Regorafenib Shows Promise Against Metastatic Colorectal Cancer

The investigational drug regorafenib improves survival and delays cancer progression among patients with metastatic colorectal cancer that has worsened in spite of other treatments. These results will be presented at the 2012 Gastrointestinal Cancers Symposium.

Colorectal cancer remains the second leading cause of cancer-related death in the United States. Metastatic colorectal cancer refers to cancer that has spread from the colon to distant sites in the body.

Targeted therapies are anticancer drugs that interfere with specific pathways involved in cancer cell growth or survival. Some targeted therapies block growth signals from reaching cancer cells; others reduce the blood supply to cancer cells; and still others stimulate the immune system to recognize and attack the cancer cell. Depending on the specific “target,” targeted therapies may slow cancer cell growth or increase cancer cell death.

Regorafenib is an investigational targeted therapy that targets multiple biological pathways involved in cancer development. To evaluate regorafenib for the treatment of metastatic colorectal cancer, researchers conducted a Phase III clinical trial among 760 patients whose cancer had progressed (worsened) after standard treatment. Study participants were treated with either regorafenib or a placebo. All study participants also received best supportive care (care to manage symptoms).

  • Overall survival was 6.4 months among patients treated with regorafenib and 5.0 months among patients treated with placebo.
  • The disease control rate (either stable disease or a reduction in detectable cancer) was 44 percent among patients treated with regorafenib and 15 percent among patients treated with placebo.
  • The most common severe side effects in the regorafenib group were hand-foot skin reaction (17 percent) and fatigue (15 percent).

These results suggest that regorafenib may benefit patients who have previously treated metastatic colorectal cancer. Some patients benefited more than others, and researchers are now exploring the reasons for this.

Reference: Grothey A, Sobrero AF, Siena S et al. Results of a phase III randomized, double-blind, placebo-controlled, multicenter trial (CORRECT) of regorafenib plus best supportive care (BSC) versus placebo plus BSC in patients (pts) with metastatic colorectal cancer (mCRC) who have progressed after standard therapies. Paper presented at: 2012 Gastrointestinal Cancers Symposium; January 19-21, 2012; San Francisco, CA. Abstract LBA385.

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