- The Washington Times - Monday, June 4, 2007

CHICAGO — For the first time, doctors say they have found a pill that improves survival in liver cancer, a notoriously hard-to-treat disease diagnosed in more than a half-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’s 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’s a difference of 44 percent.

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.

Less than three months “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 University’s Bloomberg School of Public Health. “It is the first effective systemic treatment for liver cancer, which is such a huge problem internationally.”

Results were prepared for release today in Chicago at the American Society of Clinical Oncology’s (ASCO) annual meeting.

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 thought 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 Dr. Llovet, of Mount Sinai School of Medicine in New York and Hospital Clinic of Barcelona.

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 U.S. 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. Dr. Llovet has done consulting work for the sponsors.

Liver cancer is diagnosed in about 19,000 Americans annually but is much more common elsewhere and is the fifth commonest cancer globally. 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 chemotherapy and is often diagnosed too late for surgery to be an option. Many patients die within a year of diagnosis.

Another cancer study, presented yesterday at the ASCO’s meeting, suggests that women with early-stage breast tumors can undergo a shorter course of radiation without a greater risk that their cancer will come back years later. The results are good news for women who must quit work or travel far to receive the five-week, daily treatments usually given.

“This is very disruptive to your life. If we could achieve the same outcome with less-frequent visits to the radiation center … this would be a tremendous benefit,” said Dr. Julie Gralow of the Fred Hutchinson Cancer Center in Seattle, who was not involved in the study, but reviewed and discussed it at the society’s meeting.

Most of the 180,000 breast cancers diagnosed each year in the United States are the type this study addressed — still confined to the breast. The usual treatment is surgery plus chemotherapy or hormone therapy, followed by radiation to prevent a recurrence.

Dr. John Dewar of the University of Dundee in Scotland led a two-part study of nearly 4,500 women in Britain to test shorter courses of radiation.

Women received either the standard 50 grays, the unit used in measuring radiation, in 25 treatments spread over five weeks; roughly 40 grays given in 13 treatments every other day for five weeks; or 40 grays in 15 treatments over three weeks. Five years later, cancer-recurrence rates were low for all groups, ranging from 2 percent to 5 percent. So few recurrences occurred — 158 — that doctors think the treatments are equivalent but cannot say so with certainty.

Most U.S. doctors give a total of 60 to 64 grays — the standard 50 plus a boost dose directly to the tumor area.

Among the findings in other studies presented at the conference yesterday and Saturday were:

• Magnetic resonance imaging scans detect 10 percent to 20 percent more pre-invasive breast cancers than standard mammograms, especially the type most likely to spread, a study of 6,000 women in Germany found. However, no information was available on how many false alarms MRIs gave — which limits their use now.

• Many survivors of childhood cancers are not getting recommended follow-up tests to watch for second cancers later in life, a survey of 8,500 cancer survivors found. Only one-fourth at risk of developing heart problems because of their cancer treatment were tested for this every year or two as doctors recommend, and only half of women at risk of breast cancer got annual mammograms.

• Arsenic, best known as a deadly poison, also can prolong the lives of patients with a rare blood cancer, acute promyelocytic leukemia.

• Older women with advanced lung cancer live longer than men the same age, which the researchers said suggests that estrogen might affect chemotherapy. The study found that women aged over 60 who have advanced lung cancer lived a median of 11 months, compared with just eight months for men.

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