Table 1. Baseline characteristics of the randomised patients.
| Placebo (n = 13) | Zoledronic Acid (n = 11) | |
|---|---|---|
| Male, n (%) | 11 (85) | 5 (45) |
| Age, mean (SD) | 72.6 (9.9) | 71.2 (8.3) |
| Side | ||
| Left, n (%) | 4 (31) | 4 (36) |
| Right, n (%) | 9 (69) | 6 (55) |
| Bilateral, n (%) | 0 | 1 (9) |
| Cell type | ||
| Mesothelioma, n (%) | 7 (54) | 7 (64) |
| Lung Cancer, n (%) | 3 (23) | 3 (27) |
| Other, n (%) | 3 (23) | 1 (9) |
| Presence of malignant pleural effusion, n (%) | 11 (85) | 8 (73) |
| Mode of diagnosis | ||
| Pleural biopsy, n (%) | 8 (62) | 7 (64) |
| Pleural fluid cytology, n (%) | 4 (31) | 3 (27) |
| Other, n (%) | 1 (8) | 1 (9) |
| Time from diagnosis to trial entry, days, median (IQR) | 180 (105–293) | 205 (48–241) |
| Previous chemotherapy | 6 (46) | 7 (64) |
| On steroids at trial entry, n (%) | 2 (15) | 1 (9) |
| Previous talc pleurodesis, n (%) | 4 (31) | 2 (18) |
| Previous thoracic surgery, n (%) | 1 (8) | 2 (18) |
| IPC in situ at trial entry, n (%) | 4 (31) | 2 (18) |
| Trapped lung, n (%) | 3 (23) | 2 (18) |
| Dental treatment required in study run-in period, n (%) | 3 (25) | 6 (55) |
| Imaging | ||
| DCE-MRI ‘area under the curve in the first 90s’ (iAUC), mean (SD) | 113.9 (49.9) | 128.1 (57.6) |
| Modified RECIST score, mean (SD) | 55.6 (30.3) | 63.9 (34.2) |
| Summed ultrasound effusion depth, mean (SD) | 8.6 (11.5) | 5.0 (5.8) |
| Blood tests | ||
| Serum WCC, mean (SD) | 11.3 (10.4) | 8.3 (3.2) |
| Haemoglobin, mean (SD) | 12.7 (1.7) | 12.7 (2.1) |
| Platelets, mean (SD) | 280 (102) | 345 (126) |
| Creatinine clearance, mean (SD) | 72.6 (17.1) | 81.6 (19.4) |
| Corrected calcium, mean (SD) | 2.4 (0.2) | 2.4 (0.1) |
| Phosphate, mean (SD) | 1.2 (0.2) | 1.1 (0.2) |
| Magnesium, mean (SD) | 0.79 (0.08) | 0.80 (0.06) |
| NLR, mean (SD) | 6.0 (6.6) | 4.0 (3.6) |
| Quality of life | ||
| EORTC QLQC30- global quality of life, mean (SD) | 67.4 (20.6) | 55.8 (11.8) |
| EORTC QLQC30- physical functioning score, mean (SD) | 72.8 (16.4) | 62.7 (19.7) |
| ESAS score, mean (SD) | 15.9 (7.7) | 24.1 (9.9) |
| Dyspnoea Scores | ||
| Dyspnoea VAS score (mm) | 22.9 (12.3) | 33.5 (15.2) |
| Bother about breathlessness VAS score | 23.0 (13.1) | 31.6 (14.6) |
| MRC dyspnoea score | 2.3 (1.1) | 3.1 (1.1) |
| EORTC QLQC30- dyspnoea score, mean (SD) | 27.8 (13.0) | 56.7 (22.5) |
SD = Standard Deviation; IPC = Indwelling pleural catheter; DCE-MRI = Dynamic Contrast Enhanced Magnetic Resonance Imaging; RECIST = Response evaluation criteria in solid tumours; WCC = white cell count; NLR = Neutrophil to Lymphocyte ratio; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; ESAS = Edmonton Symptom Assessment Scale; VAS = Visual Analogue Scale; MRC = Medical Research Council.