MONDAY, June 4 (HealthDay News) -- Researchers have announced the first drug to make major inroads against liver cancer, one of the more voracious forms of the disease.
Nexavar, made by Bayer, gave patients with advanced liver cancer 44 percent more time to live, compared to patients who did not receive the drug, according to results presented Monday at the annual meeting of the American Society of Clinical Oncology, in Chicago.
Results of a major clinical trial with Nexavar (sorafenib) were, in fact, so successful that the trial was halted early, the researchers announced.
"This is the first systemic therapy to prolong survival in [liver cancer] patients," said Dr. Joseph Llovet, lead author of the study and director of research in liver cancer at Mount Sinai School of Medicine in New York City. "This is a new reference standard for systemic therapy of [liver cancer] patients after 30 years of research and more than 100 randomized controlled trials performed."
Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, added, "This is going to change the standard of practice."
Liver cancer is the third leading cause of cancer death in the world and often causes death within a year of diagnosis. About 40 percent of liver cancers (up to 80 percent in Asia and sub-Saharan Africa) are diagnosed at an advanced stage. Surgery is sometimes possible, and radiation and chemotherapy can also be options. But there is no systemic treatment, meaning a medication that enters the bloodstream.
"There is no established standard of care for liver cancer even though it is one of the leading causes of death," said Dr. A. William Blackstock, a Wake Forest University radiation oncology professor who moderated a Monday news conference to announce the study results.
Nexavar, which is taken in tablet form, is already approved in the United States for treating advanced kidney cancer. It is being studied for various other cancers; results of some of those studies are also being presented at ASCO annual meeting.
In this study, 602 patients with advanced liver cancer were randomly assigned to receive either 400 milligrams of Nexavar twice a day or a placebo for six months.
Patients receiving the drug lived a median of 10.7 months, compared with only 7.9 months for those on a placebo. Time to cancer progression was 5.5 months in the Nexavar group, versus only 2.8 months in the placebo group. The findings were so positive that the study was terminated early.
"We recommended ending the trial early because of survival advantages favoring the sorafenib group," said Llovet.
Side effects were similar in the two groups, the most common being diarrhea, skin reactions, fatigue and bleeding.
"Sorafenib was well tolerated with manageable side effects," Llovet said.
A second study presented Monday at the cancer meeting offered a bit of good news for colorectal cancer patients.
When chemotherapy was given both before and after surgery to remove liver metastases in colorectal cancer patients, the risk of the liver tumor recurring was reduced almost 30 percent.
"A few years ago, we had only palliation to offer these patients and survival lasted no longer than six months," said Dr. Bernard Nordlinger, lead author of the study and chairman of surgery and oncology at Ambroise Pare Hospital in Paris. "This treatment should be proposed as a new standard for these patients."
One million people are diagnosed with colorectal cancer each year; up to half will see their cancer spread to the liver. Liver tumors are removed when possible, but only 30 percent to 35 percent of patients who have liver metastases survive five years after surgery.
Adding the targeted therapy Erbitux (cetuximab) to chemotherapy reduced the risk of metastatic colorectal cancer spread by 15 percent. The drug is currently approved as a second-line or third-line therapy, not as the first option.
These new results indicate that Erbitux has promise as a first-line treatment, the researchers said.
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