Table 3.
Targeted agents in advanced or recurrent endometrial cancer.
| Study | Design | No. of patients | Treatment | Primary end point | Results | p |
|---|---|---|---|---|---|---|
| mTOR inhibitors | ||||||
| Oza et al. [83] | Phase 2 | 60 | Temsirolimus 25 mg | RR | CTx-naïve group; RR 14% CTx-treated group; 4% |
|
| Slomovitz et al. [84] | Phase 2, open label | 35 | Everolimus 10 mg | CBR | CBR 21% RR, none |
|
| GOG-86P [85] | Phase 2, randomized | 349 | PC & bevacizumab vs. PC & temsirolimus vs. ixabepilone & carboplatin & bevacizumab | PFS | HR 0.81, 92% CI 0.63-1.02 HR 1.22, 92% CI 0.96-1.55 HR 0.87, 92% CI 0.68-1.11 |
>0.039 |
| GOG 3007 | Phase 2, randomized, open label, noncomparable | EL vs. PT | RR | RR 24 vs. 22% PFS 6.4 vs. 3.8 mths OS 20 vs. 16.6 mths |
||
| Anti-HER2 therapy | ||||||
| Fleming et al. [87] | Phase 2 | 33 | Trastuzumab 2 mg/kg | RR | RR, none | |
| Leslie et al. [88] | Phase 2, open label | 30 | Lapatinib 1500 mg | 6 mths PFS | 10%, 90% CI 2.3-23.9 | |
| Fader et al. [89] | Phase 2, randomized | 61 | PC vs. PC & trastuzumab | PFS | 8 vs. 12.6 mths HR 0.44, 90% CI 0.26-0.76 |
0.005 |
|
| ||||||
| Antiangiogenic therapy | ||||||
| Aghajanian et al. [92] | Phase 2 | 52 | Bevacizumab 15 mg/kg | 6 mths PFS RR |
6 mths PFS 40.4% RR 13.5% |
|
| Median PFS 4.2 mths Median OS 10.5 mths |
||||||
| Simpkins et al. [93] | Phase 2 | 15 | PC & bevacizumab | 6 mths PFS | 93%, 95% CI 82-100 Median PFS 18 mths (CI 11-25) |
|
| MITO END-2 [94] | Phase 2, randomized | 108 | PC vs. PC & bevacizumab | PFS | PFS 10.5 vs. 13.7 mths, HR 0.84 RR 53.1 vs. 74.4% OS 29.7 vs. 40 mths, HR 0.71 |
0.43 0.24 |
No.: number; RR: response rate; CTx: chemotherapy; CBR: clinical benefit rate (complete response or partial response or stable disease ≥ 8 weeks); PC: paclitaxel+carboplatin; PFS: progression-free survival; HR: hazard ratio; CI: confidence interval; EL: everolimus 10 mg + letrozole 2.5 mg; PT: tamoxifen 40 mg + medroxyprogesterone acetate 200 mg; mths: months; OS: overall survival.