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Background  Amplification of the  ERBB2  ( Her-2/neu ) oncogene, which occurs in approximately 25% of breast carcinomas, is a known negative prognostic factor. Available data indicate that a variable number of nearby genes on chromosome 17q may be co-amplified or deleted, forming a continuous amplicon of variable size. In approximately 25% of these patients, the amplicon extends to the gene for  topoisomerase II alpha  ( TOP2A ), a target for anthracyclines. We sought to understand the significance of these associated genomic changes for breast cancer prognosis and predicting response to therapy.    Methods and patients  Archival tissue samples from 63 breast cancer patients with  ERBB2  amplification, stages 0–IV, were previously analyzed with FISH probes for genes located near  ERBB2 . In the present study, the clinical outcome data were determined for all patients presenting at stages I–III for whom adequate clinical follow up was available.    Results  Four amplicon patterns (Classes) were identified. These were significantly associated with the clinical outcome, specifically, recurrence of breast cancer. The Amplicon class IV with deleted  TOP2A  had 67% (6/9) cases with recurrence, whereas the other three classes combined had only 12% (3/25) cases (p-value = 0.004) at the time of last follow-up.  TOP2A  deletion was also significantly associated with time to recurrence (p-value = 0.0002). After adjusting for age in Cox regression analysis, the association between  TOP2A  deletion and time to recurrence remains strongly significant (p-value = 0.002) whereas the association with survival is marginally significant (p-value = 0.06).    Conclusion   TOP2A  deletion is associated with poor prognosis in  ERBB2 -amplified breast carcinomas. Clarification of the mechanism of this association will require additional study.

journal of hematology and oncology

Topoisomerase II alpha gene copy loss has adverse prognostic significance in ERBB2-amplified breast cancer: a retrospective study of paraffin-embedded tumor specimens and medical charts