Regional Nodal Irradiation in Early-Stage Breast Cancer.

METHODS We randomly assigned women with node-positive or high-risk node-negative breast cancer who were treated with breast-conserving surgery and adjuvant systemic therapy to undergo either whole-breast irradiation plus regional nodal irradiation (including internal mammary, supraclavicular, and axillary lymph nodes) (nodalirradiation group) or whole-breast irradiation alone (control group). The primary outcome was overall survival. Secondary outcomes were disease-free survival, isolated locoregional disease-free survival, and distant disease-free survival.

[1]  Laurence Collette,et al.  Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer. , 2015, The New England journal of medicine.

[2]  R. Peto,et al.  Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials , 2014, The Lancet.

[3]  T. Whelan,et al.  NCIC CTG MA.20: An intergroup trial of regional nodal irradiation in early breast cancer. , 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[4]  A. Giuliano,et al.  Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. , 2011, JAMA.

[5]  S. Paik,et al.  Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  T. Nielsen,et al.  Breast cancer subtypes and the risk of local and regional relapse. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[7]  A. Luini,et al.  The value of radiotherapy on metastatic internal mammary nodes in breast cancer. Results on a large series. , 2008, Annals of oncology : official journal of the European Society for Medical Oncology.

[8]  F. B. Sørensen,et al.  Estrogen receptor, progesterone receptor, HER-2, and response to postmastectomy radiotherapy in high-risk breast cancer: the Danish Breast Cancer Cooperative Group. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[9]  Guangyu Liu,et al.  Breast cancer subpopulation with high risk of internal mammary lymph nodes metastasis: analysis of 2,269 Chinese breast cancer patients treated with extended radical mastectomy , 2008, Breast Cancer Research and Treatment.

[10]  Stephen W Lagakos,et al.  Statistics in medicine--reporting of subgroup analyses in clinical trials. , 2007, The New England journal of medicine.

[11]  I. Wallace.  Radiotherapy for invasive breast cancer in North America and Europe: Results of a Survey , 2005 .

[12]  J. Overgaard,et al.  Late treatment-related morbidity in breast cancer patients randomized to postmastectomy radiotherapy and systemic treatment versus systemic treatment alone. , 1999, Acta oncologica.

[13]  B. Rasmussen,et al.  Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial , 1999, The Lancet.

[14]  K. Zedeler,et al.  Postoperative Radiotherapy in High-Risk Premenopausal Women with Breast Cancer Who Receive Adjuvant Chemotherapy , 1997 .

[15]  N. Le,et al.  Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. , 1997, The New England journal of medicine.

[16]  T. Whelan,et al.  Randomized Clinical Trial of Breast Irradiation Following Lumpectomy and Axillary Dissection for Node-Negative Breast Cancer: an Update , 1996 .

[17]  Richard J. Cook,et al.  Multiplicity Considerations in the Design and Analysis of Clinical Trials , 1996 .

[18]  A. Luini,et al.  Radiotherapy after breast-preserving surgery in women with localized cancer of the breast. , 1993, The New England journal of medicine.

[19]  R. Siddon,et al.  Three-dimensional internal mammary lymphoscintigraphy: implications for radiation therapy treatment planning for breast carcinoma. , 1988, International journal of radiation oncology, biology, physics.

[20]  B Fisher,et al.  Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. , 1985, The New England journal of medicine.

[21]  S. Pocock,et al.  Clinical Trials: A Practical Approach , 1984 .