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- Title
Phase II study of 5-fluorouracil and folinic acid in the treatment of patients with advanced gastric cancer. A Southwest Oncology Group study.
- Authors
Berenberg, Jeffrey L.; Tangen, Catherine; Macdonald, John S.; Hutchins, Laura F.; Natale, Ronald B.; Oishi, Noboru; Guy, Jerry T.; Fleming, Thomas R.; Berenberg, J L; Tangen, C; Macdonald, J S; Hutchins, L F; Natale, R B; Oishi, N; Guy, J T; Fleming, T R
- Abstract
<bold>Background: </bold>The biochemical modulation of 5-fluorouracil (5-FU) by the reduced folate folinic acid (FA) in the treatment of patients with advanced gastric cancer was examined.<bold>Methods: </bold>The Southwest Oncology Group performed parallel randomized Phase II trials of two schedules of 5-FU and FA in 80 patients with advanced gastric cancer. Of 76 analyzable patients, 36 were randomized to receive bolus FA (200 mg/m2, days 1-4) along with continuous infusion 5-FU (1000 mg/m2, days 1-4) and 40 were randomized to receive bolus FA (200 mg/m2, days 1-5) before the bolus 5-FU (375 mg/m2, days 1-5).<bold>Results: </bold>There were three (8%) partial responses (95% confidence interval [CI] 2%-22%) on the continuous infusion arm. The bolus arm had two (5%) complete responses and six (15%) partial responses for an overall response rate of 20% (95% CI 9%-36%). The median duration of response was 4.6 months for the infusion patients and 16.6 months for the bolus patients. Survival was poor, with median survival of 5 months on both regimens. Gastrointestinal toxicity was substantial, with Grade 3 mucositis observed in 36% of patients on the continuous infusion regimen versus only 10% of patients on the bolus regimen. Grade 3 or higher hematologic toxicity occurred more often in the bolus arm than in the continuous infusion arm (28% vs. 14%, respectively). Two toxic deaths occurred, one related to sepsis the other secondary to coronary insufficiency.<bold>Conclusions: </bold>Biochemical modulation of 5-FU by FA using the dose and schedules tested has only modest activity in the treatment of advanced gastric cancer.
- Publication
Cancer (0008543X), 1995, Vol 76, Issue 5, p715
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/1097-0142(19950901)76:5<715::AID-CNCR2820760502>3.0.CO;2-3