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.
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.
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).
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.