MammaPrint Feasibility in a Large Tertiary Urban Medical Center: An Initial Experience

Abstract

Background. The MammaPrint (MP) diagnostic assay stratifies breast cancer patients into high- and low-risk groups using mRNA analysis of a 70-gene profile. The assay is validated for assessment of patients with estrogen receptor positive or negative tumors less than 5 cm with 3 or fewer malignant lymph nodes. TargetPrint (TP) is an assay for assessing estrogen, progesterone, and HER2-neu receptor status based on mRNA expression. A potential limitation of these assays is that they require an evaluation of fresh tissue samples. There is limited published experience describing MP or TP implementation. Methods. Over 10 months, 4 breast surgeons obtained samples from 54 patients for MP/TP analysis. The samples were analyzed by Agendia Labs. The tumors were independently evaluated for receptor status using immunohistochemistry (IHC). Retrospectively, we identified patients who were assessed by MP/TP during this period. Patients who underwent OncotypeDx evaluation were also identified. Results. Of the 54 patients receiving MP, 4 were found ineligible for MP risk assessment because >3 lymph nodes were found to be malignant. Out of all eligible patients, 14/50 (28%) had samples whose quantity of tumor was not sufficient for analysis (QNS). Out of eligible patients with tumors <1 cm, 7/8 (88%) had QNS samples. 7/42 with tumors ≥1 cm (17%) had QNS samples. Nine patients had discordant receptor results when evaluated by IHC versus. TP. Of patients who also underwent OncotypeDx testing, 6/14 (43%) had discordant results with MP. Conclusions. This study indicates that using MP/TP assay is feasible in a tertiary care center but there may be utility in limiting MP testing to patients with tumors between 1 and 5 cm due to high likelihood of uninformative results in subcentimeter tumors. Further study is needed to explore the discordance between oncotype and MP results.