Table 2. Analysis of tumor response and survival according to the continuation or not of trastuzumab from the second-line of chemotherapy.
Overall Population N = 104 | Second-line therapy without trastuzumab N = 65 | Second-line therapy with trastuzumab N = 39 | P-value | |
---|---|---|---|---|
Tumor response | ||||
Complete response | 3 (2.9%) | 1 (1.5%) | 2 (5.1%) | |
Partial response | 6 (5.7%) | 2 (3.1%) | 4 (10.3%) | |
Stable disease | 24 (23.1%) | 12 (18.5%) | 12 (30.8%) | |
Progression disease | 58 (55.8%) | 40 (61.5%) | 18 (46.1%) | |
Not evaluable | 13 (12.5%) | 10 (15.4%) | 3 (7.7%) | |
Objective response rate * | 9.9% | 5.4% | 16.7% | 0.08 |
Disease control rate * | 36.3% | 27.3% | 50.0% | 0.03 |
Median PFS, mo. (95% CI) | 2.7 (2.3-4.0) | 2.3 (2.0-3.0) | 4.4 (2.4-5.6) | 0.002 |
6-mo. PFS rate (95% CI) | 20.8% (13.5-29.3) | 13.5% (6.5-23.1) | 30.2% (16.2-45.4) | |
Median OS, mo. (95% CI) | 7.1 (5.5-9.4) | 6.1 (4.8-8.3) | 12.6 (5.5-18.5) | 0.001 |
1-yr OS rate (95% CI) | 29.1% (19.9-38.9) | 17.9% (9.3-28.8) | 48.4% (29.8-64.7) |
* Objective response rate and disease control rate were evaluated in patients who had measurable disease (n=91).
The P values for comparison of objective response and disease control rates were assessed using the Chi2 test.
The P value for the comparison of time to event endpoints was assessed using the log-rank test.
Abbreviations: mo., months; yr, year