Summary of findings 3. Sentinel node biopsy compared with full axillary surgery for operable primary breast cancer.
| Sentinel node biopsy compared with full axillary surgery for operable primary breast cancer | |||||
| Patient or population: women with operable primary breast cancer Settings: hospital Intervention: sentinel node biopsy Comparison: full axillary surgery | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | |
| Assumed risk | Corresponding risk | ||||
| Full axillary surgery | Sentinel node biopsy | ||||
| All‐cause mortality | 96% overall survival at 5 yearsa | 96% overall survival at 5 years (95% to 96%) | HR 1.05 (0.89 to 1.25) | 6352 (3 studies) | ⊕⊕⊕⊝ moderateb |
| Lymphoedema Patient‐reported lymphoedema of any severity Follow‐up: 12 months | 132 per 1000 | 48 per 1000 (22 to 115) | OR 0.33 (0.15 to 0.86) | 815 (3 studies) | ⊕⊕⊝⊝ lowb,c |
| Subjective arm movement impairment Follow‐up: 12 months | 100 per 1000 | 40 per 1000 (24 to 69) | OR 0.38 (0.22 to 0.67) | 877 (2 studies) | ⊕⊝⊝⊝ very lowb,d,e |
| Paraesthesia Follow‐up: 12 months | 776 per 1000 | 343 per 1000 (238 to 444) | OR 0.15 (0.09 to 0.23) | 495 (2 studies) | ⊕⊕⊝⊝ lowd,e |
| Pain Follow‐up: 12 months | 177 per 1000 | 86 per 1000 (61 to 126) | OR 0.44 (0.3 to 0.67) | 877 (2 studies) | ⊕⊕⊝⊝ lowd,e |
| Numbness Follow‐up: 12 months | 346 per 1000 | 185 per 1000 (152 to 222) | OR 0.43 (0.34 to 0.54) | 1799 (3 studies) | ⊕⊕⊕⊝ moderatef |
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; HR: hazard ratio; OR: odds ratio. | |||||
| GRADE Working Group grades of evidence. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | |||||
aAssumed risk taken from the full axillary surgery arm of Milan. bLow number of events. cIncomplete follow‐up for patient‐reported lymphoedema in ALMANAC. Event rates not reported in Addenbrookes 2. dModerate or substantial heterogeneity. eNo blinding or blinding not reported. fNo explanation provided.