Table 2.
FT of the ESMO-MCBS for the treatment of thyroid cancer 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 |
Cabozantinib versus placebo Elisei et al, JCO16 |
Progressive disease medullary thyroid cancer | PFS | 4 months | 7.2 months | 0.28 (0.19–0.40) |
42% versus 23% SAE, downgrade 1 point | − | 2 | |||
Vandetanib versus placebo Wells et al, JCO17 |
Medullary thyroid cancer | PFS | 19 months | 11.2 months | 0.46 (0.31–0.69) |
More grade III/IV AEs | − | 2–3* | |||
Lenvatinib versus placebo (SELECT) Schlumberger et al, NEJM18 |
Progressive disease iodine-refractory differentiated thyroid cancer | PFS | 3.6 months | 14.7 months | 0.21 (0.14–0.31) |
Increased toxicity including toxic deaths, downgrade 1 point | − | 2 | |||
Sorafenib versus placebo (DECISION) Brose et al, Lancet19 |
Progressive disease iodine-refractory differentiated thyroid cancer | PFS | 5.8 months | 5 months | 0.59 (0.45–0.76) |
37% versus 26% SAE, downgrade 1 point | − | 2 |
*Unclear toxicity data.
AE, adverse event; EP, endpoint; ESMO, European Society for Medical Oncology; FT, field testing; MCBS, Magnitude of Clinical Benefit Score; OS, overall survival; PFS, progression-free survival; SAE, serious adverse event.