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. 2017 Jan 4;2017(1):CD004561. doi: 10.1002/14651858.CD004561.pub3

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%).