Randomized prospective phase II study to compare the combination chemotherapy regimen epirubicin, cisplatin, and 5-fluorouracil with epirubicin, cisplatin, and capecitabine in patients with advanced or metastatic gastric cancer.

Abstract

OBJECTIVES:

The aim of this study was to compare the efficacy and safety of the epirubicin, cisplatin, and continuous infusion of 5-fluorouracil (ECF) regimen with that of the epirubicin, cisplatin, and capecitabine (ECX) regimen in patients with advanced or metastatic gastric cancer.

METHODS:

Patients were randomized to receive either the ECF or ECX regimen. The primary end point was the response rate. The secondary end points were time to progression (TTP), overall survival (OS), and safety.

RESULTS:

Eighty-five patients were enrolled in the study from January 2003 to March 2007. Forty-five patients received the ECF regimen and 40 patients received the ECX regimen. The objective response rate was 31% [9% complete response (CR) and 22% partial response (PR)] for ECF and 30% (10% CR and 20% PR) for ECX. The disease control rate was 51% and 73%, respectively (P<0.05). Median OS and TTP were 6.8 and 5.5 months, respectively, in the ECF group and 8.3 and 6.0 months, respectively, in the ECX group. The majority of adverse events were grade 1/2. The most frequent grade 3/4 adverse events in both groups were fatigue (ECF 15%, ECX 21%), neutropenia (ECF 16%, ECX 16%), vomiting (ECF 11%, ECX 8%), nausea (ECF 9%, ECX 3%), and anemia (ECF 7%, ECX 5%).

CONCLUSIONS:

The ECX regimen was at least as effective as the ECF regimen with a similar tolerability profile, and could therefore replace the ECF regimen for the first-line treatment of patients with advanced gastric cancer.

• Authors: Janja Ocvirk, Martina Reberšek, Erik Skof, Zvezdana Hlebanja, Marko Boc
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 35 Issue 3 Pg. 237-41 (Jun 2012) ISSN: 1537-453X [Electronic] United States
• PMID: 21399488 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Deoxycytidine
• Epirubicin
• Capecitabine
• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Capecitabine
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Epirubicin (administration & dosage)
• Female
• Fluorouracil (administration & dosage, analogs & derivatives)
• Follow-Up Studies
• Humans
• Liver Neoplasms (drug therapy, mortality, secondary)
• Male
• Middle Aged
• Neoplasm Staging
• Peritoneal Neoplasms (drug therapy, mortality, secondary)
• Prognosis
• Prospective Studies
• Stomach Neoplasms (drug therapy, mortality, pathology)
• Survival Rate
• Young Adult