Roche’s Xeloda gets SMC green light for stomach cancer

by | 10th Sep 2007 | News

The Scottish Medicines Consortium has recommended the use of Roche's oral chemotherapy treatment, Xeloda (capecitabine), as first line treatment for advanced stomach cancer in NHS Scotland.

The Scottish Medicines Consortium has recommended the use of Roche’s oral chemotherapy treatment, Xeloda (capecitabine), as first line treatment for advanced stomach cancer in NHS Scotland.

The new guidance issued on September 10 will mean that the 700 people diagnosed with advanced stomach cancer each year in Scotland will have access to an alternative to the current standard treatment which involves invasive treatment with 5-fluorouracil (5-FU), which typically lasts six months of the 9-10 months life expectancy of a patient with the advanced form of the disease. Approval of the use of Xeloda in combination with a platinum-based chemotherapy regimen will avoid the need for frequent trips to hospital for the lengthy infusion process with 5-FU.

SMC guidance was based on the two trials, ML17032 and REAL 2, used by Roche to gain European approval for Xeloda’s indication for advanced stomach cancer earlier this year. Both trials showed that patients on the Xeloda-containing arms (ECX: epirubicin, cisplatin and Xeloda) lived as long as those on the 5-FU arms (ECF: epirubicin, cisplatin and 5-FU). A comparative cost analysis of the two regimens, plus the associated costs of providing continuous 5-FU infusion, resulted in net savings of £1,139 per patient with Xeloda.

The direct cost of Xeloda to NHS Scotland is estimated by Roche at £32,000 in year one for 100 patients, rising to £169,000 in year five for 367 patients. Although Xeloda is more expensive than 5-FU, the benefits of oral administration of Xeloda could produce estimated net savings of £58,000 in year one, rising to £300,000 by year five.

The use of Xeloda in place of 5-FU is expected to produce benefits for patients as well as the health service. Unlike 5-FU, oral Xeloda does not require specialist staff or facilities for administration, while patients will benefit from the avoidance of complications and safety issues associated with continuous intravenous infusion and potential number of hospital visits. While capecitabine is associated with some side-effects, most are reversible and do not require discontinuation of therapy.

Stomach cancer is the seventh most common cancer in the UK, with an above UK-average incidence among patients in Scotland. Some 845 people are diagnosed with stomach cancer each year in Scotland, with Greater Glasgow and Lothian having the highest incidence. Stomach cancer is nearly twice as common in men as in women. Jeanette Marchant

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