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Surgery plus ELFE (epirubicin, leucovorin, 5-fluorouracil and etoposide) vs surgery alone in radically resected gastric cancer (GC): Final results of a randomised phase III trial by the Gruppo Oncologico dell' Italia Meridionale (GOIM).

4014 Background: In a previous phase II study the ELFE regimen resulted to be active and well tolerated for the treatment of advanced GC (Am J Clin Oncol 22:262;1999). Based on this background the G.O.I.M. conducted a randomised phase III study (trial 9602) to evaluate efficacy and toxicity of ELFE regimen as adjuvant therapy for radically resected GC patients (pts).


METHODS
All enrolled pts underwent total or subtotal gastrectomy with at least a D1 lymphoadenectomy. After stratification for nodal involvement (N+ vs N-) pts were randomised to follow-up alone (116 pts) or 6 cycles of ELFE regimen ( EPI 60mg/m2 d1, LV100 mg/m2 d 1-5, 5FU 375 mg/m2 d 1-5, VP-16 100 mg/m2 d1-3, every 3 weeks).


RESULTS
From June 1997 to June 2001, 228 pts with stage IB-IIIB GC were enrolled. Pts characteristics were: median age 63 yrs (29-70); total gastrectomy 148 pts; N+ 163 pts; PS 0-1 according ECOG scale 210. A total number of 638 cycles were delivered with a median number of 5/pt. During chemotherapy, the most frequent G3-4 side-effects graded according to NCI-CTC included alopecia (32%), neutropenia (26%), diarrhea (26%), nausea/emesis (17%), thrombocytopenia (12%) and stomatitis (11%). With a median follow-up of 60 months, the 5-years overall survival was 48% in the treatment arm and 43.5% in the control arm ( p=0.610); the 5-years disease-free survival was 44% in the treatment arm and 39% in the control arm ( p=0.305). Between patients with positive nodes the 5-years overall survival was 41% in the treatment arm and 34% in the control arm( p=0.068), while the 5-years disease-free survival was 39% in the treatment arm and 31% in the control arm (p=0.052). Multivariate analysis showed TNM stage as the only covariate that was independently associated with overall and disease-free survival.


CONCLUSIONS
In radically resected GC adjuvantELFE chemotherapy produces an absolute difference in overall survival and disease-free survival at 5 years respectively of 4.5% and 5%, but this advantage was not statistically significant. No significant financial relationships to disclose.