[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]

Gan To Kagaku Ryoho. 1998 Aug;25(10):1543-8.
[Article in Japanese]

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • English Abstract
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Doxorubicin / administration & dosage
  • Doxorubicin / analogs & derivatives
  • Drug Administration Schedule
  • Female
  • Fluorouracil / administration & dosage*
  • Humans
  • Male
  • Methotrexate / administration & dosage
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Recurrence, Local / mortality
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / mortality
  • Survival Analysis

Substances

  • Antimetabolites, Antineoplastic
  • Doxorubicin
  • pirarubicin
  • Fluorouracil
  • Methotrexate