Table 5.
Analysed treatment | Setting | Primary EP | PFS control | PFS gain | PFS HR | OS control | OS gain | OS HR | Adjustment/ remark | MCBS | MCBS- FT |
Radiotherapy ± temozolomide Stupp et al, NEJM30 |
Untreated disease | OS | 12.1 months | 2.5 months | 0.63 (0.52–0.75) |
− | 2 | ||||
Radiotherapy, temozolomide± bevacizumab Gilbert et al, NEJM31 |
Untreated disease | OS, PFS | 7.3 months | 3.4 months | 0.79 (0.66–0.94) |
16 months | − | Non-significant | Deterioration in QOL | − | No clinical benefit |
Radiotherapy, temozolomide ± bevacizumab Chinot et al, NEJM32 |
Untreated disease | OS, PFS | 6.2 months | 4.4 months | 0.64 (0.55–0.74) |
17 months | 0.1 months | Non-significant | Improved QOL, upgrade 1 point; 39% versus 26% SAEs, downgrade 1 point |
− | 3 |
Lomustine versus bevacizumab versus bevacizumab + lomustine (BELOB) Taal et al, Lancet Oncol33; Dirven et al, EJC34 |
Recurrent disease | OS 9 months | 43% | − 20% |
Not applicable | Combination selected for phase III trial, QOL assessed | NA | ||||
Lomustine ± bevacizumab (EORTC 26101) Abstract only35 |
Recurrent disease | OS | 8.6 months | 0.5 months | Non-significant | − | NA |
EP, endpoint; ESMO, European Society for Medical Oncology; FT, field testing; MCBS, Magnitude of Clinical Benefit Score; OS, overall survival; PFS, progression-free survival; QOL, quality of life.