Table 1.
Baseline characteristics
| Immediate radiotherapy (n=102) | Deferred radiotherapy (n=101) | ||
|---|---|---|---|
| Sex | |||
| Male | 91 (89%) | 90 (89%) | |
| Female | 11 (11%) | 11 (11%) | |
| Age (years) | 70 (66–76) | 70 (66–77) | |
| Time from diagnosis to randomisation (days) | 21 (14–25) | 20 (13–27) | |
| Mean time from pleural intervention to randomisation (days) | 22·8 (7·7) | 22·2 (8·1) | |
| WHO performance score | |||
| 0 | 29 (28%) | 34 (34%) | |
| 1 | 61 (60%) | 53 (52%) | |
| 2 | 9 (9%) | 11 (11%) | |
| 3 | 3 (3%) | 3 (3%) | |
| Karnofsky performance score | 90 (80–90)* | 80 (80–90) | |
| Body-mass index | 26·2 (4·3)† | 26·5 (3·3)† | |
| Extrathoracic spread on imaging | |||
| Yes | 4 (4%) | 2 (2%) | |
| No | 81 (79%) | 80 (79%) | |
| Unknown | 17 (17%) | 19 (19%) | |
| Histological subtype | |||
| Epithelioid only | 71 (70%) | 71 (70%) | |
| Sarcomatoid | 8 (8%) | 8 (8%) | |
| Biphasic (mixed) | 19 (19%) | 18 (18%) | |
| Desmoplastic | 4 (4%) | 0 | |
| Other | 0 | 4 (4%) | |
| Basis for diagnosis | |||
| Pleural fluid cytology | 0 | 3 (3%) | |
| Pleural biopsy | 102 (100%) | 98 (97%) | |
| Side of disease | |||
| Left | 32 (31%) | 40 (40%) | |
| Right | 69 (68%) | 61 (60%) | |
| Bilateral | 1 (1%) | 0 | |
| Smoking status | |||
| Current | 6 (6%) | 7 (7%) | |
| Former | 59 (58%) | 54 (53%) | |
| Never | 37 (36%) | 40 (40%) | |
| Comorbidities | |||
| Respiratory disease | 5 (5%) | 11 (11%) | |
| Cardiac disease | 9 (9%) | 12 (12%) | |
| Chronic renal failure | 3 (3%) | 3 (3%) | |
| Diabetes | 15 (15%) | 14 (14%) | |
| Steroid use | 6 (6%) | 5 (5%) | |
| Symptomatic pleural effusion at presentation | 91 (89%) | 90 (89%) | |
| Chest pain at presentation | 36 (35%) | 37 (37%) | |
| Previous pleurodesis | 54 (53%) | 68 (67%) | |
| Type of pleural intervention | |||
| Large-bore chest drain insertion | 1 (1%) | 2 (2%) | |
| Local anaesthetic thoracoscopy | 38 (37%) | 36 (36%) | |
| Thoracotomy | 3 (3%) | 6 (6%) | |
| Video-assisted thoracoscopic surgery | 45 (44%) | 46 (46%) | |
| Indwelling pleural catheter insertion | 14 (14%) | 11 (11%) | |
| Other | 1 (1%)‡ | 0 | |
| Number of pleural puncture sites | |||
| 1 | 69 (68%) | 68 (67%) | |
| 2 | 27 (26%) | 26 (26%) | |
| ≥3 | 6 (6%) | 6 (6%) | |
| Unknown | 0 | 1 (1%) | |
| Previous chemotherapy received for mesothelioma | 3 (3%) | 6 (6%) | |
| Previous radiotherapy received for mesothelioma | 1 (1%) | 2 (2%) | |
| Oral morphine-equivalent dose (mg) | 0 (0–0) | 0 (0–0) | |
| Quality of life§ | |||
| QLQ-C30 global health status subscale | 66·7 (50·0–83·3), n=98 | 66·7 (50·0–83·3), n=96 | |
| QLQ-C30 physical functioning subscale | 80·0 (53·3–93·3), n=98 | 76·7 (60·0–86·7), n=96 | |
| QLQ-C30 pain subscale | 16·7 (0·0–33·3), n=98 | 16·7 (0·0–33·3), n=97 | |
| EQ-5D utility score | 0·79 (0·69–0·85), n=100 | 0·78 (0·62–0·85), n=98 | |
| Chest pain (visual analogue scale scores)¶ | |||
| On average how much chest pain have you felt today? | 5·0 (0·0–17·0) | 4·0 (0·5–18·5) | |
| How much has chest pain bothered you today? | 3·3 (0·0–13·7) | 3·0 (0·0–14·8) | |
| On average how much pain have you felt today from the site of your previous chest wall procedure? | 3·0 (0·0–10·0) | 2·8 (0·5–15·8) | |
| How much has pain from the site of your previous chest wall procedure bothered you today? | 1·5 (0·0–8·0) | 3·0 (0·5–15·0) | |
Data are n (%), median (IQR), or mean (SD). QLQ-C30=European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire—Core 30. EQ-5D=EuroQoL-5D.
n=101; one patient had missing data for Karnofsky performance score at baseline.
n=98 in the immediate radiotherapy group and n=97 in the delayed radiotherapy group because the data were not recorded at baseline for the remaining patients.
CT-guided biopsy; this patient was randomised in error.
Quality-of-life scores were derived from two separate questionnaries (QLQ-C30 and EQ-5D), and not all patients completed both at baseline; not all patients completed individual questions necessary to calculate a certain QLQ-C30 subscale.
n=97 in the delayed radiotherapy group because the remaining patients did not complete baseline visual analogue scale scores.