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Regorafenib Approved by FDA - Adds to Liver Cancer Treatment Options Currently Used

Susanna Sisson's picture
Regorafenib (Stivarga) for liver cancer treatment

Yesterday was a big day for the people looking for liver cancer treatment new options as FDA expanded the indications of Bayer's Regorafenib (Stivarga) to include the treatment of patients with liver cancer who have until now been treated with Sorafenib.


According to FDA, the treatment of liver cancer with Regorafenib (Stivarga) in this trial continued until "until disease progression or unacceptable toxicity." The approval of Regorafenib for liver cancer treatment was based on an "international, multicenter, randomized, double-blind, placebo-controlled trial of 573 patients with Child-Pugh A and Barcelona Clinic Liver Cancer Stage B or C HCC with documented disease progression following sorafenib," states FDA's release.

The incidence of hepatocellular carcinoma (HCC) or liver cancer has more than tripled since 1980. 2017 statistics on liver cancer (primary and intrahepatic bile duct cancer) from the American Cancer Society estimate about 40,710 new cases (29,200 in men and 11,510 in women) will be diagnosed in the United States this year and about 28,920 people (19,610 men and 9,310 women) will die of these cancers.

Certain factors can influence one’s chance of getting liver cancer and include:

Gender – Men are more likely than women to have HCC although one subtype of liver cancer called fibrolamellar is more common in women.

Race – HCC affects ethnic groups in this order - Asian Americans and Pacific Islanders have the highest rates of HCC, followed by American Indians/Alaska Natives and Hispanics/Latinos, African Americans, and whites.

The most common factor in HCC in the United States is infection with Hepatitis C virus (HCV) while worldwide Hepatitis B virus (HBV) and Hepatitis C are problematic and are likely to lead to liver damage and subsequent cancer.

Cirrhosis – Damage to the liver or cirrhosis can be due to many factors including drugs, both pharmaceutical and illegal as well as alcohol, autoimmune disorders, HBV or HCV infection, hereditary disorders such as hemochromatosis which is an excess of iron in the body, and non-alcoholic fatty liver disease.

Obesity – People who are overweight have an increased risk of developing HCC.

Type 2 Diabetes – There is a link between Type 2 Diabetes and risk of liver cancer, especially when accompanied by heavy alcohol used, obesity and HCV.

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Aflatoxins – Fungus found in peanuts, wheat, corn, soybeans, rice and ground nuts may increase the risk of HCC and is more common in warmer and tropical countries.

Chemical exposure – Long-term exposure to chemicals like vinyl chloride, trichloroethylene (TCE), tetrachloroethylene (PCE), benzene, and thorium dioxide may lead to liver cancer.

Symptoms of HCC may include bloating, pain in the right upper quadrant of the abdomen radiating to the back or shoulder, nausea, loss of appetite, weight loss or gain (due to ascites), fatigue, weakness or yellowing of the skin and eyes.

Diagnosis of liver cancer may include biopsy, CT or MRI, ultrasound and blood tests in addition to history and physical.

Treatment of liver cancer depends on the stage of the disease and overall health of the patient. Early stages may include surgery to remove the cancer and part of the liver. In some cases, liver transplant may be an option. Thermal ablation via laparoscopic or open surgery is another option. For tumors smaller than 3cm, ethanol injection directly into the tumor is effective. Radiation may be used to kill cancer cells.

In advanced HCC in which the tumor cannot be removed the patient may receive chemotherapy with Sorafenib which is thought to kill the tumor by causing anti-angiogenesis which cuts of blood flow and nutrition to the tumor. Some hospitals may use alternative treatments such as fucoidan which studies show induces apoptosis or programmed cell death without adverse side effects. Fucoidan has also been shown to inhibit angiogenesis in some types of cancer.

For patients with advanced cancer who received and did not respond to Sorafenib there is another option. On April 27, 2017, the U. S. Food and Drug Administration (FDA) approved the use of Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma who did not respond to treatment with the drug Sorafenib.

Stivarga (Regorafenib) Details

Stivarga (Regorafenib) is a kinase inhibitor that works by blocking several enzymes that promote cancer growth, including enzymes in the vascular endothelial growth factor pathway. Stivarga is also approved to treat colorectal cancer and gastrointestinal stromal tumors that are no longer responding to previous treatments.

The recommended dose of Stivarga is 160 mg (four 40 mg tablets) taken orally once daily with a low fat meal for the first 21 days of each 28-day cycle. The drug should be continued unless there are s symptoms of toxicity such as worsening liver enzymes indicating liver failure, hemorrhage, skin rash or hand-foot skin reaction, cardiac ischemia or infarction, hypertension, impaired wound healing, posterior reversible encephalopathy syndrome, or gastrointestinal fistula or perforation.