© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 13, 979-989,
July 4, 2001
© 2001 Oxford University Press
SPECIAL ARTICLE |
National Institutes of Health Consensus Development Conference Statement: Adjuvant Therapy for Breast Cancer, November 1–3, 2000
National Institutes of Health Consensus Development Panel*
Correspondence to: John A. Bowersox, Communications Specialist, Office of Medical Applications of Research, National Institutes of Health, Bldg. 31, Rm. 1B03, Bethesda, MD 20892 (e-mail bowersoj{at}od.nih.gov).
Objective: Our goal was to provide health-care providers, patients, and the general public with an assessment of currently available data regarding the use of adjuvant therapy for breast cancer. Participants: The participants included a non-Federal, non-advocate, 14-member panel representing the fields of oncology, radiology, surgery, pathology, statistics, public health, and health policy as well as patient representatives. In addition, 30 experts in medical oncology, radiation oncology, biostatistics, epidemiology, surgical oncology, and clinical trials presented data to the panel and to a conference audience of 1000. Evidence: The literature was searched with the use of MEDLINETM for January 1995 through July 2000, and an extensive bibliography of 2230 references was provided to the panel. Experts prepared abstracts for their conference presentations with relevant citations from the literature. Evidence from randomized clinical trials and evidence from prospective studies were given precedence over clinical anecdotal experience. Consensus Process: The panel, answering predefined questions, developed its conclusions based on the evidence presented in open forum and the scientific literature. The panel composed a draft statement, which was read in its entirety and circulated to the experts and the audience for comment. Thereafter, the panel resolved conflicting recommendations and released a revised statement at the end of the conference. The panel finalized the revisions within a few weeks after the conference. The draft statement was made available on the World Wide Web immediately after its release at the conference and was updated with the panel's final revisions. The statement is available at http://consensus.nih.gov. Conclusions: The panel concludes that decisions regarding adjuvant hormonal therapy should be based on the presence of hormone receptor protein in tumor tissues. Adjuvant hormonal therapy should be offered only to women whose tumors express hormone receptor protein. Because adjuvant polychemotherapy improves survival, it should be recommended to the majority of women with localized breast cancer regardless of lymph node, menopausal, or hormone receptor status. The inclusion of anthracyclines in adjuvant chemotherapy regimens produces a small but statistically significant improvement in survival over non-anthracycline-containing regimens. Available data are currently inconclusive regarding the use of taxanes in adjuvant treatment of lymph node-positive breast cancer. The use of adjuvant dose-intensive chemotherapy regimens in high-risk breast cancer and of taxanes in lymph node-negative breast cancer should be restricted to randomized trials. Ongoing studies evaluating these treatment strategies should be supported to determine if such strategies have a role in adjuvant treatment. Studies to date have included few patients older than 70 years. There is a critical need for trials to evaluate the role of adjuvant chemotherapy in these women. There is evidence that women with a high risk of locoregional tumor recurrence after mastectomy benefit from postoperative radiotherapy. This high-risk group includes women with four or more positive lymph nodes or an advanced primary cancer. Currently, the role of postmastectomy radiotherapy for patients with one to three positive lymph nodes remains uncertain and should be tested in a randomized controlled trial. Individual patients differ in the importance they place on the risks and benefits of adjuvant treatments. Quality of life needs to be evaluated in selected randomized clinical trials to examine the impact of the major acute and long-term side effects of adjuvant treatments, particularly premature menopause, weight gain, mild memory loss, and fatigue. Methods to support shared decision-making between patients and their physicians have been successful in trials; they need to be tailored for diverse populations and should be tested for broader dissemination.
