Table 1.
Patient baseline characteristics
| Statistics | PFI* |
Overall (N = 69) | ||
| <6 months (n = 50) | ≥6 months (n = 19) | |||
| Age (years) | Median | 59 | 65 | 62 |
| Minimum to maximum | 37 to 79 | 47 to 78 | 37 to 79 | |
| ECOG performance status | 0a, n (%) | 37 (74.0) | 13 (68.4) | 50 (72.5) |
| 1b, n (%) | 12 (24.0) | 6 (31.6) | 18 (26.1) | |
| NDc, n (%) | 1 (2.0) | 0 | 1 (1.4) | |
| PFI | Median (months) | 2.32 | 8.71 | 3.48 |
| Minimum to maximum | −0.07 to 5.98 | 6.08 to 13.17 | −0.07 to 13.17 | |
| Primary epithelial tumor type | ||||
| Ovarian | n (%) | 45 (90.0) | 16 (84.2) | 61 (88.4) |
| Peritoneal | n (%) | 5 (10.0) | 3 (15.8) | 8 (11.6) |
| Assessable by RECIST, n (%) | Yes | 40 (80.0) | 14 (73.7) | 54 (78.3) |
| No | 10 (20.0) | 5 (26.3) | 15 (21.7) | |
| Assessable by CA-125, n (%) | Yes | 41 (82.0) | 17 (89.5) | 58 (84.1) |
| No | 9 (18.0) | 2 (10.5) | 11 (15.9) | |
| Number of previous chemotherapy lines, n (%) | 1 | 9 (18.0) | 10 (52.6) | 19 (27.6) |
| 2 | 25 (50.0) | 8 (42.1) | 33 (47.8) | |
| 3 | 16 (32.0) | 1 (5.3) | 17 (24.6) | |
| Type of previous chemotherapy, n (%) | Platinum compounds | 50 (100) | 19 (100) | 69 (100) |
| Taxanes | 50 (100) | 19 (100) | 69 (100) | |
| Anthracyclines | 30 (60.0) | 3 (15.8) | 33 (47.8) | |
| Other | 14 (28.0) | 7 (36.8) | 21 (30.4) | |
*
PFI (after the last dose of platinum) calculated as time from the last dose of platinum to start of any subsequent therapy and independent whether a nonplatinum regimen was given as last treatment before gimatecan start.
a0: Able to carry out all normal activity without restriction.
b1: Restricted in physically strenuous activity but ambulatory and able to carry out light work.
cND: Not determined.
PFI, progression-free interval; ECOG, Eastern Cooperative Oncology Group.