Regional Nodal Irradiation in Early-Stage Breast Cancer.

BackgroundMost women with breast cancer who undergo breast-conserving surgery receive whole-breast irradiation. We examined whether the addition of regional nodal irradiation to whole-breast irradiation improved outcomes. MethodsWe 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) (nodal-irradiation 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. ResultsBetween March 2000 and February 2007, a total of 1832 women were assigned to the nodal-irradiation group or the control group (916 women in each group). The median follow-up was 9.5 years. At the 10-year follow-up, there was n...

[1]  D. Groheux,et al.  Lymphoscintigraphy can select breast cancer patients for internal mammary chain radiotherapy. , 2012, International journal of radiation oncology, biology, physics.

[2]  E. Rutgers,et al.  Lymphatic Drainage Patterns From the Breast , 2004, Annals of surgery.

[3]  M. S. Thomsen,et al.  CT-planned internal mammary node radiotherapy in the DBCG-IMN study: Benefit versus potentially harmful effects , 2014, Acta oncologica.

[4]  M. S. Thomsen,et al.  Risk of second primary lung cancer in women after radiotherapy for breast cancer. , 2014, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

[5]  J. Overgaard,et al.  Morbidity and mortality of ischaemic heart disease in high-risk breast-cancer patients after adjuvant postmastectomy systemic treatment with or without radiotherapy: analysis of DBCG 82b and 82c randomised trials , 1999, The Lancet.

[6]  J. Honnorat,et al.  Recommended diagnostic criteria for paraneoplastic neurological syndromes , 2004, Journal of Neurology, Neurosurgery & Psychiatry.

[7]  Bonnie H. Wang,et al.  Anti-Yo Associated Paraneoplastic Cerebellar Degeneration in a Man with Large Cell Cancer of the Lung , 2013, Case reports in neurological medicine.

[8]  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.

[9]  F. Killander,et al.  Increased cardio and cerebrovascular mortality in breast cancer patients treated with postmastectomy radiotherapy--25 year follow-up of a randomised trial from the South Sweden Breast Cancer Group. , 2014, European journal of cancer.

[10]  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.

[11]  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.

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

[13]  H. Burstein,et al.  Nodal Irradiation after Breast-Cancer Surgery in the Era of Effective Adjuvant Therapy. , 2015, The New England journal of medicine.

[14]  D. Groheux,et al.  The Sentinel Node Procedure in Breast Cancer: Nuclear Medicine as the Starting Point , 2011, The Journal of Nuclear Medicine.

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

[16]  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.

[17]  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.

[18]  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.

[19]  Katherine E Henson,et al.  Radiation-related mortality from heart disease and lung cancer more than 20 years after radiotherapy for breast cancer , 2012, British Journal of Cancer.

[20]  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.

[21]  P. Poortmans,et al.  Volumetric modulated arc therapy and breath-hold in image-guided locoregional left-sided breast irradiation. , 2014, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

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

[23]  P. Hall,et al.  Risk of ischemic heart disease in women after radiotherapy for breast cancer. , 2013, The New England journal of medicine.

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

[25]  J. Overgaard,et al.  Late Treatment-Related Morbidity in Breast Cancer Patients Randomized to Postmastectomy Radiotherapy and Systemic Treatment Versus Systemic Treatment Alone , 2000 .

[26]  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.

[27]  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.

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

[29]  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.

[30]  T. Julian,et al.  Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer: results from the NSABP B-32 randomised phase III trial. , 2007, The Lancet. Oncology.

[31]  R. Jagsi,et al.  Radiotherapy for invasive breast cancer in North America and Europe: results of a survey. , 2005, International journal of radiation oncology, biology, physics.

[32]  Philip M Evans,et al.  The UK HeartSpare Study: randomised evaluation of voluntary deep-inspiratory breath-hold in women undergoing breast radiotherapy. , 2013, Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology.

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

[34]  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.

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

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