Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial

Sanjeevan Muruganandan, Maree Azzopardi, Deirdre B. Fitzgerald, Ranjan Shrestha, Benjamin C. H. Kwan, David C. L. Lam, Christian C. De Chaneet, Muhammad Redzwan S. Rashid Ali, Elaine Yap, Claire L. Tobin, Luke A. Garske, Phan T. Nguyen, Christopher Stanley, Natalia D. Popowicz, Christopher Kosky, Rajesh Thomas, Catherine A. Read, Charley A. Budgeon, David Feller-Kopman, Nick A. Maskell & 2 others Kevin Murray, Y. C. Gary Lee

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Background Indwelling pleural catheters are an established management option for malignant pleural effusion and have advantages over talc slurry pleurodesis. The optimal regimen of drainage after indwelling pleural catheter insertion is debated and ranges from aggressive (daily) drainage to drainage only when symptomatic.

Methods AMPLE-2 was an open-label randomised trial involving 11 centres in Australia, New Zealand, Hong Kong, and Malaysia. Patients with symptomatic malignant pleural effusions were randomly assigned (1: 1) to the aggressive (daily) or symptom-guided drainage groups for 60 days and minimised by cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group [ECOG] score 0-1 vs >= 2), presence of trapped lung, and prior pleurodesis. Patients were followed up for 6 months. The primary outcome was mean daily breathlessness score, measured by use of a 100 mm visual analogue scale during the first 60 days. Secondary outcomes included rates of spontaneous pleurodesis and self-reported quality-of-life measures. Results were analysed by an intention-totreat approach. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000963527.

Findings Between July 20, 2015, and Jan 26, 2017, 87 patients were recruited and randomly assigned to the aggressive (n=43) or symptom-guided (n=44) drainage groups. The mean daily breathlessness scores did not differ significantly between the aggressive and symptom-guided drainage groups (geometric means 13.1 mm [95% CI 9.8-17.4] vs 17.3 mm [13.0-22.0]; ratio of geometric means 1.32 [95% CI 0.88-1.97]; p=0.18). More patients in the aggressive group developed spontaneous pleurodesis than in the symptom-guided group in the first 60 days (16 [37.2%] of 43 vs five [11.4%] of 44, p=0.0049) and at 6 months (19 [44.2%] vs seven [15.9%], p=0.004; hazard ratio 3.287 [95% CI 1.396-7.740]; p=0.0065). Patient-reported quality-of-life measures, assessed with EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L), were better in the aggressive group than in the symptom-guided group (estimated means 0.713 [95% CI 0.647-0.779] vs 0.601 [0.536-0.667]). The estimated difference in means was 0.112 (95% CI 0.0198-0.204; p=0.0174). Pain scores, total days spent in hospital, and mortality did not differ significantly between groups. Serious adverse events occurred in 11 (25.6%) of 43 patients in the aggressive drainage group and in 12 (27.3%) of 44 patients in the symptom-guided drainage group, including 11 episodes of pleural infection in nine patients (five in the aggressive group and six in the symptom-guided drainage group).

Interpretation We found no differences between the aggressive (daily) and the symptom-guided drainage regimens for indwelling pleural catheters in providing breathlessness control. These data indicate that daily indwelling pleural catheter drainage is more effective in promoting spontaneous pleurodesis and might improve quality of life. Copyright (C) 2018 Elsevier Ltd. All rights reserved.

Original languageEnglish
Pages (from-to)671-680
Number of pages10
JournalLancet Respiratory Medicine
Volume6
Issue number9
DOIs
Publication statusPublished - Sep 2018

