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Cochrane Database of Systematic Reviews

Cirugía de mama por cáncer de mama metastásico

Información

DOI:
https://doi.org/10.1002/14651858.CD011276.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 15 marzo 2018see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Cáncer de mama

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Cifras del artículo

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Contraer

Autores

  • Giuliano Tosello

    Correspondencia a: Iamada Hospital, Presidente Prudente, Brazil

    [email protected]

  • Maria Regina Torloni

    Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil

  • Bruna S Mota

    Department of Obstetrics and Gynecology, Instituto do câncer de São Paulo (ICESP/FMUSP), Sao Paulo, Brazil

  • Teresa Neeman

    Statistical Consulting Unit, John Dedman Building, The Australian National University, Canberra, Australia

  • Rachel Riera

    Cochrane Brazil, Centro de Estudos de Saúde Baseada em Evidências e Avaliação Tecnológica em Saúde, São Paulo, Brazil

Contributions of authors

Draft the protocol: GT, RR, MRT, BSM.
Study selection: GT, BSM, RR (judge).
Extract data from studies: GT, BSM, RR.
Enter data into Review Manager 5: GT, BSM.
Carry out the analyses: GT, RR, MRT, TN.
Interpret the analyses: GT, BSM, MRT, TN.
Draft the final review: GT, RR, MRT, BSM.
Disagreement resolution: RR, MRT.
Update the review: GT, BSM, RR, MRT.

Sources of support

Internal sources

  • Nil, Other.

External sources

  • Nil, Other.

Declarations of interest

The review authors have no conflict of interest related to this protocol and review.

Acknowledgements

The review authors wish to thank all the members of the Cochrane Breast Cancer Group for their work in editing and reviewing. We are also grateful to the Cochrane Brazil and Handbook Study Group for methodological support.

We are very grateful to the expert Marcelo Rocha de Souza Cruz for the clinical orientation and support.

We are especially grateful to Melina Willson for her dedication, guidance, and commitment to the realisation of this review.

We have not received any type of funding to conduct this review.

Version history

Published

Title

Stage

Authors

Version

2018 Mar 15

Breast surgery for metastatic breast cancer

Review

Giuliano Tosello, Maria Regina Torloni, Bruna S Mota, Teresa Neeman, Rachel Riera

https://doi.org/10.1002/14651858.CD011276.pub2

2014 Sep 03

Breast surgery for metastatic breast cancer

Protocol

Giuliano Tosello, Maria R Torloni, Bruna Salani, Teresa Neeman, Rachel Riera

https://doi.org/10.1002/14651858.CD011276

Differences between protocol and review

At the protocol phase, we had planned to use the fixed‐effect model by default. However, as we detected clinical or methodological heterogeneity, or both, between included studies, we decided that it would be more appropriate to use the random‐effects model.

We revised subgroup analyses based on current rationale. We therefore maintained the following proposed analyses in the review: age of participants, oestrogen receptor status, HER2 status, only bone metastases, and radiotherapy at primary site or not. Notably, Soran 2016 reported a subgroup analysis for women who were older and younger than 55 years of age. Badwe 2015 grouped women as being pre‐ and postmenopausal. Because of these differences, we did not conduct the planned subgroup analysis for age (> 55 years or < 55 years).

We added that the risk ratio (RR) would be used to measure the effect of treatment for dichotomous outcomes.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Female; Humans;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

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

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Forest plot of comparison: 1 Systemic treatment plus surgery versus systemic treatment, outcome: 1.1 Overall survival.
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 Systemic treatment plus surgery versus systemic treatment, outcome: 1.1 Overall survival.

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Forest plot of comparison: 1 Systemic treatment plus surgery versus systemic treatment, outcome: 1.5 Progression‐free survival.
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Figure 4

Forest plot of comparison: 1 Systemic treatment plus surgery versus systemic treatment, outcome: 1.5 Progression‐free survival.

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Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 1 Overall survival.
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Analysis 1.1

Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 1 Overall survival.

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Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 2 Overall survival ‐ HER2 status.
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Analysis 1.2

Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 2 Overall survival ‐ HER2 status.

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Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 3 Overall survival ‐ ER status.
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Analysis 1.3

Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 3 Overall survival ‐ ER status.

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Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 4 Overall survival ‐ only bone metastasis.
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Analysis 1.4

Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 4 Overall survival ‐ only bone metastasis.

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Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 5 Progression‐free survival.
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Analysis 1.5

Comparison 1 Systemic treatment plus surgery versus systemic treatment, Outcome 5 Progression‐free survival.

