Use of Indwelling Pleural Catheter for Outpatient Talc Administration in Treatment of Malignant Pleural Effusion
In a UK study reported in The New England Journal of Medicine, Bhatnagar et al found that outpatient talc vs placebo administration via indwelling pleural catheter was associated with a higher rate of pleurodesis in patients with malignant pleural effusion.
Study Details
In the study, a target of 154 patients was reached after 584 patients were approached for enrollment over 4 years at 18 sites. Patients underwent insertion of an indwelling pleural catheter and regular drainage as outpatients. In the absence of evidence of substantial lung entrapment (prevention of lung expansion and pleural apposition due to visceral fibrosis or bronchial obstruction) at 10 days, patients were randomized in single-blind fashion to receive either 4 g of talc slurry (n = 76) or placebo (intrapleural sodium chloride 0.9% solution; n = 78) via indwelling pleural catheter on an outpatient basis. Total follow-up was 70 days.
The primary outcome measure was successful pleurodesis at day 35. Successful pleurodesis was defined as draining of < 50 ml of fluid on three consecutive occasions through the indwelling catheter and < 25% opacification of the hemithorax due to suspected fluid on chest radiography after the drainages. The most common cancer types were lung cancer (33% and 26%), breast cancer (21% and 19%), and mesothelioma (13% and 17%).
Outcomes
A total of 9 talc patients and 6 placebo patients were excluded from analysis due to insufficient data to calculate the primary outcome at day 35. At day 35, successful pleurodesis was achieved in 30 (43%) of 69 evaluable patients in the talc group vs 16 (23%) of 70 in the placebo group (hazard ratio = 2.20, P = .008). At day 70, the rate of successful pleurodesis was 51% vs 27% (HR = 2.24, P = .003).No significant differences between groups were observed in effusion size or complexity, number of hospital days (mean = 4.1 vs 3.0, P = .74), mortality (7 vs 14 deaths, P = .13), or incidence of adverse events. Blockage of the catheter occurred in 6% vs 4% of patients. The talc group had significantly better quality of life scores on the EORTC QLQ-C30 at day 28 (P = .03) and day 42 (P = .001) and improved symptom scores, including visual analogue scores for chest pain at day 14 (P = .04) and day 28 (P = 0.02) and for dyspnea at day 56 (P = .04).
The investigators concluded, “Among patients without substantial lung entrapment, the outpatient administration of talc through an indwelling pleural catheter for the treatment of malignant pleural effusion resulted in a significantly higher chance of pleurodesis at 35 days than an indwelling catheter alone, with no deleterious effects.”
The study was funded by Becton Dickinson.
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