A Medical Device Daily

Agendia (Amsterdam, the Netherlands), a leading firm in the growing field of molecular diagnostics, said that an independent international consortium has demonstrated the prognostic power of the company’s MammaPrint breast cancer prognosis test in patients who have one to three positive lymph nodes.

The data show that MammaPrint can accurately identify a low-risk group of lymph node-positive breast cancer patients with an excellent survival, implications that Agendia said would help doctors to decide the optimal treatment management.

“”Lymph node status is considered to be one of the most powerful prognostic factors for operable breast cancer, with a direct relationship between the number of positive nodes and disease outcome,” said Dr. Laura van’t Veer, chief research officer at Agendia. “However, approximately 30% of lymph node-positive patients will remain free of distant metastases without adjuvant chemotherapy,” she said.

van’t Veer, who participated in the study, added, “Identifying patients with lymph node-positive disease who are at low risk of recurrence might lead to changes in guidelines for adjuvant chemotherapy.”

In the study, 241 tumor samples from breast cancer patients with one to three positive lymph nodes at two hospitals were selected and analyzed by the international TRANSBIG consortium. Patients who were classified as “high risk” for recurrence using MammaPrint had “significantly worse” 5- and 10-year survival rates than those that were identified as low risk, according to the company.

Agendia said, “The numbers indicate that MammaPrint has excellent prognostic power, even in patients having one to three positive lymph nodes.” The study was presented as an oral presentation at the recent San Antonio Breast Cancer Symposium.

The company said it would start offering MammaPrint to patients having one to three positive lymph nodes in Europe and added that the data also would be submitted to the FDA for approval at a later date.

Cytori cites results of Japan study

In another report presented at the San Antonio Breast Cancer Symposium, Cytori Therapeutics (San Diego) said positive results were received from an independent, investigator-sponsored study in Japan in which adipose tissue-derived stem and regenerative cells were used for breast reconstruction following partial mastectomy.

The procedure evaluated 21 women with no metastases or recurrence at least one year after partial mastectomy.

In the study, tissue loss resulting from partial mastectomy was reconstructed with each patient’s own liposuctioned fat, which was combined and enhanced with her own adipose-derived stem and regenerative cells. These cells were made available at the time of surgery using Cytori’s investigational Celution System.

“This clinical series is an exciting, early development for women with breast cancer who undergo partial mastectomy,” said Marc Hedrick, MD, Cytori’s president. “The reported data suggest this novel procedure can be safely performed, is clinically practical for surgeons to implement, and confirms [our] decision to initiate clinical trials intended to establish efficacy, ascertain volume retention, and measure the magnitude of aesthetic and functional improvement.

He added: “Until now, partial mastectomy patients have had little hope other than to live with tissue loss. This procedure holds the potential to offer women the opportunity to restore the contour, volume and function lost during cancer treatment.”

Two clinical studies will be initiated by Cytori in Europe next year to further evaluate adipose-derived stem and regenerative cells, processed with the Celution System, in breast reconstruction following partial mastectomy. One study, RESTORE II, will evaluate up to 70 patients at multiple trial sites. A second study, VENUS, will be a 20-patient single center study in patients with more severe radiation damage and contour defects.