between the groups. The median survival time was roughly 170 days after the randomization for the patients with advanced cancer (n = 26 for Group A and n = 25 for Group B), with no significant difference between the groups. Two long survivors, however, belonged to Group A. The median survival time of 161 days for Group A (n = 11) was longer than that of Group B (84 days, n = 9), but the difference was not statistically significant. The incidence of toxicities (leukopenia in particular) exceeding JCOG grade 3 was significantly higher for Group A, but no morbidity was observed. These results imply that patients with advanced or recurrent gastric carcinoma may benefit from a regimen of MTX, 5-FU and THP.

摘要

一项随机对照试验旨在研究由甲氨蝶呤(MTX)、5-氟尿嘧啶(5-FU)和吡柔比星(THP)组成的联合化疗方案对晚期或复发性胃癌患者的治疗效果。患者被随机分为两组;A组患者(n = 37)接受我们的联合化疗,而B组(n = 34)接受单纯5-FU化疗作为对照。两组之间的各种背景因素无显著差异。晚期癌症患者(A组n = 26,B组n = 25)随机分组后的中位生存时间约为170天,两组之间无显著差异。然而,有两名长期存活者属于A组。A组(n = 11)的中位生存时间为161天,长于B组(84天,n = 9),但差异无统计学意义。A组毒性反应(尤其是白细胞减少)超过日本临床肿瘤学会(JCOG)3级的发生率显著更高,但未观察到死亡病例。这些结果表明,晚期或复发性胃癌患者可能从MTX、5-FU和THP方案中获益。

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