Randomized Trial of Pleural Fluid Drainage Frequency in Patients with Malignant Pleural Effusions. The ASAP Trial

Background Malignant pleural effusions (MPE) are a frequent cause of dyspnea and discomfort at the end of cancer patients' lives. The tunneled indwelling pleural catheter (TIPC) was approved by the FDA in 1997 and has been investigated as a treatment for MPE. Objective To systematically review published data on the efficacy and safety of the TIPC for treatment of MPE. Design We searched the MEDLINE, EMBASE, and ISI Web of Science databases to identify studies published through October 2009 that reported outcomes in adult patients with MPE treated with a TIPC. Data were aggregated using summary statistics when outcomes were described in the same way among multiple primary studies. Main Measures Symptomatic improvement and complications associated with use of the TIPC. Key Results Nineteen studies with a total of 1,370 patients met criteria for inclusion in the review. Only one randomized study directly compared the TIPC with the current gold standard treatment, pleurodesis. All other studies were case series. Symptomatic improvement was reported in 628/657 patients (95.6%). Quality of life measurements were infrequently reported. Spontaneous pleurodesis occurred in 430/943 patients (45.6%). Serious complications were rare and included empyema in 33/1168 patients (2.8%), pneumothorax requiring a chest tube in 3/51 (5.9%), and unspecified pneumothorax in 17/439 (3.9%). Minor complications included cellulitis in 32/935 (3.4%), obstruction/clogging in 33/895 (3.7%) and unspecified malfunction of the catheter in 11/121 (9.1%). The use of the TIPC was without complication in 517/591 patients (87.5%). Conclusions Based on low-quality evidence in the form of case series, the TIPC may improve symptoms for patients with MPE and does not appear to be associated with major complications. Prospective randomized studies comparing the TIPC to pleurodesis are needed before the TIPC can be definitively recommended as a first-line treatment of MPE.

Malignant pleural effusions (MPEs) are a common cause of dyspnea in patients with advanced cancer. Tunnelled pleural catheters (TPCs) can be used in patients with this condition, but the published experience with them is limited. To describe the use of TPCs in the management of MPE in a large group of patients in a clinical setting. Retrospective analysis of 250 sequential TPC insertions in patients with MPEs in a single center. Two hundred fifty TPC procedures for MPE were performed in 223 patients (19 contralateral procedures and 8 repeat ipsilateral procedures) during a 3-year period. Symptom control was complete following 97 procedures (38.8%), was partial in 125 procedures (50%), and was absent in 9 procedures (3.6%); in addition, there were 10 failed TPC insertions (4.0%) and 9 TPC insertions (3.6%) without assessment of symptoms at the 2-week follow-up visit. Spontaneous pleurodesis occurred following 103 of the 240 successful TPC procedures (42.9%) and was more frequent when < or = 20% of the hemithorax contained fluid at the 2-week follow-up visit (57.2% vs 25.3%, respectively; p < 0.001). Catheters stayed in place for a median duration of 56 days. Following successful TPC placement, no further ipsilateral pleural procedures were required in 90.1% of cases. The overall median survival time following TPC insertion was 144 days. Complication rates were low and compared favorably with those seen with other treatment options. TPC placement is an effective method of palliation for MPE that allows outpatient management and low complication rates. The insertion of a TPC should be considered as a first-line treatment option in the management of patients with MPE.

The purpose of this study was to compare the effectiveness and safety of a chronic indwelling pleural catheter with doxycycline pleurodesis via tube thoracostomy in the treatment of patients with recurrent symptomatic malignant pleural effusions (MPE). In this multi-institutional study conducted between March 1994 and February 1997, 144 patients (61 men and 83 women) were randomized in a 2:1 distribution to either an indwelling pleural catheter or doxycycline pleurodesis. Patients receiving the indwelling catheter drained their effusions via vacuum bottles every other day or as needed for relief of dyspnea. The median hospitalization time was 1.0 day for the catheter group and 6.5 days for the doxycycline group. The degree of symptomatic improvement in dyspnea and the quality of life was comparable in each group. Six of 28 patients who received doxycycline (21%) had a late recurrence of pleural effusion, whereas 12 of 91 patients who had an indwelling catheter (13%) had a late recurrence of their effusions or a blockage of their catheter after the initially successful treatment (P = 0.446). Of the 91 patients sent home with the pleural catheter, 42 (46%) achieved spontaneous pleurodesis at a median of 26.5 days. A chronic indwelling pleural catheter is an effective treatment for the management of patients with symptomatic, recurrent, malignant pleural effusions. When compared with doxycycline pleurodesis via tube thoracostomy, the pleural catheter requires a shorter hospitalization and can be placed and managed on an outpatient basis. Copyright 1999 American Cancer Society.