Phase II study with the combination etoposide, doxorubicin, and cisplatin in advanced measurable gastric cancer.

Abstract

In this phase II multicenter trial, 67 evaluable patients with advanced measurable gastric carcinoma were treated with a combination of etoposide, Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and cisplatin (EAP). The overall response rate was 64%, including 21% complete responses (CRs). In 55 patients with metastatic disease, 31 responses (51%) including eight CRs (15%) were achieved. Responses were seen in all metastatic sites, but the response rate was lower in patients with peritoneal carcinomatosis. In 12 patients with locoregional disease, six CRs and six partial responses (PRs) were observed. Eight CRs (three and five in patients with metastatic and locoregional disease, respectively) were pathologically confirmed. The overall median response duration was 7 months; it was 16 months for patients achieving CR (22 months for pathologically confirmed CR [pCR]), and 6 months for PR. The median survival time for all patients was 9 months, for the patients who achieved CR 17 months, for pCR 23 months, and for PR 9.5 months. Median survival time for all patients with metastatic disease was 8 months, and for locoregional disease 12.5 months. Six patients (9%) (four local, two metastatic disease) were alive at 2 years, and four patients are alive and disease free at 35+ to 56+ months. Main toxicities were leukopenia and thrombocytopenia, with 64% of patients developing grade 3 to 4 myelosuppression and 12% severe infections. Nonhematologic toxicities of World Health Organization (WHO) grade 4 were not observed.

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).…”

Combination chemotherapy of irinotecan plus cisplatin for advanced gastric cancer: efficacy and feasibility in clinical practice

“…[2][3][4][5] However, none of the combination regimens have yet demonstrated a prolongation of survival as compared with 5-fluorouracil alone; [6][7][8] accordingly new active chemotherapy regimens are needed. Irinotecan hydrochloride (CPT-11) is a water-soluble, semisynthetic derivative of camptothecin (CPT) that retains the original antitumor activity of CPT, but has lower toxicity.…”

Docetaxel and oxaliplatin combination in second-line treatment of patients with advanced gastric cancer

“…The combination of 5-fl uorouracil (5-FU), doxorubicin, and mitomycin-C (FAM) was considered the standard regimen until the FAMTX schedule (including 5-FU, doxorubicin, high-dose methotrexate, and leucovorin) was shown to be superior in terms of both response rates (41% vs 9%) and overall survival (42 vs 29 weeks) [8]. On the other hand, cisplatin (CDDP)-based regimens demonstrated response rates of between 37% and 72% in phase II studies [9,10], although these results were not confi rmed in phase III studies [11][12][13]. More recently, the ECF combination regimen of CDDP, epirubicin (EPI), and infusional 5-FU proved very effective in phase II studies [14,15], and it was superior to FAMTX in terms of response rates (46% vs 21%; P = 0.0002) and overall survival (8.7 vs 6.1 months; P = 0.0005) in a randomized phase III comparison, with mild toxicity (16).…”