Chemo and surgery may help colon cancer
Tue, 05 Jun 2007 01:45:28 GMT
By LINDSEY TANNER, AP Medical Writer
CHICAGO - Scientists reported promising gains Monday for treating colorectal cancer that has spread to the liver, showing that chemotherapy before and after surgery to remove liver tumors can help keep the disease in check.
The study is the first to scientifically test an approach that many doctors have tried for patients with advanced colon and rectal cancers.
"It justifies what some of us have already been doing" and shows that aggressively treating patients with limited spread of colorectal cancer is reasonable, said Dr. Jeffrey Meyerhardt, a cancer specialist at Dana Farber Cancer Institute in Boston.
About 1 million people worldwide develop colorectal cancer each year, including more than 150,000 in the United States, where it is the third most common major cancer. In up to half of all patients, the disease spreads after initial treatment to the liver. For many cancers, spread to the liver means the disease has also spread elsewhere, is incurable and surgery isn't an option.
But with colorectal cancer, sometimes the disease spreads only to the liver, and surgery to remove these growths increasingly is being attempted, said Dr. Neal Meropol, director of the gastrointestinal cancer program at Fox Chase Cancer Center in Philadelphia. Even so, recurrence is common, and only about 30 percent of patients who have this surgery survive five years.
In the new study, 42 percent of patients who got chemotherapy before and after the liver surgery had no recurrence after an average of three years, versus 33 percent of patients who had surgery alone.
The good results mean the approach could become standard treatment for these patients, said Dr. Bernard Nordlinger, the lead author and a cancer specialist at Ambroise Pare Hospital in Paris.
Nordlinger presented the results in Chicago at the American Society of Clinical Oncology's annual meeting.
A separate colorectal cancer study presented Monday showed the targeted cancer drug Erbitux can modestly improve survival when added to standard chemotherapy in patients whose disease has spread. Patients who got Imclone Systems Inc.'s drug survived an average of 8.9 months without disease progression versus eight months for those who got chemotherapy alone.
"Although we would all love to have huge breakthroughs that would revolutionize cancer treatment, those are few and far between," said Northwestern University's Dr. Al Benson III. Instead, cancer treatment advances typically come in smaller but important steps like the colorectal cancer studies presented Monday, which over time lead to real progress, Benson said.
The chemotherapy-plus-surgery study involved 151 patients who had both treatments and 152 who had surgery alone. The chemotherapy used was a commonly used combination of drugs called oxaliplatin leucovorin fluorouracil.
Complications, including diarrhea and reduced amounts of disease-fighting white blood cells, were more common in chemotherapy patients but were still within an acceptable range, Nordlinger said.
A separate study presented Monday involved primary liver cancer — disease that originates in the liver rather than spreads there. Researchers said they have found the first drug that improves survival for liver cancer patients — a breakthrough that likely will become standard treatment.
Those results occurred in patients with advanced liver cancer treated with the drug sorafenib, or Nexavar, which is marketed by Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. to treat advanced kidney cancer.
The companies are expected to seek U.S. approval this summer for treating liver cancer with the drug.
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American Society of Clinical Oncology: http://www.asco.org
http://www.cancer.org
Study Liver cancer breakthrough found
Tue, 05 Jun 2007 01:45:10 GMT
By LINDSEY TANNER, AP Medical Writer
CHICAGO - For the first time, doctors said Monday 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, say cancer specialists, including the study authors.
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."
The results were released Monday at the American Society of Clinical Oncology's annual meeting.
"We now have moved forward" in treating advanced liver cancer "when it was not really possible before," Dr. William Blackstock of Wake Forest University School of Medicine said at a press briefing about the study.
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, Tenn.
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, Calif., said his doctor told him "You 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."
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American Society of Clinical Oncology: http://www.asco.org
http://www.cancer.org
Vaccine claims to get their day in court
Tue, 05 Jun 2007 01:44:58 GMT
By KEVIN FREKING, Associated Press Writer
WASHINGTON - Science has spoken when it comes to the theory that some childhood vaccines can cause autism. They don't, the Institute of Medicine concluded three years ago. Soon, it will be the courts turn to speak.
More than 4,800 claims have been filed against the federal government during the past six years alleging that a child contracted autism as a result of a vaccine. The first test case from among those claims will be the subject of a hearing that was to begin next Monday in a little-known "People's Court" — the U.S. Court of Federal Claims. A special master appointed by the court will hear the case.
