Fresh clinical data on Roche’s cancer drug Xeloda indicate that it is at least as effective as the current gold standard treatment for colorectal cancer, and is associated with fewer side effects.

The group presented five-year follow-up survival data from the X-ACT (Xeloda in Adjuvant Colon Cancer Trial) study at the 14th European Cancer Conference in Barcelona, Spain, which showed survival rates of 71.4% in patients with D colon cancer taking the adjuvant oral chemotherapy Xeloda (capecitabine) compared to 68.4% for those given the standard intravenous bolus 5-FU/LV (5 fluorouracil/leucovorin).

Furthermore, additional data unveiled at the meeting from a previous analysis demonstrate that Xeloda is also comparable to 5-FU/LV with respect to disease-free survival and relapse-free survival, the group added.

Commenting on the findings, Dr Howard Burris of the Sarah Cannon Research Institute in Nashville, Tennessee, and lead US investigator in the study, said that they "provide further proof that Xeloda can be a safe and effective alternative to the current standard of care for adjuvant colorectal cancer, which can require upwards of 30 clinic visits over the 24-week treatment course.” This is an important point because results from X-ACT showed that, on average, a patient only needs eight hospital visits when treated with Xeloda.

“Based on this evidence, physicians – especially those who have relied on 5- FU/LV - should feel confident about exploring Xeloda as a treatment option with their patients who could benefit from the flexibility of oral chemotherapy," he concluded.

Xeloda is certainly a key player in Roche’s oncology franchise, and is the only US Food and Drug Administration-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer, according to the firm.

Targeted therapy

The drug’s flagship benefit is that it is administered orally in pill format, only becoming activated when it comes into contact with a naturally occurring protein called thymidine phosphorylase, which triggers an enzyme reaction transforming it into a cytotoxic drug. Many cancers have higher levels of this protein than normal tissue, so the drug is largely delivered to where it is needed, killing more cancerous than healthy tissue.

Previous results from the X-ACT study have shown that Xeloda is associated with fewer side effects than the standard therapy, and the group claims that, importantly, “many of the side effects can be easily managed by altering the dose without compromising efficacy.” To further illustrate this, Roche said that, in the same analysis, costs for medicines to treat side effects were cut nearly 75% in the Xeloda arm compared to use of intravenous 5-FU/LV.

"We are pleased to see that Xeloda is standing up to its initial promise as an alternative to 5-FU/LV," commented Lars Birgerson, Vice President of Medical Affairs at Roche.