A COOPERATIVE RANDOMIZED STUDY ON TEGAFUR PLUS MITOMYCIN-C VERSUS COMBINED TEGAFUR AND URACIL PLUS MITOMYCIN-C IN THE TREATMENT OF ADVANCED GASTRIC-CANCER

被引:42
作者
KURIHARA, M
IZUMI, T
YOSHIDA, S
OHKUBO, T
SUGA, S
KIYOHASHI, A
YAOSAKA, T
TAKAHASHI, H
ITO, T
SASAI, T
AKIYA, T
AKAZAWA, S
BETSUYAKU, T
TAGUCHI, S
机构
[1] NATL CANC CTR,DEPT INTERNAL MED,CHUO KU,TOKYO 104,JAPAN
[2] HIRAGA HOSP,DEPT INTERNAL MED 1,YOKOTE 013,JAPAN
[3] NAGOYA NATL HOSP,DEPT GASTROENTEROL,NAKA KU,NAGOYA 460,JAPAN
[4] KITAZATO UNIV,DEPT INTERNAL MED,SAGAMIHARA 228,JAPAN
[5] SAPPORO KOSEI HOSP,DEPT GASTROENTEROL,CHUO KU,SAPPORO 060,JAPAN
[6] TOHOKU UNIV,TB & CANC RES INST,DEPT CLIN CANC CHEMOTHERAPY,AOBA KU,SENDAI,MIYAGI 980,JAPAN
[7] JUNTENDO UNIV,DEPT INTERNAL MED,BUNKYO KU,TOKYO 113,JAPAN
[8] NATL OKAYAMA HOSP,DEPT INTERNAL MED,OKAYAMA 700,JAPAN
[9] TOHMO HOSP,GUNMA CANC CTR,DEPT INTERNAL MED,OHTA 373,JAPAN
[10] SAITAMA CANC CTR HOSP,DEPT GASTROENTEROL,INA 362,JAPAN
[11] NATL SAPPORO HOSP,DEPT GASTROENTEROL,SHIROISHI KU,SAPPORO 003,JAPAN
[12] SHOWA UNIV,DEPT INTERNAL MED 2,SHINAGAWA KU,TOKYO 142,JAPAN
来源
JAPANESE JOURNAL OF CANCER RESEARCH | 1991年 / 82卷 / 05期
关键词
RANDOMIZED STUDY; TEGAFUR; TEGAFUR AND URACIL; MMC; GASTRIC CANCER;
D O I
10.1111/j.1349-7006.1991.tb01894.x
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
A randomized controlled trial involving 13 institutions in Japan was conducted in order to compare the efficacy of tegafur plus mitomycin C (MMC) (Regimen A) and UFT (a combination of uracil and tegafur at a molar ratio of 4 to 1) plus MMC (Regimen B) for patients with advanced gastric cancer, who had not received any prior cancer chemotherapy. Regimen A (tegafur + MMC) consisted of 5 mg of MMC/m2/week given intravenously, and 500 mg of tegafur/m2/day given orally. Regimen B consisted of the same schedule of MMC and 375 mg of UFT/m2/day given orally. One hundred and eighty-six patients with primary gastric cancer were entered; 183 were eligible and 3 were ineligible for the study. A total of 169 were evaluable for efficacy of the treatment, including 90 patients with Regimen A and 79 with Regimen B. A response rate of 7.8% (7/90 cases) for Regimen A and one of 25.3% (20/79 cases) for Regimen B were obtained, indicating a significantly higher response rate for Regimen B according to the Criteria for Evaluating Efficacy of Chemotherapy/Radiation Therapy in the Treatment of Gastric Cancer (P = 0.004). Regarding side effects, no marked differences in either severity or incidence were observed between the two groups. The group assigned to Regimen B showed a significant survival advantage after adjustment for major prognostic factors using a proportional hazards model (P = 0.0398). Moreover, a close correlation of antitumor effect and survival duration was found when the above criteria were used.
引用
收藏
页码:613 / 620
页数:8
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