© The Author 2006. Published by Oxford University Press.
ARTICLE |
Randomized Multicenter Trial of Sentinel Node Biopsy Versus Standard Axillary Treatment in Operable Breast Cancer: The ALMANAC Trial
Affiliations of authors: Department of Surgery, Cardiff University, Cardiff, U.K. (REM, AG, IM, DC); Cancer Research UK Psychosocial Oncology Group, Brighton and Sussex Medical School, Falmer, U.K. (LF, AF); Department of Surgery, Royal Surrey County Hospital, Guildford, U.K. (MK); Department of Epidemiology, Statistics and Public Health, Cardiff University, Cardiff, U.K. (RGN); Department of Surgery, Western General Hospital, Edinburgh, U.K. (JMD, UC); Department of Surgery, Queen Alexandra Hospital, Portsmouth, U.K. (CY); Department of Surgery, Leeds General Infirmary, Leeds, U.K. (KH); Department of Surgery, South Manchester University Hospital, Manchester, U.K. (NB, LB); Department of Surgery, Queen Elizabeth Medical Centre, Birmingham, U.K. (DE); Department of Surgery, Derby City General Hospital, Derby, U.K. (MS); Department of Surgery, Edith Cavell Hospital, Peterborough, U.K. (TIA); Department of Surgery, Charing Cross Hospital, London, U.K. (DHS); Department of Nuclear Medicine, The Middlesex Hospital, London, U.K. (PJE)
Correspondence to: Robert E. Mansel, FRCS, Department of Surgery, Wales College of Medicine, Cardiff University, Cardiff CF14 4XN, United Kingdom (e-mail: ManselRE{at}cf.ac.uk).
Background: 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. Methods: 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. Results: The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the standard axillary treatment group at 12 months were 0.37 (95% confidence interval [CI] = 0.23 to 0.60; absolute rates: 5% versus 13%) and 0.37 (95% CI = 0.27 to 0.50; absolute rates: 11% versus 31%), respectively. Drain usage, length of hospital stay, and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group (all P<.001), and axillary operative time was reduced (P = .055). Overall patient-recorded quality of life and arm functioning scores were statistically significantly better in the sentinel lymph node biopsy group throughout (all P
.003). These benefits were seen with no increase in anxiety levels in the sentinel lymph node biopsy group (P>.05). Conclusion: Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than standard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinically negative nodes.
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- Sentinel Lymph Node Biopsy in Early Breast Cancer: Has Its Time Come?
- Joseph Pater and Wendy Parulekar
J Natl Cancer Inst 2006 98: 568-569.[Extract] [Full Text] [PDF]
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