Annals of Oncology Advance Access originally published online on May 24, 2007
Annals of Oncology 2007 18(8):1354-1358; doi:10.1093/annonc/mdm128
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© 2007 European Society for Medical Oncology
gastrointestinal tumors |
Adjuvant chemotherapy with epirubicin, leucovorin, 5-fluorouracil and etoposide regimen in resected gastric cancer patients: a randomized phase III trial by the Gruppo Oncologico Italia Meridionale (GOIM 9602 Study)
1 Division of Medical Oncology, Second University, Napoli
2 Department of Medical Oncology, Istituto Oncologico Bari
3 Department of Medical Oncology, Casa Sollievo della Sofferenza Hospital, S. Giovanni Rotondo
4 Department of Surgical Oncology, Second University, Napoli
5 Unit of Surgical Oncology, Istituto Oncologico Bari
6 Department of Medical Oncology, A.O.R.N. Cardarelli, Napoli
7 Department of Medical Oncology, Potenza
8 Department of Medical Oncology, Campobasso
9 Department of Medical Oncology, Palermo, Italy
* Correspondence to: Dr F. De Vita, Division of Medical Oncology, "F. Magrassi & A. Lanzara" Department of Clinical and Experimental Medicine, Second University of Naples School of Medicine, Naples, Italy, c/o II Policlinico-Via S. Pansini, 5 80131- Naples, Italy. Tel: +39-081-5666713; Fax: +39-081-5666728; E-mail: fernandodevita{at}yahoo.it
Background: This randomized, multicenter, phase III trial evaluated the efficacy and safety of the combination of epirubicin, leucovorin, 5-fluorouracil and etoposide (ELFE regimen) as adjuvant therapy for radically resected gastric cancer patients.
Patients and methods: From June 1996 to June 2001, 228 stage IB–IIIB gastric cancer patients were enrolled. All patients received a total or subtotal gastrectomy with at least a D1 lymphoadenectomy and were randomly assigned to receive surgery alone or surgery followed by chemotherapy.
Results: A total number of 630 cycles was delivered with a median number of 5. With a median follow-up of 60 months, the 5-year overall survival (OS) was 48% in the treatment arm and 43.5% in the control arm [hazard ratio (HR) 0.91; 95% confidence interval (CI) 0.69–1.21; P = 0.610); the 5-year disease-free survival (DFS) was 44% in the treatment arm and 39% in the control arm (HR 0.88; 95% CI 0.78–0.91; P = 0.305). In node-positive patients, the 5-year OS was 41% in the treatment arm and 34% in the control arm (HR 0.84; 95% CI 0.69–1.01; P = 0.068), while the 5-year DFS was 39% in the treatment arm and 31% in the control arm (HR 0.88; 95% CI 0.78–0.91; P = 0.051). The most common grade 3–4 toxic effects according to World Health Organization criteria were hematological and gastrointestinal.
Conclusions: In radically resected gastric cancer patients, adjuvant chemotherapy with ELFE regimen does not improve OS over surgery alone.
Key words: adjuvant chemotherapy, ELFE regimen, gastric cancer
Received for publication January 8, 2007. Revision received March 7, 2007. Accepted for publication March 8, 2007.
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