Linfadenectomía para el tratamiento del cáncer de endometrio
Información
- DOI:
- https://doi.org/10.1002/14651858.CD007585.pub4Copiar DOI
- Base de datos:
-
- Cochrane Database of Systematic Reviews
- Versión publicada:
-
- 02 octubre 2017see what's new
- Tipo:
-
- Intervention
- Etapa:
-
- Review
- Grupo Editorial Cochrane:
-
Grupo Cochrane de Cáncer ginecológico, neurooncología y otros cánceres
- Copyright:
-
- Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
Altmetric:
Citado por:
Autores
Contributions of authors
JF and JM contributed equally to the review update. The protocol was originally developed by JM, KW, HD, and AB. JF, KW, AB, and JM sifted references, and KW, JF, and AB extracted data, which were checked by JM. AB, JF, and JM co‐wrote the results and conclusions of the review with input from KW.
Sources of support
Internal sources
-
No sources of support supplied
External sources
-
Department of Health, UK.
NHS Cochrane Collaboration programme Grant Scheme CPG‐506
Declarations of interest
Jonathan Frost ‐ none known
Katie Webster ‐ none known
Jo Morrsion ‐ none known
Andrew Bryant ‐ none known
Acknowledgements
We thank Chris Williams for providing clinical and editorial advice on the original protocol and review, Jane Hayes and Jo Platt for designing the search strategy and running the searches, Gail Quinn and Clare Jess for contributing to the editorial process, and the reviewers for providing helpful comments. We are grateful to Sean Kehoe and Heather Dickinson for providing assistance with the original version of this review.
This project was supported by the National Institute for Health Research, via Cochrane Infrastructure, Cochrane Programme Grant or Cochrane Incentive funding to the Cochrane Gynaecological, Neuro‐oncology and Orphan Cancer Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS, nor the Department of Health.
Version history
| Published | Title | Stage | Authors | Version |
| 2017 Oct 02 | Lymphadenectomy for the management of endometrial cancer | Review | Jonathan A Frost, Katie E Webster, Andrew Bryant, Jo Morrison | |
| 2015 Sep 21 | Lymphadenectomy for the management of endometrial cancer | Review | Jonathan A Frost, Katie E Webster, Andrew Bryant, Jo Morrison | |
| 2010 Jan 20 | Lymphadenectomy for the management of endometrial cancer | Review | Katie May, Andrew Bryant, Heather O Dickinson, Sean Kehoe, Jo Morrison | |
| 2009 Jan 21 | Lymphadenectomy for the management of endometrial cancer | Protocol | Jo Morrison, Katie May, Rayma Srinivasan, Alexander Swanton, Sally Collins, Sean Kehoe, Andrew Bryant, Heather O Dickinson | |
Differences between protocol and review
In addition to methods described in the protocol, we used the GRADE approach to define the quality of the evidence and the extent to which we can be confident that an estimate of effect or association is free from bias.
In the most recent update of the review in 2017, as the first step of screening, we applied the machine learning classifier (RCT model) available in the Cochrane Register of Studies (CRS‐web; Wallace 2017). The classifier assigns a probability (from 0 to 100) to each citation for being a true RCT. For citations that are assigned a probability score of less than 10, the machine learning classifier currently has a specificity/recall of 99.987% (James Thomas, personal communication). For citations assigned a score from 10 to 100, we screened them independently and in duplicate using Covidence on‐line software (Covidence).
The following methods were specified in the protocol but were not implemented, as we found only three trials that met our inclusion criteria, only two of which could be included in the meta‐analysis. Both trials included in the meta‐analysis reported HRs, so we did not need to estimate RRs. Neither trial reported continuous outcomes such as quality of life and neither included multiple treatment groups. Both trials were at low risk of bias, so we did not conduct sensitivity analysis around quality. However, the methods specified below may be required when this review is next updated.
Measures of treatment effect
-
If it is not possible to estimate the HR, we will abstract the number of participants in each treatment arm who experienced the outcome of interest and the number of participants assessed, to estimate a risk ratio (RR).
-
For continuous outcomes (QOL measures), we will abstract the final value and the standard deviation of the outcome of interest in each treatment arm at the end of follow‐up for each study, if available.
For dichotomous and continuous data, we will extract the number of participants assessed at endpoint.
Assessment of reporting biases
We will examine funnel plots corresponding to meta‐analyses of the primary outcome to assess the potential for small‐study effects such as publication bias. If these plots suggest that treatment effects may not be sampled from a symmetrical distribution, as assumed by the random‐effects model, we will perform further meta‐analyses using the fixed‐effect model.
Data synthesis
-
For continuous outcomes (e.g. QOL measures), we will pool mean differences between treatment arms at the end of follow‐up, if all trials measured outcomes on the same scale; otherwise we will pool standardised mean differences.
If any trials include multiple treatment groups, we will divide the ‘shared’ comparison group into single treatment groups, and we will treat comparisons between treatment groups and the split comparison group as independent comparisons.
If possible, we will synthesise studies making different comparisons by using the subgroup methods of Bucher 1997.
Subgroup analysis and investigation of heterogeneity
We will perform subgroup analyses by grouping the trials by:
-
early‐stage disease low‐risk participants (stage IA‐B, G1 or G2) versus high‐risk participants (stage IB, G3 or stage IC or higher, any grade); or
-
no obvious lymph node enlargement versus lymph node enlargement.
We will consider factors such as age, stage, type of intervention, length of follow‐up, and adjusted/unadjusted analysis when interpreting any heterogeneity.
