The value of combination chemotherapy in advanced oesophagogastric cancer has been clarified. Three randomized clinical trials have demonstrated the superiority of chemotherapy over best supportive care alone (Murad et al, 1993;Pyrhonen et al, 1995;Glimelius et al, 1997). However, the optimal regimen has not yet been established. The combination of 5-fluorouracil (5-FU), adriamycin and methotrexate (FAMTX) has been considered standard therapy, with superior response and survival rates compared with previous regimens (Wils et al, 1991;Kelsen et al, 1992). A combination of cisplatin, epirubicin, leucovorin and 5-FU (PELF) has also demonstrated impressive response rates in a randomized study (Cocconi et al, 1994). The regimen of epirubicin, cisplatin and 5-FU (ECF) was developed at the Royal Marsden Hospital (RMH) and first reported in 1991 (Cunningham et al, 1991). The three drugs in this regimen were selected on the basis of their single agent activity in upper gastrointestinal tract tumours (Beer et al, 1983;Cersosimo and Hong, 1986;Machover et al, 1986), and on the synergy demonstrated between 5-FU and cisplatin in preclinical models (Etienne et al, 1991). The 5-FU is delivered as a protracted infusion as this schedule has produced higher response rates with less myelotoxicity compared with bolus administration in patients with colorectal cancer (Lokich et al, 1989). Following the demonstration of response rates of 71% with moderate toxicity in a phase II study (Findlay et al, 1994), we undertook a multicentre randomized study comparing ECF with FAMTX in advanced oesophagogastric cancer. The initial results of this trial were reported in 1996 when recruitment was completed (Webb et al, 1997). At that stage, an advantage for ECF in response rate and survival was evident. However, median follow-up was only 6.1 months and only 75% of patients had died. We now present a final survival analysis with all patients followed up for 26.9 months or more (median 44 months), and 95% of patients having died. METHODSOur methods have been described previously (Webb et al, 1997). Briefly, patients with inoperable adenocarcinoma or undifferentiated carcinoma of the oesophagus, oesophagogastric junction, or stomach were randomized to receive ECF or FAMTX chemotherapy. ECF chemotherapy was administered through a central venous catheter placed in the subclavian vein. 5-FU was given as a continuous intravenous infusion at a dose of 200 mg m -2 day -1 for up to 6 months. Epirubicin (50 mg m -2 ) and cisplatin (60 mg m -2 ) were given every 3 weeks to a maximum of 8 cycles. FAMTX chemotherapy comprised methotrexate 1500 mg m -2 and 5-FU 1500 mg m -2 on day 1, and doxorubicin 30 mg m -2 on day 15. Cycles were repeated every 28 days to a maximum of 24 weeks. Patients were followed up with clinical and symptomatic SummaryWe report the final results of a prospectively randomized study that compared the combination of epirubicin, cisplatin and protracted venous infusion fluorouracil (5-FU) (ECF regimen) with the standard combination of 5-...

The ECF regimen displays high anti-tumour activity with moderate toxicity in patients with gastric cancer and in some cases enabled resection of previously inoperable tumours.

In a multivariate analysis of 154 patients receiving chemotherapy, baseline CA19-9 was an independent prognostic factor for overall survival (OS) (HR 1.8; 95% CI: 1.3 -2.5, P ¼ 0.0004). The 1-year OS was 19 and 46%, respectively, for patients with a baseline CA19-9 above or below the median value. A fall of 20% in CA19-9 level from baseline was an independent prognostic factor for OS (HR 1.9; 95% CI: 1.1 -3.4, P ¼ 0.019).

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