Breathlessness control comparable with daily, as-needed indwelling pleural catheter drainage
medwireNews: In patients with malignant pleural effusion requiring an indwelling pleural catheter (IPC), daily drainage does not significantly improve breathlessness relative to symptom-driven drainage, shows the AMPLE-2 trial.
However, spontaneous pleurodesis was more likely and quality of life (QoL) was better with daily than with as-needed drainage, and these improvements did not come at a cost of additional side effects, the investigators report in The Lancet Respiratory Medicine.
For patients in whom early catheter removal is an important goal, they recommend daily drainage for at least 60 days, while symptom-guided drainage offers “an effective means of breathlessness control without the burden and costs of daily drainages” for patients whose primary aim is palliation.
The trial recruited 87 participants from 11 centers in Australia, New Zealand, Hong Kong, and Malaysia, who needed an IPC for malignant pleural effusion resulting most commonly from lung cancer (n=34), mesothelioma (n=29), or ovarian cancer (n=10). Participants were randomly assigned to either drain their IPCs daily (aggressive regimen) or in response to effusion-related symptoms, such as breathlessness, cough, and chest tightness.
The primary endpoint of mean daily breathlessness score during the initial 60 days after randomization was comparable between the groups, with corresponding geometric means of 13.1 and 17.3 mm on a 100 mm visual analog scale (VAS).
But in a competing risk model, the rate of spontaneous pleurodesis at the 60-day mark was significantly higher in the daily than as-needed drainage group, at 37.2% versus 11.4%, and this was also the case at the end of the 6-month follow-up period, at 44.2% versus 15.9%.
Patients who drained daily reported significantly better scores on the EuroQoL-5 Dimensions-5 Levels questionnaire than their counterparts who drained in response to symptoms, but the between-group difference was not significant when QoL was assessed on a VAS.
Furthermore, the study arms did not differ significantly with respect to mean pain scores on a VAS during the initial 60-day period, the number and duration of hospital admissions over the study period, and mortality rates at the 60-day and 6-month timepoints, report YC Gary Lee, from the University of Western Australia in Perth, and co-researchers.
And serious adverse events were observed in 25.6% of participants in the daily drainage group and in a comparable 27.3% of those in the symptom-driven drainage group, with a respective five and six patients experiencing pleural infection.
Lee et al note that in the trial protocol, “the drainage schedules after 60 days were left to the choice of the attending clinicians and patients,” and it is possible that many of the patients in the daily drainage group may have adopted a less aggressive approach after this time.
“Whether prolonging daily drainage beyond 60 days will facilitate late pleurodesis requires further research,” the team concludes.
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