. 2001 Jul;93(13).
doi: 10.1093/jnci/93.13.979.

National Institutes of Health Consensus Development Conference Statement: adjuvant therapy for breast cancer, November 1-3, 2000

P Eifel 1 J A Axelson  J Costa  J Crowley  W J Curran  A Deshler  S Fulton  C B Hendricks  M Kemeny  A B Kornblith  T A Louis  M Markman  R Mayer  D Roter  
  • PMID: 11438563
  •     149 citations


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 MEDLINE(TM) 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

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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Biomed Res Int, 2014 Jun 21; 2014. PMID: 24949450    Free PMC article.
Membranous Nectin-4 expression is a risk factor for distant relapse of T1-T2, N0 luminal-A early breast cancer.
R Lattanzio, R Ghasemi, +7 authors, M Piantelli.
Oncogenesis, 2014 Sep 02; 3. PMID: 25178039    Free PMC article.
99mTc-3P4-RGD2 scintimammography in the assessment of breast lesions: comparative study with 99mTc-MIBI.
Qingjie Ma, Bin Chen, +6 authors, Lin Liu.
PLoS One, 2014 Sep 25; 9(9). PMID: 25250628    Free PMC article.
Variations in Guideline-Concordant Breast Cancer Adjuvant Therapy in Rural Georgia.
Gery P Guy, Joseph Lipscomb, +3 authors, Kevin C Ward.
Health Serv Res, 2014 Dec 11; 50(4). PMID: 25491350    Free PMC article.
Adjuvant ovarian suppression in premenopausal breast cancer.
Prudence A Francis, Meredith M Regan, +28 authors, International Breast Cancer Study Group.
N Engl J Med, 2014 Dec 17; 372(5). PMID: 25495490    Free PMC article.
Highly Cited.
The predictive accuracy of PREDICT: a personalized decision-making tool for Southeast Asian women with breast cancer.
Hoong-Seam Wong, Shridevi Subramaniam, +7 authors, Nirmala Bhoo-Pathy.
Medicine (Baltimore), 2015 Feb 26; 94(8). PMID: 25715267    Free PMC article.
Intraoperative radiotherapy in early stage breast cancer: potential indications and evidence to date.
G G Hanna, A M Kirby.
Br J Radiol, 2015 Mar 04; 88(1049). PMID: 25734489    Free PMC article.
Prognostic impact of chemotherapy-induced amenorrhea on premenopausal breast cancer: a meta-analysis of the literature.
Qiong Zhou, Wenjin Yin, +2 authors, Jingsong Lu.
Menopause, 2015 Mar 19; 22(10). PMID: 25783467    Free PMC article.
Breast cancer survivorship: a comprehensive review of long-term medical issues and lifestyle recommendations.
Balazs I Bodai, Phillip Tuso.
Perm J, 2015 Apr 23; 19(2). PMID: 25902343    Free PMC article.
Racial/Ethnic and socioeconomic disparities in endocrine therapy adherence in breast cancer: a systematic review.
Megan C Roberts, Stephanie B Wheeler, Katherine Reeder-Hayes.
Am J Public Health, 2015 Apr 24; 105 Suppl 3. PMID: 25905855    Free PMC article.
Systematic Review.
Hormone receptor status (estrogen receptor, progesterone receptor), human epidermal growth factor-2 and p53 in South Indian breast cancer patients: A tertiary care center experience.
Rashmi Patnayak, Amitabh Jena, +4 authors, Mandyam Kumaraswamy Reddy.
Indian J Med Paediatr Oncol, 2015 Jul 15; 36(2). PMID: 26157289    Free PMC article.
Clinical Significance of Sentinel Node Positivity in Patients with Superficial Esophageal Cancer.
Hiroya Takeuchi, Hirofumi Kawakubo, +4 authors, Yuko Kitagawa.
World J Surg, 2015 Aug 25; 39(12). PMID: 26296842
Multiplexed detection of serological cancer markers with plasmon-enhanced Raman spectro-immunoassay.
Ming Li, Jeon Woong Kang, +2 authors, Ishan Barman.
Chem Sci, 2015 Sep 26; 6(7). PMID: 26405519    Free PMC article.
Identifying patients at high risk of breast cancer recurrence: strategies to improve patient outcomes.
Yehoda M Martei, Jennifer M Matro.
Breast Cancer (Dove Med Press), 2015 Oct 28; 7. PMID: 26504408    Free PMC article.
Doxorubicin-Hyaluronan Conjugated Super-Paramagnetic Iron Oxide Nanoparticles (DOX-HA-SPION) Enhanced Cytoplasmic Uptake of Doxorubicin and Modulated Apoptosis, IL-6 Release and NF-kappaB Activity in Human MDA-MB-231 Breast Cancer Cells.
