The investigational agent Xilonix™ appears safe and effective for patients with advanced colorectal cancer. These findings were presented at the 2015 Gastrointestinal Cancers Symposium, January 15–17, in San Francisco, California.
According to estimates from the American Cancer Society, 93,090 cases of colon cancer and 39,610 cases of rectal cancer will be diagnosed in 2015. Colorectal cancer is the third leading cause of cancer death in both men and women and the second leading cause of cancer death for men and women are combined. But there is good news in colorectal cancer survival: mortality rates have been declining since 1980 in men and since 1947 in women. Improvements in survival are the result of lower incidence of the disease and improvements in early detection and treatment. 
Xilonix is a drug known as an anti-interleukin-1α True Human™ monoclonal antibody that’s thought to have broad antitumor activity. Xilonix is being studied as cancer therapy to improve overall survival in advanced colorectal cancer patients. By blocking a substance that helps tumours grow and spread, Xilonix therapy may not only slow tumour growth, but also may improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with colorectal cancer.
In this recent study, researchers evaluated Xilonix in 40 patients with colorectal cancer who also suffered from cachexia (loss of body weight and muscle mass and weakness). Patients included in the study had metastatic colorectal cancer and had lost at least 5% of their total body weight in the previous six months. Participants were divided into two treatment groups: one group received Xilonix every two weeks at a dose of 3.75 mg/kg (milligrams per kilogram of body weight); the other group received daily the synthetic progestin megestrol acetate (800 mg).
The most important outcome the researchers measured was overall survival. They also looked into patient well-being and measured platelet counts to watch for tumor progression (platelets increase during cancer progression).
Patients who received Xilonix had longer overall survival than those who received megestrol. The Xilonix group survived 39% longer, or 2.8 months versus 2 months. In fact, patients receiving megestrol had worse outcomes in all areas evaluated. The megestrol group had twice the risk death as those on Xilonix and also had declining well-being during treatment. The Xilonix group had no decline in well-being. Patients receiving Xilonix also had less tumor progression, as indicated by reduced platelet counts. Xilonix also appeared acceptably safe—no patients had to stop treatment due to side effects or had severe side effects.
Based on the overall survival benefit with Xilonix and positive patient well-being outcomes, the researchers concluded that the drug is a promising treatment for individuals with advanced colorectal cancer. Additional studies are ongoing evaluating the efficacy of Xilonix in metastatic colorectal cancer patients to slow tumour growth, as well as to improve symptoms of muscle loss, fatigue, appetite loss, and pain.
 Fisher GA. A Phase III Study of Xilonix in Refractory Colorectal Cancer Patients with Weight Loss. Presented at the 2015 Gastrointestinal Cancers Symposium; January 15–17; San Francisco, California. Abstract 685.
 Cancer Facts & Figures 2015. The American Cancer Society. Available at https://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf. Accessed February 2, 2015.
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