Agendia Inc, Irvine, Calif, has presented prospective data demonstrating the strong impact of its 70-gene breast cancer recurrence assay, MammaPrint, and its corresponding 80-gene molecular subtyping assay, BluePrint, in clinical decisionmaking for patients with early-stage breast cancer in Germany.1
The prospective study to measure the impact of MammaPrint on adjuvant treatment in hormone receptor-positive HER2-negative breast cancer patients (the Prime study) was undertaken by the West German Study Group (WSG). It included 452 patients from 27 centers and evaluated the impact of gene expression-based tests MammaPrint and BluePrint, compared to conventional clinico-pathological factors, in deciding whether or not patients would benefit from, and should therefore be treated with adjuvant chemotherapy.
Presented at the San Antonio Breast Cancer Conference, the study results showed a 28.4% change in patients’ treatment plans, originally based on clinico-pathological factors, as a direct result of data provided by MammaPrint and BluePrint.
“The discordance between conventional clinico-pathological assessment and the results of gene expression-based tests like MammaPrint is substantial,” says Nadia Harbeck, MD, PhD, scientific director of the West German Study Group, chair for conservative oncology in the department of obstetrics and gynecology at the University of Munich, and principal investigator of the Prime study. “Our study demonstrated that, in Germany, physicians not only welcomed these tests but showed a strong adherence to the test results—even actively changing their previous treatment plans. The greater than 90% adherence rate to the MammaPrint results regarding adjuvant treatment decisions demonstrated the confidence of physicians in these gene-expression results.”
Bastiaan van der Baan, Agendia.
“The final analysis of the WSG Prime study makes plain the importance of gene expression-based tests like MammaPrint, in giving physicians in Germany, and beyond, the definitive results and the confidence they need to provide the safest and most effective treatment plans for their patients,” says Bastiaan van der Baan, chief clinical and business development officer at Agendia.
“As the data show, the current clinico-pathological approach leaves a significant number of women in an unpleasant situation where they are under- or overtreated,” adds van der Baan. “We believe strongly that early-stage breast cancer patients and their physicians in Germany should be able to access the benefits of a gold-standard gene-expression test like MammaPrint, to enable individualized treatment based on quantitative, reliable, genomic data.”
The clinical performance of MammaPrint and its ability to inform and guide treatment decisions were demonstrated in the Mindact trial, the results of which appeared in the New England Journal of Medicine last August.2 The phase III prospective, randomized, controlled study provided the highest level of clinical evidence (Level 1A) for the use of MammaPrint in making adjuvant chemotherapy decisions in early-stage breast cancer. The Mindact trial included almost 7,000 patients across 112 institutions from nine European countries.
For more information visit Agendia.
REFERENCES
- Wuerstlein R, et al. Results of multigene assay (MammaPrint) and molecular subtyping (BluePrint) substantially impact treatment decision making in early breast cancer: final analysis of the WSG Prime decision impact study. Poster presented at the San Antonio Breast Cancer Symposium (San Antonio, Tex: December 2016).
- Cardoso F, van’t Veer LJ, Bogaerts J, et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375(8):717–729; doi: 10.1056/nejmoa1602253.
