Table 2 Primary analysis of PFS-6 and ST-6 —per protocol population for primary endpoint
Bevacizumab + Trabectedin + Carboplatin | Bevacizumab + Trabectedin | |
|---|---|---|
STAGE I (17 patients in each arm) | ||
PFS rate at 6 months (PFS-6)—no. (%) | 14 (82.4) | 10 (58.8) |
80%CI | 65% to 93% | 41% to 75% |
Severe toxicity at 6 months (ST-6)—no. (%) | 8 (47.1) | 4 (23.5) |
80%CI | 30% to 65% | 11% to 42% |
ANC <0.5 × 10/L >7 days and/or fever | 4 (50.0) | 0 (0.0) |
Platelets <25 × 10/L | 4 (50.0) | 0 (0.0) |
Any other grade 3–4 non-haematological toxicities that required permanent interruption of one or both drugs | 2 (25.0) | 4 (75.0) |
STAGE II (36 patients) | ||
PFS rate at 6 months (PFS-6) –no. (%) | – | 25 (69.4) |
80%CI | 58% to 80% | |
Severe toxicity at 6 months (ST-6) –no. (%) | – | 6 (16.7) |
80%CI | 9% to 27% | |
ANC <0.5 × 10/L >7 days and/or fever | – | 0 (0.0) |
Platelets <25 × 10/L | – | 1 (16.7) |
Any other grade 3–4 non-haematological toxicities that required permanent interruption of one or both drugs | – | 5 (83.3) |