For the parents filing a claim, there is the potential for vindication, and for financial redress.
The test case addresses the theory that the cause of autism is the measles, mumps and rubella vaccine in combination with other vaccines containing the preservative thimerosal. That preservative, which contains a form of mercury, is no longer in routine childhood vaccines. However, it is used in influenza vaccines.
One of the parents who has filed a claim against the federal government and has great interest in the case is Scott Bono of Durham, N.C. His son, Jackson, 18, has autism. While acknowledging the findings of the IOM's study, Bono believes those findings were preordained by the federal government.
"The charge before the IOM committee was: 'You're not going to find anything wrong here,'" Bono said.
He said that parents of children with autism have been marginalized, but they see specific outcomes in their children that are consistent with exposure to mercury. And those outcomes did not present themselves until after they received their vaccinations. In short, the children tell the story better than the numbers, he said.
"It's a thrill in the sense that, for the first time, the stories of these children are going to be heard in court," Bono said.
In July 1999, the U.S. government asked vaccine manufacturers to eliminate or reduce, as expeditiously as possible, the mercury content of their vaccines to avoid any possibility of infants who receive vaccines being exposed to more mercury than is recommended by federal guidelines.
Dr. Paul Offit, who developed a vaccine for the rotovirus, is chief of the division of infectious diseases at the Children's Hospital of Philadelphia. He said epidemiological studies pick up minute, almost invisible differences in the populations that have received a vaccine versus those that have not.
For example, a swine flu vaccine in the 1970s caused the sometimes paralyzing Guillain-Barre syndrome in 1 out of 100,000 cases, he said.
But no such correlations have been found for autism, which affects about 1 out of 150 children, he said.
"It should be easily picked up," he said. "It hasn't been and the reason it hasn't been is because vaccines do not cause autism."
Offit said mercury is part of the natural environment. There's no escaping it and, in fact, children will get more mercury from breast milk than they get from a vaccine. Yet, he's frustrated when he hears lawmakers speak of having zero tolerance for mercury.
"On this planet you can't have zero tolerance for mercury," he said. "You would have to move to another planet."
Autism is characterized by impaired social interaction. Those affected often have trouble communicating, and they exhibit unusual or severely limited activities and interests. Meanwhile, classic symptoms of mercury poisoning include anxiety, fatigue and abnormal irritation, as well as cognitive and motor dysfunction.
The report from the Institute of Medicine pointed to five large studies, here and abroad, that tracked thousands of children since 2001 and found no association between autism and vaccines containing the preservative thimerosal.
Members of the National Autism Association see drug manufacturers and the federal government as working too closely together to the point that the federal government is working to protect the industry from liability. The association says its mission is to raise awareness of environmental toxins as causing neurological damage that often results in an autism or related diagnosis.
Bono, a member of the association, said he doesn't believe his son was intentionally poisoned.
"I just want someone to step up and say, 'You're right, this did happen,'" he said.
During the hearing, lawyers for the parents were expected to present their expert testimony during the first week. Then lawyers representing the federal government were expected to present their case. The hearing was to be open to the public.
Officials planned to post transcripts on the court's Web site about 24 hours after each day's proceedings.
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On the Net:
U.S. Court of Federal Claims: http://www.uscfc.uscourts.gov
Doctors say roller shoes injuring kids
Mon, 04 Jun 2007 22:46:26 GMT
By LINDSEY TANNER, AP Medical Writer
CHICAGO - Trendy wheeled sneakers that let kids zip down sidewalks, across playgrounds and through mall crowds could also send them rolling into emergency rooms on a stretcher, say doctors who blame a rash of injuries on the international craze.
It's called "heeling," named after Heelys, the most popular brand. They're sold in 70 countries and are so hot that their Carrollton, Texas, maker, Heelys Inc., recently landed atop BusinessWeek's annual list of fastest growing companies.
But doctors from Ireland to Singapore have reported treating broken wrists, arms and ankles; dislocated elbows and even cracked skulls in children injured while wearing roller shoes.
Over a 10-week period last summer, 67 children were treated for injuries from Heelys or strap-on wheels called Street Gliders at Temple Street Children's University Hospital in Dublin, Ireland, according to a report in the June edition of Pediatrics.
From September 2005 through December 2006, one death and at least 64 roller-shoe injuries were reported to the U.S.
http://www.aap.org
Heelys, Inc.: http://www.heelys.com