Randomised comparison of fluorouracil, epidoxorubicin and methotrexate (FEMTX) plus supportive care with supportive care alone in patients with non-resectable gastric cancer.
TLDR
FEMTX combined with vitamin A and E is a fairly well-tolerated treatment, giving a response rate of 29% in patients with advanced gastric cancer, and also prolonging patients' survival, and can be used as a reference treatment in testing new investigational combinations.Abstract:
A phase III randomised study, comparing treatment with fluorouracil, epidoxorubicin and methotrexate (FEMTX) with the best supportive care, was conducted in patients with unresectable or metastatic gastric cancer. During the period from July 1986 to June 1992, 41 patients were randomised to receive FEMTX or best supportive care. MTX was given in a dose of 1500 mg m-2 intravenously (i.v.) followed after 1 h by 5-FU 1500 mg m-2 i.v. on day 1; leucovorin rescue was started after 24 h (30 mg orally every 6 h for 48 h) and epidoxorubicin 60 mg m-2 i.v. was administered on day 15. In addition both groups received tablets containing vitamins A and E. Response rates for FEMTX were as follows: complete response (CR), 19% (4/21); partial response (PR), 10% (2/21); no change (NC), 33% (7/21); and progressive disease (PD), 24% (5/21). Response rates in the control group were: NC, 20% (4/20); and PD, 80% (16/20). Increased pain was observed in one patient in the treated group and in 11 patients in the control group within the first 2 months. WHO grade III/IV toxicity in the chemotherapy group was as follows: nausea/vomiting 40%, diarrhoea 10%, stomatitis 15%, leucopenia 50% and thrombocytopenia 10%. One possible treatment-related death was due to sepsis. The median time to progression in the FEMTX group was 5.4 months [95% confidence interval (CI) 3.1-11.7 months], but only 1.7 months in the control group (95% CI 1.2-2.7 months) (P = 0.0013). Similarly, the FEMTX group displayed significantly (P = 0.0006) prolonged survival compared with the control group, i.e. median survival 12.3 months (95% CI 7.1-15.6 months) vs 3.1 months (95% CI 1.6-4.6 months). In conclusion, FEMTX combined with vitamin A and E is a fairly well-tolerated treatment, giving a response rate of 29% in patients with advanced gastric cancer, and also prolonging patients' survival. It can be used as a reference treatment in testing new investigational combinations.read more
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References
More filters
Journal ArticleDOI
Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples.
Richard Peto,M.C. Pike,P. Armitage,N. E. Breslow,David Cox,S V Howard,N Mantel,Klim McPherson,Julian Peto,Pete Smith +9 more
TL;DR: Efficient methods of analysis of randomized clinical trials in which the authors wish to compare the duration of survival among different groups of patients are described.
Journal ArticleDOI
Reporting results of cancer treatment.
TL;DR: Recommendations have been developed for standardized approaches to the recording of baseline data relating to the patient, the tumor, laboratory and radiologic data, the reporting of treatment, grading of acute and subacute toxicity, reporting of response, recurrence and disease‐free interval, and reporting results of therapy.
Journal ArticleDOI
Assessment of response to therapy in advanced breast cancer.
TL;DR: A system is proposed by the UICC for assessing response to treatment of advanced breast cancers and its application in clinical practice is proposed.
Journal ArticleDOI
Modified therapy with 5-fluorouracil, doxorubicin, and methotrexate in advanced gastric cancer
Andre M. Murad,Flavia F. Santiago,Andy Petroianu,Paulo Roberto Savassi Rocha,Marco A. G. Rodrigues,Marcelo Rausch +5 more
TL;DR: The authors designed the modified FAMTX treatment that was evaluated in a prospective Phase II‐III randomized trial, and it was found to reduce the dose of methotrexate by 50% compared to the original regimen.
Journal ArticleDOI
Sequential high-dose methotrexate and fluorouracil combined with doxorubicin: A step ahead in the treatment of advanced gastric cancer: a trial of the European organization for research and treatment of cancer gastrointestinal tract cooperative group
Jaques Wils,H.O. Klein,D.J.T. Wagener,Harry Bleiberg,H Reis,F Korsten,Thierry Conroy,M. Fickers,S Leyvraz,Marc Buyse +9 more
TL;DR: The FAMTX protocol should be the reference treatment in future clinical trials that seek to improve the therapeutic outcome in advanced gastric cancer.