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
|