A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer

New England Journal of Medicine

Volumn 351, Issue 27, 2004, Pages 2817-2826

  Paik, Soonmyung ^a,e   Shak, Steven ^b   Tang, Gong ^a,c   Kim, Chungyeul ^a   Baker, Joffre ^a,b,c   Cronin, Maureen ^b   Baehner, Frederick L ^d   Walker, Michael G ^b   Watson, Drew ^b   Park, Taesung ^a   Hiller, William ^a   Fisher, Edwin R ^a   Wickerham, D Lawrence ^a   Bryant, John ^a,b,c   Wolmark, Norman ^a  

^a Division of Pathology   (United States)

^b Genomic Health   (United States)

^c UNIVERSITY OF PITTSBURGH   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e NSABP Foundation Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ESTROGEN RECEPTOR; TAMOXIFEN;

ADULT; ARTICLE; BREAST CARCINOMA; CANCER RECURRENCE; CANCER RISK; CANCER SURVIVAL; CONFIDENCE INTERVAL; CONTROLLED STUDY; GENE EXPRESSION; GENETIC ANALYSIS; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; KAPLAN MEIER METHOD; LYMPH NODE; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; RISK ASSESSMENT; SURVIVAL RATE;

ALGORITHMS; ANTINEOPLASTIC AGENTS, HORMONAL; BREAST NEOPLASMS; DNA, NEOPLASM; ESTROGEN ANTAGONISTS; FEMALE; FOLLOW-UP STUDIES; GENE EXPRESSION; GENES, ERBB-2; HUMANS; LYMPHATIC METASTASIS; MIDDLE AGED; MULTIVARIATE ANALYSIS; NEOPLASM METASTASIS; PROGNOSIS; PROPORTIONAL HAZARDS MODELS; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; RECURRENCE; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; RISK; SURVIVAL ANALYSIS; TAMOXIFEN; TUMOR MARKERS, BIOLOGICAL;

EID: 19944422061     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa041588     Document Type: Article

References (38)

