Table 1.
Baseline characteristics
| Erlotinib (N=350) | Placebo (N=320) | ||
|---|---|---|---|
| Age at randomisation | |||
| Median (years) | 77 (72–82) | 77 (72–81) | |
| ≥75 years | 220 (63%) | 203 (63%) | |
| Sex | |||
| Men | 215 (61%) | 194 (61%) | |
| Women | 135 (39%) | 126 (39%) | |
| ECOG performance status | |||
| 0–1 | 54 (15%)* | 52 (16%)* | |
| 2 | 194 (55%) | 178 (56%) | |
| 3 | 102 (29%) | 90 (28%) | |
| Stage | |||
| IIIb | 127 (36%) | 107 (33%) | |
| IV | 223 (64%) | 213 (67%) | |
| Cell type | |||
| Adenocarcinoma | 133 (38%) | 123 (38%) | |
| Squamous | 136 (39%) | 127 (40%) | |
| Large cell | 15 (4%) | 15 (5%) | |
| Other | 66 (19%) | 55 (17%) | |
| Ethnic origin | |||
| White | 336 (96%) | 314 (98%) | |
| Asian | 7 (2%) | 3 (1%) | |
| Other | 7 (2%) | 3 (1%) | |
| Smoking status | |||
| Smoker | 124 (35%) | 119 (37%) | |
| Ex-smoker | 207 (59%) | 183 (57%) | |
| Never smoked | 19 (5%) | 18 (6%) | |
| Median pack-years (current or ex-smoker)† | 40 (24–60) | 38 (21–55) | |
| Total CCI‡ | |||
| Median | 4·0 (3–5) | 4·0 (3–5) | |
| 0 | 3 (1%) | 1 (<1%) | |
| 1 | 4 (1%) | 6 (2%) | |
| 2 | 17 (5%) | 18 (6%) | |
| 3 | 72 (21%) | 70 (22%) | |
| ≥4 | 241 (69%) | 219 (68%) | |
| Unknown | 13 (4%) | 6 (2%) | |
Data are n (%) or median (IQR). ECOG=Eastern Cooperative Oncology Group. CCI=Charlson comorbidity index.
*
All patients with a performance score of 0–1 had comorbidities, ie, 92% (98 of 106) had CCI scores of ≥3, 95% (101 of 106) had creatinine clearance <60 mL/min, and a median age of 81 years with 81% (86 of 106) aged >75 years old. Characteristics were well balanced between groups.
†
One pack-year is defined as 20 cigarettes (one pack) smoked per day for one year.
‡
The CCI is measured on a 0 to 37 scale: 0 means no comorbidities whereas a high score suggests patients have more severe comorbidities. Patients with a score ≥4 are deemed to have serious comorbidity.