Table 1.
Baseline demographic and characteristics of patients in the ITT population
| Benmelstobart + anlotinib + EC group (N = 246) | Anlotinib + EC group (N = 245) | EC alone group (N = 247) | |
|---|---|---|---|
| Age, years | |||
| Median (range) | 62.0 (36–75) | 60.0 (32–75) | 63.0 (30–75) |
| <65 years, n (%) | 150 (61.0) | 160 (65.3) | 147 (59.5) |
| ≥65 years, n (%) | 96 (39.0) | 85 (34.7) | 100 (40.5) |
| Sex, n (%) | |||
| Male | 209 (85.0) | 204 (83.3) | 207 (83.8) |
| Female | 37 (15.0) | 41 (16.7) | 40 (16.2) |
| ECOG performance status, n (%) | |||
| 0 | 47 (19.1) | 47 (19.2) | 48 (19.4) |
| 1 | 199 (80.9) | 198 (80.8) | 199 (80.6) |
| Smoking status, n (%) | |||
| Never | 59 (24.0) | 59 (24.1) | 54 (21.9) |
| Former | 154 (62.6) | 148 (60.4) | 158 (64.0) |
| Current | 33 (13.4) | 38 (15.5) | 35 (14.2) |
| Clinical stagea, n (%) | |||
| Limited stage | 1 (0.4) | 3 (1.2) | 7 (2.8) |
| ES | 245 (99.6) | 242 (98.8) | 240 (97.2) |
| Disease stageb, n (%) | |||
| Stage II | – | – | 1 (0.04%)c |
| Stage III | 30 (12.2) | 26 (10.6) | 21 (8.5) |
| Stage IV | 216 (87.8) | 219 (89.4) | 225 (91.1) |
| Brain metastasesd, n (%) | 25 (10.2) | 22 (9.0) | 26 (10.5) |
| Liver metastasesd, n (%) | 79 (32.1) | 78 (31.8) | 79 (32.0) |
| Bone metastasesd, n (%) | 69 (28.0) | 74 (30.2) | 69 (27.9) |
| Previous therapye, n (%) | |||
| Surgery | 2 (0.8) | 5 (2.0) | 6 (2.4) |
| Chemotherapy | 2 (0.8) | 3 (1.2) | 7 (2.8) |
| Radiotherapy | 4 (1.6) | 5 (2.0) | 6 (2.4) |
| Traditional Chinese medicine | 9 (3.7) | 10 (4.1) | 14 (5.7) |
Data are median (range) or n (%).
aClinical stage was classified according to Veterans Administration Lung Study Group (VALG) criteria at first diagnosis.
bDisease stage was classified according to the American Joint Committee on Cancer (AJCC) 8th edition
cThe tumor lesions of this stage II patient include the primary tumor in the right lung (tumor >3 cm but ≤4 cm in greatest dimension), regional lymph node metastasis in the ipsilateral hilar and inferior lobe, which cannot be delineated in a target area of radiation therapy and determined as ES-SCLC (assessed by IRC and investigator).
dMetastatic lesions were categorized on the basis of their presence or absence. Any patient with liver metastasis, regardless of whether it was the sole metastatic site or coexisting with other metastases, was included in the liver metastasis group for analysis.
e‘Previous therapy’ refers to the treatment previously for limited-stage SCLC.