PROMIS Trial

In 2015, PROMIS4 (Prospective Study of MammaPrint in Breast Cancer Patients with an Intermediate Recurrence Score) evaluated 840 patients with early-stage breast cancer who had received an “intermediate” recurrence result from the Oncotype DX genomic test. The aim was to assess the change in physician treatment decisions after receiving a MammaPrint result.

PROMIS Findings

When analyzing the subgroup of 368 patients for whom the original treatment recommendation (based on the Oncotype DX intermediate result) conflicted with that indicated by MammaPrint, 76% of patients had their treatment plan changed, with chemotherapy either added or removed.

The study’s authors concluded that MammaPrint provides clinically actionable information on patients who were classified as intermediate risk by the Oncotype DX (21-gene signature) test, and that physicians may consider ordering MammaPrint to help with treatment decisions for these patients.

45

of Oncotype DX intermediate risk patients were reclassified as low risk by MammaPrint

55

of Oncotype DX intermediate risk patients were reclassified as high risk by MammaPrint

76

of patients had their treatment plan changed based on their MammaPrint result

In 79% of cases, physicians reported greater confidence in their treatment recommendation based on MammaPrint results.

STO-3 Trial

97

20-year breast cancer-specific survival with limited hormone therapy only

In a study5 published in 2017, MammaPrint was used to analyze 652 patient samples with 20-year follow-up data from the prospective,randomized Stockholm Tamoxifen Trial.

It demonstrated that a new MammaPrint threshold could identify a subgroup of patients with exceedingly low risk of cancer recurrence 20 years after diagnosis (Late Recurrence (20yr) Low Risk).

These patients, most of whom received only two years of treatment with tamoxifen, had an observed 20-year breast cancer specific survival of 97%. Patients with a Late Recurrence (20yr) Low Risk result who did not receive any treatment post-surgery (neither chemotherapy nor hormone therapy) had a 94% breast cancer specific survival rate.

This information can be helpful to physicians in deciding whether to recommend extended, standard, or limited hormone therapy for certain patients. It gives both physicians and their patients more options for better management of the disease.

*The time to appearance of distant metastasis. A distant metastasis refers to cancer that has spread from the original tumor to distant organs.

 

†Prospective refers to when patients are recruited to a clinical study and followed forward in time.

 

‡Randomization is a procedure to allocate clinical study participants into different groups. By using chance to allocate participants, the groups are likely to be similar and allow the effects of the treatments to be compared more fairly.

 

REFERENCES

 

4 Tsai M, Lo S, Audeh W, et al. Association of 70-Gene Signature Assay Findings With Physicians’ Treatment Guidance for Patients With Early Breast Cancer Classified as Intermediate Risk by the 21-Gene Assay. JAMA Oncol. 2018; 4(1):e173470

 

5 Esserman LJ, Yau C, Thompson CK, et al. Use of Molecular Tools to Identify Patients With Indolent Breast Cancers With Ultralow Risk Over 2 Decades. JAMA Oncol. 2017; 3(11):1503-1510