Summary of findings 2. Any O‐BCS compared to mastectomy for women with primary breast cancer.
Any O‐BCS compared to mastectomy for women with primary breast cancer | ||||||
Patient or population: women with primary breast cancer Setting: mixed multicentre/single‐centre studies with initial inpatient procedure and outpatient follow‐up Intervention: any O‐BCS Comparison: mastectomy | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with Mx | Risk with any O‐BCS | |||||
Local recurrence‐free survival (up to 5 years) | Study population | HR 0.55 (0.34 to 0.91) | 4713 (2 observational studies) | ⊕⊝⊝⊝ Very lowa,b | Estimates of risk with BCS were calculated using an average of non‐adjusted baseline control rates from included studies. | |
161 per 1000 | 92 per 1000 (58 to 148) | |||||
Cumulative local recurrence rate | (0 studies) | ‐ | No studies evaluated local recurrence as cumulative rate | |||
Disease‐free survival | Study population | RR 0.58 (0.41 to 0.82) | 1193 (1 observational study) | ⊕⊝⊝⊝ Very lowc,d | Dichotomous data used as no studies reported time‐to‐event data | |
139 per 1000 | 81 per 1000 (57 to 114) | |||||
Re‐excision rates | (0 studies) | Re‐excisions are not often needed for mastectomy, therefore this outcome is not relevant for this comparison. | ||||
Complications | Study population | RR 0.75 (0.67 to 0.83) | 4839 (4 observational studies) | ⊕⊝⊝⊝ Very lowc,e | O‐BCS may reduce complications compared to mastectomy but the evidence is very uncertain. | |
312 per 1000 | 234 per 1000 (209 to 259) | |||||
Recall rates | (0 studies) | Recall biopsies are not often needed for mastectomy, therefore this outcome is not relevant for this comparison. | ||||
Patient‐reported outcome measures | There are insufficient data to make any conclusions | ‐ | (1 observational study) | ‐ | There are insufficient data to make any conclusions | |
*The risk in the intervention group (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). BCS: breast‐conserving surgery; CI: confidence interval; HR: hazard ratio;Mx: mastectomy; O‐BCS: oncoplastic breast‐conserving surgery; RR: risk ratio. | ||||||
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect. |
aDowngraded by one level due to study limitation: moderate risk of bias due to confounding. bDowngraded by two levels due to heterogeneity: I2 = 81%, P = 0.02. cDowngraded by two levels due to study limitation: serious risk of bias due to confounding. dDowngraded by one level due to imprecision: optimal size not met. eDowngraded by two levels due to heterogeneity: I2 = 61%, P < 0.0001.