Early stage HER2-positive breast cancer patients at increased risk of recurrence

In early cancer patients stage breast tumors with HER2-positive one centimeter or less are at high risk of disease recurrence compared to those with the disease at the outset to have n ' not express aggression, according to a study by researchers at the University of Texas led MD Anderson Cancer Center. The results, published online today in the Journal of Clinical Oncology, is the first major study to analyze this cohort, and represents a change in how women with HER2-positive should be no risk of reoffending will be evaluated and treatment is planned, said senior study author, Dr. Ana Gonzalez-Angulo, MD, associate professor at the MD Anderson Departments of Breast Medical Oncology and Systems Biology.

The research was first presented to the CRTC-AACR San Antonio Breast Cancer Symposium in December 2008.

Herceptin, also known as trastuzumab, was approved for use in 1998 for women whose advanced breast cancer expressing human epidermal growth factor receptor 2 or HER2. Approximately 15-20 percent of breast cancer cells produce an amount of excessive growth of the protein HER2 on their surface, which makes the cancer more aggressive. Herceptin is a monoclonal antibody that binds to these proteins and inhibits tumor growth castles.

"This study is an ongoing debate in clinical practice - the risk of recurrence for patients with breast cancer early stage tumors with HER2-positive one centimeter or smaller," said Gonzalez-Angulo . "Our results show that women with HER2 breast cancer, a chance of 23 per cent of Recidivism. In contrast, the five-year survival of women with early stage breast cancer is more than 90 percent.

"The results show that physicians must provide these women, treatment with Herceptin in post-operative or adjuvant, Gonzalez-Angulo said.

Current guidelines require no further treatment after surgery and radiation, when tumors are less than five millimeters and Herceptin-based adjuvant therapy should be discussed with the patient, are explained if the tumors from six to 10 millimeters, Gonzalez -Angulo.

According to Gonzalez-Angulo, the number of patients with tumors of HER2-positive less than one centimeter further increased surveillance for breast cancer and early detection are becoming more sophisticated.

"Before today, there is no data on how these women because it confirmed by all studies dealing with the final value excluded Herceptin. These data suggest that we rethink how we use patients early breast cancer HER2 - positive tumors treated and will probably need to offer an anti-HER2 therapy in the adjuvant setting. "

For the retrospective study, Gonzalez-Angulo, and his team of MD Anderson Breast Cancer Research's database used to analyze treatment to 965 patients from 1990 to 2002. All patients had tumors smaller than one centimeter, patients whose receptor status could be analyzed and / or had received adjuvant chemotherapy, Herceptin, or to exclude at any time. The women's average age at diagnosis is 57 years. To verify the results of a second cohort of 350 patients from the European institutions has also been analyzed.

MD Anderson patient population had more than 10 percent or 98 patients with tumors of HER2-positive. In addition, 77 percent of hormone receptor positive and 13 percent had triple-receptor-negative.

In those with HER2-positive tumors were analyzed for the five years of recurrence free survival 77.1 per cent, in contrast to the re-survival HER2-negative patients was 93.7 per cent. Five-year distant metastasis-free survival was 86.4 per cent among women with tumors HER2-positive compared to 97.2 percent among women with tumors HER2-negative. Patients with tumors of HER2-positive was 2.68 times higher risk of recurrence, and 5.3 times higher risk of distant metastases than those with HER2-negative tumors.

In addition, women with HER2-positive 5.09 times the risk of recurrence and had 7.81 times greater risk of distant metastases than women with hormone receptor positive.

The subset European MD Anderson confirmed the findings and showed reproducibility, "said Gonzalez-Angulo.

"The risk of recurrence was much higher than we had imagined. In this study, we now have concrete evidence of our discussions with HER2-positive patients with even the smallest tumors, and Herceptin alone or in combination with chemotherapy should be stronger than adjuvant therapy should be considered, "said Jennifer Litton , MD, assistant professor in MD Anderson Department of Breast Medical Oncology, and also a study author. "These data should include this subset of patients will be enrolled in clinical trials with the HER2-targeted therapies.

Gonzalez-Angulo and Litton hope that an individual may, three-arm clinical trial comparing, observing, Herceptin and Herceptin in combination with chemotherapy.

Currently, a study on the website of the MD Anderson Beth (bevacizumab and trastuzumab adjuvant therapy in HER2-) breast cancer, an international Phase III examined the benefits of the combination of Avastin and Herceptin with chemotherapy in HER2-positive. Vicente Valero, MD, professor in the Department of Breast Medical Oncology and an author on the research JCO is to examine the institutional P