High dose folinic acid/etoposide/5-fluorouracil in advanced gastric cancer — a phase II study in elderly patients or patients with cardiac risk

Abstract

Thirty-four consecutive patients with measurable advanced gastric cancer were treated in a disease oriented Phase II study with high-dose folinic acid (HDFA) 300 mg/m2 10 min. inf., followed immediately by etoposide 120 mg/m2 50 min. inf., followed immediately by 5-fluorouracil (5-FU) 500 mg/m2 10 min. inf., given on day 1,2,3 (ELF). Courses were repeated every 22-28 days. All patients who entered this study were older than 65 years or had underlying cardiac disease. Thirty-three patients were evaluable for response and toxicity (greater than or equal to 1 course). One patient was lost to follow up. The overall response rate was 48% (16/23) including 12% (4/33) complete remissions. Eight patients had minor responses or no change and 9 had progressive disease. Five of six patients with locally advanced and non-resectable disease had an objective response (1 CR, 4 PR's). The response rate in patients with metastatic disease was 41% (11/27). After a median observation time of 6.5 months, the median survival time was 10.5 months, with a median remission (CR + PR) duration of 8 months. Toxicity was manageable and included mild to moderate myelosuppression and gastrointestinal toxicities. One episode of life-threatening (Grade IV) leukopenia, and two episodes of severe diarrhea requiring hydration were noted. No treatment related death occurred. ELF is an effective combination in advanced gastric cancer and can be safely administered to elderly patients and patients with cardiac risk.

A phase II study of paclitaxel, weekly, 24-hour continuous infusion 5-fluorouracil, folinic acid and cisplatin in patients with advanced gastric cancer

“…In phase II trials, response rates up to 60% have been reported for regimens such as FAMTX, ELF, EAP, Cisplatin/5-FU or ECF (Klein et al, 1986;Preusser et al, 1989;Wilke et al, 1990;Findley and Cunningham, 1993;Wils, 1996). However, in randomised phase III trials, this high level of activity has only been confirmed for the ECF-regimen (Webb et al, 1997;Waters et al, 1999), whereas for the FAMTX, ELF or cisplatin/5-FU-regimen response rates of 20-25% have been reported (Kelsen et al, 1992;Wilke et al, 1995).…”

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).…”

A phase II study of weekly cisplatin, 6S-stereoisomer leucovorin and fluorouracil as first-line chemotherapy for elderly patients with advanced gastric cancer

“…To the best of our knowledge, six phase II studies have been published in international peer-reviewed journals between 1990 and 2002 (Wilke et al, 1990;Cascinu et al, 1994;Cascinu and Catalano, 1995;Di Bartolomeo et al, 1995;Hartung et al, 2000;Ikeda et al, 2002). In five of these trials, chemotherapy consisted of leucovorin-modulated 5-fluorouracil in combination with cisplatin, epi-doxorubicin, etoposide or mitomycin-C. A phase II study investigated the toxicity profile and the activity of single-agent doxifluridine (Ikeda et al, 2002).…”