Randomized Multicenter Trial of Sentinel Node Biopsy Versus Standard Axillary Treatment in Operable Breast Cancer: The ALMANAC Trial
Cardiff University · Queen Elizabeth Hospital Birmingham · +11 more institutions
Abstract
Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from randomized trials on morbidity and mortality outcomes. We conducted a multicenter randomized trial to compare quality-of-life outcomes between patients with clinically node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received standard axillary treatment.
The primary outcome measures were arm and shoulder morbidity and quality of life. From November 1999 to October 2003, 1031 patients were randomly assigned to undergo sentinel lymph node biopsy (n = 515) or standard axillary surgery (n = 516). Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy (depending on the protocol at the treating institution). Intention-to-treat analyses of data at 1, 3, 6, and 12 months after surgery are presented. All statistical tests were two-sided.
Citation impact
- FWCI
- 39.54
- Percentile
- 100%
- References
- 39
Authors
19- RERobert E. ManselCorresponding
Cardiff University
- LFLesley Fallowfield
Queen Elizabeth Hospital Birmingham, Charing Cross Hospital, Western General Hospital, Royal Derby Hospital, University of Manchester, Queen Alexandra Hospital, North Middlesex Hospital, Cancer Research UK, Brighton and Sussex Medical School, Leeds General Infirmary, Peterborough City Hospital, Cardiff University, Royal Surrey County Hospital
- MKMark Kissin
Leeds General Infirmary, Charing Cross Hospital, Queen Elizabeth Hospital Birmingham, Cardiff University, Brighton and Sussex Medical School, Peterborough City Hospital, Queen Alexandra Hospital, North Middlesex Hospital, University of Manchester, Royal Surrey County Hospital, Cancer Research UK, Western General Hospital, Royal Derby Hospital
- AGAmit Goyal
Royal Derby Hospital, Cancer Research UK, Brighton and Sussex Medical School, Queen Alexandra Hospital, Cardiff University, University of Manchester, Western General Hospital, Leeds General Infirmary, North Middlesex Hospital, Peterborough City Hospital, Queen Elizabeth Hospital Birmingham, Charing Cross Hospital, Royal Surrey County Hospital
- RGRobert G. Newcombe
Western General Hospital, Charing Cross Hospital, Royal Surrey County Hospital, Queen Elizabeth Hospital Birmingham, North Middlesex Hospital, Royal Derby Hospital, Peterborough City Hospital, Queen Alexandra Hospital, Cancer Research UK, Cardiff University, Leeds General Infirmary, Brighton and Sussex Medical School, University of Manchester
Topics & keywords
- Medicine
- Sentinel node
- Randomized controlled trial
- Breast cancer
- Multicenter trial
- Biopsy
- Oncology
- Internal medicine
- Good health and well-being