Thursday, July 03, 2003

By Thomas H. Maugh II, Los Angeles Times

Two new studies published yesterday confirm earlier findings that high-dose chemotherapy followed by a bone marrow transplant is not an effective way to treat breast cancer.

The Dutch and American studies published in the New England Journal of Medicine found a longer time until relapse associated with the controversial treatment in selected women, but no overall increase in survival.

The expensive and debilitating procedure was very popular among women in the 1990s, but has fallen into disuse following several 1999 reports showing no benefit.

"For all of the hassle associated with the treatment, we are not getting a lot of bang for the buck," said Dr. Derek Raghavan of the University of Southern California.

"There's a high level of morbidity and mortality associated with these treatments," added Rebecca Garcia of the Susan G. Komen Breast Cancer Foundation.

The chemotherapy/transplant combination was developed more than two decades ago and became very popular after preliminary studies appeared encouraging. The idea is to use unusually high doses of anti-cancer drugs to kill as many breast cancer cells as possible.

These high doses also kill bone marrow cells, however, leaving patients at risk of anemia and infections. To avoid this problem, physicians follow the chemotherapy with a transplant of bone marrow cells collected either from the patient before chemotherapy or from a donor.

This whole process is painful and exhausting, and the mortality rate from the procedure initially ran as high as 20 percent.

That rate has been reduced, but is still significant. And the procedure costs $100,000 to $150,000.

Results from four major clinical trials reported in 1999 showed no apparent benefit from the procedure. A fifth study by a South African researcher did purport to show benefit, but an investigation found that he had fabricated his results.

Demand for the procedure dropped off dramatically. In 1992, there were as many as 10,000 chemotherapy/transplant procedures performed yearly, according to Dr. George Somlo of the City of Hope Medical Center in Duarte, Calif. "Today, there are a couple of hundred."