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. 2016 May 8;2016(5):CD010529.
doi: 10.1002/14651858.CD010529.pub2.

Interventions for the management of malignant pleural effusions: a network meta-analysis

Amelia O Clive  1 , Hayley E Jones, Rahul Bhatnagar, Nancy J Preston, Nick Maskell
Affiliations

Interventions for the management of malignant pleural effusions: a network meta-analysis

Amelia O Clive et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Malignant pleural effusion (MPE) is a common problem for people with cancer as a result of malignant infiltration of the pleura. It is usually associated with considerable breathlessness. A number of treatment options are available to manage the uncontrolled accumulation of pleural fluid including administration of a pleurodesis agent (either via a chest tube or at thoracoscopy) or indwelling pleural catheter insertion.

Objectives: To ascertain the optimal management strategy for adults with malignant pleural effusion in terms of pleurodesis success. Additionally, to quantify differences in patient-reported outcomes and adverse effects between management strategies.

Search methods: We searched The Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid EMBASE; EBSCO CINAHL; SCI-EXPANDED and SSCI (ISI Web of Science) to April 2015.

Selection criteria: We included randomised controlled trials of intrapleural interventions for adults with symptomatic MPE in the review.

Data collection and analysis: Two review authors independently extracted data on study design, study characteristics, outcome measures, potential effect modifiers and risk of bias.The primary outcome measure was pleurodesis failure rate. Secondary outcome measures were adverse effects and complications, patient-reported control of breathlessness, quality of life, cost, mortality, duration of inpatient stay and patient acceptability.We performed network meta-analysis with random effects to analyse the primary outcome data and those secondary outcomes with enough data. We also performed pair-wise random-effects meta-analyses of direct comparison data. If interventions were not deemed jointly randomisable, or insufficient data were available, we reported the results by narrative synthesis. We performed sensitivity analyses to explore heterogeneity and to evaluate only those pleurodesis agents administered via a chest tube at the bedside.

Main results: Of the 1888 records identified, 62 randomised trials, including a total of 3428 patients, were eligible for inclusion. All studies were at high or uncertain risk of bias for at least one domain.Network meta-analysis evaluating the rate of pleurodesis failure, suggested talc poudrage to be a highly effective method (ranked second of 16 (95% credible interval (Cr-I) 1 to 5)) and provided evidence that it resulted in fewer pleurodesis failures than eight other methods. The estimated ranks of other commonly used agents were: talc slurry (fourth; 95% Cr-I 2 to 8), mepacrine (fourth; 95% Cr-I 1 to 10), iodine (fifth; 95% Cr-I 1 to 12), bleomycin (eighth; 95% Cr-I 5 to 11) and doxycyline (tenth; 95% Cr-I 4 to 15). The estimates were imprecise as evidenced by the wide credible intervals and both high statistical and clinical heterogeneity.Most of the secondary outcomes, including adverse events, were inconsistently reported by the included studies and the methods used to describe them varied widely. Hence the majority of the secondary outcomes were reported descriptively in this review. We obtained sufficient data to perform network meta-analysis for the most commonly reported adverse events: pain, fever and mortality. The fever network was imprecise and showed substantial heterogeneity, but suggested placebo caused the least fever (ranked first of 11 (95% Cr-I 1 to 7)) and mepacrine and Corynebacterium parvum (C. parvum) appeared to be associated with the most fever (ranked tenth (95% Cr-I 6 to 11) and eleventh (95% Cr-I 7 to 11) respectively). No differences between interventions were revealed by the network meta-analysis of the pain data. The only potential difference in mortality identified in the mortality network was that those receiving tetracycline appeared to have a longer survival than those receiving mitoxantrone (OR 0.16 (95% Confidence Interval (CI) 0.03 to 0.72)). Indwelling pleural catheters were examined in two randomised studies, both of which reported improved breathlessness when compared to talc slurry pleurodesis, despite lower pleurodesis success rates.The risk of bias in a number of the included studies was substantial, for example the vast majority of studies were unblinded, and the methods used for sequence generation and allocation concealment were often unclear. Overall, however, the risk of bias for all studies was moderate. We have not reported the GRADE quality of evidence for the outcomes, as the role of GRADE is not well established in the context of Network Meta-analysis (NMA).

