Table 3.
Response rates according to RECIST
| |
Evaluable patients, n (%) |
|
|---|---|---|
|
Responder status |
Cohort 1 |
Cohort 2 |
| (n = 9) | (n = 10) | |
|
ORR |
3 (33) |
4 (40) |
| CR |
0 |
0b |
| PRa |
3 (33) |
4 (40) |
|
SD ≥7 weeks |
3 (33) |
3 (30) |
| Unconfirmed PRa |
1 (11) |
2 (20) |
| PD | 3 (33) | 3 (30) |
ORR, objective response rate; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease.
aOne patient in cohort 1 and two patients in cohort 2 had unconfirmed partial responses and so were included in the SD seven or more weeks response category.
bFollowing data cut-off, one patient in cohort 2 achieved a CR and, as of December 2012, remained in complete radiological remission; no mutation in the BRCA1 and/or BRCA2 genes was identified in this patient by sequencing and multiplex ligation-dependent probe amplification (MLPA).