Table 4.
FT of the ESMO-MCBS for the treatment of head and neck 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 |
| Cisplatin ± cetuximab Burtness et al, JCO26 |
Previously untreated | PFS | 2.7 months | 1.5 months | Non-significant | Increase in response rate | − | NA | |||
| Platinum-based CT±cetuximab followed by maintenance (EXTREME) Vermorken et al, NEJM27 |
Previously untreated | OS | 7.4 months | 2.7 months | 0.80 (0.64–0.99) |
− | 3 | ||||
| Afatinib versus methotrexate (LUX-Head & Neck 1) Machiels et al, Lancet Oncol28 |
Previously treated with platin-based therapy | PFS | 1.7 months | 0.9 months | 0.80 (0.65–0.98) |
Improved QOL, upgrade 1 point | − | 3 | |||
| Nivolumab versus investigator’s choice (CheckMate 141) Ferris et al, NEJM29 |
Previously treated with plating-based therapy | OS | − | − | − | 5.1 months | 2.4 months | 0.70 (0.51–0.96) |
Less toxicity, upgrade 1 point; improved QOL, upgrade 1 point | − | 4* |
*More mature survival data may improve outcome of MCBS.
EP, endpoint; ESMO, European Society for Medical Oncology; FT, field testing; MCBS, Magnitude of Clinical Benefit Score; OS, overall survival; PFS, progression-free survival; CT, chemotherapy; QOL, quality of life.