Table 7Summary clinical evidence profile: Comparison 1. No whole breast radiotherapy versus whole breast radiotherapy

OutcomesIllustrative comparative risks* (95% CI)Relative effect (95% CI)No of Participants (studies)Quality of the evidence (GRADE)
Assumed risk: RT+Corresponding risk: RT−
Overall survival - T stage: 1 (12 year follow-up)12 yr OS 85%12 yr OS 77% (73% to 81%)

HR 1.59

(1.29 to 1.96)

263

(1 study)

Moderate1
Overall survival - N stage: 0 (5 to 12 year follow-up)5 yr OS 88%5 yr OS 85% (83% to 87%)

HR 1.29

(1.12 to 1.5)

1154

(3 studies)

Moderate2
Overall survival - Margins: negative (5 to 12 year follow-up)5 yr OS 88%5 yr OS 85% (83% to 87%)

HR 1.29

(1.12 to 1.5)

1154

(3 studies)

Moderate2
Overall survival - Age: 65+ (5 to 10 year follow-up)5 yr OS 88%5 yr OS 87% (85% to 90%)

HR 1.06

(0.87 to 1.3)

891

(2 studies)

High

Overall survival - Adjuvant systemic therapy: none (20 year follow-up)

20 yr OS 50%20 yr OS 47% (37% to 56%)

HR 1.1

(0.85 to 1.42)

381

(1 study)

Moderate3
Local recurrence - T stage: 1 (10 to 12 year follow-up)90% free from local recurrence at 10 yrs75% free from local recurrence at 10 yrs (66% to 82%)

HR 2.7

(1.84 to 3.97)

1378

(2 studies)

Moderate3
Local recurrence - N stage: 0 (5 to 12 year follow-up)96% free from local recurrence at 5 yrs88% free from local recurrence at 5 yrs (83% to 91%)

HR 3.22

(2.31 to 4.49)

3340

(4 studies)

Moderate3
Local recurrence - Margins: negative (5 to 12 year follow-up)96% free from local recurrence at 5 yrs88% free from local recurrence at 5 yrs (83% to 91%)

HR 3.22

(2.31 to 4.49)

3340

(4 studies)

Moderate3
Local recurrence - Age: 65+ (5 to 10 year follow-up)99% free from local recurrence at 5 yrs95% free from local recurrence at 5 yrs (90% to 97%)

HR 5.35

(2.78 to 10.29)

1962

(2 studies)

Low1
Treatment-related morbidity – fractures (cause unspecified; all patients N stage 0, 65+, negative margins; 5 year follow-up)106 per 1000116 per 1000 (50 to 272)

RR 1.10

(0.47 to 2.57)

171 (1 study)Low4
Treatment-related morbidity - congestive cardiac failure (all patients N stage 0, 65+, negative margins; 5 year follow-up)35 per 1000

35 per 1000

(7 to 168)

RR 0.99

(0.21 to 4.76)

171

(1 study)

Low6
Treatment-related morbidity - myocardial infarction (all patients N stage 0, 65+, negative margins; 5 year follow-up)71 per 1000

58 per 1000

(18 to 184)

RR 0.82

(0.26 to 2.6)

171

(1 study)

Low4
Treatment-related morbidity - secondary cancer (cause unspecified; all patients N stage 0, 65+, negative margins; 5 year follow-up)35 per 100089 per 1000 (8 to 928)

RR 2.53

(0.24 to 26.51)

1497

(2 studies)

Low1
Treatment-related morbidity - score 10+ on HADS depression scale (all patients N stage 0, 65+, negative margins; 5 year follow-up)10 per 1000

30 per 1000

(3 to 281)

RR 3.12

(0.33 to 29.49)

206

(1 study)

Low4
Treatment-related morbidity - score 10+ on HADS anxiety scale (all patients N stage 0, 65+, negative margins; 5 year follow-up)86 per 1000

119 per 1000

(52 to 270)

RR 1.39

(0.61 to 3.15)

206

(1 study)

Low4
HRQoL - EQ5D scale (all patients N stage 0, 65+, negative margins; 5 year follow-up)

The mean HRQoL – EQ5D scale (all patients N stage 0, 65+, negative margins) in the intervention groups was

0.02 lower

(0.1 lower to 0.06 higher)

168

(1 study)

Low5
HRQoL - reduction in scores on Breast Cancer Chemotherapy Questionnaire (all patients N stage 0, negative margins; 2 month follow-up)270 per 1000

160 per 1000

(119 to 214)

RR 0.59

(0.44 to 0.79)

720 (1 study)Not possible to GRADE this outcome due to study included from previous guideline

Rates of overall survival and local recurrence in the control group correspond to the weighted average across included trials or the trial with the shortest follow-up period where these differ across included trials

CI: Confidence interval; EQ5D, EuroQol Research Foundation measure of general health status; HADS: Hospital Anxiety and Depression Scale; HR: Hazard ratio; HRQoL: Health related quality of life; OS: overall survival; RR: Risk ratio;

1

<300 events

2

Random effects model with significant heterogeneity - I squared value 74% - not possible to investigate heterogeneity as additional subgroups of interest identified by the GC were not reported for the trials that contributed to this estimate. All estimated effects were in the same direction

3

Total events <300

4

<300 events and 95% CI crosses both thresholds for minimally important difference based on GRADE default values (0.80 and 1.25)

5

N<400

6

total events<300; not downgraded based on 95% CI due to very small differences in absolute risk

From: Evidence reviews for breast radiotherapy

Cover of Evidence reviews for breast radiotherapy
Evidence reviews for breast radiotherapy: Early and locally advanced breast cancer: diagnosis and management: Evidence review H.
NICE Guideline, No. 101.
National Guideline Alliance (UK).
Copyright © NICE 2018.

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