Phase II study of sequential methotrexate and 5-fluorouracil chemotherapy against peritoneally disseminated gastric cancer with malignant ascites: a report from the Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group, JCOG 9603 Trial.

Abstract

BACKGROUND:

The efficacy of systemic chemotherapy against peritoneal dissemination from advanced gastric cancer (AGC) remains unclear, because the peritoneal dissemination was not defined as a measurable lesion in conventional phase II studies. In this study, we evaluated the efficacy and toxicity of sequential MTX and 5FU therapy (MF) in chemotherapy-naive patients with AGC accompanied by malignant ascites in a phase II setting.

METHODS:

The treatment schedule comprised weekly administration of MTX (100 mg/m2, i.v. bolus) followed by 5FU (600 mg/m2, i.v. bolus) with a 3 h interval. Leucovorin rescue (10 mg/m2 every 6 h, for a total of six times) was commenced 24 h after MTX administration.

RESULTS:

Thirty-seven chemotherapy-naive patients with AGC presenting with malignant ascites were enrolled in this trial. The median age was 60 years (range, 25-74 years) and most patients (86%) had a performance status of 0-1. In total, 355 administrations of the sequential MTX/5FU therapy were performed. Major toxicity consisted of myelosuppression and gastrointestinal toxicity. Grade 4 neutropenia occurred in 10.8% of the patients. The overall objective response rate was 5.7% (two partial responses in 35 patients; 95% confidence interval: 0.7-19.2%). However, the response rate of ascites was 35.1% (complete disappearance in three patients and apparent decrease in 10 patients; 95% confidence interval: 20.2-52.5%).

CONCLUSIONS:

Sequential MTX/5FU therapy is effective against AGC with malignant ascites with acceptable toxicity and warrants further investigations in a phase III setting.

• Authors: Takekazu Yamao, Yasuhiro Shimada, Kuniaki Shirao, Atsushi Ohtsu, Nobumasa Ikeda, Ichinosuke Hyodo, Hiroshi Saito, Hiroaki Iwase, Yasushi Tsuji, Takao Tamura, Seiichiro Yamamoto, Shigeaki Yoshida
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 34 Issue 6 Pg. 316-22 (Jun 2004) ISSN: 0368-2811 [Print] England
• PMID: 15333683 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Leucovorin
• Fluorouracil
• Methotrexate

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Ascites (etiology)
• Drug Administration Schedule
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Japan
• Leucovorin (administration & dosage)
• Male
• Methotrexate (administration & dosage, adverse effects)
• Middle Aged
• Peritoneal Neoplasms (drug therapy, secondary)
• Stomach Neoplasms (drug therapy)
• Survival Rate