Table 1. Baseline Demographic Data for 146 Randomized Patients With Malignant Pleural Effusion.
| Characteristic | Indwelling Pleural Catheter (n = 74) |
Talc Pleurodesis (n = 72) |
|---|---|---|
| Age, median (range), y | 71.0 (38-92) | 70.5 (43-90) |
| Male, No. (%) | 39 (53) | 43 (60) |
| Side of intervention: right, No. (%)a | 44 (59) | 38 (53) |
| Type of primary malignancy, No. (%) | ||
| Mesothelioma | 20 (27) | 18 (25) |
| Nonmesothelioma | ||
| Lung | 19 (26) | 29 (40) |
| Breast | 14 (19) | 4 (6) |
| Others | 21 (28) | 21 (29) |
| Known trapped lung, before randomization, No. (%)b | 2 (3) | 3 (4) |
| ECOG score, No. (%)c | ||
| 0-2 | 53 (72) | 53 (74) |
| 3-4 | 19 (26) | 14 (19) |
| Unknown | 2 (3) | 5 (17) |
| Effusion size grade, No. (%)d | ||
| Small (0-1) | 0 | 0 |
| Moderate (2-3) | 38 (51) | 38 (53) |
| Large (4-5) | 36 (49) | 34 (47) |
| VAS dyspnea score, mean (SD), mme | 48.4 (27.0) | 50.2 (26.0) |
| VAS QoL score, mean (SD), mmf | 51.6 (26.1) | 55.9 (25.1) |
| EQ5D QoL score, mean (SD)g | 31.3 (10.5) | 32.6 (9.7) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; EQ5D, EuroQol 5 Dimensions; QoL, quality-of-life; VAS, visual analog scale.
Patients subsequently requiring contralateral procedures were treated according to the treating clinician and complications were reported in the trial only if they occurred on the trial intervention side and/or were attributable to the trial intervention.
Defined as incomplete ipsilateral lung expansion on imaging after pleural drainage.
ECOG performance status score runs from 0 to 5, where 0 is fully active, 1 is restricted in physical strenuous activity, 2 is unable to carry out any work activities, 3 is only able to carry out limited self-care activities, 4 is completely disabled, and 5 is dead.
Baseline effusion size was graded on chest radiograph immediately prior to trial intervention, using a validated grading system whereby grade 0 referred to no radiographic evidence of pleural fluid; grade 1, blunting of the costophrenic angle; grade 2 to 5, fluid occupying less than 25%, 25% to 50%, 51% to 75%, and more than 75% of the hemithorax, respectively. This scale has previously been used to predict pleurodesis and indwelling pleural catheter use in patients with a malignant pleural effusion.
The VAS was a 100-mm line anchored with “no breathlessness” at 100 mm and “worst imaginable breathlessness” at 0 mm.
QoL was measured using a VAS; the VAS was a 100-mm line anchored with “best QoL” at 100 mm and “worst QoL” at 0 mm.
EQ5D QoL score consisted of 5 domains: mobility, self-care, usual activities, discomfort/pain, and anxiety/depression. Each domain was graded by the patient from 0 (worst imaginable) to 10 (best imaginable) and the total score out of a maximum 50 points was recorded.