Phase II study of short-time oxaliplatin, capecitabine and epirubicin (EXE) as first-line therapy in patients with non-resectable gastric cancer

Abstract

Epirubicin, cisplatin and continuous infusion of 5-FU is a widely used palliative regimen in patients with gastric cancer. If cisplatin is substituted by oxaliplatin and 5-FU by capecitabine this regimen can be administered in the outpatient setting. Dose-limiting toxicity of oxaliplatin is peripheral sensory neuropathy and it is recommended to give oxaliplatin as a 120 min infusion. However, in patients with colorectal cancer a 30 min infusion of oxaliplatin can safely be administered without increasing neurotoxicity, standard infusion time is 30 min at our departments. In our phase I study the recommended doses of EXE was established (Dupont et al, 2006). Patients with non-resectable gastric adenocarcinoma were eligible. Patients received EXE (epirubicin 50 mg m À2 day 1; capecitabine 1000 mg m À2 day À1 continuously and oxaliplatin 130 mg m À2 day 1) as outpatient therapy every third week for a maximum of 8 cycles. From June 2004 to September 2005, we enroled 54 patients. Median age was 60 years (31 -74 years) Median number of courses was 6 (1 -8). Response rate was 45%. Median PFS was 6.8 (5.2 -7.9) months and median survival was 10.1 (7.9 -11.1) months. Most important grade 3 toxicities were as follows: nausea, vomiting, and diarrhoea (6%). Neurotoxicity grade 2 was seen in 36.5%. We therefore conclude, that EXE every third week is a convenient regimen that easily can be administrated in the outpatient setting but the regimen needs further evaluation in a phase III study.

Docetaxel, oxaliplatin, and capecitabine combination chemotherapy for metastatic gastric cancer

“…A potential concern with the modified doses was that efficacy may be compromised. Nevertheless, both our study and a series of other reports exploiting the same doses of capecitabine and oxaliplatin indicated that the therapeutic index was maintained [33][34][35][36][37], as outcomes were comparable with those reported with standard regimens such as DCF, EOX, and ECF. Therefore, comparative trials with the commonly employed regimens mentioned here should be carried out to better define the role of DOC in gastric cancer.…”

A Phase II Trial of Epirubicin, Oxaliplatin, and Capecitabine (EOX) as First-Line Chemotherapy in Advanced Gastric Cancer: A Chinese Single-Center Experience

“…There was a nonsignificant difference in PFS among the groups, but OS was longer in the EOX group than in the ECF group (11.2 vs. 9.9 months; p = 0.02). Recently, Schoennemann et al [28] reported a similar regimen EXE (epirubicin 50 mg/m 2 day 1, capecitabine 500 mg/m 2 twice daily continuously and oxaliplatin 130 mg/ m 2 day 1; every 3 weeks), which also showed promising results in nonresectable gastric cancer patients. Response rate was 45%, median PFS was 6.8 months, and median OS was 10.1 months.…”

The Advanced Generation of Oral 5-Fluorouracil Available in Europe – Teysuno® (S-1)

“…with greater toxicity and requires adequate hydration in patients with renal damage, and substituting 5-FU for capecitabine, eliminating the need for central-venous access and portable infusion pumps. 51,52 In the phase III trial, patients (n=1,002) were randomised to one of four regimens: ECF, ECX, EOF or EOX. 34 Capecitabine and oxaliplatin were found to be as effective 5-FU and cisplatin, with no significant differences in efficacy, but compared head to head, EOX was more effective than ECF.…”