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Summary of findings for the main comparison. Breast surgery plus systemic treatment compared to systemic treatment for metastatic breast cancer

Breast surgery plus systemic treatment compared to systemic treatment for metastatic breast cancer

Patient or population: metastatic breast cancer
Setting: inpatients and outpatients
Intervention: breast surgery plus systemic treatment
Comparison: systemic treatment

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with systemic treatment

Risk with breast surgery plus systemic treatment

Overall survival at 2 years

Follow‐up: range 23 months to 40 months

Study population

HR 0.83
(0.53 to 1.31)

624
(2 RCTs)

⊕⊝⊝⊝
VERY LOW 1 2 3

The estimates for the control group are based upon an average of the estimates from Badwe 2015 and Soran 2016.

511 per 1000

448 per 1000
(318 to 608)

Quality of life

Not reported

Not reported

‐

‐

‐

Local PFS at 2 years

Follow‐up: range 23 months to 40 months

Study population

HR 0.22
(0.08 to 0.57)

607
(2 RCTs)

⊕⊕⊝⊝
LOW 2 4

The estimates for the control group are based upon an average of the estimates from Badwe 2015 and Soran 2016.

500 per 1000

141 per 1000
(54 to 326)

Distant PFS at 2 years

Follow‐up: 23 months

Study population

HR 1.42
(1.08 to 1.86)

350
(1 RCT)

⊕⊕⊕⊝
MODERATE 5

The estimates for the control group are based upon the estimates from Badwe 2015.

548 per 1000

676 per 1000
(576 to 772)

Breast cancer‐specific survival

Not reported

Not reported

‐

‐

‐

Toxicity from local therapy

Follow‐up: 40 months

Study population

RR 0.99
(0.14 to 6.90)

274
(1 RCT)

⊕⊕⊝⊝
LOW 1 6

The estimates for the control group are based upon the estimates from Soran 2016.

15 per 1000

15 per 1000
(2 to 101)

*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; RCT: randomised controlled trial; RR: risk ratio

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 effect.

1In Soran 2016, trial random sequence generation and allocation concealment were unclear. Downgraded one level.
2Statistical or clinical heterogeneity, or both. Downgraded one level.
3Wide 95% CI (0.53 to 1.31) including the null effect. Downgraded one level.
4In Soran 2016, trial random sequence generation and allocation concealment were unclear. Outcome assessors were not blinded, and this is a subjective outcome. Downgraded one level.
5Outcome assessors were not blinded, and this is a subjective outcome. Downgraded one level.
6Very wide 95% CI (0.14 to 6.9). Downgraded one level.

Figuras y tablas -
Summary of findings for the main comparison. Breast surgery plus systemic treatment compared to systemic treatment for metastatic breast cancer
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Table 1. Overall survival ‐ subgroup analyses

Overall survival subgroup analysis

Number of studies

N

HR

Lower CI

Upper CI

P value

HER2‐positive

2

192

0.90

0.60

1.35

NS

HER2‐negative

2

421

0.85

0.67

1.08

NS

ER positive

2

426

0.79

0.61

1.03

NS

ER negative

2

200

1.01

0.73

1.40

NS

Bone‐only metastasis

2

226

0.91

0.49

1.69

NS

CI: confidence interval
ER: oestrogen receptor
HR: hazard ratio
NS: not significant

Figuras y tablas -
Table 1. Overall survival ‐ subgroup analyses
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Comparison 1. Systemic treatment plus surgery versus systemic treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Overall survival Show forest plot

2

624

Hazard Ratio (Random, 95% CI)

0.83 [0.53, 1.31]

2 Overall survival ‐ HER2 status Show forest plot

2

Hazard Ratio (Random, 95% CI)

Subtotals only

2.1 HER2‐positive

2

192

Hazard Ratio (Random, 95% CI)

0.85 [0.48, 1.50]

2.2 HER2‐negative

2

421

Hazard Ratio (Random, 95% CI)

0.84 [0.50, 1.40]

3 Overall survival ‐ ER status Show forest plot

2

Hazard Ratio (Random, 95% CI)

Subtotals only

3.1 ER‐positive

2

426

Hazard Ratio (Random, 95% CI)

0.83 [0.48, 1.42]

3.2 ER‐negative

2

200

Hazard Ratio (Random, 95% CI)

1.04 [0.70, 1.55]

4 Overall survival ‐ only bone metastasis Show forest plot

2

226

Hazard Ratio (Random, 95% CI)

0.91 [0.49, 1.69]

5 Progression‐free survival Show forest plot

2

Hazard Ratio (Random, 95% CI)

Subtotals only

5.1 Local progression‐free survival

2

Hazard Ratio (Random, 95% CI)

0.22 [0.08, 0.57]

5.2 Distant progression‐free survival

1

Hazard Ratio (Random, 95% CI)

1.42 [1.08, 1.86]
Figuras y tablas -
Comparison 1. Systemic treatment plus surgery versus systemic treatment
Ir a la tabla de la revisión