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. 2021 Jan 2;55:119–127. doi: 10.1016/j.breast.2020.12.012

Table 1.

Summary of findings (SoF) table for outcomes of benefit.

Study design Risk of bias Inconsistency Indirectness Imprecision N. of patients Effect Certainty
PMRT no PMRT Relative (95% CI) Absolute (95% CI)
OS (Shim, Int J Radiation Oncol Biol Phys 2014) (follow-up: median 59 months; assessed with: events)
Observational Not serious Not serious Seriousa Seriousb 5-years OS: RT: 93.3% vs no RT 89.9% (p = 0.443) Very low
OS (Liu, Oncotarget, 2015) (follow-up: median 56 months; assessed with: HR)
Observational Not serious Not serious Seriousc Seriousd HR for RT: 0.82 (0.63–1.068)
SUB-GROUP ANALYSIS: 5-years OS IIIB-IIIC: RT 79.3% vs no RT 71.2% (p = 0.027); 5-years OS T3-T4: RT: 82.6% vs no RT 76.6% (p = 0.025)
Very low
OS (Cho, Clinical Breast Cancer, 2019) (follow-up median 79 months)
Observational Not serious Not serious Seriousa Seriousd HR for RT: 0.350 (0.096–1.272) Very low
OS (Kantor, J Surg Oncol, 2017) (follow-up: median 69 months; assessed with: HR)
Observational Seriouse Not serious Not serious Not serious 5-years OS: RT 92.9% vs no RT 83% (p = 0.441) Very low
DFS (Shim, Int J Radiation Oncol Biol Phys 2014) (follow-up: median 59 months; assessed with: KM)
Observational Not serious Not serious Seriousa Seriousb 5-years DFS: RT 91.2% vs no RT 83% (p = 0.441) Very low
DFS (Cho, Clinical Breast Cancer, 2019) (follow-up median 79 months; assessed with: HR)
Observational Not serious Not serious Seriousa Seriousd HR: 0.561 (0.249–1.264) Very low
LRRFS (Shim, Int J Radiation Oncol Biol Phys 2014)
Observational Not serious Not serious Seriousa Seriousb 5-years LRRFS: RT 98.1% vs no RT 92.3% (p = 0.148) Very low
LRRFS (Cho, Clinical Breast Cancer, 2019) (follow-up median 79 months; assessed with: HR)
Observational Not serious Not serious Seriousa Seriousd HR: 0.310 (0.148–1.833) Very low

Abbreviations: RT: radiotherapy; OS: overall survival; DFS: disease free survival; LRRFS: loco-regional recurrence-free; HR: hazard ratio; CI: confidence interval; RR: risk ratio; PST: preoperative chemotherapy.

Explanations.

a

Indirectness for population, included both cN1 and cN2 diagnosis downstaged to ypN0 after PST.

b

Small population.

c

Indirectness for population, included both in Stage II and III.

d

CI both included effect and no effect.

e

Possible selection bias due to a sub-group analysis of large database.