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      Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer.

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          Abstract

          No single standard treatment exists for patients with small, node-negative, human epidermal growth factor receptor type 2 (HER2)-positive breast cancers, because most of these patients have been ineligible for the pivotal trials of adjuvant trastuzumab.

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          Efficacy and Safety of Trastuzumab as a Single Agent in First-Line Treatment of HER2-Overexpressing Metastatic Breast Cancer

          C Vogel (2002)
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            High risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cm or smaller.

            Richard Theriault, Aysegul Sahin, Martine Piccart-Gebhart … (2009)
            To evaluate the risk of recurrence in women diagnosed with T1a and T1b, node-negative, human epidermal growth factor receptor 2 (HER2) -positive breast cancer. We reviewed 965 T1a,bN0M0 breast cancers diagnosed at our institution between 1990 and 2002. Dedicated breast pathologists confirmed HER2 positivity if 3+ by immunohistochemistry or if it had a ratio of 2.0 or greater by fluorescence in situ hybridization (FISH). Patients who received adjuvant chemotherapy or trastuzumab were excluded. Kaplan-Meier product was used to calculate recurrence-free survival (RFS) and distant recurrence-free survival (DRFS). Cox proportional hazard models were fit to determine associations between HER2 status and survival after adjustment for patient and disease characteristics. Additionally, 350 breast cancers from two other institutions were used for validation. Ten percent of patients had HER2-positive tumors. At a median follow-up of 74 months, there were 72 recurrences. The 5-year RFS rates were 77.1% and 93.7% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). The 5-year DRFS rates were 86.4% and 97.2% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). In multivariate analysis, patients with HER2-positive tumors had higher risks of recurrence (hazard ratio [HR], 2.68; 95% CI, 1.44 to 5.0; P = .002) and distant recurrence (HR, 5.3; 95% CI, 2.23 to 12.62; P < .001) than those with HER2-negative tumors. Patients with HER2-positive tumors had 5.09 times (95% CI, 2.56 to 10.14; P < .0001) the rate of recurrences and 7.81 times (95% CI, 3.17 to 19.22; P < .0001) the rate of distant recurrences at 5 years compared with patients who had hormone receptor-positive tumors. Patients with HER2-positive T1abN0M0 tumors have a significant risk of relapse and should be considered for systemic, anti-HER2, adjuvant therapy.
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              Clinical significance of HER-2/neu oncogene amplification in primary breast cancer. The South Australian Breast Cancer Study Group.

              Frank A Firgaira, P Kitchen, R. Seshadri … (1993)
              To determine prospectively the prognostic significance of HER-2/neu oncogene amplification in the primary tumors of breast cancer patients. HER-2/neu amplification in tumor DNA was determined by the slot-blot technique in 1,056 patients with breast cancer (stage I to III) diagnosed between 1987 and 1990. Parameters such as estrogen receptor (ER) and progesterone receptor (PgR) levels, tumor size, axillary nodal involvement, tumor grade, and time to relapse were prospectively obtained. HER-2/neu oncogene amplification, > or = 2, > or = 3, and > or = 5 copy number, was detected in 21%, 11%, and 7% of patients, respectively. In a test set of 529 patients, Cox multivariate analysis showed HER-2/neu copy number > or = 3 or > or = 5 was associated with shorter disease-free survival (DFS) duration. HER-2/neu copy number > or = 3 correlated significantly with pathologic stage of disease, number of axillary nodes with tumor, histologic type, and absence of ER and PgR. For all patients, after a median follow-up duration of 39 months, Kaplan-Meier univariate analysis indicated that tumor oncogene copy number > or = 3 correlated with shorter DFS in both node-negative and node-positive patients. In Cox multivariate analysis, HER-2/neu copy number > or = 3 was associated with shorter DFS, independent of nodal status, ER level, and tumor size. Although the follow-up duration of this study is relatively short, we conclude that HER-2/neu amplification is an independent predictor of shorter DFS in both node-negative and node-positive patients.
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                Author and article information

                Journal
                Journal ID (iso-abbrev): N. Engl. J. Med.
                Title: The New England journal of medicine
                ISSN (Electronic): 1533-4406
                ISSN (Print): 0028-4793
                Publication date (Electronic): Jan 8 2015
                Volume: 372
                Issue: 2
                Affiliations
                [1 ] From the Departments of Medical Oncology (S.M.T., B.A.O., A.H.P., I.E.K., H.J.B., E.P.W.) and Biostatistics and Computation Biology (W.T.B., H.G.), Dana-Farber Cancer Institute, and Department of Hematology-Oncology, Massachusetts General Hospital (B.M.) - both in Boston; Breast Cancer Medicine Service, Department of Medicine, Solid Tumor Division, Memorial Sloan Kettering Cancer Center, and Department of Medicine, Weill Cornell Medical Center, New York (C.T.D., C.A.H.), and Department of Medical Oncology, Hofstra North Shore-LIJ School of Medicine, New Hyde Park (I.S.) - all in New York; Sarah Cannon Cancer Center, Department of Medical Oncology, Nashville (D.A.Y.); Department of Medicine, Division of Medical Oncology, Duke Cancer Institute, Durham (P.K.M.), and Department of Medical Oncology, University of North Carolina, Chapel Hill (L.A.C.) - both in North Carolina; Cardinal Bernardin Cancer Center, Department of Medicine, Division of Hematology-Oncology, Loyola University Chicago Stritch School of Medicine, Maywood, IL (K.S.A.); Comprehensive Cancer Center, Department of Medicine, Division of Oncology, University of California, San Francisco, San Francisco (H.S.R.); Department of Medical Oncology, Washington University in St. Louis, St. Louis (M.E.); and Johns Hopkins Kimmel Cancer Center, Department of Oncology, Baltimore (A.C.W.).
                Article
                Mid ID: NIHMS658718
                DOI: 10.1056/NEJMoa1406281
                PubMed ID: 25564897
                SO-VID: b9ccee9b-e610-4fbb-b36e-04ab1cabd0ff
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