A PILOT CLINICAL-TRIAL OF POSTOPERATIVE INTENSIVE WEEKLY CHEMOTHERAPYUSING CISPLATIN, EPI-DOXORUBICIN, 5-FLUOROURACIL, 6S-LEUCOVORIN, GLUTATHIONE AND FILGRASTIM IN PATIENTS WITH RESECTED GASTRIC-CANCER

Aims and background: The study was performed to assess the feasibility and activity of an intensive chemotherapeutic regimen as adjuvant tre atment for patients with resected gastric cancer at high risk of recur rence (PT2N1-2; PT3-4Nany M-0). Patients and methods: Starting 21 to 2 8 days after potentially curative surgery for primary gastric cancer, 25 patients received 8 weekly cycles of cisplatin 40 mg/m(2), 5-fluoro uracil 500 mg/m(2) epidoxorubicin 35 mg/m(2), GS-stereoisomer of leuco vorin at a dose of 250 mg/m(2), and glutathione at a dose of 1.5 g/m(2 ). From the day after to the day before each cycle of chemotherapy, fi lgrastim was administered by subcutaneous Injection at a dose of 5 mu g/kg. Results: After a median follow-up of 33 months, 80% of the patie nts were alive and disease-free. Five patients had relapsed: three in the liver, one in the peritoneum and one in the lymph nodes. Toxicity was mild: five patients experienced WHO grade III toxicity (three leuk openia, two thrombocytopenia); no toxic deaths occurred. Conclusion: i ntensive weekly chemotherapy is a feasible postoperative treatment opt ion for patients with resected gastric cancer at high risk of relapse. These data, together with recent results in advanced disease, make th is approach of interest for the development of new programs of adjuvan t therapy in this setting.