Abstract 4449
Background
The non-interventional NIMES-ROC phase IV trial (NCT02825420) aimed to evaluate trabectedin (1.1 mg/m²)+PLD (30 mg/m²) in real-life clinical practice and given in accordance with the marketing authorization to women with PSROC regardless of previous anti-angiogenic treatment.
Methods
Eligible patients were adults with PSROC who have received ≥1 cycle of trabectedin+PLD before inclusion. The primary endpoint was to assess the PFS according to investigator criteria.
Results
Table: 987P
| NIMES-ROC* | PRIOR USE OF ANTIANGIOGENICS | ||
|---|---|---|---|
| Yes (n = 96) | No (n = 62) | Total (n = 158) | |
| Median age (range) | 62 (39-81) | 61 (39-86) | 62 (39-86) |
| ECOG PS, n (%) | |||
| 0 | 41 (42.7) | 26 (41.9) | 67 (42.4) |
| 1 | 25 (26.0) | 8 (12.9) | 33 (20.9) |
| 2 | 2 (2.1) | 3 (4.8) | 5 (3.2) |
| Missing | 28 (29.2) | 25 (40.3) | 53 (33.5) |
| Papillary/serous cancer | 75 (78.1) | 40 (64.5) | 115 (72.8) |
| Platinum sensitivity | |||
| Partially platinum sensitive ROC (PFI 6-12 m) | 66 (68.8) | 34 (54.8) | 100 (63.3) |
| Fully platinum sensitive ROC (PFI >12 m) | 50 (52.1) | 40 (64.5) | 90 (57.0) |
| Missing | 3 (3.1) | 4 (6.5) | 7 (4.4) |
| Prior surgery, n (%) | 88 (91.7) | 56 (90.3) | 144 (91.1) |
| Prior chemotherapy, n (%) | 95 (99.0) | 61 (98.4) | 156 (98.7) |
| Prior platinum-based therapy, n (%) | 96 (100) | 60 (96.8) | 156 (98.7) |
| Prior bevacizumab, n (%) | 81 (84.4) | 0 | 81 (51.3) |
| Number of T+PLD cycles, median (range) | 6.0 (1-34) | 6.5 (2-16) | 6.0 (1-34) |
| In-patients only | 24 (25.0) | 15 (24.2) | 39 (24.7) |
| Out-patients only | 58 (60.4) | 41 (66.1) | 99 (62.7) |
| Both | 8 (8.3) | 6 (9.7) | 14 (8.9) |
| Missing | 6 (6.3) | 0 | 6 (3.8) |
| Progression-free survival (PFS), months (95% CI) | 10.0 (7.3-12) | 14.3 (11.4-nr) | 11.4 (10-14) |
| PFS at 6 months, months (95% CI) | 70.9 (60-79) | 84.3 (72-92) | 76.3 (68-83) |
| PFS at 12 months, months (95% CI) | 39.1 (27-51) | 60.9 (44-74) | 47.7 (37-57) |
| Overall survival (OS), months (95% CI) | 17.7 (13.2-nr) | nr (16.8-nr) | nr (16.8-nr) |
| Compete response (CR) | 6 (6.3) | 9 (14.5) | 15 (9.5) |
| Partial response (PR) | 25 (26.0) | 20 (32.3) | 45 (28.5) |
| Stable disease (SD) | 25 (26.0) | 20 (32.3) | 45 (28.5) |
| Progressive disease (PD) | 25 (26.0) | 7 (11.3) | 32 (20.3) |
| Not evaluable / Missing | 15 (15.6) | 6 (9.7) | 21 (13.3) |
Patients may be represented in multiple categories. CI, confidence interval; nr, not reached; PFI, platinum-free interval; PLD, pegylated liposomal doxorubicin; PS, performance status; ROC, recurrent ovarian cancer; T, trabectedin.
158 patients from 50 sites across Europe were evaluated. Median number of trabectedin+PLD cycles received per patient was 6, with 95 patients (50.6%) receiving ≥6 cycles and up 34 cycles. Median treatment duration was 22.2 weeks (range: 3-124), with no statistical difference concerning prior use of antiangiogenics, and mostly on an outpatient basis (≥63% of patients). Bevacizumab was the most used antiangiogenic in 84% of patients. With 73 PFS events and 32 deaths recorded, median PFS (11.4 months; 95% CI: 10-14) and OS (see Table) was significantly larger in patients not pretreated with antiangiogenics (PFS: p < 0.009; OS: p < 0.018). Non-antiangiogenic pretreated patients also obtained better overall response rate (ORR, 47% vs 32%) and disease control rate (ORR + SD: 79% vs 58%). A total of 108 trabectedin-emergent adverse reactions (TEAR) occurred. Most common grade 3/4 TEARs were neutropenia (25%) and asthenia (4%). The toxicity profile between subgroups was not different from that of the overall population.
Conclusions
Our results confirm that trabectedin+PLD is active in patients with PSROC with an acceptable and manageable safety profile. Overall our data favorably compare with those of the pivotal OVA-301 trial (NCT00113607) and suggest major benefits in patients non-pretreated with antiangiogenics who obtained significantly longer PFS.
Clinical trial identification
NCT02825420; ET-D-031-14.
Legal entity responsible for the study
PharmaMar, S.A.
Funding
PharmaMar, S.A.
Editorial Acknowledgement
The authors would like to acknowledge Adnan Tanović (PharmaMar) for providing writing assistance for the manuscript.
Disclosure
All authors have declared no conflicts of interest.