Authors' conclusions: Based on the available evidence, talc poudrage is a more effective pleurodesis method in MPE than a number of other frequently used methods, including tetracycline and bleomycin. However further data are required to definitively confirm whether it is more effective than certain other commonly used interventions such as talc slurry and doxycycline, particularly in view of the high statistical and clinical heterogeneity within the network and the high risk of bias of many of the included studies. Based on the strength of the evidence from both direct and indirect comparisons of randomised data of sclerosants administered at the bedside, there is no evidence to suggest large differences between the other highly effective methods (talc slurry, mepacrine, iodine and C. parvum). However, local availability, global experience of these agents and their adverse events, which may not be identified in randomised trials, must also be considered when selecting a sclerosant. Further research is required to delineate the roles of different treatments according to patient characteristics (e.g. according to their prognosis or presence of trapped lung) and to explore patient-centred outcomes, such as breathlessness and quality of life, in more detail. Careful consideration to minimise the risk of bias and standardise outcome measures is essential for future trial design.

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Conflict of interest statement

AOC is involved in co‐ordinating and recruiting to the TIME‐3 trial (TIME‐3).

HJ: none known.

RB has been the trial co‐ordinator for the TAPPS and IPC‐Plus studies since 2012 (IPC‐Plus; TAPPS) but did not perform the data extractions for these studies for the purposes of this review.

NJP: none known.

NM is a member of the trial steering committee for TIME‐1 and TIME‐3 trials (TIME‐1; TIME‐3). NM is a co‐author for one of the included studies (Maskell 2004). However, he did not perform the data extractions for this study for the purposes of this review. North Bristol NHS Trust received unrestricted research funding from CareFusion, to run the IPC‐Plus trial (IPC‐Plus) (2013‐2016) for which NM was the chief investigator. NM also received honoraria from CareFusion for medical advisory board meetings (2013‐2015). This has no direct link with the Cochrane Review.

