Roche has filed an additional indication in Europe and the US for its cancer drug Xeloda to treat colon cancer patients after surgery (adjuvant therapy). The submission to the European and the US regulatory authorities is based on results from the successful X-ACT trial (Xeloda in Adjuvant Colon Cancer Therapy) which demonstrated that Xeloda, an oral chemotherapy treatment, could replace commonly used intravenous 5-FU/LV based therapy. Adjuvant therapy is one of the most common treatment approaches in colon cancer patients.
The global study involved almost 2,000 patients and has first been presented at this year's American Society of Clinical Oncology (ASCO) conference in New Orleans. The X-ACT trial successfully met its primary endpoint of demonstrating at least equivalent disease free survival compared to intravenous 5-FU/LV. Moreover, it proved that Xeloda reduced the risk of tumours coming back (relapse-free survival) by an impressive 14 per cent. This means that, each year, if treated with Xeloda, nearly 4,000 additional colon cancer patients worldwide would not suffer a recurrence of their cancer, a release from Roche said.
William M Burns, head of Roche's Pharmaceuticals Division said, "Our endeavour is to constantly improve treatment options in cancer. We are therefore pleased to be able to work with the regulatory authorities to also improve the therapy of patients with early stage colon cancer, encouraged by the outstanding results of the X-ACT study."
As further presented at ASCO, Xeloda also saved medical resources compared to intravenous chemotherapy. On average, a patient only needed about 8 hospital visits if treated with Xeloda compared to about 30 visits if treated with intravenous chemotherapy and Xeloda treatment resulted in fewer drug costs to treat chemotherapy side effects. Roche will present a full pharmacoeconomic analysis of Xeloda at this year's European Society of Medical Oncology congress in Vienna, Austria.
The lead investigator Professor Jim Cassidy concluded his oral presentation at ASCO by stating: "Capecitabine (Xeloda) should replace 5-FU/LV in adjuvant treatment of colon cancer."
The results of the X-ACT trial further support the ongoing and planned adjuvant studies of Xeloda in combination with other chemotherapies and targeted therapy such as Avastin, enrolling over 6000 patients on a global level.