Treatment of patients with advanced gastric carcinoma with the combination of etoposide plus oral tegafur modulated by uracil and leucovorin: A phase II study of the ONCOPAZ Cooperative Group

✍ Scribed by J. Feliu; M. González Barón; C. García-Girón; E. Espinosa; P. García-Alfonso; J. Belón; E. Blanco; P. Garrido; A. Ordóñez; J. Gómez-Navarro; P. Zamora

• Publisher: John Wiley and Sons
• Year: 1996
• Tongue: English
• Weight: 562 KB
• Volume: 78
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/(sici)1097-0142(19960715)78:2<211::aid-cncr4>3.0.co;2-o

✦ Synopsis

Background:

Both the biochemical modulation and the continuous administration of 5-fluorouracil (5-fu) have achieved promising results in patients with gastric carcinoma. conversely, several studies on gastric carcinoma have demonstrated that the combination of etoposide (vp-16), leucovorin (lv), and 5-fu (elf) is efficacious and moderately toxic. uft is a combination of uracil and tegafur (ftorafur) in a 4:1 molar ratio. it can be administered orally for several weeks, thus stimulating the effects of a continuous infusion of 5-fu. its combination with lv increased the efficacy of uft. we conducted a phase ii study on patients with gastric carcinoma using the combination vp-16-lv-uft. this combination is administered mainly orally (p.o) and could yield a good response rate and low toxicity.

Methods:

Forty-six patients with bidimensionally measurable disease were entered into the study. patients received vp-16 100 mg/m2 iv on day 1 and 200 mg/ m2 p.o. on days 2 and 3; lv 500 mg/m2 administered intravenously (i.v.) on day 1, followed by p.o. lv 15 mg every twelve hours on days 2 to 14. patients also received uft p.o. 390 mg/m2/day on days 1 to 14. treatment was repeated every 28 days for a minimum of 3 courses per patient. all courses were given on an outpatient basis.

Results:

Four patients (9%) had a complete response, and 12 a partial response (26%) for an overall response rate of 35% (95% confidence interval: 22-51%). the median duration of response was 10 months. the median overall survival was 9 months. the main side effects were gastrointestinal. grade 3 to 4 toxicity was encountered as follows: diarrhea in 17% of the patients, nausea/vomiting in 11%, anemia in 13%, mucositis and leukopenia in 4% each, and thrombocytopenia in 2%. one patient died of sepsis and neutropenia.

Conclusions:

Vp-16-lv-uft has an activity comparable to that of other schemes and a low incidence of side effects. furthermore, since it is administered mainly orally, hospitalization is avoided, which makes this scheme suitable for patients with advanced gastric carcinoma.