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Network plot of the pleurodesis efficacy network. The nodes are weighted according to the number of participants randomised to the intervention. The edges (line thicknesses) are weighted according to the number of studies included in each comparison.
5
5
Estimated (95% Cr‐I) ranks for each of the pleurodesis methods from the main network
6
6
Inconsistency plot for the main network. Treatment codes: 01 = Talc slurry; 02 = Talc poudrage; 03 = Bleomycin; 04 = Tetracycline; 05 = C. parvum; 06 = Interferon; 07 = Iodine; 08 = Indwelling pleural catheter; 09 = Placebo; 10 = Mustine; 11 = Mitoxantrone; 12 = Mepacrine; 13 = Doxycyline; 14 = Triethylenethiophosphoramide; 15 = Adriamycin. Abbreviations: ROR = Ratio of Odds Ratios; 95% CI = 95% Confidence interval. Heterogeneity variance was set at 0.8847 (reflecting the estimation of Tau from the network)
7
7
Estimated rank (95% Cr‐I) for causing fever (a low rank suggests less fever)
1.1
1.1. Analysis
Comparison 1 Bleomycin, Outcome 1 Pleurodesis failure.
1.2
1.2. Analysis
Comparison 1 Bleomycin, Outcome 2 Pain.
1.3
1.3. Analysis
Comparison 1 Bleomycin, Outcome 3 Mortality.
1.4
1.4. Analysis
Comparison 1 Bleomycin, Outcome 4 Fever.
2.1
2.1. Analysis
Comparison 2 Talc slurry, Outcome 1 Pleurodesis failure.
2.2
2.2. Analysis
Comparison 2 Talc slurry, Outcome 2 Mortality.
2.3
2.3. Analysis
Comparison 2 Talc slurry, Outcome 3 Pain.
2.4
2.4. Analysis
Comparison 2 Talc slurry, Outcome 4 Fever.
3.1
3.1. Analysis
Comparison 3 Talc poudrage, Outcome 1 Pleurodesis failure.
3.2
3.2. Analysis
Comparison 3 Talc poudrage, Outcome 2 Mortality.
3.3
3.3. Analysis
Comparison 3 Talc poudrage, Outcome 3 Pain.
3.4
3.4. Analysis
Comparison 3 Talc poudrage, Outcome 4 Fever.
4.1
4.1. Analysis
Comparison 4 Tetracycline, Outcome 1 Pleurodesis failure.
4.2
4.2. Analysis
Comparison 4 Tetracycline, Outcome 2 Pain.
4.3
4.3. Analysis
Comparison 4 Tetracycline, Outcome 3 Fever.
4.4
4.4. Analysis
Comparison 4 Tetracycline, Outcome 4 Mortality.
5.1
5.1. Analysis
Comparison 5 C. parvum, Outcome 1 Pleurodesis failure.
5.2
5.2. Analysis
Comparison 5 C. parvum, Outcome 2 Pain.
5.3
5.3. Analysis
Comparison 5 C. parvum, Outcome 3 Fever.
5.4
5.4. Analysis
Comparison 5 C. parvum, Outcome 4 Mortality.
6.1
6.1. Analysis
Comparison 6 Indwelling pleural catheter (IPC), Outcome 1 Pleurodesis failure.
6.2
6.2. Analysis
Comparison 6 Indwelling pleural catheter (IPC), Outcome 2 Mortality.
6.3
6.3. Analysis
Comparison 6 Indwelling pleural catheter (IPC), Outcome 3 Pain.
7.1
7.1. Analysis
Comparison 7 Iodine, Outcome 1 Pleurodesis failure.
7.2
7.2. Analysis
Comparison 7 Iodine, Outcome 2 Fever.
7.3
7.3. Analysis
Comparison 7 Iodine, Outcome 3 Mortality.
7.4
7.4. Analysis
Comparison 7 Iodine, Outcome 4 Pain.
8.1
8.1. Analysis
Comparison 8 Doxycycline, Outcome 1 Pleurodesis failure.
8.2
8.2. Analysis
Comparison 8 Doxycycline, Outcome 2 Pain.
8.3
8.3. Analysis
Comparison 8 Doxycycline, Outcome 3 Fever.
8.4
8.4. Analysis
Comparison 8 Doxycycline, Outcome 4 Mortality.
9.1
9.1. Analysis
Comparison 9 Mode of administration, Outcome 1 Pleurodesis failure.
10.1
10.1. Analysis
Comparison 10 Duration of drainage after pleurodesis administration, Outcome 1 Pleurodesis failure.
10.2
10.2. Analysis
Comparison 10 Duration of drainage after pleurodesis administration, Outcome 2 Mortality.
11.1
11.1. Analysis
Comparison 11 OK‐432, Outcome 1 Pleurodesis failure.
11.2
11.2. Analysis
Comparison 11 OK‐432, Outcome 2 Pain.
11.3
11.3. Analysis
Comparison 11 OK‐432, Outcome 3 Fever.
11.4
11.4. Analysis
Comparison 11 OK‐432, Outcome 4 Mortality.
12.1
12.1. Analysis
Comparison 12 Mepacrine, Outcome 1 Pain.
12.2
12.2. Analysis
Comparison 12 Mepacrine, Outcome 2 Fever.
12.3
12.3. Analysis
Comparison 12 Mepacrine, Outcome 3 Pleurodesis failure.
12.4
12.4. Analysis
Comparison 12 Mepacrine, Outcome 4 Mortality.
13.1
13.1. Analysis
Comparison 13 Interferon (IFN), Outcome 1 Pleurodesis failure.
13.2
13.2. Analysis
Comparison 13 Interferon (IFN), Outcome 2 Pain.
13.3
