Sentinel node biopsy in breast cancer: The first results of the randomized multicenter ALMANAC trial

Background: Sentinel node biopsy is becoming the standard of care in some centres despite a lack of randomized evidence. Methods: The ALMANAC trial is a randomized, multicenter trial in the UK comparing SNB to conventional axillary treatment in clinically node-negative breast cancer patients. The 3 main outcome measures were: a) arm and axillary morbidity b) quality of life (QoL) using FACT +B4 and Spielberger State/Trait Anxiety Inventory and c) resource costs. The randomized phase was preceded by a validation phase. Surgeons achieving a set standard in the validation phase, a localization rate of =90% and a false negative rate of =5%, proceeded to the randomized phase. From November 1999 to October 2003, 1031 patients with clinically node-negative invasive breast cancer were randomized to undergo SNB(515) or standard axillary treatment(516). Sentinel node identification used a combined technique involving blue dye and radioisotope. All patients underwent pre-operative lymphoscintigraphy. Sentinel node positive patients proceeded to axillary clearance. Patients were followed up at 1, 3, 6, 12 and 18 months post-op. Results: In the SNB group, sentinel node localization was successful in 504 patients (97.9%). Axillary metastases were detected in 115 patients (22%) in the SNB group, and in 104(20%) patients in the standard axillary treatment group. In an intention-to-treat analysis, relative risks for sensory loss and lymphoedema at 3 months in the SNB group relative to the standard management group were 0.39 and 0.28. Hospital stay, axillary operative time and drain usage were significantly reduced in the SNB group (p<0.001). Time to return to normal activities was reduced in the SNB group (p=0.002). At baseline QoL scores did not differ between groups. At 3 months assessment, overall QoL and self-rated arm morbidity were significantly better in the SNB group (p<0.01). Furthermore, these benefits were not at the cost of raised anxiety in the SNB group. Conclusion: SNB is associated with less arm morbidity and better quality of life and is cost-effective compared to standard axillary treatment.