A pilot clinical trial of postoperative intensive weekly chemotherapy using 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 treatment for patients with resected gastric cancer at high risk of recurrence (pT(2)N(1-2); pT(3-4)N(any) M0). PATIENTS AND METHODS: Starting 21 to 28 days after potentially curative surgery for primary gastric cancer, 25 patients received 8 weekly cycles of cisplatin 40 mg/m2, 5-fluorouracil 500 mg/m2, epidoxorubicin 35 mg/m2, 6S-stereoisomer of leucovorin at a dose of 250 mg/m2, and glutathione at a dose of 1.5 g/m2. From the day after to the day before each cycle of chemotherapy, filgrastim was administered by subcutaneous injection at a dose of 5 microg/kg. RESULTS: After a median follow-up of 33 months, 80% of the patients 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 leukopenia, two thrombocytopenia); no toxic deaths occurred. CONCLUSION: Intensive weekly chemotherapy is a feasible postoperative treatment option for patients with resected gastric cancer at high risk of relapse. These data, together with recent results in advanced disease, make this approach of interest for the development of new programs of adjuvant therapy in this setting.

High dosage alpha-interferon for treatment of children and young adults with chronic hepatitis C disease.

BACKGROUND: There are limited data on the use of high interferon (IFN) dosage for treatment of children and young adults with hepatitis C virus infection and in those affected by thalassemia major (TM). OBJECTIVES: To assess the response of children and young adults with chronic hepatitis C disease, including those affected by TM, to high dose natural alpha-interferon (IFN-alpha). To evaluate the effect of iron overload in response to high dose IFN-alpha in young chronic hepatitis C virus thalassemia patients. METHODS: We conducted a therapeutic trial of natural IFN-alpha, using 10 million units/m2 three times a week for 6 months in 14 chronic hepatitis C patients ages 5 to 28 years; 7 also had TM. The follow-up period lasted 12 months. RESULTS: Ten patients (73%) showed normal or nearly normal alanine aminotransferase values at the end of follow-up (biochemical response), but only five (35%) were negative for serum hepatitis C virus-RNA (complete responders). Four of the patients (57%) with TM were sustained complete responders. No correlation was found between the initial serum concentration of ferritin and response to IFN therapy. Patients infected with genotype 1b showed a poor response although high dose of natural IFN was used. CONCLUSIONS: These results indicate that IFN-alpha can be used in children and young patients with chronic hepatitis C disease as well as in those affected by TM. Treatment with high dosage natural IFN-alpha in children and young adults with hepatitis C infection does not appear to be more effective than dosages previously used.