Cite this

Muruganandan, Sanjeevan ; Azzopardi, Maree ; Fitzgerald, Deirdre B. ; Shrestha, Ranjan ; Kwan, Benjamin C. H. ; Lam, David C. L. ; De Chaneet, Christian C. ; Ali, Muhammad Redzwan S. Rashid ; Yap, Elaine ; Tobin, Claire L. ; Garske, Luke A. ; Nguyen, Phan T. ; Stanley, Christopher ; Popowicz, Natalia D. ; Kosky, Christopher ; Thomas, Rajesh ; Read, Catherine A. ; Budgeon, Charley A. ; Feller-Kopman, David ; Maskell, Nick A. ; Murray, Kevin ; Lee, Y. C. Gary. / Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2) : an open-label randomised trial. In: Lancet Respiratory Medicine. 2018 ; Vol. 6, No. 9. pp. 671-680.
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title = "Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial",
abstract = "Background Indwelling pleural catheters are an established management option for malignant pleural effusion and have advantages over talc slurry pleurodesis. The optimal regimen of drainage after indwelling pleural catheter insertion is debated and ranges from aggressive (daily) drainage to drainage only when symptomatic.Methods AMPLE-2 was an open-label randomised trial involving 11 centres in Australia, New Zealand, Hong Kong, and Malaysia. Patients with symptomatic malignant pleural effusions were randomly assigned (1: 1) to the aggressive (daily) or symptom-guided drainage groups for 60 days and minimised by cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group [ECOG] score 0-1 vs >= 2), presence of trapped lung, and prior pleurodesis. Patients were followed up for 6 months. The primary outcome was mean daily breathlessness score, measured by use of a 100 mm visual analogue scale during the first 60 days. Secondary outcomes included rates of spontaneous pleurodesis and self-reported quality-of-life measures. Results were analysed by an intention-totreat approach. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000963527.Findings Between July 20, 2015, and Jan 26, 2017, 87 patients were recruited and randomly assigned to the aggressive (n=43) or symptom-guided (n=44) drainage groups. The mean daily breathlessness scores did not differ significantly between the aggressive and symptom-guided drainage groups (geometric means 13.1 mm [95{\%} CI 9.8-17.4] vs 17.3 mm [13.0-22.0]; ratio of geometric means 1.32 [95{\%} CI 0.88-1.97]; p=0.18). More patients in the aggressive group developed spontaneous pleurodesis than in the symptom-guided group in the first 60 days (16 [37.2{\%}] of 43 vs five [11.4{\%}] of 44, p=0.0049) and at 6 months (19 [44.2{\%}] vs seven [15.9{\%}], p=0.004; hazard ratio 3.287 [95{\%} CI 1.396-7.740]; p=0.0065). Patient-reported quality-of-life measures, assessed with EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L), were better in the aggressive group than in the symptom-guided group (estimated means 0.713 [95{\%} CI 0.647-0.779] vs 0.601 [0.536-0.667]). The estimated difference in means was 0.112 (95{\%} CI 0.0198-0.204; p=0.0174). Pain scores, total days spent in hospital, and mortality did not differ significantly between groups. Serious adverse events occurred in 11 (25.6{\%}) of 43 patients in the aggressive drainage group and in 12 (27.3{\%}) of 44 patients in the symptom-guided drainage group, including 11 episodes of pleural infection in nine patients (five in the aggressive group and six in the symptom-guided drainage group).Interpretation We found no differences between the aggressive (daily) and the symptom-guided drainage regimens for indwelling pleural catheters in providing breathlessness control. These data indicate that daily indwelling pleural catheter drainage is more effective in promoting spontaneous pleurodesis and might improve quality of life. Copyright (C) 2018 Elsevier Ltd. All rights reserved.",
keywords = "TALC PLEURODESIS, MANAGEMENT",
author = "Sanjeevan Muruganandan and Maree Azzopardi and Fitzgerald, {Deirdre B.} and Ranjan Shrestha and Kwan, {Benjamin C. H.} and Lam, {David C. L.} and {De Chaneet}, {Christian C.} and Ali, {Muhammad Redzwan S. Rashid} and Elaine Yap and Tobin, {Claire L.} and Garske, {Luke A.} and Nguyen, {Phan T.} and Christopher Stanley and Popowicz, {Natalia D.} and Christopher Kosky and Rajesh Thomas and Read, {Catherine A.} and Budgeon, {Charley A.} and David Feller-Kopman and Maskell, {Nick A.} and Kevin Murray and Lee, {Y. C. Gary}",
year = "2018",
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language = "English",
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pages = "671--680",
journal = "Lancet Respiratory Medicine",
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Muruganandan, S, Azzopardi, M, Fitzgerald, DB, Shrestha, R, Kwan, BCH, Lam, DCL, De Chaneet, CC, Ali, MRSR, Yap, E, Tobin, CL, Garske, LA, Nguyen, PT, Stanley, C, Popowicz, ND, Kosky, C, Thomas, R, Read, CA, Budgeon, CA, Feller-Kopman, D, Maskell, NA, Murray, K & Lee, YCG 2018, 'Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2): an open-label randomised trial' Lancet Respiratory Medicine, vol. 6, no. 9, pp. 671-680. https://doi.org/10.1016/S2213-2600(18)30288-1

Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2) : an open-label randomised trial. / Muruganandan, Sanjeevan; Azzopardi, Maree; Fitzgerald, Deirdre B.; Shrestha, Ranjan; Kwan, Benjamin C. H.; Lam, David C. L.; De Chaneet, Christian C.; Ali, Muhammad Redzwan S. Rashid; Yap, Elaine; Tobin, Claire L.; Garske, Luke A.; Nguyen, Phan T.; Stanley, Christopher; Popowicz, Natalia D.; Kosky, Christopher; Thomas, Rajesh; Read, Catherine A.; Budgeon, Charley A.; Feller-Kopman, David; Maskell, Nick A.; Murray, Kevin; Lee, Y. C. Gary.

In: Lancet Respiratory Medicine, Vol. 6, No. 9, 09.2018, p. 671-680.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Aggressive versus symptom-guided drainage of malignant pleural effusion via indwelling pleural catheters (AMPLE-2)

T2 - an open-label randomised trial

AU - Muruganandan, Sanjeevan

AU - Azzopardi, Maree

AU - Fitzgerald, Deirdre B.

AU - Shrestha, Ranjan

AU - Kwan, Benjamin C. H.

AU - Lam, David C. L.

AU - De Chaneet, Christian C.

AU - Ali, Muhammad Redzwan S. Rashid

AU - Yap, Elaine

AU - Tobin, Claire L.

AU - Garske, Luke A.

AU - Nguyen, Phan T.

AU - Stanley, Christopher

AU - Popowicz, Natalia D.

AU - Kosky, Christopher

AU - Thomas, Rajesh

AU - Read, Catherine A.

AU - Budgeon, Charley A.

AU - Feller-Kopman, David

AU - Maskell, Nick A.

AU - Murray, Kevin

AU - Lee, Y. C. Gary

PY - 2018/9

Y1 - 2018/9

N2 - Background Indwelling pleural catheters are an established management option for malignant pleural effusion and have advantages over talc slurry pleurodesis. The optimal regimen of drainage after indwelling pleural catheter insertion is debated and ranges from aggressive (daily) drainage to drainage only when symptomatic.Methods AMPLE-2 was an open-label randomised trial involving 11 centres in Australia, New Zealand, Hong Kong, and Malaysia. Patients with symptomatic malignant pleural effusions were randomly assigned (1: 1) to the aggressive (daily) or symptom-guided drainage groups for 60 days and minimised by cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group [ECOG] score 0-1 vs >= 2), presence of trapped lung, and prior pleurodesis. Patients were followed up for 6 months. The primary outcome was mean daily breathlessness score, measured by use of a 100 mm visual analogue scale during the first 60 days. Secondary outcomes included rates of spontaneous pleurodesis and self-reported quality-of-life measures. Results were analysed by an intention-totreat approach. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000963527.Findings Between July 20, 2015, and Jan 26, 2017, 87 patients were recruited and randomly assigned to the aggressive (n=43) or symptom-guided (n=44) drainage groups. The mean daily breathlessness scores did not differ significantly between the aggressive and symptom-guided drainage groups (geometric means 13.1 mm [95% CI 9.8-17.4] vs 17.3 mm [13.0-22.0]; ratio of geometric means 1.32 [95% CI 0.88-1.97]; p=0.18). More patients in the aggressive group developed spontaneous pleurodesis than in the symptom-guided group in the first 60 days (16 [37.2%] of 43 vs five [11.4%] of 44, p=0.0049) and at 6 months (19 [44.2%] vs seven [15.9%], p=0.004; hazard ratio 3.287 [95% CI 1.396-7.740]; p=0.0065). Patient-reported quality-of-life measures, assessed with EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L), were better in the aggressive group than in the symptom-guided group (estimated means 0.713 [95% CI 0.647-0.779] vs 0.601 [0.536-0.667]). The estimated difference in means was 0.112 (95% CI 0.0198-0.204; p=0.0174). Pain scores, total days spent in hospital, and mortality did not differ significantly between groups. Serious adverse events occurred in 11 (25.6%) of 43 patients in the aggressive drainage group and in 12 (27.3%) of 44 patients in the symptom-guided drainage group, including 11 episodes of pleural infection in nine patients (five in the aggressive group and six in the symptom-guided drainage group).Interpretation We found no differences between the aggressive (daily) and the symptom-guided drainage regimens for indwelling pleural catheters in providing breathlessness control. These data indicate that daily indwelling pleural catheter drainage is more effective in promoting spontaneous pleurodesis and might improve quality of life. Copyright (C) 2018 Elsevier Ltd. All rights reserved.