Dinesh Vyas, Nicolas Lopez-Hisijos, +6 authors, Lakshmi S Chaturvedi.
J Nanosci Nanotechnol, 2015 Dec 23; 15(9). PMID: 26690867    Free PMC article.
STAT3-survivin signaling mediates a poor response to radiotherapy in HER2-positive breast cancers.
Jae-Sung Kim, Hyun-Ah Kim, +6 authors, Woo Chul Noh.
Oncotarget, 2016 Jan 13; 7(6). PMID: 26755645    Free PMC article.
Impact of Adjuvant Endocrine Therapy on Quality of Life and Symptoms: Observational Data Over 12 Months From the Mind-Body Study.
Patricia A Ganz, Laura Petersen, Julienne E Bower, Catherine M Crespi.
J Clin Oncol, 2016 Jan 21; 34(8). PMID: 26786934    Free PMC article.
21-Gene Recurrence Score Assay As a Predictor of Adjuvant Chemotherapy Administration for Early-Stage Breast Cancer: An Analysis of Use, Therapeutic Implications, and Disparity Profile.
Jagar Jasem, Arya Amini, +4 authors, Peter Kabos.
J Clin Oncol, 2016 Mar 24; 34(17). PMID: 27001563    Free PMC article.
Exploratory Cost-Effectiveness Analysis of Response-Guided Neoadjuvant Chemotherapy for Hormone Positive Breast Cancer Patients.
Anna Miquel-Cases, Valesca P Retèl, +3 authors, Wim H van Harten.
PLoS One, 2016 Apr 29; 11(4). PMID: 27124410    Free PMC article.
Increased Proportion of Variance Explained and Prediction Accuracy of Survival of Breast Cancer Patients with Use of Whole-Genome Multiomic Profiles.
Ana I Vazquez, Yogasudha Veturi, +4 authors, Gustavo de Los Campos.
Genetics, 2016 May 01; 203(3). PMID: 27129736    Free PMC article.
Visualization of basement membranes in normal breast and breast cancer tissues using multiphoton microscopy.
Xiufeng Wu, Gang Chen, +5 authors, Jun Yan.
Oncol Lett, 2016 Jun 18; 11(6). PMID: 27313695    Free PMC article.
Nanoparticles for imaging and treatment of metastatic breast cancer.
Qingxin Mu, Hui Wang, Miqin Zhang.
Expert Opin Drug Deliv, 2016 Jul 13; 14(1). PMID: 27401941    Free PMC article.
Interpretable per case weighted ensemble method for cancer associations.
Adrin Jalali, Nico Pfeifer.
BMC Genomics, 2016 Jul 21; 17. PMID: 27435615    Free PMC article.
Identification of breast cancer recurrence risk factors based on functional pathways in tumor and normal tissues.
Xiujie Chen, Lei Liu, +7 authors, Hongbo Xie.
Oncotarget, 2016 Aug 27; 8(13). PMID: 27564264    Free PMC article.
Functional and prognostic significance of the genomic amplification of frizzled 6 (FZD6) in breast cancer.
Gabriele Corda, Gianluca Sala, +22 authors, Arturo Sala.
J Pathol, 2016 Nov 20; 241(3). PMID: 27859262    Free PMC article.
Advancement of mass spectrometry-based proteomics technologies to explore triple negative breast cancer.
Sayem Miah, Charles A S Banks, +3 authors, Michael P Washburn.
Mol Biosyst, 2016 Nov 29; 13(1). PMID: 27891540    Free PMC article.
Evaluation of the Quality of Adjuvant Endocrine Therapy Delivery for Breast Cancer Care in the United States.
Bobby Daly, Olufunmilayo I Olopade, +3 authors, Dezheng Huo.
JAMA Oncol, 2017 Feb 06; 3(7). PMID: 28152150    Free PMC article.
Using the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: A multicenter trial.
Harry D Bear, Wen Wan, +8 authors, Amy P Sing.
J Surg Oncol, 2017 Apr 14; 115(8). PMID: 28407247    Free PMC article.
Traumatic Brain Injury and Neuropsychiatric Complications.
Saeed Ahmed, Hema Venigalla, +3 authors, Shahana Ayub.
Indian J Psychol Med, 2017 May 19; 39(2). PMID: 28515545    Free PMC article.
Spotlight on triptorelin in the treatment of premenopausal women with early-stage breast cancer.
Marta Venturelli, Giorgia Guaitoli, Claudia Omarini, Luca Moscetti.
Breast Cancer (Dove Med Press), 2018 Mar 20; 10. PMID: 29551913    Free PMC article.
Practice patterns and outcomes for patients with node-negative hormone receptor-positive breast cancer and intermediate 21-gene Recurrence Scores.
