Table 1.
Demographic and clinical characteristics at baseline.
| Characteristics | ITT (n = 141) | A (n = 4) | B (n = 20) | C (n = 46) | D (n = 10) | E (n = 46) | F (n = 6) | G (n = 9) |
|---|---|---|---|---|---|---|---|---|
| Age at enrollment, median (range), year | ||||||||
| 50 (23–74) | 59.5 (54–65) | 54 (33–74) | 50.5 (29–71) | 46 (29–56) | 49 (28–66) | 47 (34–58) | 51 (23–65) | |
| ECOG performance statusa, No. of patients (%) | ||||||||
| 0 | 5 (3.5) | 0 | 0 | 4 (8.7) | 0 | 1 (2.2) | 0 | 0 |
| 1 | 120 (85.1) | 4 (100.0) | 19 (95.0) | 39 (84.8) | 8 (80.0) | 38 (82.6) | 4 (66.7) | 8 (88.9) |
| 2 | 16 (11.3) | 0 | 1 (5.0) | 3 (6.5) | 2 (20.0) | 7 (15.2) | 2 (33.3) | 1 (11.1) |
| No. of previous therapies for metastatic disease, median (IQR) | ||||||||
| 3 (2–4) | 4.5 (4–5) | 3 (2–4) | 3 (2–3) | 3 (3–4) | 3 (2–3) | 2.5 (2–3) | 3 (2–3) | |
| Previous chemotherapy exposure, No. of patients (%) | ||||||||
| Taxane | 140 (99.3) | 4 (100.0) | 20 (100.0) | 46 (100.0) | 9 (90.0) | 46 (100.0) | 6 (100.0) | 9 (100.0) |
| Anthracycline | 131 (92.9) | 4 (100.0) | 18 (90.0) | 44 (95.7) | 9 (90.0) | 44 (95.7) | 5 (83.3) | 7 (77.8) |
| Platinum | 132 (93.6) | 4 (100.0) | 19 (95.0) | 40 (87.0) | 10 (100.0) | 44 (95.7) | 6 (100.0) | 9 (100.0) |
| Gemcitabine | 99 (70.2) | 3 (75.0) | 16 (80.0) | 30 (65.2) | 6 (60.0) | 34 (73.9) | 5 (83.3) | 5 (55.6) |
| Capecitabine | 124 (87.9) | 4 (100.0) | 19 (95.0) | 37 (80.4) | 8 (80.0) | 41 (89.1) | 6 (100.0) | 9 (100.0) |
| Vinorelbine | 114 (80.9) | 3 (75.0) | 16 (80.0) | 35 (76.1) | 9 (90.0) | 39 (84.8) | 6 (100.0) | 6 (66.7) |
| No. of metastases, No. of patients (%) | ||||||||
| 1 | 21 (14.9) | 0 | 7 (35.0) | 5 (10.9) | 1 (10.0) | 5 (10.9) | 2 (33.3) | 1 (11.1) |
| 2 | 49 (34.8) | 2 (50.0) | 4 (20.0) | 19 (41.3) | 2 (20.0) | 16 (34.8) | 2 (33.3) | 4 (44.4) |
| ≥ 3 | 71 (50.4) | 2 (50.0) | 9 (45.0) | 22 (47.8) | 7 (70.0) | 25 (54.3) | 2 (33.3) | 4 (44.4) |
| Location of metastases, No. of patients (%) | ||||||||
| Lymph nodes | 96 (68.1) | 2 (50.0) | 6 (30.0) | 35 (76.1) | 8 (80.0) | 35 (76.1) | 5 (83.3) | 5 (55.6) |
| Lung | 69 (48.9) | 2 (50.0) | 8 (40.0) | 19 (41.3) | 5 (50.0) | 29 (63.0) | 2 (33.3) | 4 (44.4) |
| Liver | 43 (30.5) | 2 (50.0) | 12 (60.0) | 11 (23.9) | 3 (30.0) | 10 (21.7) | 1 (16.7) | 4 (44.4) |
| Bone | 69 (48.9) | 3 (75.0) | 8 (40.0) | 21 (45.7) | 5 (50.0) | 25 (54.3) | 3 (50.0) | 4 (44.4) |
| Chest wall | 51 (36.2) | 1 (25.0) | 7 (35.0) | 15 (32.6) | 5 (50.0) | 20 (43.5) | 1 (16.7) | 2 (22.2) |
| Breast | 32 (22.7) | 1 (25.0) | 4 (20.0) | 12 (26.1) | 4 (40.0) | 7 (15.2) | 1 (16.7) | 3 (33.3) |
| Others | 30 (21.3) | 0 | 5 (25.0) | 11 (23.9) | 4 (40.0) | 8 (17.4) | 2 (33.3) | 0 |
| Duration of first-line therapy, No. of patients (%) | ||||||||
| < 3 months | 48 (34.0) | 1 (25.0) | 6 (30.0) | 14 (30.4) | 2 (20.0) | 19 (41.3) | 2 (33.3) | 4 (44.4) |
| 3–6 months | 42 (29.8) | 2 (50.0) | 6 (30.0) | 13 (28.3) | 4 (40.0) | 16 (34.8) | 1 (16.7) | 0 |
| > 6 months | 35 (24.8) | 1 (25.0) | 3 (15.0) | 14 (30.4) | 2 (20.0) | 8 (17.4) | 2 (33.3) | 5 (55.6) |
| Unknown | 16 (11.3) | 0 | 5 (25.0) | 5 (10.9) | 2 (20.0) | 3 (6.5) | 1 (16.7) | 0 |
| Disease-free intervalb, No. of patients (%) | ||||||||
| < 6 months | 53 (37.6) | 2 (50.0) | 5 (25.0) | 15 (32.6) | 3 (30.0) | 24 (52.2) | 3 (50.0) | 1 (11.1) |
| 6–12 months | 17 (12.1) | 1 (25.0) | 5 (25.0) | 5 (10.9) | 0 | 5 (10.9) | 1 (16.7) | 0 |
| > 12 months | 47 (33.3) | 1 (25.0) | 7 (35.0) | 16 (34.8) | 3 (30.0) | 14 (30.4) | 2 (33.3) | 4 (44.4) |
| Initially diagnosed as stage IV | 24 (17.0) | 0 | 3 (15.0) | 10 (21.7) | 4 (40.0) | 3 (6.5) | 0 | 4 (44.4) |
ITT Intention-to-treat, ECOG Eastern Cooperative Oncology Group, IQR interquartile range.
aScores on the ECOG scale range from 0 (no disability) to 5 (death).
bInterval between the time of metastasis or relapse and the last dose of adjuvant chemotherapy or surgery (for neoadjuvant chemotherapy cases without adjuvant chemotherapy).