Intracystic bleomycin for cystic craniopharyngiomas in children
Information
- DOI:
- https://doi.org/10.1002/14651858.CD008890.pub4Copy DOI
- Database:
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- Cochrane Database of Systematic Reviews
- Version published:
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- 14 July 2016see what's new
- Type:
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- Intervention
- Stage:
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- Review
- Cochrane Editorial Group:
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Cochrane Childhood Cancer Group
- Copyright:
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- Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Cited by:
Authors
Contributions of authors
S Zhang: searching for trials (this updated review), GRADE assessment and 'Summary of findings' table (this updated review).
Y Fang: searching for trials (previous publication and this updated version), GRADE assessment and 'Summary of findings' table (this updated review), 'Risk of bias' assessment (previous publication), data analyses (previous publication).
BW Cai: searching for trials (previous publication), 'Risk of bias' assessment (previous publication).
JG Xu: searching for trials (previous publication).
C You: protocol and review development, searching for trials (previous publication), 'Risk of bias' assessment (previous publication), data analyses (previous publication).
All authors approved the final version of this updated review.
Sources of support
Internal sources
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No sources of support supplied
External sources
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Research Grants No. 81001117, 30872646/H1618 and 30973082/H1618 from the National Natural Science Foundation, China.
Declarations of interest
S Zhang: nothing to declare.
Y Fang: nothing to declare.
BW Cai: nothing to declare.
JG Xu: nothing to declare.
C You: nothing to declare.
Acknowledgements
We would like to thank the Editorial Base of Cochrane Childhood Cancer for their advice and support.
The editorial base of Cochrane Childhood Cancer is funded by 'Stichting Kinderen Kankervrij' (KIKA), the Netherlands.
Version history
| Published | Title | Stage | Authors | Version |
| 2016 Jul 14 | Intracystic bleomycin for cystic craniopharyngiomas in children | Review | Si Zhang, Yuan Fang, Bo Wen Cai, Jian Guo Xu, Chao You | |
| 2014 Sep 19 | Intracystic bleomycin for cystic craniopharyngiomas in children | Review | Jun Zheng, Yuan Fang, Bo Wen Cai, Heng Zhang, Wenke Liu, Bo Wu, Jian Guo Xu, Chao You | |
| 2012 Apr 18 | Intracystic bleomycin for cystic craniopharyngiomas in children | Review | Yuan Fang, Bo Wen Cai, Heng Zhang, Wenke Liu, Bo Wu, Jian Guo Xu, Chao You | |
| 2010 Dec 08 | Intracystic bleomycin for cystic craniopharyngiomas in children | Protocol | Yuan Fang, Bo Wu, Chao You | |
Differences between protocol and review
We added "The dose, frequency and duration could vary" under the heading Types of interventions.
We added "or via neuroendoscopic technique" under the heading Types of interventions; this technique was not used for this procedure when we wrote the protocol and the original version of the review, but it is now.
We did not contact authors for missing data under the heading Dealing with missing data.
We deleted "We scanned the proceedings abstracts of the International Symposium of Pediatric Neuro‐Oncology (ISPNO) conferences and paediatric neurosurgical conferences (from 2005 to 2010)" under the heading Search methods for identification of studies and Results of the search.
We added "visual outcome" under the heading Secondary outcomes.
We added "cerebrovascular event" under the heading Secondary outcomes; since writing the protocol this adverse effect has been shown in non‐randomised studies.
As opposed to the earlier version of the review we now have prepared a 'Summary of findings' table and we have performed a GRADE assessment of the quality of the evidence.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Antibiotics, Antineoplastic [*administration & dosage];
- Bleomycin [*administration & dosage];
- Craniopharyngioma [*drug therapy];
- Cysts [*drug therapy];
- Injections, Intralesional [methods];
- Phosphorus Radioisotopes [administration & dosage];
- Pituitary Neoplasms [*drug therapy];
- Randomized Controlled Trials as Topic;
Medical Subject Headings Check Words
Child; Humans;
PICOs
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Comparison 1 Intracystic bleomycin versus intracystic 32P, Outcome 1 Reduction of cyst size.
Comparison 1 Intracystic bleomycin versus intracystic 32P, Outcome 2 Fever.
Comparison 1 Intracystic bleomycin versus intracystic 32P, Outcome 3 Total adverse effects.
| Intracystic bleomycin compared to intracystic radiotherapy with 32P for cystic craniopharyngiomas in children | ||||||
| Patient or population: cystic craniopharyngiomas in children from birth to 18 years old | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
| Risk with intracystic 32P | Risk with intracystic bleomycin | |||||
| Survival | NA | NA | ‐ | ‐ | ‐ | There was no information on overall survival and event‐free survival reported in this trial |
| Change in cyst size | Mean reduction in cyst size was 65.5% | Mean reduction in cyst size was 50.7% | MD ‐15% (‐69% to 39%) | 7 | ⊕⊝⊝⊝ | MD was 15% reduction in cyst size; the 95% CI mean a 69% reduction to a 39% increase in cyst size |
| Neurological status | See comment | See comment | Not estimable | Not estimable | ⊕⊝⊝⊝ | 1 patient in the bleomycin group had left paralysis, while none of the patients in the 32P group had severe sequelae. There was no significant difference between the 2 groups (Fisher's exact P value = 0.429). |
| Total number of adverse effects | 500 per 1000 | 875 per 1000 | RR 1.75 | 7 | ⊕⊝⊝⊝ | Adverse effects including fever, 3rd nerve paralysis, headache and vomiting were included in this outcome measure |
| Fever | 250 per 1000 | 730 per 1000 | RR 2.92 | 7 | ⊕⊝⊝⊝ | ‐ |
| 3rd nerve paralysis | See comment | See comment | Not estimable | 7 | ⊕⊝⊝⊝ | 1 patient in the 32P group had 3rd nerve paralysis, while none of the patients in the bleomycin group suffered from this. There was no significant difference between the 2 groups (Fisher's exact P value = 1.00). |
| Headache and vomiting | See comment | See comment | Not estimable | 7 | ⊕⊝⊝⊝ | All 3 patients in the bleomycin group had headache and vomiting, while none of the patients in the 32P group did. There was a significant difference in favour of the 32P group (Fisher's exact P value = 0.029). |
| *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). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1We downgraded a total of 3 levels due to study limitations (the trial had a high risk of performance bias, detection bias and baseline imbalance bias, and an unclear risk of selection bias, attrition bias, reporting bias and early stopping bias), small sample size (the current review includes only one trial with small sample size (n = 7)), and wide confidence intervals including 'no effect', 'appreciable harm' and 'appreciable benefit'. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Reduction of cyst size Show forest plot | 1 | 7 | Mean Difference (IV, Fixed, 95% CI) | ‐0.15 [‐0.69, 0.39] |
| 2 Fever Show forest plot | 1 | 7 | Risk Ratio (M‐H, Fixed, 95% CI) | 2.92 [0.73, 11.70] |
| 3 Total adverse effects Show forest plot | 1 | 7 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.75 [0.68, 4.53] |
