PHASE-II STUDY OF A SEQUENTIAL SCHEDULE OF ETOPOSIDE, FOLINIC ACID, 5-FLUOROURACIL, AND CISPLATIN (ELF-P) IN PATIENTS WITH ADVANCED GASTRIC-CANCER

Background: ELF (etoposide, leucovorin, and 5-fluorouracil) is one of the new active chemotherapy regimens in gastric cancer. Based on the s ingle agent activity of cisplatin in gastric cancer, a sequential sche dule of ELF and cisplatin (ELF-P) was investigated in a phase II study . Methods: 33 previously untreated patients with unresectable locally advanced (LAD) or metastatic gastric cancer were entered. Chemotherapy consisted of folinic acid 300 mg/m(2), etoposide 120 mg/m(2), and 5-f luorouracil 500 mg/m(2) on days 1 - 3 and cisplatin 50 mg/m(2) on days 8 and 15; the chemotherapy was repeated every 29 days. Patients with LAD were planned to undergo secondary tumor resection. Results: 32 pat ients were evaluable for response and toxicity. Two (6%) complete and 15 (47%) partial remissions were achieved, (overall response rate 53% (95% confidence interval: 35%-71%)). In patients with locally advanced disease 73% (95% confidence interval: 46 % - 100%) remissions were in duced, while patients with metastatic disease showed in 43% (95% confi dence interval: 21% - 65%) an objective response. Eight out of 11 pati ents with LAD achieved a remission and seven of them underwent complet e resection of the tumor. The median survival time was 9 months in pat ients with metastatic disease, and 15 months for patients with LAD. Th e main toxicity of ELF-P was myelosuppression, which caused a dose red uction of cisplatin or a treatment delay in 53% of all courses. No tre atment-related deaths occured. Conclusions: ELF-P is an active combina tion for the treatment of advanced gastric cancer. However, the result s of the present study do not indicate that ELF-P is superior to other chemotherapeutic regimens (e.g. ELF, FAMTX, 5-FU/CDDP) with respect t o response rates and survival time.