INTENSIVE WEEKLY CHEMOTHERAPY FOR ADVANCED GASTRIC-CANCER USING FLUOROURACIL, CISPLATIN, EPI-DOXORUBICIN, 6S-LEUCOVORIN, GLUTATHIONE, AND FILGRASTIM - A REPORT FROM THE ITALIAN GROUP FOR THE STUDY OF DIGESTIVETRACT CANCER

Purpose: A multiinstitutional trial was performed to clinical activity , in terms of response rate and toxicity (primary objectives) and dura tion of responses and survival (secondary objectives), of an intensive weekly regimen in advanced gastric cancer. Patients and Methods: pati ents with measurable unresectable and/or metastatic gastric carcinoma received 1-day per week administration of cisplatin (CDDP) 40 mg/m(2), fluorouracil (5FU) 500 mg/m(2), epi doxorubicin (epi-ADR) 35 mg/m(2), 6S-stereoisomer of leucovorin 250 mg/m(2), and glutathione 1.5 g/m(2) . On the ether days, filgrastim was administered by subcutaneous injec tion at a dose of 5 mg/kg. One cycle of therapy consisted of eight I-w eek treatments. Patients who showed a response or stable disease recei ved a further 6 weeks of therapy. Results: Of 105 enrolled patients, 1 1 had locally advanced unresectable disease only; 33 had primary nonre sected and metastatic disease; 48 had metastatic disease and primary t umor resected; 10 had locoregional recurrence and metastatic disease; and three had locoregional recurrence only. After one cycle, 18 comple te responses (CRs) and 47 partial responses (PRs) were achieved, for a n overall response rate of 62% (95% confidence interval [CI], 53% to 7 1%), Twenty patients had stable disease and 20 progressed on therapy. The median survival duration of all 105 patients was 11 months, with 1 - and 2-year survival rates of 42% and 5%, respectively, World Health Organization (WHO) grade III to IV toxicity, in terms of anemia, neutr openia, thrombocytopenia, and mucositis, was experienced by 40 patient s (38%). There were no treatment-related deaths. Conclusion: These dat a support the results of the pilot study and confirmed the high activi ty of the regimen, with acceptable toxicity. This schedule deserves ev aluation in the adjuvant setting. (C) 1997 by American Society of Clin ical Oncology.