Summary of findings for the main comparison. No axillary surgery compared with full axillary surgery for operable primary breast cancer.
No axillary surgery compared with full axillary surgery for operable primary breast cancer | |||||
Patient or population: women with operable primary breast cancer Settings: hospital Intervention: no axillary surgery 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 | No axillary surgery | ||||
All‐cause mortality | 92% overall survival at 5 yearsa | 92% overall survival at 5 years (91% to 93%) | HR 1.06 (0.96 to 1.17) | 3849 (10 studies) | ⊕⊕⊕⊝ moderateb |
Locoregional recurrence | 86% locoregional recurrence‐free survival at 5 yearsc | 71% locoregional recurrence‐free survival at 5 years (66% to 76%) | HR 2.35 (1.91 to 2.89) | 20,863d (5 studies) | ⊕⊕⊕⊝ moderatee |
Lymphoedema Increase in arm circumference Follow‐up: 1 or more years | 236 per 1000 | 87 per 1000 (66 to 117) | OR 0.31 (0.23 to 0.43) | 1714 (4 studies) | ⊕⊕⊝⊝ lowe,f |
Arm or shoulder movement impairment Follow‐up: 1 or more years | 91 per 1000 | 67 per 1000 (47 to 95) | OR 0.72 (0.49 to 1.05) | 1495 (5 studies) | ⊕⊝⊝⊝ very lowf,g |
*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 is taken from full axillary surgery arm of Institut Curie. bConfidence interval around the effect estimate includes both no effect and appreciable harm associated with no axillary surgery. cAssumed risk is taken from full axillary surgery arm of Institut Curie, local or axillary recurrence rates. dPerson‐years of follow‐up. eSubstantial heterogeneity (I2 > 50%). fUnclear blinding of outcome assessment. gConsiderable heterogeneity (I2 > 75%).