| Everolimus | advanced breast cancer (metastatic), in all type of patients | vs trastuzumab + vinorelbine alone | progression or death (progression free survival PFS) by 22% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.78 [0.65 0.94] | p=0.04 | 0 | 569 | 1 | BOLERO-3, |
| Trial | Studied treatment | Control | Patients |
|---|
| BOLERO-3, 2014 | daily everolimus (5 mg/day) plus weekly trastuzumab (2 mg/kg) and vinorelbine (25 mg/m(2)) in 3-week cycles | placebo plus trastuzumab plus vinorelbine, | women with HER2-positive, trastuzumab-resistant, advanced breast carcinoma who had previously received taxane therapy |
| |
| Everolimus | | vs exemestane alone | progression or death (progression free survival PFS) by 57% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | death (overall survival) | 0.89 [0.73 1.09] | p=1.00 | 0 | 724 | 1 | BOLERO-2, | | progression or death (progression free survival PFS) | 0.43 [0.35 0.53] | p=0.04 | 0 | 724 | 1 | BOLERO-2, |
| Trial | Studied treatment | Control | Patients |
|---|
| BOLERO-2, 2011 | everolimus and exemestane | exemestane and placebo | 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). |
| |
| Everolimus | | vs tamoxifen alone | progression (Time to progression TTP) by 46% suggested death (overall survival) by 55% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 0.54 [0.36 0.81] | p=0.04 | 0 | 111 | 1 | TAMRAD , | | death (overall survival) | 0.45 [0.24 0.84] | p=0.04 | 0 | 111 | 1 | TAMRAD , | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| TAMRAD , 2012 | tamoxifen 20 mg/d plus everolimus 10 mg/d | tamoxifen 20 mg/d alone | postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative, AI-resistant mBC |
| |
| Everolimus | advanced breast cancer (metastatic), in patients recurring or progressing after prior endocrine therapy | vs exemestane alone | progression or death (progression free survival PFS) by 57% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | death (overall survival) | 0.89 [0.73 1.09] | p=1.00 | 0 | 724 | 1 | BOLERO-2, | | progression or death (progression free survival PFS) | 0.43 [0.35 0.53] | p=0.04 | 0 | 724 | 1 | BOLERO-2, |
| Trial | Studied treatment | Control | Patients |
|---|
| BOLERO-2, 2011 | everolimus and exemestane | exemestane and placebo | 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). |
| |
| Everolimus | | vs tamoxifen alone | progression (Time to progression TTP) by 46% suggested death (overall survival) by 55% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 0.54 [0.36 0.81] | p=0.04 | 0 | 111 | 1 | TAMRAD , | | death (overall survival) | 0.45 [0.24 0.84] | p=0.04 | 0 | 111 | 1 | TAMRAD , | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| TAMRAD , 2012 | tamoxifen 20 mg/d plus everolimus 10 mg/d | tamoxifen 20 mg/d alone | postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative, AI-resistant mBC |
| |
| Everolimus | advanced breast cancer (metastatic), in HR+ HER2- | vs exemestane alone | progression or death (progression free survival PFS) by 57% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | death (overall survival) | 0.89 [0.73 1.09] | p=1.00 | 0 | 724 | 1 | BOLERO-2, | | progression or death (progression free survival PFS) | 0.43 [0.35 0.53] | p=0.04 | 0 | 724 | 1 | BOLERO-2, |
| Trial | Studied treatment | Control | Patients |
|---|
| BOLERO-2, 2011 | everolimus and exemestane | exemestane and placebo | 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). |
| |
| Everolimus | | vs tamoxifen alone | progression (Time to progression TTP) by 46% suggested death (overall survival) by 55% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | 0.54 [0.36 0.81] | p=0.04 | 0 | 111 | 1 | TAMRAD , | | death (overall survival) | 0.45 [0.24 0.84] | p=0.04 | 0 | 111 | 1 | TAMRAD , | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| TAMRAD , 2012 | tamoxifen 20 mg/d plus everolimus 10 mg/d | tamoxifen 20 mg/d alone | postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative, AI-resistant mBC |
| |
| Everolimus | advanced breast cancer (metastatic), in patient trastuzumab-resistant, and previously treated by taxanes | vs trastuzumab + vinorelbine alone | progression or death (progression free survival PFS) by 22% fully demonstrated | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | death (overall survival) | no data | | progression or death (progression free survival PFS) | 0.78 [0.65 0.94] | p=0.04 | 0 | 569 | 1 | BOLERO-3, |
