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The Wall Street Journal, August 12, 2009

By JENNIFER LEVITZ

Some women with early-stage breast cancer could benefit from more rigorous treatment than is now typical, Dutch researchers reported in a new study.

Breast-cancer patients with microscopic cells in their lymph nodes who received chemotherapy or hormonal treatment were more likely to be disease-free after five years than those who didn't get the treatments, according to the study, published in the New England Journal of Medicine.

Oncology experts estimate that the findings could change the standard of care for between 2% and 6% of the 184,000 women a year who develop breast cancer in the U.S. The study "questions the dogma of how we approach isolated tumor cells and whether we should be offering people more aggressive therapy," says Don Dizon, an oncologist at Brown University Medical School and Women and Infants Hospital of Rhode Island, and president of the National Consortium of Breast Centers, a nonprofit group of professionals and clinics. Dr. Dizen wasn't involved in the Dutch study.

Testing the lymph nodes closest to the breast—to see if the cancer has spread from the breast tissue —is considered the most important prognostic indicator for breast cancer. Advances in technology allow doctors to spot even microscopic isolated tumor cells.

Under current treatment standards, isolated tumor cells—less than about one-sixteenth of an inch—in the lymph nodes are generally ignored and the lymph node is said to be cancer-free. A patient with these isolated cells would likely receive a lumpectomy and radiation, but may not receive more aggressive treatment, particularly if the breast tumor is small.

The study, led by oncologists at Maastricht University Medical Center, in the Netherlands, followed 856 patients whose lymph nodes showed microscopic tumor cells, and who hadn't received chemotherapy or hormonal treatment, and 995 similar patients who had received such treatment.

After five years, 86% of the group that had isolated tumor cells and received treatment remained disease-free, compared with 77% of the group that didn't get the therapy.

Some doctors said the results should be considered with caution because treatments such as chemotherapy aren't risk-free.

"It becomes a difficult task to sort out in my mind which patients are going to benefit and which patients could potentially suffer from excessive treatment," says Michael Linver, an Albuquerque, N.M., radiologist and vice president of the National Consortium of Breast Centers. He also wasn't involved in the Dutch study.

Another study published this week in the New England Journal of Medicine toppled some conventional wisdom for breast-cancer survivors. A common complication for survivors is lymphedema, which causes limbs to swell with fluid. Doctors and many Web sites advise patients with lymphedema to avoid heavy lifting—including picking up children—for fear of making the condition worse.

But a study led by the University of Pennsylvania School of Medicine found that 141 breast-cancer survivors with lymphedema who engaged in regular weight-lifting saw no increase in limb swelling, and in fact saw benefits such as reduced symptoms of lymphedema and improved strength.

 

The Wall Street Journal, February 5, 2009

By KEITH J. WINSTEIN

Breast cancer's sudden decrease in several countries can be credited to a 2002 federal warning against overuse of hormone-replacement drugs after menopause, a new study argued. The findings, published Wednesday in the New England Journal of Medicine, were disputed by a hormone-pill maker and others, adding to the debate over the safety of such treatment.

Before 2002, about 210,000 U.S. women each year were diagnosed with breast cancer, according to federal statistics. After 2002, the rate suddenly dropped to below 190,000 each year and has stayed there through 2005, the latest year in which figures are available. Other countries also registered drops.

In 2002, the National Institutes of Health halted a large study of Wyeth's drug Prempro and warned that the treatment, a combination of the hormones estrogen and progestin, increased breast cancer, heart attacks and strokes. Another study found Prempro also increases dementia in elderly women. Both findings were part of research launched by the Women's Health Initiative.

In the new analysis, researchers from the WHI re-examined the medical records of the 16,608 women in the study, both before and after 2002. Half of the women had been randomly assigned to take Prempro until 2002. The new analysis found that Prempro's added breast-cancer risk fell quickly, within about two years, after women stopped taking hormone therapy. That's similar to what was observed in the overall U.S. population.

Taking hormones during menopause is generally regarded as safe, but treatment standards recommend as few years of use as possible. Previously, about six million women had been taking Prempro for strengthening bones, curbing hot flashes and vaginal dryness and various other benefits.

The government warning caused most women to quit hormone therapy immediately, and the breast-cancer decrease followed immediately. Similar declines were seen in Germany, Australia and France.

But researchers haven't agreed on whether the cancer drop can be credited to the decrease in hormone use. "It's post hoc ergo propter hoc," said Joseph Camardo, Wyeth's senior vice president of global medical affairs, using a Latin expression for a logic fallacy that means "after it, therefore because of it." Wyeth is facing lawsuits from more than 11,000 women over Prempro.

"It may be coincidence that as mammography was increasing in the late '90s, more and more cancers were being detected earlier, and when the study was halted, there's a coincidence in time," leading to fewer cancers now being found, Dr. Camardo said.

Avrum Bluming, a doctor at the University of Southern California who has been critical of the Women's Health Initiative, said the drop was too fast to have occurred because of any "decrease in the cancer-producing effect of hormones. ...You don't see a decrease in six months."

Today's study, by doctors involved in the WHI, is an effort to rebut those criticisms. In addition to concluding that stopping hormone therapy does produce an immediate decline in cancer, it also found that changes in mammography usage were unrelated.

"These are nonconventional analyses, but I think this is the best data we have," said Rowan Chlebowski, a University of California, Los Angeles doctor who led the new study. "For two to a few more years, combined hormone therapy is safe. This really suggests there's a great benefit to women for stopping, because the risk goes down almost immediately."

Write to Keith J. Winstein at keith.winstein@wsj.com