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John Alfred Carr, MD; Suzanne Havstad, MA; Richard J. Zarbo, MD; George Divine, PhD; Pat Mackowiak, MS; Vic Velanovich, MD

Arch Surg. 2000;135:1469-1474.

Hypothesis  Amplification of the HER-2/neu oncogene in 25% of breast cancers is associated with a shortened disease-free survival.

Design  Retrospective analysis of a patient population referred to a tertiary care facility for HER-2/neu testing. The mean follow-up was 56 months.

Setting  Large, urban, tertiary care hospital.

Patients  From 1995 to 1999, a consecutive sample of 190 patients with breast cancer had tissue samples tested for overexpression of the cell surface oncoprotein by immunostaining (IM) or amplification of the HER-2/neu oncogene by fluorescence in situ hybridization or both. Forty-nine subjects were excluded because they had tissue samples tested at our institution but received their treatment elsewhere. All patients tested for HER-2/neu after diagnosis with breast cancer in 1999 (n = 47) were excluded from analysis because of short follow-up time. One patient was excluded who had in situ ductal carcinoma. The remaining 93 patients were analyzed.

Results  Of 93 patients, 40 (43%) had gene amplification. Overall, patients with oncogene amplification had a shorter median disease-free interval (22 months) compared with controls (40 months) (P = .003). Analysis by the Cox regression model showed that the HER-2/neu status remained significantly associated with time to relapse even after adjusting for age and tumor grade (P = .002; adjusted relative risk, 2.4; 95% confidence interval, 1.4-4.4). No association was found between gene amplification and tumor grade (P = .98), estrogen/progesterone receptor status (P = .29 and P = .43, respectively), or lymph node status (P = .98). Seventy-two patients (77%) eventually had disease recurrence, with 18 (25%) of these recurring locally.

Conclusions  The HER-2/neu oncogene is an independent prognostic indicator of a subset of breast cancers that are at high risk of early recurrence, regardless of tumor grade, estrogen/progesterone receptor status, and lymph node status. Patients amplifying the HER-2/neu oncogene have a shorter disease-free survival than patients without the oncogene.

From the Josephine Ford Cancer Center (Drs Carr and Velanovich), the Departments of Surgery and Biostatistics (Ms Havstad and Dr Divine) and Pathology (Dr Zarbo and Ms Mackowiak), Henry Ford Hospital, Detroit, Mich.

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