Programs Help Women/Physicians Decide on Adjuvant Therapy for Breast Cancer

SAN ANTONIO—Two computer programs designed to aid women with early breast cancer and their physicians in making decisions about adjuvant therapy will soon be available, according to presentations at the 23^rd Annual San Antonio Breast Cancer Symposium.

With these programs, the physician enters several patient variables, including age, tumor size, and nodal status, and the program swiftly quantifies and compares the 10-year benefits of endocrine therapy, chemotherapy, and combined therapy. In this manner, the physician can customize projections of benefit for different treatment options for a particular patient. The results are presented in simple language and an easy-to-understand format, such as colored bar graphs.

Peter M. Ravdin, MD, of the University of Texas Health Science Center, San Antonio, presented the decision aid called "Adjuvant!" Stephan D. Thomé, MD, of the Mayo Clinic, presented a similar program, called "Numeracy." Both researchers have papers in press at the Journal of Clinical Oncology describing these teaching tools. Upon publication, each institution will make the programs available at no cost.

The analysis performed by both decision tools is based on data derived from SEER (Surveillance, Epidemiology, and End Results Program) and large clinical trials, especially the meta-analysis of breast cancer adjuvant therapy clinical trials done by the Early Breast Cancer Trialists’ Collaborative Group. The programs factor in life expectancy and natural mortality as well as death due to breast cancer recurrence.

These figures can be adjusted, however, for both programs (although a version of Numeracy currently available over the Internet does not allow for such adjustments). "If a physician doesn’t like our numbers, he or she can customize the program with his or her own prognostic numbers," Dr. Ravdin said in an interview with ONI.

Adjuvant! asks users to enter detailed information about the patient (age, menopausal status, comorbidity) and the tumor characteristics (size, number of positive axillary lymph nodes, estrogen-receptor status). Using this information, the program makes prognostic estimates for different treatment options as well as no adjuvant therapy.

In an example, Adjuvant! gave estimates for a 60-year-old, postmenopausal woman who was estrogen-receptor positive, with a tumor between 1.1 and 2.0 cm in size and no positive nodes.

Among 100 women with those characteristics, the program showed that without adjuvant therapy, at 10 years, 81 women are alive, 10 die of cancer, and 9 die of other causes. But with endocrine therapy (5 years of tamoxifen [Nolvadex]), 81 of the 100 women are alive, plus another 3 are alive because of added therapy, 7 die of cancer, and 9 die of other causes.

The wording is deliberate, Dr. Ravdin said. "It’s written in language that people understand," he said. "A surprising number of Americans don’t understand percentages." The results are also shown as colored proportions of a single bar graph in a "USA Today format," he said.

For patients and professionals who wish for a detailed discussion of what the numbers mean, Adjuvant! has a variety of help features, including a discussion of the controversial aspects of the Early Breast Cancer Trialists’ Collaborative Group meta-analyses.

It also includes Internet links to websites for both health professionals and patients. "It’s chock-full of information for health care professionals," Dr. Ravdin said.

‘Numeracy’ Program

Dr. Thomé presented a similar computerized decision aid inspired by Dr. Ravdin’s earlier work. Called Numeracy, it requires the input of fewer variables. As a result, he said, it is easier and slightly faster to use than Adjuvant!

Dr. Thomé also said that the baseline prognostic values for Dr. Ravdin’s program are "slightly more optimistic" and that it uses a more sophisticated way of projecting survival. Yet despite the additional "bells and whistles" on Adjuvant!, the two programs yield essentially the same results, Dr. Thomé said.

Visitors to the Mayo Clinic website (www.mhs.mayo.edu/adjuvant) can use the Numeracy program now.

The use of Adjuvant! increased patient satisfaction with their treatment decision, according to a study by Dr. Ravdin and Dr. Laura Siminoff presented at San Antonio. However, no differences were seen in the actual treatment decisions based on whether patients made the decision using an individualized decision guide produced by Adjuvant! or a generic brochure about adjuvant therapy.

The randomized study enrolled 400 women from Cleveland and San Antonio who had a primary diagnosis of breast cancer (median age, 63 years). The study found that patients who used the individualized decision guide reported "significantly more satisfaction" with their treatment decision than women in the control group.