Scolaris Content Display Scolaris Content Display

Cochrane Database of Systematic Reviews

Sobreimpresión del lecho tumoral para las pacientes que han sido sometidas a una cirugía conservadora de mama

Information

DOI:
https://doi.org/10.1002/14651858.CD011987.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 06 November 2017see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Breast Cancer Group

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Article metrics

Altmetric:

Cited by:

Cited 0 times via Crossref Cited-by Linking

Collapse

Authors

  • Isabelle Kindts

    Correspondence to: Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium

    [email protected]

    [email protected]

  • Annouschka Laenen

    Leuven Biostatistics and Statistical Bioinformatices Centre, KULeuven, Leuven, Belgium

  • Tom Depuydt

    Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium

  • Caroline Weltens

    Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium

Contributions of authors

Isabelle Kindts (IK): drafted the protocol, selected which trials to include, extracted data from trials, entered data into Review Manager 5, carried out the analysis, interpreted the analysis, drafted the final review.
Annouschka Laenen (AL): drafted the protocol, carried out the analysis, interpreted the analysis and drafted the final review.
Tom Depuydt (TD): was to be consulted by IK and CW in case of disagreement on selected or extracted data.
Caroline Weltens (CW): drafted the protocol, selected which trials to include, extracted data from trials, entered data into Review Manager 5, interpreted the analysis, drafted the final review.

Declarations of interest

IK: None known.
AL: None known.
TD: None known.
CW: None known.

Acknowledgements

The review authors acknowledge the editorial base of the Cochrane Breast Cancer Group and those editors who made helpful comments on the protocol. We also thank Trudy Bekkering from the Academic Center for General Practice, Leuven for her feedback on the protocol.

Version history

Published

Title

Stage

Authors

Version

2017 Nov 06

Tumour bed boost radiotherapy for women after breast‐conserving surgery

Review

Isabelle Kindts, Annouschka Laenen, Tom Depuydt, Caroline Weltens

https://doi.org/10.1002/14651858.CD011987.pub2

2015 Dec 11

Tumour bed boost radiotherapy for women after breast conserving surgery

Protocol

Isabelle Kindts, Annouschka Laenen, Tom Depuydt, Caroline Weltens

https://doi.org/10.1002/14651858.CD011987

Differences between protocol and review

The protocol stated that only women with invasive breast cancer would be included in the analysis. However, we reconsidered this based on the SGW study in which women with carcinoma in situ were also included (59 out of 688 participants). We excluded SGW in the sensitivity analysis for local control. However, we included SGW in the meta‐analysis for toxicity and cosmesis.

Keywords

MeSH

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Illustration of the breast retraction assessment (BRA) measurements as reported by EORTC. BRA = √((a1 ‐ b1)² + (a2 ‐ b2)²); reference length = √(b1² + b2²); percentage breast retraction assessment = (BRA/reference length) x 100.
Figures and Tables -
Figure 1

Illustration of the breast retraction assessment (BRA) measurements as reported by EORTC. BRA = √((a1 ‐ b1)² + (a2 ‐ b2)²); reference length = √(b1² + b2²); percentage breast retraction assessment = (BRA/reference length) x 100.

Study flow diagram.
Figures and Tables -
Figure 2

Study flow diagram.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

Forest plot of comparison: 1 Tumour bed boost radiotherapy versus no boost, outcome: 1.1 Local control.
Figures and Tables -
Figure 4

Forest plot of comparison: 1 Tumour bed boost radiotherapy versus no boost, outcome: 1.1 Local control.

Forest plot of comparison: 1 Tumour bed boost radiotherapy versus no boost, outcome: 1.5 Overall survival.
Figures and Tables -
Figure 5

Forest plot of comparison: 1 Tumour bed boost radiotherapy versus no boost, outcome: 1.5 Overall survival.

Forest plot of comparison: 1 Tumour bed boost radiotherapy versus no boost, outcome: 1.8 Cosmesis, Panel.
Figures and Tables -
Figure 6

Forest plot of comparison: 1 Tumour bed boost radiotherapy versus no boost, outcome: 1.8 Cosmesis, Panel.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 1 Local control.
Figures and Tables -
Analysis 1.1

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 1 Local control.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 2 Local control ‐ sensitivity analysis.
Figures and Tables -
Analysis 1.2

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 2 Local control ‐ sensitivity analysis.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 3 Local control ‐ subgroup +40 years.
Figures and Tables -
Analysis 1.3

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 3 Local control ‐ subgroup +40 years.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 4 Local control ‐ subgroup low boost dose.
Figures and Tables -
Analysis 1.4

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 4 Local control ‐ subgroup low boost dose.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 5 Overall survival.
Figures and Tables -
Analysis 1.5

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 5 Overall survival.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 6 Disease‐free survival.
Figures and Tables -
Analysis 1.6

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 6 Disease‐free survival.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 7 Late toxicity, pBRA.
Figures and Tables -
Analysis 1.7

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 7 Late toxicity, pBRA.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 8 Cosmesis, Panel.
Figures and Tables -
Analysis 1.8

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 8 Cosmesis, Panel.

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 9 Cosmesis, Physician.
Figures and Tables -
Analysis 1.9

Comparison 1 Tumour bed boost radiotherapy versus no boost, Outcome 9 Cosmesis, Physician.

