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 Popowicz, Christopher Kosky, Rajesh Thomas, Catherine A. Read, Charley A Budgeon, David Feller-Kopman, Nick MaskellKevin Murray, Y C Gary Lee

Research output: Contribution to journalArticle (Academic Journal)peer-review

49 Citations (Scopus)
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Abstract

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

Methods
AMPLE-2 was an open-labelled, randomized trial that involved 11 centers in Australia, New Zealand, Hong Kong and Malaysia between July 2015 and January 2017 [ACTRN12615000963527]. Patients (n=87) with symptomatic MPEs were randomized (1:1) to the Aggressive (daily) or Symptom-guided drainage arms for 60 days and minimized by cancer type (mesothelioma vs others), performance status (ECOG 0-1 vs ≥2), presence of trapped lung and prior pleurodesis, and followed up for 6 months. The results were analyzed by an intention-to-treat approach.

Findings
The primary outcome compared the mean daily breathlessness scores of each patient, measured using a 100mm visual analogue scale (VAS), over the first 60 days and found no significant difference between the Aggressive and Symptom-guided drainage arms (geometric means=13·1 vs 17·3 mm respectively, p=0·1766, ratio of geometric means 1·32, 95% CI 0·88-1·97). More patients in the Aggressive arm developed spontaneous pleurodesis than in the Symptom-guided arm in the first 60 days (37·2% [16/43] vs 11·4% [5/44] respectively, p=0·0049) and at 6 months (44·2% [19/43] vs 15·9% [7/44] respectively, p=0·0065; HR=3·287 [95% CI 1·396-7·740]). Patient-reported quality-of-life measures, using EQ-5D-5L, were better in the Aggressive arm than in the Symptom-guided arm: estimated means 0·713 (95% CI 0·647-0·779) vs 0·601 (95% CI 0·536-0·667) respectively. The estimated difference in means was 0·112 (95% CI 0·0198-0·204), p=0·0174. There were no significant between-group differences in pain scores, total days spent in hospital or mortality. Serious adverse events occurred in 25.6% (11/43) and 27.3% (12/44) patients in the Aggressive and Symptom-guided drainage arms respectively, including 11 episodes of pleural infection in 9 patients (5 in the Aggressive arm and 6 in the Symptom-guided drainage arm).

Interpretation
No differences were found between the aggressive (daily) and the symptom-guided drainage regimens for IPC in providing breathlessness control. Patients managed with the two schedules did not differ on their pain scores, days spent in hospital or mortality. Daily IPC drainage is more effective in promoting spontaneous pleurodesis and may improve quality-of-life.
Original languageEnglish
Pages (from-to)671-680
Number of pages10
JournalLancet Respiratory Medicine
Volume6
Issue number9
Early online date20 Jul 2018
DOIs
Publication statusPublished - Sep 2018

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