Table 2.
Efficacy results by BRCA status
| Variable | BRCA pathogenic variants (n = 15) |
BRCA wild type (n = 53) |
BRCA untested (n = 15) |
Pa | All patients (N = 83) |
|---|---|---|---|---|---|
| Response n (%)b | |||||
| Overall | 4 (26.7) | 22 (41.5) | 5 (33.3) | 0.375 | 31 (37.3) |
| Complete | 0 | 1 (1.9) | 1 (6.7) | 2 (2.4) | |
| Partial | 4 (26.7) | 21 (39.6) | 4 (26.7) | 29 (34.9) | |
| Nonec | 11 (73.3) | 31 (58.5) | 10 (66.6) | 52 (62.7) | |
| Clinical benefit rated | 4 (26.7) | 30 (57.7) | 6 (40) | 0.043 | 40 (48.8) |
| Response duratione months | |||||
| Median | 2.4 | 6.6 | 5.1 | 0.008 | 6.1 |
| 95% CI | 2.0-6.1 | 4.1-8.4 | 2.0-7.1 | 4.1-7.2 | |
| Progression-free survival months | |||||
| Median | 2.6 | 6.4 | 5.1 | <0.001 | 5.1 |
| 95% CI | 2.0-4.5 | 4.4-9.3 | 2.4-6.9 | 4.1-6.9 | |
| Overall survival months | |||||
| Median | 9.6 | 17.9 | 13.0 | 0.020 | 14.5 |
| 95% CI | 2.6-11.3 | 11.1-21.5 | 4.6-20.1 | 10.1-19.8 | |
CI, confidence interval; n/N, number.
a
Fisher's exact test or log-rank test for the comparison between BRCA-mutated and wild-type patients.
b
First stage results of 37 patients: overall response: 16/37 (43.2%), complete response: 0, partial response: 16/37; no response: 21/37 (56.8%).
c
No response was defined as stable, progressive, or non-assessed disease.
d
One BRCA wild-type patient was not evaluable for clinical benefit rate because they were not assessed for short (<6 months) versus long (≥6 months) stable disease duration.
e
Response duration was defined as the time from documentation of tumor response to disease progression.