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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
Author(s) -
Feliu J.,
Barón M. González,
GarcíaGirón C.,
Espinosa E.,
GarcíaAlfonso P.,
Belón J.,
Blanco E.,
Garrido P.,
Ordóñez A.,
GómezNavarro J.,
Zamora P.
Publication year - 1996
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/(sici)1097-0142(19960715)78:2<211::aid-cncr4>3.0.co;2-o
Subject(s) - medicine , tegafur , gastroenterology , etoposide , fluorouracil , phases of clinical research , gastric carcinoma , carcinoma , toxicity , surgery , chemotherapy , cancer
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/m 2 IV on Day 1 and 200 mg/m 2 p.o. on Days 2 and 3; LV 500 mg/m 2 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/m 2 /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. Cancer 1996;78:211‐6.