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Study: Liver cancer breakthrough found

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  • Study: Liver cancer breakthrough found

    CHICAGO, June 4, 2007 (AP) - For the first time, doctors say they have found a pill that improves survival for people with liver cancer, a notoriously hard to treat disease diagnosed in more than half a million people globally each year.

    The results in a multinational study of 602 patients with advanced liver cancer are impressive and likely will change the way patients are treated, cancer specialists including the study authors say.

    Patients got either two tablets daily of a drug called sorafenib or dummy pills in the study, which started in March 2005. Some patients are still alive, although on average, sorafenib patients survived 10.7 months versus almost 8 months for those on dummy pills.

    That type of survival advantage "has never happened'' with liver cancer "and is a major breakthrough in the management of the disease,'' said Dr. Josep Llovet, the lead author.

    "That may not sound like a lot of time,'' but for liver cancer, "this is actually a quite impressive gain,'' said Dr. Nancy Davidson of Johns Hopkins' Bloomberg School of Public Health. "It is the first effective systemic treatment for liver cancer, which is such a huge problem internationally.''

    Sorafenib attacks cancer with a targeted double-barreled approach. It zeros in on malignant cells themselves and cuts off the blood supply feeding the tumor. It is believed to work on tumors within the liver and those that have spread elsewhere.

    In the study, tumors didn't shrink or disappear but in many cases they also didn't grow.

    "You are not curing the disease but you are delaying the progression of the disease significantly and strikingly,'' said Llovet, of Mount Sinai School of Medicine in New York and Hospital Clinic of Barcelona, Spain.

    The study was halted early, in February, because of the good results, and patients on dummy pills were switched to sorafenib.

    "This is a very good step forward in this disease,'' said Dr. Emily Chan of Vanderbilt-Ingram Cancer Center in Nashville, Tennessee.

    Results were prepared for release Monday in Chicago at the American Society of Clinical Oncology's annual meeting.

    The drug, sold under the brand name Nexavar, is approved in the United States and dozens of other countries to treat advanced kidney cancer. It is marketed by Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc., which funded the liver cancer study. They hope to receive approval for liver cancer use from U.S. and foreign regulators.

    Llovet has done consulting for the sponsors.

    Liver cancer is diagnosed in about 19,000 Americans annually but is much more common elsewhere and is the fifth most common cancer globally. Risk factors include chronic liver infections and some forms of hepatitis. The disease is common in China and countries without widespread use of the hepatitis B vaccine, which is routinely given to U.S. infants.

    Liver cancer doesn't respond well to conventional chemotherapy and is often diagnosed too late for surgery to be an option. Many patients die within a year of diagnosis.

    Robert Throckmorton, a 73-year-old attorney in Orange County, California, said his doctor told him "You had better get your affairs in order,'' after he was diagnosed with inoperable liver cancer last August.

    But then the doctor offered sorafenib off-label, and Throckmorton readily agreed. He did not take part in the study.

    After nine months on the drug, Throckmorton said his cancer shows no sign of progression and he has no significant side effects. He said he walks three miles six days a week to stay active and feels fine.

    Instead of thinking about wills and funerals, Throckmorton is looking forward to get-togethers with his eight children and 18 grandchildren, and even a possible church trip to Uruguay with his wife.

    "I have good energy,'' Throckmorton said. "We are optimistic.''

  • #2
    CHICAGO: A new drug looks poised to become the first effective medication for liver cancer, one of the most common and deadliest cancers in the world, doctors here said.

    In a large clinical trial, the drug, called Nexavar, extended the lives of patients by almost three months, or 44 percent. While that is far from a cure, experts say it represents a breakthrough after years of efforts to find a drug that works.

    "We did not have anything for these patients," said Dr. Josep Llovet, one of the principal investigators in the trial. "Now we have an effective drug that prolongs survival."

    Llovet, who has appointments at the Mount Sinai School of Medicine in New York and the University of Barcelona, said Sunday that there had been 100 unsuccessful trials of drugs for liver cancer in the last 30 years.

    Nexavar, also known as sorafenib, was developed by Onyx Pharmaceuticals, a California biotechnology company, and Bayer, the German pharmaceutical company. The companies said they would apply this summer for regulatory approval to sell Nexavar as a treatment for liver cancer.

    The drug is already approved as a treatment for kidney cancer, which means that doctors are allowed to prescribe it "off label" for patients with liver cancer.

    In the trial, patients who received Nexavar lived a median of 10.7 months, compared with 7.9 months for those who received a placebo. The main side effects were diarrhea and a painful syndrome in the hands and feet.

    The results were scheduled to be presented here Monday at the annual meeting of the American Society of Clinical Oncology.

    The trial involved 602 patients with hepatocellular carcinoma, the most common form of liver cancer by far. Experts said the results would not apply to other forms of liver cancer or to cancers that originated elsewhere, like in the lung or breast, and then spread to the liver.

    An improvement of survival of 2.8 months is considered significant for cancer drugs, given the difficulty of treating the disease.

    However, there has been rising concern among doctors, patients and insurers about the cost of adding a few months to life. Nexavar, like many other new cancer drugs, is expensive, costing $4,500 a month.

    Most cases of liver cancer occur in people who already have cirrhosis of the liver, a scarring that can be caused by hepatitis B or C, alcohol abuse or obesity. Liver cancer has been fairly uncommon in the United States, with about 19,000 new cases expected this year, with nearly 17,000 deaths.

    But the number of cases has been rising because of an increasing incidence of hepatitis C. And worldwide, there are about 600,000 new cases a year, making liver cancer one of the most common cancers and causes of cancer death globally. That is mainly because of the large number of people in the Far East with hepatitis B and C.

    If liver cancer is diagnosed when the tumor is confined to a small area of the liver, it can often be treated by surgically removing part of the liver. Liver transplants can cure the disease, though there is a shortage of donor organs. There are also some other localized treatments, like one that involves inserting particles into the liver artery to cut off the flow of blood to the tumor.

    For about half of all patients in the United States and Europe, however, the disease is not diagnosed until it is too late for any of those techniques to be useful, said Llovet, a consultant to Bayer. And many patients who are treated through surgery or another technique suffer a recurrence of cancer.

    Nexavar is one of a new generation of biotechnology drugs that has started to transform cancer treatment. Taken as four pills a day, the drug blocks the blood supply to the tumor as well as proteins in cancer cells that spur tumor growth.

    Outside experts said the drug represented a promising advance, but some cautioned that the patients in the trial had fairly healthy livers.

    "We don't know yet whether this treatment will be as safe and effective in patients with more profoundly impaired liver function," said Dr. Louis Weiner, a specialist in gastrointestinal tumors at the Fox Chase Cancer Center in Philadelphia.

    Dr. Steven Alberts of the Mayo Clinic said that he would consider prescribing the drug off label to liver cancer patients but that cost could be a deterrent because insurers often would not pay for unapproved uses.

    But Dr. Richard Finn, a liver cancer specialist at the University of California, Los Angeles Medical Center, said he had already prescribed Nexavar. One of his patients, Robert Throckmorton, a 73-year-old lawyer in North Tustin, California, said in an interview that his cancer had not worsened in 10 months on the drug.


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