13.3. Analysis
Comparison 13 Interferon (IFN), Outcome 3 Fever.
13.4
13.4. Analysis
Comparison 13 Interferon (IFN), Outcome 4 Mortality.
14.1
14.1. Analysis
Comparison 14 Triethylenethiophophoramide, Outcome 1 Pleurodesis failure.
14.2
14.2. Analysis
Comparison 14 Triethylenethiophophoramide, Outcome 2 Pain.
14.3
14.3. Analysis
Comparison 14 Triethylenethiophophoramide, Outcome 3 Fever.
15.1
15.1. Analysis
Comparison 15 Adriamycin, Outcome 1 Pleurodesis failure.
15.2
15.2. Analysis
Comparison 15 Adriamycin, Outcome 2 Fever.
15.3
15.3. Analysis
Comparison 15 Adriamycin, Outcome 3 Pain.
16.1
16.1. Analysis
Comparison 16 Placebo, Outcome 1 Pleurodesis failure.
16.2
16.2. Analysis
Comparison 16 Placebo, Outcome 2 Pain.
16.3
16.3. Analysis
Comparison 16 Placebo, Outcome 3 Fever.
17.1
17.1. Analysis
Comparison 17 Mustine, Outcome 1 Pleurodesis failure.
17.2
17.2. Analysis
Comparison 17 Mustine, Outcome 2 Fever.
17.3
17.3. Analysis
Comparison 17 Mustine, Outcome 3 Mortality.
17.4
17.4. Analysis
Comparison 17 Mustine, Outcome 4 Pain.
18.1
18.1. Analysis
Comparison 18 Mitoxantrone, Outcome 1 Pleurodesis failure.
18.2
18.2. Analysis
Comparison 18 Mitoxantrone, Outcome 2 Pain.
18.3
18.3. Analysis
Comparison 18 Mitoxantrone, Outcome 3 Fever.
18.4
18.4. Analysis
Comparison 18 Mitoxantrone, Outcome 4 Mortality.
19.1
19.1. Analysis
Comparison 19 Drain size, Outcome 1 Pleurodesis failure.
19.2
19.2. Analysis
Comparison 19 Drain size, Outcome 2 Pain.
19.3
19.3. Analysis
Comparison 19 Drain size, Outcome 3 Mortality.
20.1
20.1. Analysis
Comparison 20 Thoracoscopic mechanical pleurodesis (TMP), Outcome 1 Pleurodesis failure.
20.2
20.2. Analysis
Comparison 20 Thoracoscopic mechanical pleurodesis (TMP), Outcome 2 Mortality.
21.1
21.1. Analysis
Comparison 21 Other, Outcome 1 Pleurodesis failure.
21.2
21.2. Analysis
Comparison 21 Other, Outcome 2 Pain.
21.3
21.3. Analysis
Comparison 21 Other, Outcome 3 Fever.
21.4
21.4. Analysis
Comparison 21 Other, Outcome 4 Mortality.
22.1
22.1. Analysis
Comparison 22 Silver nitrate, Outcome 1 Pleurodesis failure.
22.2
22.2. Analysis
Comparison 22 Silver nitrate, Outcome 2 Fever.
23.1
23.1. Analysis
Comparison 23 Cisplatin, Outcome 1 Pleurodesis failure.
23.2
23.2. Analysis
Comparison 23 Cisplatin, Outcome 2 Pain.
23.3
23.3. Analysis
Comparison 23 Cisplatin, Outcome 3 Fever.
23.4
23.4. Analysis
Comparison 23 Cisplatin, Outcome 4 Mortality.
24.1
24.1. Analysis
Comparison 24 Duration of drainage prior to administration of sclerosant, Outcome 1 Pleurodesis failure.
25.1
25.1. Analysis
Comparison 25 Dose of silver nitrate, Outcome 1 Pleurodesis failure.
25.2
25.2. Analysis
Comparison 25 Dose of silver nitrate, Outcome 2 Mortality.
25.3
25.3. Analysis
Comparison 25 Dose of silver nitrate, Outcome 3 Pain.
25.4
25.4. Analysis
Comparison 25 Dose of silver nitrate, Outcome 4 Fever.
See this image and copyright information in PMC

References

References to studies included in this review

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Salomaa 1995 {published data only}
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Schmidt 1997 {published data only}
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Sorensen 1984 {published data only}
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Terra 2009 {published data only (unpublished sought but not used)}
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Terra 2015 {published data only (unpublished sought but not used)}
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References to studies excluded from this review

Caglayan 2008 {published data only}
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References to studies awaiting assessment

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References to ongoing studies

AMPLE Trial {published data only}
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IPC‐Plus {published and unpublished data}
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TAPPS {published and unpublished data}
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Publication types