Capecitabine Plus Irinotecan Appears as Initial Therapy for (CRC)

Capecitabine Plus Irinotecan Appears Promising as Initial Therapy for Metastatic Colorectal Cancer

According to results presented at the first-ever Gastrointestinal Cancers Symposium, the chemotherapy combination consisting of capecitabine (Xeloda®) and irinotecan (Camptosar®) appears to be a promising treatment regimen as initial therapy for metastatic colorectal cancer.

The colon and rectum are the major parts of the large intestine. Metastatic colorectal refers to cancer that has spread from the colon or rectum to distant sites in the body. Treatment for metastatic colorectal cancer typically includes chemotherapy, delivered with the intent of extending the duration of survival and/or improving the quality of life of a patient. One standard treatment regimen for metastatic colorectal cancer consists of the chemotherapy agents irinotecan, 5-fluorouracil (5-FU) and leucovorin (LV). Capecitabine is also a chemotherapy agent that is used in the treatment of colorectal cancer, however, it is FDA approved as a single agent for treatment of advanced colorectal cancer in patients where 5-FU/LV is the preferred treatment, compared to combinations of chemotherapy agents. Capecitabine contains the compounds of 5-FU that elicit anti-cancer activity. However, capecitabine may be taken orally, instead of being administered into a vein like 5-FU.

Researchers from the University of Maryland recently conducted a multi-institutional clinical trial evaluating capecitabine in combination with irinotecan as initial treatment for metastatic colorectal cancer. This trial included 52 patients, the majority of whom had cancer that had spread to several sites in the body. Nearly half of the patients experienced an anti-cancer response to irinotecan/capecitabine, (referred to as XELIRI). The average time to cancer progression was 7.1 months and the average overall survival was approximately 16 months. In addition, 4 of 29 patients with cancer spread to the liver were able to have their cancer surgically removed following XELIRI. Most side effects were mild to moderate in severity, with the most common being nausea and vomiting, diarrhea and abdominal pain.

A second clinical trial conducted by the Sarah Cannon Cancer Center in Tennessee also evaluated XELIRI as initial treatment for metastatic colorectal cancer, although a different dosing strategy than the first trial was utilized. This trial also included 52 patients, the majority of whom had cancer that had spread to several sites in the body. Approximately one-third of patients experienced an anti-cancer response, and another one-third experienced disease stabilization. The average time to cancer progression was 5.4 months, and the average overall survival was approximately 17 months. Side effects in this trial were mostly mild to moderate in severity, with diarrhea, and nausea and vomiting being the most common.

The researchers from both of these clinical trials concluded that the chemotherapy combination consisting of capecitabine and irinotecan appears to be very active and generally well tolerated as initial therapy for metastatic colorectal cancer. The oral administration of capecitabine provides greater convenience than would the intravenous administration of 5-FU in terms of time management for the patient and healthcare staff, medical cost, pain and the possibility of infection. Future clinical trials directly comparing XELIRI to irinotecan/5-FU are warranted to establish the true clinical benefit of capecitabine in this treatment regimen. Patients with metastatic colorectal cancer who are to undergo chemotherapy may wish to discuss the risks and benefits of participation in a clinical trial further evaluating XELIRI or other promising therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (

cancer.gov) and

www.cancerconsultants.com Personalized clinical trial searches are also performed on behalf of cancerconsultants.com.

Reference: Roche Pharmaceuticals. New studies with Xeloda (capecitabine) in colorectal cancer treatment presented at first-ever GI cancer symposium. Available at: http://www.rocheusa.com/newsroom/current/2004/pr2004012402.html. Accessed February 2004.

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