Table 6.
Field testing of the ESMO-MCBS for the treatment of advanced renal cell carcinoma at the Medical University of Vienna
| Analysed treatment | Setting | Primary EP | PFS control | PFS gain | PFS HR | OS control | OS gain | OS HR | Adjustment/remark | MCBS | MCBS-FT |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Temsirolimus vs interferon vs combined Hudes et al79 |
First-line metastatic (poor prognosis) | OS (tem.) OS (comb.) |
– | – | – | 7.3 m | 3.3 m 1.1 m |
0.73 (0.58 to 0.92) 0.96 (0.76 to 1.2) |
OS gain for temsirolimus | NA NA |
4 1 |
| Sunitinib vs interferon* Motzer et al80 Motzer et al81 |
First-line metastatic | PFS | 5 m | 6 m | 0.42 (0.32 to 0.54) | 21.8 m | 4.6 m | Non-significant | QOL improved | 4 | NA |
| Interferon±bevacizumab (AVOREN) Escudier et al82 Escudier et al83 |
First-line metastatic with clear cell | PFS | 5.4 m | 4.6 m | 0.63 (0.52 to 0.75) | – | – | Non-significant | Primary end point OS amended to PFS | NA | 3 |
| Interferon±bevacizumab (CALBG 90206) Rini et al84 Rini et al85 |
First-line metastatic with clear cell | PFS | 5.2 m | 3.3 m | 0.71 (0.66 to 0.83) | – | – | Non-significant | Primary end point OS amended to PFS | NA | 1 |
| Sorafenib vs placebo (TARGET)* Escudier et al86 |
Second-line locally advanced or metastatic | OS | 2.8 m | 2.7 m | 0.44 (0.35 to 0.55) | 15.9 m | 3.4 m | 0.77 (0.63 to 0.95) | 3 | NA | |
| Pazopanib vs placebo* Sternberg et al87 |
Second-line locally advanced or metastatic | PFS | 4.2 m | 5.0 m | 0.46 (0.34 to 0.62) | – | – | – | 3 | NA | |
| Axitinib vs sorafenib (AXIS)* Rini et al88 |
Previously treated metastatic | PFS | 4.7 m | 2.0 m | 0.66 (0.55 to 0.81) | – | – | – | 3 | NA | |
| Everolimus vs placebo (RECORD-1)* Motzer et al89 |
Second-line or third-line after tyrosine kinase inhibitor metastatic | PFS | 1.9 m | 2.1 m | 0.30 (0.22 to 0.40) | – | – | – | 3 | NA | |
| Nivolumab vs everolimus (Checkmate-025) Motzer et al90 |
Advanced or metastatic with progress after at least one antiangiogenic treatment | OS | 4.4 m | 0.2 m | 0.88 (0.75 to 10.3) | 19.6 m | 5.4 m | 0.73 (0.57 to 0.93) | Significantly less grade III/IV AEs | NA | 5 |
| Cabozantinib vs everolimus (METEOR) Choueiri et al91 |
Advanced or metastatic with progress after at least one antiangiogenic treatment (pretreated with sunitinib) |
PFS (all) PFS (sunitinib) |
3.8 m 3.7 m |
3.6 m 5.4 m |
0.58 (0.45 to 75) 0.41 (0.28 to 0.61) |
– – |
– – |
– – |
Survival data immature but expected to be positive | NA NA |
3 3 |
*Adapted according to Cherny et al.8
AEs, adverse events; comb., combined; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; FT, field testing; m, months; NA, not applicable; OS, overall survival; PFS, progression-free survival; EP, end point; QOL, quality of life; tem., temsirolimus.