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Oral Capecitabine: a Promising Alternative Treatment for Advanced Gastric Cancer: Presented at ESMO

By Adrian Burton

NICE, FRANCE -- October 21, 2002 -- Capecitabine has been found to provide good objective responses, improve time to disease progression, and yield good survival rates in the treatment of patients with advanced gastric cancer. The added advantage is that capecitabine is an orally administered drug and therefore improves patient quality of life, said researchers at the 27^th Congress of the European Society for Medical Oncology.

"In general, locally advanced metastatic gastric cancer is incurable," explained Dr. Eucario León-Rodríguez, Head of Oncology, National Science and Nutrition Institute, Mexico. "The regimens we have at the moment employ three drugs given intraveneously, toxicity is high, and the results not very good. Capecitabine, however, has a low toxicity profile and can be taken orally. We wanted to see whether this drug could help patients in this situation."

In this small phase II trial, 18 chemotherapy-naive patients (median age 58 years; range, 34-74 years) were enrolled to receive oral capecitabine (fluoropyrimidine carbamate, which converts to 5-fluorouracil (5-FU) once assimilated, especially in tumor tissue) at a dosage of 2500 mg/m² per day in two equally divided doses for 14 days, repeated every 3 weeks. The median number of cycles administered per patient was 5.5. All patients had histologic proof of disease. The median Karnofsky performance score was 90 percent.

Of 16 patients evaluable for response, 4 (25 percent) had a partial response and nine (56.3 percent) achieved stable disease for more than four cycles. Only three progressed to more advanced-stage disease. Eleven (68.8 percent) experienced alleviation of vomiting, nausea, and pain intensity.

Median time to progression was 21 weeks, median survival was 6.5 months, and actuarial survival at 1 year was 40 percent. Grade 3 and 4 toxicities (hand-foot syndrome, stomatitis, and nausea) were very rare, and all improved after dose reduction.

"Using standard treatment regimens, we might expect response figures to be rather similar," said Dr. León-Rodríguez, "In that respect, this new therapy is not at all worse. However, the toxicity profile of this drug is much more manageable – in fact, there are virtually no toxicity problems. When you add to this the fact that you can take this medicine at home and do not have to come to hospital for intravenous infusions, I think we can say this could be a promising treatment."

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