Evaluating the effectiveness and safety of capecitabine maintenance versus active monitoring for the treatment of patients with metastatic colorectal cancer.

This study investigated the effectiveness and safety of capecitabine (Xeloda) as maintenance therapy versus active monitoring for the treatment of patients with stable metastatic colorectal cancer (mCRC). The data showed that capecitabine maintenance improved survival without cancer worsening with manageable side effects for these patients.

Standard treatment for patients with mCRC usually involves a combination of chemotherapy and targeted therapy. Maintenance treatment is commonly used after first-line treatment in some cancers to delay relapse or slow down cancer.

Capecitabine is a chemotherapy drug that has shown good results when used alone for patients with metastatic CRC. Bevacizumab is a type of targeted therapy. It works by stopping tumors from forming new blood vessels and spreading. Studies have shown that a combination of capecitabine and bevacizumab improves the outcomes of patients when compared with a complete treatment break with active monitoring. However, the effectiveness and safety of capecitabine alone as maintenance therapy versus active monitoring for the treatment of patients with mCRC remain under investigation.

This study involved 254 patients with mCRC. All patients received 16 weeks of first-line therapy and were responding to treatment or had stable disease. Patients were randomly assigned into 2 groups. Group 1 included 127 patients who received capecitabine maintenance. Group 2 included 127 patients who received active monitoring.

The average survival without cancer worsening was 3.88 months in group 1 compared to 1.87 months in group 2. Patients in group 1 were 60% more likely to survive without cancer worsening compared to patients in group 2.

The average overall survival was 15.2 months in group 1 compared to 14.8 months in group 2. Patients in group 1 were 7% more likely to have a better overall survival compared to patients in group 2. This difference was not statistically significant.

The most common side effects were fatigue (25% in group 1 vs 12% in group 2), diarrhea (23% in group 1 vs 13% in group 2), and redness, swelling, and pain in the palms and feet (26% in group 1 vs 3% in group 2). There was no difference in the quality of life between the 2 groups.

This study concluded that capecitabine maintenance improved survival without cancer worsening compared to active monitoring, but did not significantly improve overall survival in patients with mCRC.

The sample size was small. This study was carried out only in institutions in the United Kingdom and may not translate to different populations.