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
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.