"This is very exciting," says William Wood, MD, chair of the seminar’s breast cancer panel and chairman of surgery at Emory University School of Medicine in Atlanta, of Dr. Stearns’ research. "It’s the first thing that has appeared to dramatically help these women."

Most women newly diagnosed with breast cancer are expected to survive the disease because of earlier detection and new treatments that have improved survival rates, according to according to Vered Stearns, MD, of the Lombardi Cancer Center at Georgetown. More than 55 percent of survivors experience hot flashes that can be intensely uncomfortable, Dr. Stearns says. Survivors also report experiencing depression, agitation, insomnia and an inability to concentrate.

Although the hormones estrogen and progestin can be used to control hot flashes, many breast cancer survivors do not use them because of concerns the hormones may increase the risk of their breast cancer returning. Some other treatment options have not been shown to be effective, or have had toxic side effects.

Dr. Stearns studied the use of paroxetine (Paxil) in 30 women previously treated for breast cancer who were experiencing at least two hot flashes a day. The women took 10 milligrams of Paxil daily for one week, no treatment for another week and then 20 milligrams of Paxil daily for four weeks.

Women Reported Fewer Hot Flashes

They reported 67 percent fewer hot flashes, with the hot flashes 75 percent less severe, compared to the period before they took Paxil. Eighty percent of the participants chose to continue taking Paxil as treatment for hot flashes after the study ended. "I think many women will benefit from this drug," said Dr. Stearns. "Women report improvement in hot flashes very quickly." The women also reported improvements in depression, sleep and anxiety levels.

The most common side effects were drowsiness, dry mouth and nausea, according to Dr. Stearns.

Two women stopped taking the drug because of drowsiness, and one due to anxiety. The study was a Phase II study, and Dr. Stearns has plans underway for a Phase III trial to confirm the results. Phase II trials determine the effects of treatment. Usually, groups of 30 to 40 patients with one type of cancer receive a Phase II treatment. Phase III trials require entry of large numbers of patients and usually compare the new treatment to a commonly available treatment or, if none is available, to a placebo.

The Phase III trial will include women who don’t have breast cancer as well as breast cancer survivors. "We also need to study whether the drug will work for other women," Dr. Stearns says. "There are many women who may not want to take estrogen, or can’t take it."

Other Research in Breast Cancer

In other news reported by researchers at the panel on breast cancer:

• William D. DuPont, MD, of Vanderbilt University School of Medicine, reported on his research that found specific changes in breast cells. This can help doctors identify which women with a kind of benign breast disease are most likely to develop invasive breast cancer in the future. Dr. DuPont’s study looked at women with epithelial hyperplasia lacking atypia (EHLA), a breast abnormality that is associated with a mild elevation in breast cancer risk. He found those women whose breast cells had 25 percent or less of a receptor for transforming growth factor beta, a substance that regulates cell growth, had more than triple the chances of developing an invasive breast cancer as those whose breast cells had 75 percent or more of the normal amount of receptors for the substance. Women identified as more likely to develop breast cancer may choose to adopt protective measures, such as reduction of known risk factors where possible, new chemoprevention drugs or breast cancer vaccines now being developed.
• Andrew D. Seidman, MD, and colleagues at Memorial Sloan-Kettering Cancer Center in New York, reported findings that give doctors valuable new information about which metastatic breast cancers are likely to respond best to a powerful class of chemotherapy drugs. These drugs, known as taxanes, include paclitaxel (Taxol) and docetaxel (Taxotere). Dr. Seidman’s team found breast cells with the lowest levels of a substance called p27^Kip1 responded best to those drugs. This will help doctors select the most effective therapy for patients, by examining breast cancer cells for levels of the substance before selecting treatment. The finding may prove especially useful because breast cancers with low levels of p27^Kip1 normally have a poorer prognosis than those with high levels of the substance.