Table 3.
Tumor response (confirmed best overall response) and clinical benefit by genetic phenotype (n=48)*
Response | Germline BRCA1or BRCA2 mutation positive, n=14 |
Germline BRCA1and BRCA2 wild-type n=26 |
Unknown mutation status n=8 |
Total, n=48* |
---|---|---|---|---|
Best overall response, n(%) | ||||
Complete response (CR) | 1 (7%) | 1 (4%) | -- | 2 (4%) |
Partial response (PR) | 7 (50%) | 7 (27%) | 1(12%) | 15 (31%) |
Stable disease (SD) | 5 (36%) | 12 (46%) | 4 (50%) | 21 (44%) |
Progressive disease (PD)** | 1 (7%) | 6 (23%) | 3 (38%) | 10 (21%) |
Clinical benefit (PFS6) rate, n(%) | 10 (71%) | 8/27* (30%) | 2 (25%) | 20/49 (41%) |
excludes one patient who withdrew after C1D1 for insurance reasons (unknown mutation status) and one (from response but not PFS6) who withdrew after 2 cycles to avoid study travel and died within 6 months of enrollment (BRCA 1/2 wild-type).
includes as PD 2 patients who withdrew consent due to anxiety about disease (BRCA1 mutation positive, unknown mutation status); 2 patients who withdrew early in C1 for worsening disease (BRCA 1/2 wild type), and 2 patients with dose-limiting toxicities (unknown mutation status)
PFS6 = disease progression >6 months after starting study therapy