SELECT REFERENCES

ASSESSMENT OF HER2 STATUS

Bloom K et al. Comparison of HER-2/neu analysis using FISH and IHC when HercepTest™ is scored using conventional microscopy and image analysis. San Antonio Breast Cancer Conference 2000. Abstract 416. No Abstract Available.

Bucher C et al. Automated, high-throughput tissue microarray analysis for assessing the significance of HER-2 involvement in breast cancer. Proc ASCO 2000;Abstract 2388.

Buehler H et al. Effective HER-2/neu diagnosis in breast cancer by a combination of immunohistochemistry and FISH. Proc ASCO 2000; Abstract 294.

Cobleigh MA et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2- overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999;17:2639-2648. Abstract

Couturier J et al. Strong correlation between results of fluorescent in situ hybridization and immunohistochemistry for the assessment of the ERBB2 (Her-2/neu) gene status in breast carcinoma. Mod Pathol 2000;13(11):1238- 1243. Abstract

De Santes K et al. Radiolabeled antibody targeting of the HER-2/neu oncoprotein. Cancer Res 1992;52:1916-1923. Abstract

Field AS et al. Suggestions for HER-2/neu testing in breast carcinoma, based on a comparison of immunohistochemistry and fluorescence in situ hybridisation. Pathology 2001;33:278-282. Abstract

Hatanaka Y et al. Quantitative immunohistochemical evaluation of HER2/neu expression with HercepTest™ in breast carcinoma by image analysis. Pathol Int 2001 Jan;51(1):33-36. Abstract

Hayes DF et al. Circulating HER-2/erbB-2/c-neu (HER-2) extracellular domain as a prognostic factor in patients with metastatic breast cancer: Cancer and Leukemia Group B Study 8662. Clin Cancer Res 2001;7:2703-2711. Abstract

Hoang MP et al. HER-2/neu gene amplification compared with HER-2/neu protein overexpression and interobserver reproducibility in invasive breast carcinoma. Am J Clin Pathol 2000 Jun;113(6):852-859. Abstract

Jacobs TW et al. Specificity of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administrationapproved scoring system. J Clin Oncol 1999;17:1983-1987. Abstract

Jacobs TW et al. HER-2/neu protein expression in breast cancer evaluated by immunohistochemistry. Am J Clin Pathol 2000;13:251-258. Full-Text

Jacobs TW et al. Comparison of fluorescence in situ hybridization and immunohistochemistry for the evaluation of HER-2/neu in breast cancer. J Clin Oncol 1999;17:1974-1982. Abstract

Kakar S et al. Comparison of PathVysion and INFORM fluorescence in situ hybridization kits for assessment of HER-2/neu status in breast carcinoma. Molecular Diagnosis 2000;5:193-197. Abstract

Kallioniemi OP et al. ERBB2 amplification in breast cancer analyzed by fluorescence in situ hybridization. Proc Natl Acad Sci U S A 1992;89:5321- 5325. Full-Text

Kay EW et al. C-erbB-2 immunostaining: Problems with interpretation. J Clin Pathol 1994;47:816-822. Full-Text

Lebeau A et al. HER-2/neu analysis in archival tissue samples of human breast cancer: Comparison of immunohistochemistry and fluorescence in situ hybridization. J Clin Oncol 2001;19:354-363. Abstract

Leitzel K et al. Elevated soluble c-erbB-2 antigen levels in the serum and effusions of a proportion of breast cancer patients. J Clin Oncol 1992;10:1436-1443. Abstract

Mass RD et al. Improved survival benefit from Herceptin (trastuzumab) in patients selected by fluorescence in situ hybridization (FISH). Proc ASCO 2001;Abstract 85.

Mass RD et al. The concordance between the clinical trials assay (CTA) and fluorescence in situ hybridization (FISH) in the Herceptin pivotal trials. Proc ASCO 2000;Abstract 291.

Namer M et al. Comparison of C-erb-B2 expression in 104 primary breast tumors and their metastases by two immunohistochemical tests. Proc ASCO 2000;Abstract 2577.

Onody P et al. Fluorescence in situ hybridization and immunohistochemical assays for HER-2/neu status determination. Application to node-negative breast cancer. Arch Pathol Lab Med 2001;125:746-750. Abstract

Pauletti G et al. Assessment of methods for tissue-based detection of the HER-2/neu alteration in human breast cancer: A direct comparison of fluorescence in situ hybridization and immunohistochemistry. J Clin Oncol 2000;18:3651-3664. Abstract

Pauletti G et al. Detection and quantitation of HER-2/neu gene amplification in human breast cancer archival material using fluorescence in situ hybridization. Oncogene 1996;13:63-71. Abstract

Persons DL et al. Quantitation of HER-2/neu and c-myc gene amplification in breast carcinoma using fluorescence in situ hybridization. Mod Pathol 1997;10:720-727. Abstract

Press MF et al. HER-2/neu gene amplification characterized by fluorescence in situ hybridization: Poor prognosis in node-negative breast carcinomas. J Clin Oncol 1997;15:2894-2904. Abstract

Press MF et al. HER-2/neu expression in node-negative breast cancer: Direct tissue quantitation by computerized image analysis and association of overexpression with increased risk of recurrent disease. Cancer Res 1993;53:4960-4970. Abstract

Press MF et al. Sensitivity of HER-2/neu antibodies in archival tissue samples: Potential source of error in immunohistochemical studies of oncogene expression. Cancer Res 1994;54:2771-2777. Abstract

Ridolfi RL et al. HER-2/neu testing in breast carcinoma: A combined immumohistochemical and fluorescence in situ hybridization approach. Mod Pathol 2000;13:866-873. Abstract

Ross JS, Fletcher JA. HER-2/neu (c-erb-B2) gene and protein in breast cancer. Am J Clin Pathol 1999;112(suppl 1):S53-S67. Abstract Schaller G et al. Current use of HER2 tests. Ann Oncol 2001;12 (suppl 1):S97- S100. Abstract

Schaller G et al.Current use of HER2 tests.Ann Oncol 2001;12 (suppl 1):S97-S100.Abstract

Slamon DJ et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-792. Abstract

Starr A et al. Comparison of fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) in determining HER-2/neu status in breast cancer patients. Proc ASCO 2000;Abstract 2610.

