Prospective study evaluating the impact of tissue confirmation of metastatic disease in patients with breast cancer

Abstract

Purpose: Decisions about treatment for women with metastatic breast cancer are usually based on the estrogen (ER), progesterone (PgR), and human epidermal growth factor receptor 2 (HER2) status of the primary tumor. Retrospective data suggest that discordance between primary and metastatic lesions leads to detrimental outcome. This prospective study investigated receptor status of primary tumors and metastases in the same patient and assessed the impact of discordance on patient management and survival.

Patients and methods: Biopsies of suspected metastases were analyzed for ER, PgR, and HER2. Primary tumors and metastases were analyzed using similar methodology. The treating oncologist indicated a treatment plan before and after biopsy to determine whether the result influenced management. Patients were followed up for progression or death.

Results: Of 121 women undergoing biopsy, 80% could be analyzed for receptor status. Discordance in ER, PgR, and HER2 between the primary and the metastasis was 16%, 40%, and 10%, respectively. Biopsy led to a reported change of management in 14% of women (95% CI, 8.4% to 21.5%). Fine-needle aspiration and biopsy of bone led to reduced ability to analyze receptors. After a median follow-up of 12 months, there were no trends for an association between receptor discordance and either time to treatment failure or overall survival.

Conclusion: Biopsy of metastases is technically feasible. Clinicians alter immediate management in one of seven patients on the basis of results of the biopsy, and discordance is not then associated with detrimental effects on outcome. Tissue confirmation should be considered in women with breast cancer and suspected metastatic recurrence.

Fig 1.

Flow diagram for the study. FISH, fluorescent in situ hybridization.

Fig 2.

Changes in estrogen receptor (ER), progesterone receptor (PgR), and HER2 between the original pathology report of the primary tumor and the metastasis.

Fig 3.

Waterfall plot showing absolute change in hormone receptor expression. A positive score confirms increased expression of receptor from the primary to the metastasis; a negative score confirms reduced expression. (A) Estrogen receptor; (B) progesterone receptor. Blue, concordance with primary; gold, discordance with primary.

Fig 4.

Survival by discordance. (A) Time to treatment failure. (B) Overall survival.