| pathology | Demonstrated benefit and harm | k | | | |
|---|
| advanced breast cancer (metastatic) | versus CT alone No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Schwartzberg, 2013 | sorafenib + gemcitabine or capecitabine vs gemcitabine or capecitabine alone | PFS 0.64 [0.44; 0.93] | | OS 1.01 [0.71; 1.44] | | Baselga, 2012 | sorafenib + capecitabine vs capecitabine alone | PFS 0.58 [0.41; 0.82] | | OS 0.86 [0.61; 1.22] |
| Trial | Treatments | Patients | Method |
|---|
| Schwartzberg, 2013 | sorafenib (400 mg, twice daily) (n=-9) vs. placebo (n=-9) | patients with HER-2-negative advanced breast cancer that progressed during or after bevacizumab | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: | | Baselga, 2012 | - or second-line capecitabine 1,000 mg/m(2) orally twice a day for days 1 to 14 of every 21-day cycle with sorafenib 400 mg orally twice a day (n=-9) vs. capecitabine alone (n=-9) | HER2-negative locally advanced or metastatic breast cancer | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: PFS FU duration: |
|
| advanced breast cancer (metastatic) | versus taxanes alone No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Gradishar, 2013 | sorafenib + paclitaxel vs paclitaxel alone | | | OS 1.02 [0.71; 1.46] PFS 0.79 [0.56; 1.11] |
| Trial | Treatments | Patients | Method |
|---|
| Gradishar, 2013 | paclitaxel (90mg/m(2), weekly, intravenously, 3 weeks on/1 week off) plus sorafenib (400mg, orally, twice daily) (n=-9) vs. paclitaxel (90mg/m(2), weekly, intravenously, 3 weeks on/1 week off) (n=-9) | first-line therapy in patients with HER2-negative advanced breast cancer | double-blind Parallel groups Sample size: -9/-9 Primary endpoint: FU duration: |
|
| lung cancer (metastatic) | versus No demonstrated result for efficacy | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | | | T1 vs T0 | | | |
| Trial | Treatments | Patients | Method |
|---|
| Wakelee, 2012 | (n=-9) vs. (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: phase-II | | Paz-Ares, 2012 | daily sorafenib (400 mg twice a day) or matching placebo plus gemcitabine (1,250 mg/m(2) per day on days 1 and 8) and cisplatin (75 mg/m(2) on day 1) for up to six 21-day cycles (n=385) vs. gemcitabine/cisplatin alone (n=-9387) | chemotherapy-naive patients with unresectable stage IIIB to IV nonsquamous non-small-cell lung cancer | Sample size: 385/-9387 Primary endpoint: FU duration: | | Spigel, 2011 | (n=-9) vs. (n=-9) | previously treated advanced non-small-cell lung cancer | Sample size: -9/-9 Primary endpoint: FU duration: phase II | | Scagliotti, 2010 | up to six 21-day cycles of carboplatin area under the curve 6 and paclitaxel 200 mg/m(2) (CP) on day 1, followed by sorafenib 400 mg twice a day on days 2 to 19 (n=464) vs. (n=462) | chemotherapy-naïve patients with unresectable stage IIIB or IV non-small-cell lung cancer | Sample size: 464/462 Primary endpoint: FU duration: phase III |
|
| renal-cell carcinoma (advanced) | versus No demonstrated result for efficacy | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Escudier, 2009 | sorafenib vs interferon alpha | | | PFS 0.88 [0.61; 1.27] | | TARGET, 2007 | sorafenib vs placebo | PFS 0.44 [0.35; 0.55] | | OS 0.88 [0.74; 1.04] | | Ratain, 2006 | sorafenib vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| Escudier, 2009 | oral sorafenib 400 mg twice daily (n=97) vs. subcutaneous IFN--2a 9 million U three times weekly (n=92) | patients with untreated, advanced renal cancer. | Parallel groups Sample size: 97/92 Primary endpoint: FU duration: phase 2 | | TARGET, 2007 | continuous treatment with oral sorafenib (at a dose of 400 mg twice daily) (n=451) vs. placebo (n=452) | patients with renal-cell carcinoma that was resistant to standard therapy | Parallel groups Sample size: 451/452 Primary endpoint: OS FU duration: | | Ratain, 2006 | (n=-9) vs. (n=-9) | patients with metastatic renal cell carcinoma | Sample size: -9/-9 Primary endpoint: FU duration: |
|