1. Buetow KH, Klausner RD, Fine H, Kaplan R, Singer DS, Strausberg RL. Cancer Molecular Analysis Project: weaving a rich cancer research tapestry. Cancer Cell 2002;1:315-8.
2. Hahn WC, Weinberg RA. Rules for making human tumor cells. N Engl J Med 2002;347:1593-603. [Erratum, N Engl J Med 2003; 348:674.]
3. Fisher B, Costantino J, Redmond C, et al. A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med 1989;320:479-84.
4. Fisher B, Jeong JH, Bryant J, et al. Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Lancet 2004;364:858-68.
5. Fisher B, Dignam J, Wolmark N, et al. Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor-positive breast cancer. J Natl Cancer Inst 1997;89:1673-82.
6. Bryant J, Fisher B, Gunduz N, Costantino JP, Emir B. S-phase fraction combined with other patient and tumor characteristics for the prognosis of node-negative, estrogen-receptor-positive breast cancer. Breast Cancer Res Treat 1998;51:239-53.
7. Henderson IC, Patek AJ. The relationship between prognostic and predictive factors in the management of breast cancer. Breast Cancer Res Treat 1998;52:261-88.
8. Hayes DF. Do we need prognostic factors in nodal-negative breast cancer? Arbiter. Eur J Cancer 2000;36:302-6.
9. Esteva FJ, Hortobagyi GN. Prognostic molecular markers in early breast cancer. Breast Cancer Res 2004;6:109-18.
10. Fitzgibbons PL, Page DL, Weaver D, et al. Prognostic factors in breast cancer: College of American Pathologists Consensus Statement 1999. Arch Pathol Lab Med 2000;124:966-78.
11. Clinical practice guidelines for the use of tumor markers in breast and colorectal cancer: adopted on May 17, 1996 by the American Society of Clinical Oncology. J Clin Oncol 1996;14:2843-77.
12. Bast RC Jr, Ravdin P, Hayes DF, et al. 2000 Update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 2001;19:1865-78. [Errata, J Clin Oncol 2001;19:4185-8, 2002;20:2213.]
13. Goldhirsch A, Glick JH, Gelber RD, Coates AS, Senn HJ. Meeting highlights: International Consensus Panel on the Treatment of Primary Breast Cancer: Seventh International Conference on Adjuvant Therapy of Primary Breast Cancer. J Clin Oncol 2001;19:3817-27.
14. Eifel P, Axelson JA, Costa J, et al. National Institutes of Health Consensus Development Conference Statement: adjuvant therapy for breast cancer, November 1-3, 2000. J Natl Cancer Inst 2001;93:979-89.
15. Carlson RW, Edge SB, Theriault RL. NCCN: breast cancer. Cancer Control 2001;8:Suppl 2:54-61.
16. Davis RE, Staudt LM. Molecular diagnosis of lymphoid malignancies by gene expression profiling. Curr Opin Hematol 2002;9:333-8.
17. Perou CM, Sorlie T, Eisen MB, et al. Molecular portraits of human breast tumours. Nature 2000;406:747-52.
18. Golub TR, Slonim DK, Tamayo P, et al. Molecular classification of cancer: class discovery and class prediction by gene expression monitoring. Science 1999;286:531-7.
19. van't Veer LJ, Dai H, van de Vijver MJ, et al. Gene expression profiling predicts clinical outcome of breast cancer. Nature 2002;415:530-6.
20. van de Vijver MJ, He YD, van 't Veer LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med 2002;347:1999-2009.
21. Schena M, Shalon D, Davis RW, Brown PO. Quantitative monitoring of gene expression patterns with a complementary DNA microarray. Science 1995;270:467-70.
22. Cronin M, Pho M, Dutta D, et al. Measurement of gene expression in archival paraffin-embedded tissues: development and performance of a 92-gene reverse transcriptase-polymerase chain reaction assay. Am J Pathol 2004;164:35-42.
23. Sorlie T, Perou CM, Tibshirani R, et al. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A 2001;98:10869-74.
24. Esteban J, Baker J, Cronin M, et al. Tumor gene expression and prognosis in breast cancer: multi-gene RT-PCR assay of paraffin-embedded tissue. Prog Proc Am Soc Clin Oncol 2003;22:850. abstract.
25. Cobleigh MA, Bitterman P, Baker J, et al. Tumor gene expression predicts distant disease-free survival (DDFS) in breast cancer patients with 10 or more positive nodes: high throughout RT-PCR assay of paraffin-embedded tumor tissues. Prog Proc Am Soc Clin Oncol 2003;22:850. abstract.
26. Paik S, Shak S, Tang G, et al. Multi-gene RT-PCR assay for predicting recurrence in node negative breast cancer patients - NSABP studies B-20 and B-14. Breast Cancer Res Treat 2003;82:A16. abstract.
27. Elston CW, Ellis IO. Pathological prognostic factors in breast cancer. I. The value of histological grade in breast cancer: experience from a large study with long-term follow-up. Histopathology 1991;19:403-10.
28. Gray RJ. Flexible methods for analyzing survival data using splines, with applications to breast cancer prognosis. J Am Stat Assoc 1992;87:942-51.
29. Valenta Z, Weissfeld L. Estimation of the survival function for Gray's piecewise-constant time-varying coefficients model. Stat Med 2002;21:717-27.
30. Fisher B, Redmond C, Legault-Poisson S, et al. Postoperative chemotherapy and tamoxifen compared with tamoxifen alone in the treatment of positive-node breast cancer patients aged 50 years and older with tumors responsive to tamoxifen: results from the National Surgical Adjuvant Breast and Bowel Project B-16. J Clin Oncol 1990;8:1005-18.
31. Fisher B, Wickerham DL, Brown A, Redmond CK. Breast cancer estrogen and progesterone receptor values: their distribution, degree of concordance, and relation to number of positive axillary nodes. J Clin Oncol 1983;1:349-58.
32. Anderson WF, Chatterjee N, Ershler WB, Brawley OW. Estrogen receptor breast cancer phenotypes in the Surveillance, Epidemiology, and End Results database. Breast Cancer Res Treat 2002;76:27-36.
33. Robbins P, Pinder S, de Klerk N, et al. Histological grading of breast carcinomas: a study of interobserver agreement. Hum Pathol 1995;26:873-9.
34. Hopton DS, Thorogood J, Clayden AD, MacKinnon D. Observer variation in histological grading of breast cancer. Eur J Surg Oncol 1989;15:21-3.
35. Davis BW, Gelber RD, Goldhirsch A, et al. Prognostic significance of tumor grade in clinical trials of adjuvant therapy for breast cancer with axillary lymph node metastasis. Cancer 1986;58:2662-70.
36. Theissig F, Kunze KD, Haroske G, Meyer W. Histological grading of breast cancer: interobserver, reproducibility and prognostic significance. Pathol Res Pract 1990;186:732-6.
37. Singletary SE, Allred C, Ashley P, et al. Revision of the American Joint Committee on Cancer staging system for breast cancer. J Clin Oncol 2002;20:3628-36.
38. Esteva FJ, Sahin AA, Coombes K, et al. Multi-gene RT-PCR assay for predicting recurrence in node negative breast cancer patients - MD Anderson Clinical Validation Study. Breast Cancer Res Treat 2003;82:A16. abstract.