Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial

Mansel, Robert E., Fallowfield, Lesley J., Kissin, Mark, Goyal, Amit, Newcombe, Robert G., Dixon, J. Michael, Yiangou, Constantinos, Horgan, Kieran, Bundred, Nigel, Monypenny, Ian, England, David, Sibbering, Mark, Abdullah, Tholkifl I., Barr, Lester, Chetty, Utheshtra, Sinnett, Dudley H., Fleissig, Anne, Clarke, Dayalan and Ell, PeterJ. (2006) Randomized multicenter trial of sentinel node biopsy versus standard axillary treatment in operable breast cancer: the ALMANAC Trial. Journal of the National Cancer Institute, 98 (9). pp. 599-609. ISSN 0027-8874

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Abstract

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 < or = .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.

Item Type: Article
Keywords: Arm/physiopathology Axilla Breast Neoplasms/*pathology/physiopathology/radiotherapy/*surgery Breast Neoplasms, Male/surgery Carcinoma, Ductal, Breast/surgery Carcinoma, Lobular/surgery Drainage Female Humans Incidence Length of Stay *Lymph Node Excision Lymphatic Metastasis Lymphedema/etiology Male Mastectomy/methods Middle Aged Movement *Quality of Life Radiotherapy, Adjuvant Risk Assessment *Sentinel Lymph Node Biopsy Shoulder/physiopathology Surgical Wound Infection/epidemiology/etiology Treatment Outcome
Schools and Departments: Brighton and Sussex Medical School > Brighton and Sussex Medical School
Subjects: R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
Depositing User: Tracy Woodcock
Date Deposited: 15 Dec 2006
Last Modified: 30 Nov 2012 16:50
URI: http://sro.sussex.ac.uk/id/eprint/677
Google Scholar:503 Citations
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