| Trial | Studied treatment | Control | Patients |
|---|
| BOLERO-3, 2014 | daily everolimus (5 mg/day) plus weekly trastuzumab (2 mg/kg) and vinorelbine (25 mg/m(2)) in 3-week cycles | placebo plus trastuzumab plus vinorelbine, | women with HER2-positive, trastuzumab-resistant, advanced breast carcinoma who had previously received taxane therapy |
| |
| Everolimus | renal-cell carcinoma (advanced), in all type of patients | vs placebo | progression or death (progression free survival PFS) by 70% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | 0.83 [0.50 1.37] | p=1.00 | 0 | 410 | 1 | RECORD-1, | | progression or death (progression free survival PFS) | 0.30 [0.22 0.40] | p=0.04 | 0 | 410 | 1 | RECORD-1, |
| Trial | Studied treatment | Control | Patients |
|---|
| RECORD-1, 2008 | everolimus 10 mg once daily | placebo | Patients with metastatic renal cell carcinoma which had progressed on sunitinib, sorafenib, or both |
| |
| Everolimus | | vs sunitinib | progression or death (progression free survival PFS) by 40% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | no data | | progression or death (progression free survival PFS) | 1.40 [1.14 1.71] | p=0.04 | 0 | 471 | 1 | RECORD 3, |
| Trial | Studied treatment | Control | Patients |
|---|
| RECORD 3, 2014 | everolimus | sunitinib | patients with metastatic renal cell carcinoma |
| |
| Temsirolimus | advanced breast cancer (metastatic), in all type of patients | vs letrozole alone | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | death (overall survival) | 0.89 [0.65 1.22] | p=1.00 | 0 | 1112 | 1 | HORIZON, | | progression or death (progression free survival PFS) | 0.90 [0.76 1.07] | p=1.00 | 0 | 1112 | 1 | HORIZON, |
| Trial | Studied treatment | Control | Patients |
|---|
| HORIZON, 2013 | oral letrozole 2.5 mg daily/temsirolimus 30 mg daily (5 days every 2 weeks) | letrozole/placebo | first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer |
| |
| Temsirolimus | advanced breast cancer (metastatic), in first line therapy | vs letrozole alone | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | death (overall survival) | 0.89 [0.65 1.22] | p=1.00 | 0 | 1112 | 1 | HORIZON, | | progression or death (progression free survival PFS) | 0.90 [0.76 1.07] | p=1.00 | 0 | 1112 | 1 | HORIZON, |
| Trial | Studied treatment | Control | Patients |
|---|
| HORIZON, 2013 | oral letrozole 2.5 mg daily/temsirolimus 30 mg daily (5 days every 2 weeks) | letrozole/placebo | first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer |
| |
| Temsirolimus | advanced breast cancer (metastatic), in HR+ HER2- | vs letrozole alone | all NS | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| progression (Time to progression TTP) | no data | | death (overall survival) | 0.89 [0.65 1.22] | p=1.00 | 0 | 1112 | 1 | HORIZON, | | progression or death (progression free survival PFS) | 0.90 [0.76 1.07] | p=1.00 | 0 | 1112 | 1 | HORIZON, |
| Trial | Studied treatment | Control | Patients |
|---|
| HORIZON, 2013 | oral letrozole 2.5 mg daily/temsirolimus 30 mg daily (5 days every 2 weeks) | letrozole/placebo | first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer |
| |
| Temsirolimus | renal-cell carcinoma (advanced), in all type of patients | vs interferon alpha | death (overall survival) by 27% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | 0.73 [0.58 0.92] | p=0.04 | 0 | 416 | 1 | ARCC (Hudes) temsirolimus alone, | | progression or death (progression free survival PFS) | no data |
| Trial | Studied treatment | Control | Patients |
|---|
| ARCC (Hudes) temsirolimus alone, 2007 | 25 mg of intravenoustemsirolimus weekly | 3 million U of interferon alfa (with an increase to 18 millionU) subcutaneously three times weekly | patients with previously untreated, poor-prognosis metastatic renal-cell carcinoma |
| |
| Temsirolimus | | vs sorafenib | death (overall survival) by 31% suggested | | Endpoint | TE [95% CI] | p val | I2 | n | k | |
|---|
| death (overall survival) | 1.31 [1.05 1.63] | p=0.04 | 0 | 512 | 1 | INTORSECT, | | progression or death (progression free survival PFS) | 0.87 [0.71 1.07] | p=1.00 | 0 | 512 | 1 | INTORSECT, |
| Trial | Studied treatment | Control | Patients |
|---|
| INTORSECT, 2014 | temsirolimus 25 mg once weekly by intravenous (IV) infusion | sorafenib 400 mg PO twice daily | Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib |
| |
