Adjuvant chemotherapy with cisplatin, etoposide, fluorouracil and leucovorin for gastric carcinoma.

PURPOSE: The aim of this study was to evaluate the efficacy of cisplatin, etoposide, 5-fluorouracil (5-FU), and leucovorin (L; CEFL) combination chemotherapy given as adjuvant treatment to patients with stage III gastric cancer. PATIENTS AND METHODS: A total of 33 patients who had undergone curative resection for stage III gastric adenocarcinoma were enrolled in our adjuvant chemotherapy protocol to receive 6 cycles of CEFL starting within 8 weeks from surgery. CEFL consisted of cisplatin 30 mg/m2 on days 1-3; 5-FU 300 mg/m2 continuous infusion on days 1-3; and etoposide 90 mg/m2 on days 1-3. Cycles were repeated every 4 weeks. Relapse-free survival (RFS) and overall survival (OS) were estimated using Kaplan-Meier method. Comparison between groups was carried out using log-rank test. RESULTS: Treatment was completed by 30 (91%) patients. After a mean follow-up of 31 months 15 (50%) patients have relapsed. Mean RFS was 31 months (range 6 to 114+). Patients with stage IIIA disease had longer RFS that those with stage IIIB (37 vs. 25 months, p>0.05). Mean OS was 35 months (range 4 to 114+), while stage IIIA patients survived longer than IIIB ones (42 vs. 27 months, p>0.05). Principal side effects of therapy were from the bone marrow and the gastrointestinal tract. There were 2 treatment-related deaths due to neutropenic sepsis. CONCLUSION: CEFL regimen appears to be an effective adjuvant treatment for patients with stage III gastric carcinoma as it prolongs both RFS and OS. However, its pronounced myelotoxicity requires the prophylactic use of granulocyte colony stimulating factor (G-CSF).