Table 1. Patient characteristics.
|
Olaparib dose cohort,
nc
(%) |
||||||||
|---|---|---|---|---|---|---|---|---|
| 50 mg bid 7 day (n=3) | 100 mg bid 7 day (n=3) | 100 mg bid 28 day (n=4) | 200 mg bid 7 day (n=3) | 200 mg bid 28 day (n=7) | 400 mg bid 7 day (n=12) | 400 mg bid 28 day (n=12) | Total (n=44) | |
|
Characteristic | ||||||||
| Median age (range), years |
48.0 (46–54) |
63.0 (53–71) |
62.5 (49–74) |
66.0 (59–68) |
55.0 (32–63) |
55.0 (37–71) |
52.0 (31–64) |
55.5 (31–74) |
|
Sex | ||||||||
| Female |
3 (100) |
3 (100) |
4 (100) |
2 (67) |
7 (100) |
11 (92) |
12 (100) |
42 (95) |
|
ECOG status | ||||||||
| 0 | 3 (100) | 3 (100) | 3 (75) | 2 (67) | 3 (43) | 8 (67) | 12 (100) | 34 (77) |
| 1 |
– |
– |
1 (25) |
1 (33) |
4 (57) |
4 (33) |
– |
10 (23) |
|
Prior chemotherapya | ||||||||
| Yes | 3 (100) | 3 (100) | 3 (75) | 3 (100) | 2 (29) | 11 (92) | 10 (83) | 35 (80) |
| No |
– |
– |
1 (25) |
– |
5 (71) |
1 (8) |
2 (17) |
9 (20) |
|
Primary tumour site | ||||||||
| Ovarian | 3 (100) | 2 (67) | 2 (50) | 2 (67) | 3 (43) | 8 (67) | 8 (67) | 28 (64) |
| Breast | – | 1 (33) | 1 (25) | – | 4 (57) | 3 (25) | 4 (33) | 13 (30) |
| SCLC | – | – | 1 (25) | – | – | – | – | 1 (2) |
| Prostate/colon | – | – | – | – | – | 1 (8) | – | 1 (2) |
| Unknown |
– |
– |
– |
1 (33) |
– |
– |
– |
1 (2) |
|
Evaluable patients | ||||||||
| DLT | 3 (100) | 3 (100) | 3 (75) | 3 (100) | 6 (86) | 12 (100) | 12 (100) | 42 (95) |
| Safety | 3 (100) | 3 (100) | 4 (100) | 3 (100) | 7 (100) | 12 (100) | 12 (100) | 44 (100) |
| Efficacy |
3 (100) |
3 (100) |
3 (75) |
3 (100) |
6 (86) |
12 (100) |
12 (100) |
42 (95) |
|
gBRCA mutation status | ||||||||
| BRCA1 and/or BRCA2 positive | 3 (100) | 2 (67) | 1 (25) | 1 (33) | 2 (29) | 5 (42) | 9 (75) | 23 (52) |
| Negative | – | – | – | – | – | 1 (8) | – | 1 (2) |
| Unknown |
– |
1 (33) |
3 (75) |
2 (67) |
5 (71) |
6 (50) |
3 (25) |
20 (45) |
|
Platinum sensitivity statusb | ||||||||
| Sensitive | 3 (100) | – | – | – | 3 (100) | 5 (63) | 4 (50) | 15 (54) |
| Resistant | – | 2 (100) | 2 (100) | 2 (100) | – | 3 (38) | 4 (50) | 13 (46) |
Abbreviations: DLT=dose-limiting toxicity; ECOG=Eastern Cooperative Oncology Group ;gBRCA=germline BRCA; SCLC=small-cell lung cancer.
a
For advanced disease.
b
Ovarian patients only.
c
Number of patients.