Data from 3 RCTs conclusively demonstrates a marked diminution of complications associated with SLNB when compared with ALND (32-34). SLNB reduces but does not completely eliminate the risk of lymphoedema. Early results from the large ALMANAC (Axillary Lymphatic Mapping Against Nodal Clearance) trial (34) in which the morbidity associated with SLNB was compared with that associated with conventional ALND were recently published (34). Analysis at 12 months showed that less lymphoedema, shoulder discomfort, sensory deficits, and infections were associated with SLNB than with ALND. Quality of life was found to be superior for patients who had SLNB. Moderate or severe lymphoedema was reported more frequently by patients in the standard axillary treatment group than by patients in the SLNB at 1, 3, 6, and 12 months after surgery (all P<.001). The relative risk of any lymphoedema for the SLNB group compared with the standard axillary treatment group at 12 months was 0.37 (95% CI = 0.23 to 0.60). Sensory loss at 1 month after surgery was reported by 18% of patients in the SLNB, compared with 62% of patients in the standard axillary treatment group. At 12 months after surgery, the percentage of patients reporting sensory loss declined to 11% in the sentinel lymph node biopsy group and to 31% in the standard axillary treatment group; at all time points, statistically significantly more patients in the standard treatment group than in the SLNB groups reported sensory deficit (P<.001 for all). The relative risk of sensory deficit at 12 months was 0.37 (95% CI = 0.27 to 0.50) in favour of the SLNB group. Compared with patients in the sentinel node biopsy group, those in the standard axillary treatment group displayed statistically significant impairment of shoulder flexion and abduction on the ipsilateral side at 1 month after surgery (P = 0.004 and 0.001, respectively). However, shoulder flexion and abduction improved rapidly at the subsequent timepoints in both groups, and differences between the groups were no longer statistically significant.

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