Tanner M et al. Chromogenic in situ hybridization: A practical alternative for fluorescence in situ hybridization to detect HER-2/neu oncogene amplification in archival breast cancer samples. Am J Pathol 2000;57:1467- 1472. Abstract

Thor A. HER2 - a discussion of testing approaches in the USA. Ann Oncol 2001;12 (suppl 1):S101-S107. Abstract

Tubbs RR et al. Discrepancies in clinical laboratory testing of eligibility for trastuzumab therapy: Apparent immunohistochemical false-positives do not get the message. J Clin Oncol 2001;19:2714-2721. Abstract

Yamauchi H et al. When is a tumor marker ready for prime time? A case study of c-erbB-2 as a predictive factor in breast cancer. J Clin Oncol 2001;19:2334-2356. Abstract

Vogel CL et al. Superior outcomes with Herceptin (trastuzumab) in fluorescence in situ hybridization (FISH)-selected patients. Proc ASCO 2001;Abstract 86.

Wang S et al. Assessment of HER-2/neu status in breast cancer. Automated cellular imaging system (ACIS)-assisted quantitation of immunohistochemical assay achieves high accuracy in comparison with fluorescence in situ hybridization assay as the standard. Am J Clin Pathol 2001;116:495-503. Full-Text

Wang S et al. Laboratory assessment of the status of Her-2/neu protein and oncogene in breast cancer specimens: Comparison of immunohistochemistry assay with fluorescence in situ hybridisation assays. J Clin Pathol 2000;53:374-381. Abstract

ADJUVANT TIRALS OF TRASTUZUMAB

Baselga J. Clinical trials of Herceptin (trastuzumab). Eur J Cancer 2001;37 Suppl 1:S18-24. Abstract

Esteva FJ et al. Chemotherapy of metastatic breast cancer: What to expect in 2001 and beyond. Oncologist 2001;6:133-46. Abstract

Fleming TR. Issues in the design of clinical trials: Insights from the trastuzumab (Herceptin) experience. Semin Oncol 1999;26:102-7. Abstract

Hortobagyi GN. Developments in chemotherapy of breast cancer. Cancer 2000;88:3073-9. Abstract

Horton J. HER2 and trastuzumab in breast cancer. Cancer Control 2001;8(1):103-110. Full-Text

McCarthy NJ, Swain SM. Update on adjuvant chemotherapy for early breast cancer. Oncology (Huntingt). 2000;14:1267-80; discussion 1280-4, 1287-8. Abstract

Nicholson BP. Ongoing and planned trials of hormonal therapy and trastuzumab. Semin Oncol 2000;27:33-7; discussion 92-100. Abstract

Perez EA, Hortobagyi GN. Ongoing and planned adjuvant trials with trastuzumab. Semin Oncol 2000;27:26-32; discussion 92-100. Abstract

Slamon D, Pegram M. Rationale for trastuzumab (Herceptin) in adjuvant breast cancer trials. Semin Oncol 2001;28:13-9. Abstract

Smith I. Future directions in the adjuvant treatment of breast cancer: The role of trastuzumab. Ann Oncol 2001;12(Suppl 1):S75-S79. Abstract

Sparano JA. Cardiac toxicity of trastuzumab (Herceptin): Implications for the design of adjuvant trials. Semin Oncol 2001;28:20-7. Abstract

CARDIOTOXICITY WITH TRASTUZUMAB

Carey LA et al. Safety and efficacy of 4AC followed by paclitaxel plus trastuzumab in high risks breast cancer patients. Proc ASCO 2001; Abstract 1856.

Chien KR. Myocyte survival pathways and cardiomyopathy: Implications for trastuzumab cardiotoxicity. Semin Oncol 2000;27:9-14; discussion 92-100. Abstract

Feldman AM et al. Trastuzumab in the treatment of metastatic breast cancer: Anticancer therapy versus cardiotoxicity. Circulation 2000;102:272-4. Abstract

Sparano JA. Cardiac toxicity of trastuzumab (Herceptin): Implications for the design of adjuvant trials. Semin Oncol 2001;28:20-7. Abstract

NONANTHRACYCLINE REGIMES FOR METASTATIC DISEASE

Crown J. Nonanthracycline-containing docetaxel-based combinations in metastatic breast cancer. Oncologist 2001;6 Suppl 3:17-21. Abstract

Crown JP. The platinum agents: A role in breast cancer treatment? Semin Oncol 2001 Feb;28(1 Suppl 3):28-37. Abstract

Perez EA. Paclitaxel in breast cancer. Oncologist 1998;3(6):373-389. Abstract

Fountzilas G et al. First-line chemotherapy with paclitaxel by three-hour infusion and carboplatin in advanced breast cancer (final report): A phase II study conducted by the Hellenic Cooperative Oncology Group. Ann Oncol 1998;9(9):1031-4. Abstract

Perez EA, Hartmann LC. Paclitaxel and carboplatin for advanced breast cancer. Semin Oncol 1996;23(5 Suppl 11):41-5. Abstract

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