Table 1.
Baseline characteristics of randomized participants
| Placebo (n = 16) | Simvastatin (n = 16) | |
|---|---|---|
| Age at randomization (years)* | 62·7(12·3) | 66·6(8·7) |
| Time from diagnosis to randomization (days)* | 153·4(31·8) | 155(40·8) |
| Time from randomization to receiving trial medication (days) | 0 (0–1) | 0 (0–0) |
| Sex ratio (M : F) | 13 : 3 | 12 : 4 |
| Smoking status | ||
| Current smoker | 1 | 2 |
| Ex‐smoker | 10 | 11 |
| Never smoked | 5 | 3 |
| BMI (kg/m2)* | 26·2(4·1) | 26·6(4·7) |
| Co‐morbid condition | ||
| Cardiovascular | 0 | 1 |
| Diabetes | 0 | 0 |
| Charlson co‐morbidity index† | ||
| 0 | 15 | 14 |
| 1 | 1 | 2 |
| Perioperative aspirin use | 0 | 0 |
| ECOG performance status | ||
| 0 | 16 | 13 |
| 1 | 0 | 2 |
| 2 | 0 | 1 |
| LDL cholesterol (mmol/l)* | 3·51(0·89) | 3·73(0·92) |
| Tumour site | ||
| Oesophagus | 7 | 5 |
| Siewert I | 2 | 4 |
| Siewert II | 7 | 7 |
| Tumour grade | ||
| Gx | 2 | 1 |
| G1 | 0 | 0 |
| G2 | 5 | 8 |
| G3 | 9 | 6 |
| G4 | 0 | 1 |
| cT category | ||
| 2 | 0 | 1 |
| 3 | 16 | 12 |
| 4 | 0 | 1 |
| 4a | 0 | 2 |
| cN category | ||
| 0 | 2 | 5 |
| 1 | 9 | 6 |
| 2 | 4 | 4 |
| 3 | 1 | 1 |
| Neoadjuvant chemotherapy | ||
| Yes | 15 | 15 |
| No | 1 | 1 |
| Preoperative radiotherapy | ||
| Yes | 0 | 1 |
| No | 16 | 15 |
| Oesophagectomy | ||
| Open | 4 | 2 |
| Hybrid | 9 | 10 |
| Minimally invasive | 3 | 4 |
| Lymph node yield | 26 (19–42) | 22 (25–35) |
| Positive lymph nodes | 1·5 (0–4·5) | 1 (0–3) |
| Vascular invasion | ||
| Yes | 9 | 5 |
| No | 7 | 11 |
| Margin status | ||
| R1 | 4 | 3 |
| R0 | 12 | 13 |
| Postoperative length of stay (days) | 10 (6–13) | 9 (6–12) |
| Any postoperative in‐hospital complication | 7 | 6 |
| Global quality‐of‐life score*, ‡ | 68(20) | 73(10) |
Values in parentheses are interquartile ranges unless indicated otherwise;
*
values are mean(s.d.).
†
Modified Charlson co‐morbidity index (excludes solid tumours).
‡
A high score suggests a high level of functioning. ECOG, Eastern Cooperative Oncology Group; LDL, low‐density lipoprotein.