Clinical trials of temsirolimus - TrialResults-center.org

pathology

Benefit (demonstrated or suggested) and harm

advanced breast cancer (metastatic)

All results are NS for efficacy

meta-analysis

Trial

control

p<0.05

harm

HORIZON, 2013

vs letrozole alone

OS 0.89 [0.65; 1.22]

PFS 0.90 [0.76; 1.07]

Trial

Treatments

Patients

Method

HORIZON, 2013

oral letrozole 2.5 mg daily/temsirolimus 30 mg daily (5 days every 2 weeks) (n=556)

vs.

letrozole/placebo (n=556)

first-line endocrine therapy in postmenopausal women with locally advanced or metastatic breast cancer

double-blind

Parallel groups

Sample size: 556/556

Primary endpoint: PFS

FU duration:

renal-cell carcinoma (advanced)

All results are NS for efficacy

inferior to interferon alpha in terms of OS in INTORSECT, 2014

meta-analysis

Trial	control	p<0.05	harm	NS
ARCC (Hudes) temsirolimus alone, 2007	vs interferon alpha	OS 0.73 [0.58; 0.92]
INTORSECT, 2014	vs interferon alpha		OS 1.31 [1.05; 1.63]	PFS 0.87 [0.71; 1.07]

Trial

Treatments

Patients

Method

ARCC (Hudes) temsirolimus alone, 2007

25 mg of intravenoustemsirolimus weekly (n=209)

vs.

3 million U of interferon alfa (with an increase to 18 millionU) subcutaneously three times weekly (n=207)

3 arms: Temsirolimus alone, Temsirolimus plus interferon and interferon alone

patients with previously untreated, poor-prognosis metastatic renal-cell carcinoma

Sample size: 209/207

Primary endpoint: OS

FU duration:

INTORSECT, 2014

temsirolimus 25 mg once weekly by intravenous (IV) infusion (n=259)

vs.

sorafenib 400 mg PO twice daily (n=253)

Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

Sample size: 259/253

Primary endpoint: PFS

FU duration:

Temsirolimus mTOR inhibitor Description Results

Group by...

Temsirolimus mTOR inhibitor
Description Results