Summary of findings for the main comparison. Boost compared to no boost in breast cancer radiotherapy

Boost compared to no boost in breast cancer radiotherapy

Patient or population: breast‐conserving radiotherapy for breast cancer
Setting: radiotherapy centres
Intervention: boost
Comparison: no boost

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk without boost

Risk with boost

Local control: recurrence at 5 years

Study population

HR 0.64
(0.55 to 0.75)

8315
(5 RCTs)

⊕⊕⊝⊝
LOW 1 2

Nice did not report 5‐year local control.

70 per 1000

45 per 1000
(39 to 53)

Overall survival: mortality at 5 years

Study population

HR 1.04
(0.94 to 1.14)

6342
(2 RCTs)

⊕⊕⊕⊝
MODERATE 3

91 per 1000

94 per 1000
(86 to 103)

Disease‐free survival: disease progression/mortality at 5 years

Study population

HR 0.94
(0.87 to 1.02)

6549
(3 RCTs)

⊕⊕⊝⊝
LOW 4 5

EORTC did not report 5‐year disease‐free survival.

221 per 1000

209 per 1000
(195 to 224)

Late toxicity, pBRA

Mean pBRA 8.17, range 7.55 to 10

Mean pBRA 8.55,
range 8.26 to 9.4

MD 0.38 higher

(0.18 lower to 0.93 higher)

1526
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 2 5

Cosmesis, panel scored: fair or poor

Study population

OR 1.41
(1.07 to 1.85)

1116
(2 RCTs)

⊕⊕⊝⊝
LOW 1 2

202 per 1000

263 per 1000
(213 to 319)

Cosmesis, physician‐scored: fair or poor

Study population

OR 1.58
(0.93 to 2.69)

592
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 1 5 6

85 per 1000

128 per 1000
(80 to 200)

Sensitivity analysis: local control ‐ recurrence at 5 years

Study population

HR 0.62
(0.52 to 0.73)

6963
(3 RCTs)

⊕⊕⊕⊕
HIGH

74 per 1000

47 per 1000
(39 to 55)

Subgroup analysis: local control ‐ > 40 years old, recurrence at 5 years

Study population

HR 0.65
(0.53 to 0.81)

5058
(2 RCTs)

⊕⊕⊕⊕
HIGH

59 per 1000

39 per 1000
(32 to 48)

*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).
CI: confidence interval; HR: hazard ratio; MD: mean difference; OR: odds ratio; pBRA: percentage breast retraction assessment; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: 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 quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of the effect.

1High risk of selective reporting in one study.
2There was considerable clinical heterogeneity with respect to radiotherapy dose and the use of quality assurance procedures.
3One of the two studies has a very wide confidence interval.
4There was considerable clinical heterogeneity on statistical testing, but not on visual inspection.
5Both studies have wide confidence intervals.
6High risk of bias for blinding of outcome assessment in one study.

Figures and Tables -
Summary of findings for the main comparison. Boost compared to no boost in breast cancer radiotherapy
Table 1. RTOG/EORTC late radiation morbidity scoring scheme

Organ tissue

0

Grade 1

Grade 2

Grade 3

Grade 4

Skin

None

Slight atrophy; pigmentation change; some hair loss

Patchy atrophy; moderate telangiectasia; total hair loss

Marked atrophy; gross telangiectasia

Ulceration

Subcutaneous tissue

None

Slight induration (fibrosis) and loss of subcutaneous fat

Moderate fibrosis but asymptomatic; slight field contracture; < 10% linear reduction

Severe induration and loss of subcutaneous tissue; field contracture > 10% linear measurement

Necrosis

RTOG/EORTC: Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer

Figures and Tables -
Table 1. RTOG/EORTC late radiation morbidity scoring scheme
Table 2. Harvard cosmetic score

Cosmetic score

Excellent

Good

Fair

Poor

Figures and Tables -
Table 2. Harvard cosmetic score
Comparison 1. Tumour bed boost radiotherapy versus no boost

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Local control Show forest plot

5

8315

Hazard Ratio (Fixed, 95% CI)

0.64 [0.55, 0.75]

2 Local control ‐ sensitivity analysis Show forest plot

3

6963

Hazard Ratio (Fixed, 95% CI)

0.62 [0.52, 0.73]

3 Local control ‐ subgroup +40 years Show forest plot

2

5058

Hazard Ratio (Fixed, 95% CI)

0.65 [0.53, 0.81]

4 Local control ‐ subgroup low boost dose Show forest plot

2

1352

Hazard Ratio (Fixed, 95% CI)

0.95 [0.55, 1.62]

5 Overall survival Show forest plot

2

6342

Hazard Ratio (Fixed, 95% CI)

1.04 [0.94, 1.14]

6 Disease‐free survival Show forest plot

3

6549

Hazard Ratio (Fixed, 95% CI)

0.94 [0.87, 1.02]

7 Late toxicity, pBRA Show forest plot

2

1526

Mean Difference (IV, Fixed, 95% CI)

0.38 [‐0.18, 0.93]

8 Cosmesis, Panel Show forest plot

2

1116

Odds Ratio (M‐H, Fixed, 95% CI)

1.41 [1.07, 1.86]

9 Cosmesis, Physician Show forest plot

2

592

Odds Ratio (M‐H, Fixed, 95% CI)

1.58 [0.93, 2.69]

Figures and Tables -
Comparison 1. Tumour bed boost radiotherapy versus no boost