Muruganandan S, et al. - Authors assessed the optimal regimen of drainage (which ranges from aggressive (daily) drainage to drainage only when symptomatic) after indwelling pleural catheter insertion for malignant pleural effusion. For indwelling pleural catheters, findings did not suggest any difference in the aggressive (daily) and the symptom-guided drainage regimens in providing breathlessness control. They noted a greater efficacy of daily indwelling pleural catheter drainage in promoting spontaneous pleurodesis that might improve quality of life.

Methods

• Experts conducted AMPLE-2 an open-label randomised trial involving 11 centres in Australia, New Zealand, Hong Kong, and Malaysia.
• They randomly assigned (1:1) the patients with symptomatic malignant pleural effusions 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.
• They followed up the patients for 6 months.
• Mean daily breathlessness score, measured by use of a 100 mm visual analogue scale during the first 60 days was the primary outcome.
• Rates of spontaneous pleurodesis and self-reported quality-of-life measures were included in the secondary outcomes.
• Researchers analyzed the results by an intention-to-treat approach.

Results

• As per data, patients were recruited and randomly assigned between July 20, 2015, and Jan 26, 2017, 87 to the aggressive (n=43) or symptom-guided (n=44) drainage groups.
• Findings did not suggest a significant difference in the mean daily breathlessness scores 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).
• Spontaneous pleurodesis developed in more patients in the aggressive group 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).
• Results demonstrated that the 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]).
• Authors noted that the estimated difference in means was 0·112 (95% CI 0·0198–0·204; p=0·0174).
• Between groups, pain scores, total days spent in hospital, and mortality did not differ significantly.
• In 11 (25·6%) of 43 patients in the aggressive drainage group, serious adverse events occurred and in 12 (27·3%) of 44 patients in the symptom-guided drainage group, including 11 episodes of pleural infection in nine patients (5 in the aggressive group and 6 in the symptom-guided drainage group).