Sensitivity analysis
We will perform sensitivity analyses that exclude studies at high risk of bias.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Adult; Female; Humans;
PICO
Distribution of stage of endometrial cancer at presentation, USA 2004‐2010. Adapted from Siegel 2015.
Study flow diagram.
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Comparison 1 Survival, Outcome 1 Overall survival.
Comparison 1 Survival, Outcome 2 Recurrence‐free survival.
Comparison 2 Adverse events, Outcome 1 Direct surgical morbidity.
Comparison 2 Adverse events, Outcome 2 Lymphoedema or lymphocyst.
Comparison 2 Adverse events, Outcome 3 Surgery‐related systemic morbidity.
| Lymphadenectomy for the management of endometrial cancer | |||||||
| Patient or population: women with stage I endometrial cancer Settings: inpatient or outpatient Intervention: lymphadenectomy | |||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | Number of participants | Quality of the evidence | Comments | ||
| Assumed risk | Corresponding risk | ||||||
| Control | Lymphadenectomy | ||||||
| Overall survival | HR 1.07 | 1851 | ⊕⊕⊕⊝ | As a result of the way HRs are calculated, assumed and corresponding risks were not estimated | |||
| Recurrence‐free survival | HR 1.23 | 1851 | ⊕⊕⊕⊝ | As a result of the way HRs are calculated, assumed and corresponding risks were not estimated | |||
| Direct surgical morbidity | Study population | RR 1.93 | 1922 | ⊕⊕⊕⊝ | |||
| 17 per 1000 | 33 per 1000 | ||||||
| Moderate‐risk population | |||||||
| 19 per 1000 | 37 per 1000 | ||||||
| Surgery‐related systemic morbidity | Study population | RR 3.72 | 1922 | ⊕⊕⊕⊝ | |||
| 3 per 1000 | 11 per 1000 | ||||||
| Moderate‐risk population | |||||||
| 5 per 1000 | 19 per 1000 | ||||||
| Lymphoedema or lymphocyst | Study population | RR 8.39 | 1922 | ⊕⊕⊕⊕ | |||
| 8 per 1000 | 67 per 1000 | ||||||
| Moderate‐risk population | |||||||
| 11 per 1000 | 92 per 1000 | ||||||
| *The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (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). | |||||||
| GRADE Working Group grades of evidence. | |||||||
| aMedian follow‐up was 37 months (interquartile range (IQR) 24 to 58 months) in the Kitchener trial and 49 months (IQR 27 to 79 months) in the trial of Panici. bEstimate is imprecise, as a fair degree of uncertainty can be seen in the pooled estimate, as indicated by a 95% confidence interval. | |||||||
| Stage | Extent of disease | |
| I | Tumour limited to uterine body | |
| IA | Limited to endometrium | |
| IB | < 1/2 myometrial depth invaded | |
|
| IC | > 1/2 myometrial depth invaded |
| II | Tumour limited to uterine body and cervix | |
| IIA | Endocervical invasion only | |
|
| IIB | Invasion into cervical stroma |
| III |
| Extension to uterine serosa, peritoneal cavity and/or lymph nodes |
|
| IIIA | Extension to uterine serosa, adnexae or positive peritoneal fluid (ascites or washings) |
|
| IIIB | Extension to vagina |
|
| IIIC | Pelvic or para‐aortic lymph nodes involved |
| IV |
| Extension beyond true pelvis and/or involvement of bladder/bowel mucosa |
|
| IVA | Extension to adjacent organs |
|
| IVB | Distant metastases or positive inguinal lymph nodes |
| Stage | Extent of disease | |
| 1 | Tumour confined to corpus uteri | |
| IA | No or less than half myometrial invasion | |
| IB | Invasion equal to or greater than half of the myometrium | |
| II | Tumour invasion into cervical stroma but not extending beyond uterus | |
| III | Local and/or regional spread of tumour | |
| IIIA | Tumour invasion into serosa of corpus uteri and/or adnexae | |
| IIIB | Vaginal and/or parametrial involvement | |
| IIIC | Metastases to pelvic and/or para‐aortic lymph nodes | |
| IIIC1 | Positive pelvic nodes | |
| IIIC2 | Positive para‐aortic lymph nodes with or without positive pelvic lymph | |
| Stage IV tumour invasion into bladder and/or bowel mucosa, and/or distant metastases | ||
| IVA | Tumour invasion into bladder and/or bowel mucosa | |
| IVB | Distant metastases, including intra‐abdominal metastasis and/or inguinal nodes | |
| Pelvic washings/cytology should be recorded separately and now does not change the stage. | ||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Overall survival Show forest plot | 2 | 1851 | Hazard Ratio (Random, 95% CI) | 1.07 [0.81, 1.43] |
| 2 Recurrence‐free survival Show forest plot | 2 | 1851 | Hazard Ratio (Random, 95% CI) | 1.23 [0.96, 1.58] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Direct surgical morbidity Show forest plot | 2 | 1922 | Risk Ratio (IV, Random, 95% CI) | 1.93 [0.79, 4.71] |
| 2 Lymphoedema or lymphocyst Show forest plot | 2 | 1922 | Risk Ratio (IV, Random, 95% CI) | 8.39 [4.06, 17.33] |
| 3 Surgery‐related systemic morbidity Show forest plot | 2 | 1922 | Risk Ratio (IV, Random, 95% CI) | 3.72 [1.04, 13.27] |
