Epirubucin, cisplatin, and continuous infusion 5-fluorouracil is an active and safe regimen for patients with advanced gastric cancer. An italian group for the study of digestive tract cancer (GISCAD) report

Abstract

Background. A Phase II confirmatory multicenter trial was performed to evaluate a combination of epirubicin, cisplatin, and continuous infusion 5‐fluorouracil (ECF) in treating patients with advanced gastric cancer. Methods. Fifty‐three patients with locally advanced (n = 7) or metastatic (n = 46) gastric cancer received a dose of epirubicin (50 mg/m2) and cisplatin (60 mg/m2) intravenously every 21 days for eight cycles with 5‐fluorouracil (200 mg/m2/day) by intravenous continuous infusion for 21 consecutive weeks, administered through a central line using an external pump. Results. Eight complete responses and 22 partial responses (response rate = 56%, 95% confidence interval ± 13) were achieved. Twelve patients had stable disease. The median duration of response was 10 months (range, 3‐21 months), and the median survival for all the patients was 9+ months (range, 2‐28 months). Overall toxicity, which was primarily hematologic, was mild with only three patients requiring hospitalization for neutropenic fever. No death due to toxicity occurred. Conclusions. This study found that the ECF regimen is substantially active in treating patients with advanced gastric cancer and has a favorable pattern of toxicity. This schedule clearly deserves randomized comparative trials for palliation of metastatic disease and for adjuvant purposes. Cancer 1995:76:1694‐9.

Phase II study of weekly oxaliplatin and 24-h infusion of high-dose 5-fluorouracil and folinic acid in the treatment of advanced gastric cancer

“…Chemotherapy is used primarily for palliation of symptoms (Findlay and Cunningham, 1993;Wils, 1996;De Vivo et al, 2000). In the past three decades, a variety of chemotherapy regimens were developed for the treatment of advanced gastric cancer (MacDonald et al, 1980;Preusser et al, 1989;Wilke et al, 1990;Wils et al, 1991;Kim et al, 1993;Cocconi et al, 1994;Zaniboni et al, 1995;Ychou et al, 1996;Cheng et al, 1998). All these regimens had variable degrees of success in phase II trials; however, results of the subsequent phase III trials often failed to confirm the relatively high response rates of earlier reports (Kelsen et al, 1992;Kim et al, 1993;Cocconi et al, 1994;Webb et al, 1997;Vanhoefer et al, 2000).…”

Weekly etoposide, epirubicin, cisplatin, 5-fluorouracil and leucovorin: an effective chemotherapy in advanced gastric cancer

“…Cisplatin and 5-FU (PF) are synergistic in vitro (Schabel et al, 1979), and PF chemotherapy has resulted in a 51% response in advanced gastric cancer patients (Kim et al, 1993). Etoposide and epirubicin are regarded as being active agents for the treatment of gastric cancers and have been integrated into many combination chemotherapy regimens (Wilke et al, 1990;Findlay et al, 1994;Zaniboni et al, 1995). The combination of cisplatin and a 21-day infusion of 5-FU and leucovorin (PFL) has produced a 48% response rate (Leichman et al, 1994).…”

True

“…Nonetheless, this combination is clearly active in patients with advanced gastro-oesophageal cancer with an overall response rate of 38% in a limited number of evaluable patients. Whilst this is lower than the phase II response rates initially obtained with infusional 5-FU in combination with epirubicin and cisplatin (Findlay et al, 1994;Zaniboni et al, 1995), it is similar to that obtained with other platinum-containing regimens (Elliott et al, 1990;Sparano et al, 1990;Lacave et al, 1991;Cervantes et al, 1993;Bajetta et al, 1994Bajetta et al, , 1998Taal et al, 1994;Kondo et al, 1996;Cheng et al, 1998) or with ECF in randomized studies (Webb et al, 1997). The median survival of 9.9 months compares with 8.9 months obtained with ECF and between 7 and 11 months with other cisplatin-based therapies (Lacave et al, 1991;Cervantes et al, 1993;Bajetta et al, 1999Bajetta et al, , 1998Kondo et al, 1996;Cheng et al, 1998).…”

“…In an initial study with this regimen, an overall response rate of 71% and a complete response rate of 12% were observed. These encouraging results have been confirmed in two subsequent studies, with overall response rates of around 60% and with complete responses occurring in around 10% of patients (Highley et al, 1994;Zaniboni et al, 1995). In a multi-centre randomized study, ECF resulted in significantly better response rate (45%) and median survival (8.9 months), with significantly less toxicity compared to the FAMtx regimen (Webb et al, 1997).…”