Table 3.
Phase II and III trials of TKIs in ovarian cancer.
| Study | N | Treatment arm | PFS (median months) | PFS-HR (95% CI) | OS (median months) | OS-HR (95% CI) |
|---|---|---|---|---|---|---|
| AGO 2.11 | 73 | Noncontinuous treatment arm | 4.8 | 0.91 (0.62–1.32) | 13.6 | 0.95 (0.55-1.63) |
| Continuous treatment arm | 2.9 | 13.7 | ||||
| OVAR16 | 940 | Placebo | 12.3 | 0.77 (0.64 - 0.91) | 64 | 0.96 (0.805-1.145) |
| Pazopanib | 17.9 | 59.1 | ||||
| MITO 11 | 74 | Paclitaxel | 3.49 | 0.42 (0.25-0.69) | 13.7 | 0.60 (0.32-1.13) |
| Paclitaxel and pazopanib | 6.35 | 19.1 | ||||
| OVAR 12 | 1503 | Standard carboplatin and paclitaxel chemotherapy | 16.6 | 0.84 (0.72-0.98) | 62.8 | 0.99 (0.83-1.17) |
| Nintedanib with standard carboplatin and paclitaxel chemotherapy | 17.2 | 62 | ||||
| ICON6 | 486 | Chemotherapy + placebo; placebo maintenance | 8.7 | 21 | ||
| Chemotherapy + cediranib; placebo maintenance | 9.9 | — | NS | — | ||
| Chemotherapy + cediranib; cediranib maintenance | 11 | 0.56 (0.44-0.72) | 26.3 | 0.77 (0.55-1.07) | ||
| TRIAS | 185 | Placebo plus topotecan | 4.4 | 0.60 (0.43-0.83) | 10.1 | 0.65 (0.45–0.93) |
| Sorafenib plus topotecan | 6.7 | 17.1 | ||||
| PAZOFOS | 21 | Pazopanib | 3.7 | 0.30 (0.09-1.03) | 8.4 | 0.1 (0.01-0.91) |
| Pazopanib and fosbretabulin | 7.6 | NR | ||||
| NCT01610206 | 148 | Weekly gemcitabine | 2.9 | 0.61 (0.40-0.92), 1.50(0.76-2.94) | 15.6 | NS |
| Weekly gemcitabine plus pazopanib | 5.3 | 14.2 | ||||
| NCT01610869 | 117 | Oral cyclophosphamide plus placebo | 2.6 | 0.91 (0.62-1.32) | 6.4 | 1.08 (0.72-1.62) |
| Oral cyclophosphamide plus nintedanib | 2.9 | 6.8 | ||||
| REGOVAR | 68 | Regorafenib | 4.6 | 1.21 (0.78–1.86) | NR | 1.32 (0.70–2.47) |
| Tamoxifen | 5.6 | |||||
| NCT00710762 | 83 | Nintedanib | 16.3%# | 0.65 (0.41-1.02) | NS | 0.84 (0.51-1.39) |
| Placebo | 5.0%# | NS |
#PFS rate at 36 weeks; NR: not reached; NS: not stated; #0.61 (0.40-0.92) during the first 6 months, 1.50 (0.76-2.94) thereafter.