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S. K. Chia, C. H. Speers, C. J. Bryce, M. M. Hayes, and I. A. Olivotto Ten-Year Outcomes in a Population-Based Cohort of Node-Negative, Lymphatic, and Vascular Invasion-Negative Early Breast Cancers Without Adjuvant Systemic Therapies J. Clin. Oncol., May 1, 2004; 22(9): 1630 - 1637. [Abstract] [Full Text] [PDF]
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P. T. Truong, I. A. Olivotto, T. J. Whelan, and M. Levine Clinical practice guidelines for the care and treatment of breast cancer: 16. Locoregional post-mastectomy radiotherapy Can. Med. Assoc. J., April 13, 2004; 170(8): 1263 - 1273. [Abstract] [Full Text] [PDF]
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T. Sudo, M. Nitta, H. Saya, and N. T. Ueno Dependence of Paclitaxel Sensitivity on a Functional Spindle Assembly Checkpoint Cancer Res., April 1, 2004; 64(7): 2502 - 2508. [Abstract] [Full Text] [PDF]
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G. V. Glinsky, T. Higashiyama, and A. B. Glinskii Classification of Human Breast Cancer Using Gene Expression Profiling as a Component of the Survival Predictor Algorithm Clin. Cancer Res., April 1, 2004; 10(7): 2272 - 2283. [Abstract] [Full Text] [PDF]
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P. A. Ganz, L. Kwan, A. L. Stanton, J. L. Krupnick, J. H. Rowland, B. E. Meyerowitz, J. E. Bower, and T. R. Belin Quality of Life at the End of Primary Treatment of Breast Cancer: First Results From the Moving Beyond Cancer Randomized Trial J Natl Cancer Inst, March 3, 2004; 96(5): 376 - 387. [Abstract] [Full Text] [PDF]
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C. Botti, S. Buglioni, M. Benevolo, D. Giannarelli, P. Papaldo, F. Cognetti, P. Vici, F. Di Filippo, F. Del Nonno, F. M. Venanzi, et al. Altered Expression of FAS System Is Related to Adverse Clinical Outcome in Stage I-II Breast Cancer Patients Treated with Adjuvant Anthracycline-Based Chemotherapy Clin. Cancer Res., February 15, 2004; 10(4): 1360 - 1365. [Abstract] [Full Text] [PDF]
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J.-Y. Pierga, C. Bonneton, A. Vincent-Salomon, P. de Cremoux, C. Nos, N. Blin, P. Pouillart, J.-P. Thiery, and H. Magdelenat Clinical Significance of Immunocytochemical Detection of Tumor Cells Using Digital Microscopy in Peripheral Blood and Bone Marrow of Breast Cancer Patients Clin. Cancer Res., February 15, 2004; 10(4): 1392 - 1400. [Abstract] [Full Text] [PDF]
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D. Crivellari, K. Price, R. D. Gelber, M. Castiglione-Gertsch, C.-M. Rudenstam, J. Lindtner, M. F. Fey, H.-J. Senn, A. S. Coates, J. Collins, et al. Adjuvant Endocrine Therapy Compared With No Systemic Therapy for Elderly Women With Early Breast Cancer: 21-Year Results of International Breast Cancer Study Group Trial IV J. Clin. Oncol., December 15, 2003; 21(24): 4517 - 4523. [Abstract] [Full Text] [PDF]
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C. Chao, J. L. Studts, T. Abell, T. Hadley, L. Roetzer, S. Dineen, D. Lorenz, A. YoussefAgha, and K. M. McMasters Adjuvant Chemotherapy for Breast Cancer: How Presentation of Recurrence Risk Influences Decision-Making J. Clin. Oncol., December 1, 2003; 21(23): 4299 - 4305. [Abstract] [Full Text] [PDF]
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B. N. Peshkin, C. Isaacs, C. Finch, S. Kent, and M. D. Schwartz Tamoxifen As Chemoprevention in BRCA1 and BRCA2 Mutation Carriers With Breast Cancer: A Pilot Survey of Physicians J. Clin. Oncol., December 1, 2003; 21(23): 4322 - 4328. [Abstract] [Full Text] [PDF]
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 J. Liebmann, C. Haskins, B. McAneny, R. Giudice, D. Clark, and N. Marshall Chemotherapy in Women with Breast Cancer Ann Intern Med, November 18, 2003; 139(10): 867 - 868. [Full Text] [PDF]
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H. D. Bear, S. Anderson, A. Brown, R. Smith, E. P. Mamounas, B. Fisher, R. Margolese, H. Theoret, A. Soran, D. L. Wickerham, et al. The Effect on Tumor Response of Adding Sequential Preoperative Docetaxel to Preoperative Doxorubicin and Cyclophosphamide: Preliminary Results From National Surgical Adjuvant Breast and Bowel Project Protocol B-27 J. Clin. Oncol., November 15, 2003; 21(22): 4165 - 4174. [Abstract] [Full Text] [PDF]
