Table 1.
Phase II trials of bevacizumab
| GOG | Cannistra et al. | McGonigle et al. | Carmen et al. | Garcia et al. | |
|---|---|---|---|---|---|
| Setting/design | Recurrent platinum- sensitive/resistant | Recurrent platinum- resistant | Recurrent platinum- resistant | Recurrent platinum- sensitive | Recurrent platinum- sensitive/resistant |
| Bev dosage | 15mg/kg/q3w | 15mg/kg/q3w | 10mg/kg/q2w | 10mg/kg/q2w | 10mg/kg** |
| Treatment | Monotherapy | Monotherapy | Combination with TOP | Combination with PLD and CBDCA | Combination with cyclophosphamide |
| Treatment cycle (days) | 21 | 21 | 28 | 28 | 28 |
| Number of patients | 62 | 44 | 40 | 54 | 70 |
| Efficacy | |||||
| ORR | 21.0% | 15.9% | 25.0% | 72.2% | 24% |
| CR | 2 (3%) | 0 | 0 | 8 (15%) | 0 |
| PR | 11 (18%) | 7 (15.9%) | 10 (25%) | 31 (57%) | 17 (24%) |
| SD | 32 (52%) | 27 (25%) | 14 (35%) | 11 (20%) | 44 (63%) |
| Median PFS (range) (months) | 4.7 (2.7–12.9*) | 4.4 (3.1–5.5) | 7.8 (3.0–9.4) | 13.9 (11.4– 16.0) | 7.2 (5.3–8.7) |
| Median OS (range) (months) | 16.9 (9.1–32.4*) | 10.7 | 16.6 (12.8– 22.9) | N/A | 16.9 (11.4–25.2) |
| Adverse events (selected) | |||||
| Hypertension (>grade3) | 6 (9.7%) | 4 (9.1%) | 8 (20%) | 6 (11.1%) | 11 (15%) |
| GI perforation | 0 | 5 (11%) | 0 | 1 (1.9%) | 3 (4%) |
| Proteinuria (>grade3) | 1 (1.6%) | 0 | 1 (3%) | 6 (11.1%) | 3 (4%) |
| VTE | 2 (3.2%) | 1 (2.3%) | 1 (3%) | 2 (3.7%) | 3 (4%) |
GOG, gynecologic oncology group; Bev, bevacizumab; TOP, topotecan; PLD, pegylated liposomal doxorubicin; CBDCA, carboplatin; ORR, overall response rate; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; PFS, progression free survival; OS, overall survival; GI, gastrointestinal; VTE, venous thromboembolism
*
first and third quartiles
**
every week for first 3 weeks of treatment followed by administration every 2 weeks