Epirubicin, cisplatin and continuous infusion 5-fluorouracil (ECF) in locally advanced or metastatic gastric cancer: A single institution experience

Aims and Background: The role of chemotherapy in locally advanced or metast atic gastric cancer has been controversial, but chemotherapy has recently b een shown to relieve tumor-related symptoms, improve quality of life and pr olong survival when compared with best supportive care. Furthermore, pallia tive chemotherapy is also cost-effective. "Second-generation" combination c hemotherapy regimens were developed in the 1980s with high activity in adva nced or metastatic gastric cancer (EAP, FAMTX, PELF, ECF). In randomized st udies, EAP demonstrated no difference in activity but a significantly highe r overall toxicity and toxic death rate than FAMTX, and the ECF (epirubicin , cisplatin, 5-fluorouracil) regimen gave a survival and response advantage , tolerable toxicity, better quality of life and was more cost-effective th an FAMTX: Methods: Sixty patients with locally advanced or metastatic gastric cancer were treated with the ECF regimen (21 weeks of 8-fluorouracil given by cont inuous infusion through a central line at 200 mg/m(2) for 24-hr combined wi th cisplatin at 60 mg/m(2) iv and epirubicin at 50 mg/m(2) iv beginning on day 1 and repeated every 3 weeks for 8 courses). There were 42 males and 18 females, with a median age of 64 years (range, 40-74). The median performa nce status was 1. The histologic type was adenocarcinoma in 44 patients and undifferentiated carcinoma in 16 (27%). Three patients had locally advance d disease (5%) and 57 had metastatic disease (95%). Seven patients (12%) ha d received prior chemotherapy for advanced disease. Results: All patients were assessable for toxicity and 55 for response (5 h ad insufficient treatment). Toxicity was mild or moderate, and there was no toxic death. Incidence of WHO toxicity greater than or equal to 2 was naus ea and vomiting in 3%, mucositis in 3%, leukopenia in 7%, anemia in 3%, and thrombocytopenia in 2%. Fort-a-oath toxicity was thrombosis in 4, dislocat ion in 2 and infection in 3 patients. Seven complete responses and 13 parti al responses (overall response rate, 36%) were achieved, with a response ra te of 39% in untreated and 17% in pretreated patients. Nine patients (16%) had stable disease and 26 (47%) progressive disease. Most patients felt sym ptomatically improved on ECF. Conclusions: Our study confirms that the ECF regimen has a favorable patter n of toxicity and is feasible on an outpatient basis. However, it did not c onfirm the high response rate reported in other phase II trials.