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E. Biganzoli, P. Boracchi, D. Coradini, M. Grazia Daidone, and E. Marubini Prognosis in node-negative primary breast cancer: a neural network analysis of risk profiles using routinely assessed factors Ann. Onc., October 1, 2003; 14(10): 1484 - 1493. [Abstract] [Full Text] [PDF]
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 C. E. Holmes and H. B. Muss Diagnosis and Treatment of Breast Cancer in the Elderly CA Cancer J Clin, July 1, 2003; 53(4): 227 - 244. [Abstract] [Full Text]
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A. Mariotto, E. J. Feuer, and J. Abrams RESPONSE: Re: Trends in Use of Adjuvant Multi-Agent Chemotherapy and Tamoxifen for Breast Cancer in the United States: 1975-1999 J Natl Cancer Inst, May 7, 2003; 95(9): 684 - 685. [Full Text] [PDF]
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B. Overmoyer Combination Chemotherapy for Metastatic Breast Cancer: Reaching for the Cure J. Clin. Oncol., February 15, 2003; 21(4): 580 - 582. [Full Text] [PDF]
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K.-A. Phillips and J. Bernhard Adjuvant Breast Cancer Treatment and Cognitive Function: Current Knowledge and Research Directions J Natl Cancer Inst, February 5, 2003; 95(3): 190 - 197. [Abstract] [Full Text] [PDF]
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X. L. Du, C. R. Key, C. Osborne, J. D. Mahnken, and J. S. Goodwin Discrepancy between Consensus Recommendations and Actual Community Use of Adjuvant Chemotherapy in Women with Breast Cancer Ann Intern Med, January 21, 2003; 138(2): 90 - 97. [Abstract] [Full Text] [PDF]
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P. Fumoleau, P. Kerbrat, P. Romestaing, P. Fargeot, A. Bremond, M. Namer, S. Schraub, M.-J. Goudier, J. Mihura, A. Monnier, et al. Randomized Trial Comparing Six Versus Three Cycles of Epirubicin-Based Adjuvant Chemotherapy in Premenopausal, Node-Positive Breast Cancer Patients: 10-Year Follow-Up Results of the French Adjuvant Study Group 01 Trial J. Clin. Oncol., January 15, 2003; 21(2): 298 - 305. [Abstract] [Full Text] [PDF]
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 C. I. Li, K. E. Malone, and J. R. Daling Differences in Breast Cancer Stage, Treatment, and Survival by Race and Ethnicity Arch Intern Med, January 13, 2003; 163(1): 49 - 56. [Abstract] [Full Text] [PDF]
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C. I. Li, J. R. Daling, and K. E. Malone Incidence of Invasive Breast Cancer by Hormone Receptor Status From 1992 to 1998 J. Clin. Oncol., January 1, 2003; 21(1): 28 - 34. [Abstract] [Full Text] [PDF]
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J. N. Ingle Adjuvant Endocrine Therapy in Postmenopausal Breast Cancer Clin. Cancer Res., January 1, 2003; 9(1): 480s - 485s. [Abstract] [Full Text]
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L. A. Emens and N. E. Davidson Adjuvant Hormonal Therapy for Premenopausal Women with Breast Cancer Clin. Cancer Res., January 1, 2003; 9(1): 486s - 494s. [Abstract] [Full Text]
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M. J. van de Vijver, Y. D. He, L. J. van 't Veer, H. Dai, A. A.M. Hart, D. W. Voskuil, G. J. Schreiber, J. L. Peterse, C. Roberts, M. J. Marton, et al. A Gene-Expression Signature as a Predictor of Survival in Breast Cancer N. Engl. J. Med., December 19, 2002; 347(25): 1999 - 2009. [Abstract] [Full Text] [PDF]
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A. Kallioniemi Molecular Signatures of Breast Cancer -- Predicting the Future N. Engl. J. Med., December 19, 2002; 347(25): 2067 - 2068. [Full Text] [PDF]
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X. L. Du, C. Osborne, and J. S. Goodwin Population-Based Assessment of Hospitalizations for Toxicity From Chemotherapy in Older Women With Breast Cancer J. Clin. Oncol., December 15, 2002; 20(24): 4636 - 4642. [Abstract] [Full Text] [PDF]
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J. L. Malin, M. A. Schuster, K. A. Kahn, and R. H. Brook Quality of Breast Cancer Care: What Do We Know? J. Clin. Oncol., November 1, 2002; 20(21): 4381 - 4393. [Abstract] [Full Text] [PDF]
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