| advanced breast cancer (metastatic) | superior to exemestane alone in terms of PFS in BOLERO-2, 2011 superior to exemestane alone in terms of PFS in BOLERO-3, 2014 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| BOLERO-2, 2011 | vs exemestane alone | PFS 0.43 [0.35; 0.53] Demonstrated | | OS 0.89 [0.73; 1.09] | | TAMRAD , 2012 | vs exemestane alone | OS 0.45 [0.24; 0.84] Time to progression (TTP) 0.54 [0.36; 0.81] | | | | BOLERO-3, 2014 | vs exemestane alone | PFS 0.78 [0.65; 0.94] Demonstrated | | |
| Trial | Treatments | Patients | Method |
|---|
| BOLERO-2, 2011 | everolimus and exemestane (n=485) vs. exemestane and placebo (n=239) | patients with hormone-receptor-positive advanced breast cancer who had recurrence or progression while receiving previous therapy with a nonsteroidal aromatase inhibitor in the adjuvant setting or to treat advanced disease (or both). | double-blind Parallel groups Sample size: 485/239 Primary endpoint: progression-free survival FU duration: | | TAMRAD , 2012 | tamoxifen 20 mg/d plus everolimus 10 mg/d (n=54) vs. tamoxifen 20 mg/d alone (n=57) | postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative, AI-resistant mBC | open-label Sample size: 54/57 Primary endpoint: FU duration: | | BOLERO-3, 2014 | daily everolimus (5 mg/day) plus weekly trastuzumab (2 mg/kg) and vinorelbine (25 mg/m(2)) in 3-week cycles (n=284) vs. placebo plus trastuzumab plus vinorelbine, (n=285) | women with HER2-positive, trastuzumab-resistant, advanced breast carcinoma who had previously received taxane therapy | double-blind Parallel groups Sample size: 284/285 Primary endpoint: PFS by local assessment FU duration: |
|
| renal-cell carcinoma (advanced) | All results are NS for efficacy inferior to placebo in terms of PFS in RECORD 3, 2014 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RECORD-1, 2008 | vs placebo | PFS 0.30 [0.22; 0.40] | | OS 0.83 [0.50; 1.37] | | RECORD 3, 2014 | vs placebo | | PFS 1.40 [1.14; 1.71] | |
| Trial | Treatments | Patients | Method |
|---|
| RECORD-1, 2008 | everolimus 10 mg once daily (n=272) vs. placebo (n=138) | Patients with metastatic renal cell carcinoma which had progressed on sunitinib, sorafenib, or both | Sample size: 272/138 Primary endpoint: PFS FU duration: | | RECORD 3, 2014 | everolimus (n=238) vs. sunitinib (n=233) | patients with metastatic renal cell carcinoma | Cross over Sample size: 238/233 Primary endpoint: FU duration: |
|