Jonathan Chen, Xian Wu, +2 authors, Himanshu Nagar.
Breast Cancer Res, 2018 Apr 18; 20(1). PMID: 29661221    Free PMC article.
Practical consensus recommendations regarding role of postmastectomy radiation therapy.
D Singh, G Saini, +8 authors, S Aggarwal.
South Asian J Cancer, 2018 May 04; 7(2). PMID: 29721470    Free PMC article.
Practical consensus recommendations on ovarian suppression in early breast cancer (adjuvant).
M Singhal, T P Sahoo, +8 authors, Purvish M Parikh.
South Asian J Cancer, 2018 May 04; 7(2). PMID: 29721484    Free PMC article.
Trends and outcomes of neoadjuvant radiotherapy compared with postoperative radiotherapy for malignant breast cancer.
Wenyan Fu, Hefen Sun, +5 authors, Wei Jin.
Oncotarget, 2018 Jun 01; 9(36). PMID: 29849958    Free PMC article.
Clinical relevance of the 21-gene Recurrence Score® assay in treatment decisions for patients with node-positive breast cancer in the genomic era.
Eleftherios P Mamounas, Christy A Russell, +2 authors, Kathy S Albain.
NPJ Breast Cancer, 2018 Aug 30; 4. PMID: 30155517    Free PMC article.
Investigating confounders of the association between survival and adjuvant radiation therapy after breast conserving surgery in a sample of elderly breast Cancer patients in Appalachia.
Fabian Camacho, Roger Anderson, Gretchen Kimmick.
BMC Cancer, 2019 Dec 19; 19(1). PMID: 31847855    Free PMC article.
Successful Immediate Staged Breast Reconstruction with Intermediary Autologous Lipotransfer in Irradiated Patients.
Kristina M Crawford, Denis Lawlor, +2 authors, Matthew R Endara.
Plast Reconstr Surg Glob Open, 2020 Jan 17; 7(9). PMID: 31942379    Free PMC article.
Evaluation of Prognosis in Hormone Receptor-Positive/HER2-Negative and Lymph Node-Negative Breast Cancer With Low Oncotype DX Recurrence Score.
Jane Meisel, Chao Zhang, +7 authors, Xiaoxian Li.
Clin Breast Cancer, 2018 Jan 07; 18(5). PMID: 29305309    Free PMC article.
A qualitative comparison of how older breast cancer survivors process treatment information regarding endocrine therapy.
Huibrie C Pieters, Emily Green, +2 authors, Annette L Stanton.
PLoS One, 2019 Feb 01; 14(1). PMID: 30703119    Free PMC article.
Differentially Expressed Genes in Matched Normal, Cancer, and Lymph Node Metastases Predict Clinical Outcomes in Patients With Breast Cancer.
Ga-Eon Kim, Nah Ihm Kim, +2 authors, Keunsoo Kang.
Appl Immunohistochem Mol Morphol, 2020 Feb 12; 28(2). PMID: 32044879    Free PMC article.
TP53 rs1042522 polymorphism and early-onset breast cancer.
Irmak Icen-Taskin, Sevgi Irtegun-Kandemir, Omer Munzuroglu.
J Res Med Sci, 2020 May 19; 25. PMID: 32419782    Free PMC article.
The healthcare value of the Magee Decision Algorithm™: use of Magee Equations™ and mitosis score to safely forgo molecular testing in breast cancer.
Rohit Bhargava, Beth Z Clark, +2 authors, David J Dabbs.
Mod Pathol, 2020 Mar 24; 33(8). PMID: 32203092    Free PMC article.
The distinct clinicopathological and prognostic implications of PIK3CA mutations in breast cancer patients from Central China.
Haibo Wu, Wei Wang, +8 authors, Wenchu Lin.
Cancer Manag Res, 2019 Mar 14; 11. PMID: 30863158    Free PMC article.
Young-onset breast cancer: a poor prognosis only exists in low-risk patients.
Jianfei Fu, Lunpo Wu, +7 authors, Jinlin Du.
J Cancer, 2019 Jul 11; 10(14). PMID: 31289582    Free PMC article.
Cytological Grading of Breast Tumors-The Human and Canine Perspective.
Krithiga Kuppusamy, Aarathi Rajan, +3 authors, Priya Srinivas.
Front Vet Sci, 2019 Sep 12; 6. PMID: 31508437    Free PMC article.
PLC-gamma-1 phosphorylation status is prognostic of metastatic risk in patients with early-stage Luminal-A and -B breast cancer subtypes.
Rossano Lattanzio, Manuela Iezzi, +8 authors, Mauro Piantelli.
BMC Cancer, 2019 Aug 01; 19(1). PMID: 31362705    Free PMC article.