Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer: a randomised trial

Citation
T. Nakajima et al., Adjuvant mitomycin and fluorouracil followed by oral uracil plus tegafur in serosa-negative gastric cancer: a randomised trial, LANCET, 354(9175), 1999, pp. 273-277
Citations number
32
Language
INGLESE
art.tipo
Article
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
Journal title
LANCET
ISSN journal
0140-6736 → ACNP
Volume
354
Issue
9175
Year of publication
1999
Pages
273 - 277
Database
ISI
SICI code
0140-6736(19990724)354:9175<273:AMAFFB>2.0.ZU;2-2
Abstract
Background To study the survival benefit of adjuvant chemotherapy in gastri c cancer, seven cancer centres in Japan carried out a phase III clinical tr ial of adjuvant chemotherapy after curative gastrectomy for macroscopically serosa-negative gastric cancer. Methods 579 patients were enrolled in the study, stratified by disease stag e (T1, n=188; T2, n=323), and allocated randomly adjuvant chemotherapy or n o further treatment, 285 of 288 cases in the treatment group and 288 of 291 in the control group were eligible, Six cases were excluded because they d id not fulfil the entry criteria. The treatment group had intravenous mitom ycin (1.4 mg/m(2)) and fluorouracil (166.7 mg/m(2)) twice weekly for 3 week s after surgery, and oral UFT (uracil plus tegafur, 300 mg daily) for 18 mo nths. Analyses were by intention to treat. Findings No serious toxic effects were observed in the treatment group. At median follow-up of 72 months, 59 patients in the control group and 47 in t he treatment group had died. There was no significant difference in surviva l between the groups (5-year survival 82.9% control vs 85.8% treated; hazar d ratio 0.738 [95% CI 0.498-1.093]). 5-year survival of patients with T1 (m ucosal or submucosal) cancer in the control and treatment groups was 94.9% versus 92.0%, and that of patients with T2 (muscularis propria or subserosa ) cancer was 76.9% versus 83.0%. However, a test for heterogeneity and inte raction over T1 and T2 subgroups revealed no significant difference in term s of drug response. Interpretation There was no survival benefit with this adjuvant therapy reg imen for patients with macroscopically serosa-negative gastric cancer (T1 a nd T2) after curative gastrectomy. Patients with T1 cancer can be excluded from future trials, because curative surgery alone yielded a very good surv ival rate and there seemed no need for adjuvant therapy.