Histerectomía con radioterapia o quimioterapia o ambos para pacientes con cáncer de cuello de útero localmente avanzado
Información
- DOI:
- https://doi.org/10.1002/14651858.CD010260.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 07 abril 2015see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Cáncer ginecológico, neurooncología y otros cánceres
- Copyright:
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- Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
FK and AB searched for relevant trials and individually examined each potentially relevant full text reference. AB extracted data on risk of bias items. FK and AB drafted the full review; AB drafted methodological and statistical sections of the review as well as various sections of the discussion; FK drafted clinical sections of the review, added expertise and drafted some of the discussion.
EB provided clinical advice and expertise, offered critical comments and contributed to the discussion.
MP and DO reviewed the final version of the review.
Sources of support
Internal sources
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No sources of support supplied
External sources
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Department of Health, UK.
NHS Cochrane Collaboration programme Grant Scheme CPG‐10/4001/12
Declarations of interest
None known
Acknowledgements
We thank Jo Morrison for clinical and editorial advice, Jane Hayes for designing the search strategy, and Gail Quinn and Clare Jess for their contribution to the editorial process. We thank the referees for many helpful suggestions and comments. We also thank the authors of the Morice and Yamauchi trials for providing additional information on outcomes.
This project was supported by the National Institute for Health Research (NIHR), 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 authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.
Version history
| Published | Title | Stage | Authors | Version |
| 2022 Aug 22 | Hysterectomy with radiotherapy or chemotherapy or both for women with locally advanced cervical cancer | Review | Fani Kokka, Andrew Bryant, Adeola Olaitan, Elly Brockbank, Melanie Powell, David Oram | |
| 2015 Apr 07 | Hysterectomy with radiotherapy or chemotherapy or both for women with locally advanced cervical cancer | Review | Fani Kokka, Andrew Bryant, Elly Brockbank, Melanie Powell, David Oram | |
| 2013 Jan 31 | Hysterectomy for patients with locally advanced cervical cancer after primary radiotherapy and/or chemotherapy | Protocol | Fani Kokka, Andrew Bryant, David Oram, Melanie Powell | |
Differences between protocol and review
The original protocol title was, 'To assess the effectiveness and safety (surgery‐related complications) of hysterectomy with radiotherapy, chemotherapy or both in locally advanced cervical cancer (stages IB2 to III)' but was modified to the following title: 'To determine whether hysterectomy, in addition to standard treatment with radiation and/or chemotherapy in women with locally advanced cervical cancer (stage IB2‐III), is safe and effective compared with standard treatment alone'. The original title was reworded for clarity.
Types of outcome measures
Primary outcomes
The primary outcome definition was expanded to incorporate definitions by trialists.
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Overall survival: survival until death from all causes was assessed from the time when women were enrolled in the study or as defined by the trial authors.
Secondary outcomes
Progression‐free (PFS) and disease‐free survival were listed as separate outcomes in the protocol but in the review PFS was preferred. We subsequently defined trials using disease‐free survival and PFS as a subgroup analysis that was of interest (see below). Local control was specified as an outcome of interest in the protocol but was omitted in the review after discussion about its importance and our wanting to restrict outcomes to those that are important and pertinent.
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Progression‐free survival.
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If authors reported disease‐free survival rather than progression‐free survival then this was assessed.
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Quality of life measured using a scale that has been validated through reporting of norms in a peer‐reviewed publication by a validated scale.
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Adverse events:
Complications of chemotherapy and radiotherapy were added to the review as only surgery‐related complications were listed in the protocol but complications from these medical agents are important.
Chemotherapy and radiotherapy‐related complications
Grades of chemotherapeutic and radiotherapeutic toxicity were extracted and grouped as:
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haematological (leucopenia, anaemia, thrombocytopenia, neutropenia, haemorrhage);
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gastrointestinal (nausea, vomiting, anorexia, diarrhoea, liver toxicity, proctitis);
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genitourinary;
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skin (stomatitis, mucositis, alopecia, allergy);
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neurological (peripheral and central); and
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pulmonary.
Search methods for identification of studies
Some of the methods for searching were not implemented, namely approaching major co‐operative trials groups active in this area.
