Table 1.
Baseline characteristics
| All PM01183 (n=52) | Randomized, controlled second stage |
||
|---|---|---|---|
| PM01183 (n=30) | Topotecan (n=29) | ||
| n (%) | n (%) | n (%) | |
| Median age (range) (years) | 59 (35–81) | 60 (35–81) | 61 (35–80) |
| ≥70 | 8 (15%) | 7 (23%) | 11 (38%) |
| ECOG PS | |||
| 0 | 26 (50%) | 17 (57%) | 11 (38%) |
| 1 | 24 (46%) | 12 (40%) | 14 (48%) |
| 2 | 2 (4%) | 1 (3%) | 4 (14%) |
| Disease evaluation | |||
| RECIST (measurable disease) | 43 (83%) | 26 (87%) | 22 (76%) |
| GCIG (non-measurable disease) | 9 (17%) | 4 (13%) | 7 (24%) |
| Primary tumor site | |||
| Ovarian | 44 (85%) | 27 (90%) | 23 (79%) |
| Peritoneal | 7 (14%) | 2 (7%) | 4 (14%) |
| Fallopian tube | 1 (2%) | 1 (3%) | 2 (7%) |
| Most common histology type | |||
| Papillary serous | 38 (73%) | 22 (73%) | 19 (66%) |
| Endometrioid | 4 (8%) | 1 (3%) | 2 (7%) |
| Undifferentiated carcinoma | 4 (8%) | 3 (10%) | 2 (7%) |
| Clear cell | 1 (2%) | - | 3 (10%) |
| Histology grade | |||
| Well differentiated | 8 (15%) | 4 (13%) | - |
| Moderately differentiated | 9 (17%) | 6 (20%) | 8 (28%) |
| Poorly differentiateda | 24 (46%) | 14 (47%) | 9 (31%) |
| Median time from first diagnosis (range) (months) | 19 (3–109) | 19 (3–109) | 14 (4–81) |
| Disease stage (inclusion) | |||
| III | 20 (39%) | 15 (50%) | 16 (55%) |
| IV | 32 (62%) | 15 (50%) | 13 (45%) |
| Ascites | 11 (21%) | 7 (23%) | 10 (35%) |
| Most common sites of current disease | |||
| Peritoneum | 35 (67%) | 21 (70%) | 23 (79%) |
| Lymph node | 24 (46%) | 14 (47%) | 17 (59%) |
| Liver | 17 (33%) | 8 (27%) | 5 (17%) |
| Prior radical surgery | 38 (73%) | 24 (80%) | 24 (83%) |
| Prior chemotherapy lines | |||
| Median | 2 (1–3) | 2 (1–3) | 2 (1–3) |
| 1 | 18 (35%) | 9 (30%) | 13 (45%) |
| 2 | 26 (50%) | 14 (47%) | 12 (41%) |
| 3 | 8 (15%) | 7 (23%) | 4 (14%) |
| Platinum status | |||
| Refractory | 19 (37%) | 13 (43%) | 13 (45%) |
| Resistant | 33 (63%) | 17 (57%) | 16 (55%) |
| Platinum resistance | |||
| Primary resistance | 30 (58%) | 17 (57%) | 18 (62%) |
| Secondary resistance | 22 (42%) | 13 (43%) | 11 (38%) |
| Platinum-free interval median (range) (months) | 3.6 (0.1–6.0) | 3.3 (0.1–5.9) | 2.3 (0–5.9) |
| Prior angiogenesis inhibitor | 13 (25%) | 5 (17%) | 11 (38%) |
| Prior bevacizumab | 6 (12%) | 3 (10%) | 9 (31%) |
No patients were previously treated with poly ADP ribose polymerase inhibitors.
One patient in the second stage PM01183 arm was previously treated with immunotherapy.
a
Includes undifferentiated. Unknown grades are not shown.
ECOG PS, Eastern Cooperative Oncology Group performance status; GCIG, Gynecological Cancer Intergroup criteria; RECIST, Response Evaluation Criteria in Solid Tumors.