ML17032 trial: capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in advanced gastric cancer.

The combination of infusional 5-fluorouracil (5-FU) and cisplatin is commonly used for the treatment of advanced gastric cancer. Capecitabine is an oral fluoropyrimidine designed to mimic a continuous infusion of 5-FU, and its use can prevent the need for cumbersome intravenous catheters and hospitalization of patients. Capecitabine has another pharmacologic advantage over intravenous 5-FU as it is preferentially activated by 5-FU in tumor tissue, which has higher activity of thymidine phosphorylase than normal tissue, resulting in selective accumulation of 5-FU within tumor tissue. The final analysis of a large, international, multicenter Phase III trial (ML17032) comparing capecitabine/cisplatin versus 5-FU/cisplatin as first-line therapy in patients with advanced gastric cancer was recently published in Annals of Oncology. The purpose of this review is to summarize the ML17032 study, and to discuss the impact and implications of the results.