Continuous outcome data were not reported in any of the trials so the following sections in the protocol which discussed the handling of the data of such outcomes were removed as they were unnecessary (dichotomous data was not meta‐analysed so was removed in the data synthesis section).
Data extraction and management
We extracted data on outcomes as below:
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for continuous outcomes (e.g. quality of life), we will extract the final value and standard deviation of the outcome of interest and the number of women assessed at the endpoint in each treatment arm at the end of follow‐up, in order to estimate the mean difference (if trials measured outcomes on the same scale) or standardised mean difference (if trials measured outcomes on different scales) between treatment arms and its standard error.
Measures of treatment effect
We used the following measures of the effect of treatment:
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for continuous outcomes, we will use the mean difference between treatment arms.
Data synthesis
If sufficient clinically similar trials were available, their results were pooled in meta‐analyses.
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For any dichotomous outcomes, the RR will be calculated for each study and will then be pooled.
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For continuous outcomes, the mean differences between the treatment arms at the end of follow‐up will be pooled if all trials measured the outcome on the same scale, otherwise standardised mean differences will be pooled.
If any trials have multiple treatment groups, the 'shared' comparison group will be divided into the number of treatment groups and comparisons between each treatment group and the split comparison group will be treated as independent comparisons.
Subgroup analysis and investigation of heterogeneity
We will conduct subgroup analysis according to:
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the type of hysterectomy undergone (simple versus radical);
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the type of radiotherapy used;
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the chemotherapeutic regimen used;
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the histopathological types of cervical cancer cases;
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whether the trial measured progression or disease‐free survival. This was added after the protocol after going through the searches; it was likely to be important but in the end subgroup analysis by outcome definition was not possible.
Sensitivity analysis
If a sufficient number of trials are included in the review, we will conduct sensitivity analyses to examine the possible contribution of other clinical or methodological differences between the trials, specifically:
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trials at low risk of bias versus those at high and unclear risk of bias;
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trials that seem to differ from the others in their clinical criteria for defining survival.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
Medical Subject Headings Check Words
Female; Humans;
PICO
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Study flow diagram.
Comparison 1 Neoadjuvant chemotherapy and radical hysterectomy versus radiotherapy alone, Outcome 1 Overall survival.
Comparison 1 Neoadjuvant chemotherapy and radical hysterectomy versus radiotherapy alone, Outcome 2 Disease or progression‐free survival.
| Neoadjuvant chemotherapy and radical hysterectomy compared with radiotherapy alone for women with locally advanced cervical cancer | ||||
| Patient or population: Women with locally advanced cervical cancer Settings: Outpatient Intervention: Neoadjuvant chemotherapy and radical hysterectomy Comparison: Radiotherapy alone | ||||
| Outcomes | Relative effect | No of Participants | Quality of the evidence | Comments |
| Overall survival Median follow‐up ranged from 39 to 60 months in the 3 trials | HR 0.71 (0.55 to 0.93) | 571 | ⊕⊕⊕⊝ | Downgraded due to concerns regarding the uncertainty of risk of bias in individual trials |
| Disease or progression‐free survival Median follow‐up ranged from 39 to 60 months in the 3 trials | HR 0.75 (0.53 to 1.05) | 571 | ⊕⊕⊕⊝ | Downgraded due to concerns regarding the uncertainty of risk of bias in individual trials and varying definitions of disease and progression‐free survival. Although we did not feel the latter merited a further downgrade to low quality evidence |
| Severe adverse events and toxicity | Acute severe toxicity: RR 1.32, (0.47 to 3.71) long‐term severe complications: RR 0.86 (0.49 to 1.50) Severe late toxicity: RR 0.60 (0.27 to 1.34) | Acute toxicity 118 (1 RCT) Long‐term severe complications 409 (1 RCT) Severe late toxicity: 118 (1 RCT) | ⊕⊕⊝⊝ | Downgraded due to incomplete and poor reporting of important adverse events and toxicities and sparseness of data |
| GRADE Working Group grades of evidence | ||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Overall survival Show forest plot | 3 | 571 | Hazard Ratio (Random, 95% CI) | 0.71 [0.55, 0.93] |
| 2 Disease or progression‐free survival Show forest plot | 3 | 571 | Hazard Ratio (Random, 95% CI) | 0.75 [0.53, 1.05] |
