Annals of Oncology 13:299-307, 2002
© 2002 European Society for Medical Oncology
Adjuvant chemotherapy in gastric cancer: 5-year results of a randomised study by the Italian Trials in Medical Oncology (ITMO) Group
1Medical Oncology Unit B, 2Statistics and Biometry Unit, 3Surgical Oncology Unit, Istituto Nazionale per lo Studio e la Cura dei Tumori of Milano; 4Istituto "S. Raffaele", Milan; 5"C. Poma" General Hospital, Mantova; 6General Hospital, Legnano; 7General Hospital, Saronno; 8General Hospital, Varese; 9General Hospital, Lecco; 10"G. Rummo" General Hospital, Benevento, Italy
Received 29 May 2001; revised 31 July 2001; accepted 24 August 2001.
Background
The aim of this study was to determine the efficacy of the EAP regimen (etoposide, adriamycin and cisplatin) followed by the Machover schedule (fluorouracil and folinic acid) given as adjuvant treatment to patients with poor prognostic factors (N+ or T3/4).
Patients and methods
Before randomisation, the subjects were stratified on the basis of node involvement (N+ or N–) and the time from surgery to randomisation (
21 days or >22 days). The surgical procedures for sub-total or total gastrectomy with D2 dissection were standardised among the participating centres.
Results
Between December 1992 and December 1997, 274 patients were enrolled: 137 in the treatment arm and 137 in the control arm. The majority of the patients (90%) were N+. After a median follow up of 66 months (range 2–83), the 5-year overall survival (OS) was 52% in the treatment arm and 48% in the control arm [hazard ratio (HR) 0.93; 95% confidence interval (CI) 0.65–1.34]; the 5-year disease-free survival (DFS) was 49% and 44%, respectively (HR: 0.83; 95% CI 0.59–1.17). Among the patients with N–/N+ (1–6), the 5-year OS was 61% in the treatment group and 60% in the control group; in those with N+ (1–6), it was 42% and 22%. The treatment was completed by 87% of patients. Drug-related grade 3/4 WHO toxicities included leukopenia (21%), nausea and vomiting (14%), mucositis (9%), neutropenia (3%) and thrombocytopenia (2%). There were two deaths due to sepsis.
Conclusions
Although our results are not statistically significant, there was a limited relative risk reduction in the patients receiving adjuvant therapy (17% in DFS and 7% in OS). The data suggest that D2 surgery may have a favourable impact on OS.
Key words: adjuvant chemotherapy, gastric cancer, polychemotherapy
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