Table 1.
Baseline characteristics and treatment outcome of the 18 study participants.
| No | Dose level of trientine | Cancer type | Histology | First-line chemotherapy | PFI (months) after first-line chemotherapy | Baseline serum copper level (μg/dL) | Baseline ceruloplasmin level (mg/dL) | Trial cycles | RECIST 1.1 Best Response | PFS (months) | OS (months) |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 300 | Ovarian | Mucinous | Paclitaxel/carboplatin | 2.6 | 118.0 | 42.0 | 3 | PD | 2.3 | 3.2 |
| 2 | 300 | Ovarian | Serous | Paclitaxel/carboplatin | 0.4 | 92.0 | 30.3 | 1 | PD | 1.0 | 2.7 |
| 3 | 300 | Ovarian | Mixed serous and clear cell | Paclitaxel/carboplatin | 11.5 | 188.0 | 65.5 | 6 | CR | 46.3 | 58.8 |
| 4 | 600 | Ovarian | Serous | Paclitaxel/carboplatin | 9.3 | 88.0 | 30.4 | 5 | PD | 4.3 | 10.2 |
| 5 | 600 | Ovarian | Serous | Paclitaxel/carboplatin | 6.0 | 110.0 | 45.3 | 1 | PD | 1.1 | 22.6 |
| 6* | 600 | Ovarian | Serous | Paclitaxel/carboplatin | 7.0 | 102.0 | 47.5 | 0 | - | − | − |
| 7 | 600 | Ovarian | Mixed endometrioid and clear cell | Paclitaxel/carboplatin/bevacizumab | 7.1 | 176.0 | 53.9 | 3 | PD | 7.9 | 9.8 |
| 8 | 900 | Ovarian | Clear cell | Paclitaxel/carboplatin | 10.8 | 289.0 | 76.7 | 2 | PD | 1.8 | 5.8 |
| 9 | 900 | Ovarian | Serous | Paclitaxel/carboplatin | 10.7 | 103.0 | 36.3 | 6 | CR | 9.5 | 20.7 |
| 10 | 900 | Ovarian | Mucinous | Paclitaxel/carboplatin | 1.1 | 176.0 | 64.8 | 4 | PD | 4.6 | 5.4 |
| 11 | 1,200 | Ovarian | Serous | Paclitaxel/carboplatin | 4.2 | 74.0 | 24.3 | 6 | SD | 26.6 | 34.5 |
| 12 | 1,200 | Ovarian | Clear cell | Paclitaxel/carboplatin/bevacizumab | 11.9 | 122.0 | 33.2 | 5 | PD | 4.4 | 7.2 |
| 13 | 1,200 | Ovarian | Clear cell | Paclitaxel/carboplatin/bevacizumab | 0.7 | 184.0 | 43.3 | 6 | SD | 9.2 | 21.2 |
| 14 | 1,500 | Ovarian | Serous | Paclitaxel/carboplatin | 10.0 | 113.0 | 38.0 | 4 | PR | 12.7 | 32.8 |
| 15 | 1,500 | Peritoneal | Serous | Paclitaxel/carboplatin/bevacizumab | 3.3 | 87.0 | 30.7 | 3 | PD | 2.1 | 20.3 |
| 16 | 1,500 | Ovarian | Clear cell | Paclitaxel/carboplatin/bevacizumab | 10.7 | 136.0 | 41.0 | 6 | SD | 8.9 | 14.4 |
| 17 | 1,800 | Ovarian | Serous | Paclitaxel/carboplatin | 6.1 | 123.0 | 40.5 | 6 | PR | 12.5 | 32.9 |
| 18** | 1,800 | Ovarian | Serous | Paclitaxel/carboplatin | 5.9 | 76.0 | 29.5 | 0 | - | − | − |
FIGO, the International Federation of Gynecology and Obstetrics; OS, overall survival; PFS, progression free survival; PFI, progression free interval; RECIST, Response Evaluation Criteria In Solid Tumors.
*
No. 6 participant declined the trial drugs, did not proceed with treatment and died of disease progression 1 year later.
**
No. 18 participant chose another chemotherapy combination after 7-day trientine, not due to treatment failure and died of disease progression 2 years later.