SAN FRANCISCO – Indwelling pleural catheters did not provide greater relief of dyspnea, cause less chest pain, or improve quality of life compared with chest tube and talc pleurodesis in patients with symptomatic malignant pleural effusion, an unblinded, randomized study of 106 patients found.
Patients receiving indwelling pleural catheters (IPCs) had a shorter initial hospitalization (0 days vs. 4 days) but were five times more likely to develop adverse events, Najib M. Rahman, D.Phil., reported at an international conference of the American Thoracic Society.
Dr. Najib M. Rahman
The study was published online May 20, 2012 (JAMA 2012;307 [doi:10.1001/jama.2012.5535]). The lead investigator of the Second Therapeutic Intervention in Malignant Effusion Trial (TIME2) was Dr. Helen E. Davies of University Hospital of Wales, Cardiff.
The patients from seven UK centers had undergone no prior pleurodesis. In the IPC group, outpatients had the IPC inserted, had a large volume drained, and were educated to do subsequent drainage at home. In the talc group, patients were admitted for chest tube insertion and talc for slurry pleurodesis. All patients were asked to assess their dyspnea daily at the same time each day using a 100-mm visual analog scale (VAS), with 0 mm indicating no dyspnea and 100 mm representing maximum dyspnea.
Dyspnea improved in both groups. Overall, mean VAS scores decreased by 37 mm from baseline with IPC and by 30 mm with talc, which was not significantly different. Dyspnea scores did not differ significantly between groups in the first 42 days, the primary outcome measured. At 6 months, however, there was a statistically significantly greater improvement in dyspnea in the IPC group, with a mean 14-mm lower score than the talc group.
"IPC may be better than talc at 6 months" of follow-up, said Dr. Rahman of the University of Oxford (England).
In the talc group, 22% of patients required further pleural procedures, compared with 6% in the IPC group, a significant difference. Five patients in the IPC group developed pleural infection, compared with one patient in the talc group.
"A lot of chest physicians think talc pleurodesis is more painful, but it turns out that IPC is painful too," he said. Scores for chest pain and for quality of life did not differ significantly between groups.
The study was not powered to assess mortality risk, but no significant differences were seen between groups out to 12 months of follow-up.
"We must not conclude that IPCs and talc are the same" or equivalent, Dr. Rahman said. The investigators are assessing the cost implications of the results, including costs for procedures and complications after the initial treatment.
The results should be interpreted with caution because the study was powered to assess superiority, not equivalence between treatments, Dr. Nick A. Maskell said in an editorial in the same issue (JAMA 2012;307 [doi:10.1001/jama.2012.5543]).
Clinicians for years have debated the best management of malignant pleural effusions. Talc is recommended as first-line treatment of symptomatic patients by international guidelines, said Dr. Maskell of the University of Bristol (England).
Based on the TIME2 study findings, physicians should feel comfortable discussing the advantages and disadvantages of both treatments with patients to help them pick the strategy that best suits them, he said.
Combining the best of both strategies may be the way of the future, Dr. Maskell added. Some preliminary studies suggest it may be feasible and beneficial to deliver pleurodesis agents via an IPC in the outpatient setting.
The only other randomized controlled trial comparing IPCs with pleurodesis for malignant pleural effusion used doxycycline, which is not as effective as talc, and found similar improvements in dyspnea and quality of life between groups, he said (Cancer 1999;86:1992-9).
The study was funded by the British Lung Foundation and the Robert Luff Foundation. Dr. Rahman reported being a consultant to Rocket Medical, which supplied the IPCs and drainage bottles for the trial. Some of his associates reported financial associations with Boehringer Ingelheim, Medico, AstraZeneca, GlaxoSmithKline, Chiese, CareFusion, Sequana Medical, Merck, and Gilead. Dr. Maskell disclosed receiving honoraria and grants from Carefusion.