AB - Background Indwelling pleural catheters are an established management option for malignant pleural effusion and have advantages over talc slurry pleurodesis. The optimal regimen of drainage after indwelling pleural catheter insertion is debated and ranges from aggressive (daily) drainage to drainage only when symptomatic.Methods AMPLE-2 was an open-label randomised trial involving 11 centres in Australia, New Zealand, Hong Kong, and Malaysia. Patients with symptomatic malignant pleural effusions were randomly assigned (1: 1) to the aggressive (daily) or symptom-guided drainage groups for 60 days and minimised by cancer type (mesothelioma vs others), performance status (Eastern Cooperative Oncology Group [ECOG] score 0-1 vs >= 2), presence of trapped lung, and prior pleurodesis. Patients were followed up for 6 months. The primary outcome was mean daily breathlessness score, measured by use of a 100 mm visual analogue scale during the first 60 days. Secondary outcomes included rates of spontaneous pleurodesis and self-reported quality-of-life measures. Results were analysed by an intention-totreat approach. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000963527.Findings Between July 20, 2015, and Jan 26, 2017, 87 patients were recruited and randomly assigned to the aggressive (n=43) or symptom-guided (n=44) drainage groups. The mean daily breathlessness scores did not differ significantly between the aggressive and symptom-guided drainage groups (geometric means 13.1 mm [95% CI 9.8-17.4] vs 17.3 mm [13.0-22.0]; ratio of geometric means 1.32 [95% CI 0.88-1.97]; p=0.18). More patients in the aggressive group developed spontaneous pleurodesis than in the symptom-guided group in the first 60 days (16 [37.2%] of 43 vs five [11.4%] of 44, p=0.0049) and at 6 months (19 [44.2%] vs seven [15.9%], p=0.004; hazard ratio 3.287 [95% CI 1.396-7.740]; p=0.0065). Patient-reported quality-of-life measures, assessed with EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L), were better in the aggressive group than in the symptom-guided group (estimated means 0.713 [95% CI 0.647-0.779] vs 0.601 [0.536-0.667]). The estimated difference in means was 0.112 (95% CI 0.0198-0.204; p=0.0174). Pain scores, total days spent in hospital, and mortality did not differ significantly between groups. Serious adverse events occurred in 11 (25.6%) of 43 patients in the aggressive drainage group and in 12 (27.3%) of 44 patients in the symptom-guided drainage group, including 11 episodes of pleural infection in nine patients (five in the aggressive group and six in the symptom-guided drainage group).Interpretation We found no differences between the aggressive (daily) and the symptom-guided drainage regimens for indwelling pleural catheters in providing breathlessness control. These data indicate that daily indwelling pleural catheter drainage is more effective in promoting spontaneous pleurodesis and might improve quality of life. Copyright (C) 2018 Elsevier Ltd. All rights reserved.

KW - TALC PLEURODESIS

KW - MANAGEMENT

U2 - 10.1016/S2213-2600(18)30288-1

DO - 10.1016/S2213-2600(18)30288-1

M3 - Article

VL - 6

SP - 671

EP - 680

JO - Lancet Respiratory Medicine

JF - Lancet Respiratory Medicine

SN - 2213-2619

IS - 9

ER -