Table 5 Overall response rate assessment for effectiveness analysis set.
Groups | CR, n (%) | PR, n (%) | PD, n (%) | SD, n (%) | Non-CR/non-PD, n (%) | NE, n (%) | ORR (CR + PR) (95% CI) |
|---|---|---|---|---|---|---|---|
Total (n = 64) | 1 (1.56) | 42 (65.63) | 4 (6.25) | 15 (23.44) | 1 (1.56) | 1 (1.56) | 67.19% (54.31-78.41%) |
ECOG performance status | |||||||
0-2 (n = 62) | 1 (1.61) | 41 (66.13) | 4 (6.45) | 14 (22.58) | 1 (1.61) | 1 (1.61) | 67.74% (54.66-79.06%) |
≥ 3 (n = 2) | 0 | 1 (50.00) | 0 | 1 (50.00) | 0 | 0 | 50.00% (1.26-98.74%) |
Number of lines of therapy used before the start of treatment with DAB/TRA | |||||||
0 (n = 18) | 1 (5.56) | 13 (72.22) | 2 (11.11) | 2 (11.11) | 0 | 0 | 77.78% (52.36-93.59%) |
≥ 1 (n = 45) | 0 | 28 (62.22) | 2 (4.44) | 13 (28.89) | 1 (2.22) | 1 (2.22) | 62.22% (46.54-76.23%) |
Unknown/not specified (n = 1) | 0 | 1 (100.00) | 0 | 0 | 0 | 0 | 100.00% (2.50-100.00%) |
Elderly | |||||||
< 65 years (n = 17) | 0 | 12 (70.59) | 0 | 4 (23.53) | 0 | 1 (5.88) | 70.59% (44.04-89.69%) |
≥ 65 years (n = 47) | 1 (2.13) | 30 (63.83) | 4 (8.51) | 11 (23.40) | 1 (2.13) | 0 | 65.96% (50.69-79.14%) |
Late elderly | |||||||
< 75 years (n = 50) | 0 | 31 (62.00) | 3 (6.00) | 14 (28.00) | 1 (2.00) | 1 (2.00) | 62.00% (47.17-75.35%) |
≥ 75 years (n = 14) | 1 (7.14) | 11 (78.57) | 1 (7.14) | 1 (7.14) | 0 | 0 | 85.71% (57.19-98.22%) |
Renal impairment | |||||||
Absence (n = 63) | 1 (1.59) | 41 (65.08) | 4 (6.35) | 15 (23.81) | 1 (1.59) | 1 (1.59) | 66.67% (53.66-78.05%) |
Presence (n = 1) | 0 | 1 (100.00) | 0 | 0 | 0 | 0 | 100.00% (2.50-100.00%) |
Cardiac disease | |||||||
Absence (n = 60) | 1 (1.67) | 38 (63.33) | 4 (6.67) | 15 (25.00) | 1 (1.67) | 1 (1.67) | 65.00% (51.60-76.87%) |
Presence (n = 4) | 0 | 4 (100.00) | 0 | 0 | 0 | 0 | 100.00% (39.76-100.00%) |
