Randomized trial of adjuvant chemotherapy after curative resection for gastric cancer.
BACKGROUND
The aim of the study was to evaluate the efficacy of adjuvant chemotherapy on survival after resection for gastric cancer.


METHODS
Patients were enrolled if they underwent resection of gastric cancer but had lymph node or serosal involvement or both. Surgical resection was either total or partial gastrectomy according to the site of the tumor, and surgeons were allowed to perform either D1 or D2 gastrectomy. The subjects were random assigned in two treatment groups as follows: surgery alone as the control group, or surgery and adjuvant chemotherapy. Nine cycles of 5 days protocol every 4 weeks was proposed to the patients of the chemotherapy group. The protocol included a daily administration of 200 mg/m(2) of folinic acid, 5-fluorouracil (375 mg/m(2) during the first session increasing 25 mg by session until reaching 500 mg/m(2)) and CDDP 15 mg/m(2). Two hundred patients were required. Kaplan-Meier survival curves were compared according to the log-rank and the Mantel-Haenszel methods.


RESULTS
In all, 205 patients were enrolled in the study; 104 had surgery alone and 101 had surgery and adjuvant chemotherapy. The patients' characteristics were similar except for the mean age, which was 4 years less in the control group. Because of toxicity, 54% of the patients stopped the protocol before the end of the nine courses, and 46% of the patients received the nine courses including 32% with a decreased dose and 14% with a full dose. The 5-year survival rate was 39% in the control group and 39% in the chemotherapy group.


CONCLUSIONS
This protocol of adjuvant chemotherapy failed to improve the 5-year survival after resection for gastric cancer.
Chipponi
Jacques
J
Hôtel-Dieu Boulevard Leon Malfreyt 63058, Clermont-Ferrand, Cedex 1, France. jchipponi@chu-clermontferrand.fr
Huguier
Michel
M
Pezet
Denis
D
Basso
Nicolas
N
Hay
Jean-Marie
JM
Quandalle
Pierre
P
Jaeck
Daniel
D
Fagniez
Pierre-Louis
PL
Gainant
Alain
A
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D005743:Gastrectomy / Q000379:methods; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011336:Probability; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology / Q000601:surgery; D016019:Survival Analysis; D016896:Treatment Outcome
D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil