Table 4.
Field testing of the ESMO-MCBS for the treatment of advanced gastric 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| FOLFIRI vs ECX Guimbaud et al64 |
Advanced first-line gastric or gastro-oesophageal adenocarcinoma | TTF | 4.2 m | 0.9 m | 0.77 (0.63 to 0.93) | – | – | Non-significant | No benefit in QOL | NA | 2 |
| Modified DCF vs DCF Shah et al65 |
Advanced first-line gastric or gastro-oesophageal cancer adenocarcinoma | PFS at 6 m | 53% | 10% | – | 12.6 m | 6.2 m | P=0.07 | Reduced toxicity, increase in PFS and OS | NA | 4* |
| CT±trastuzumab (TOGA) Bang et al66 |
Advanced first-line HER2-positive gastric or gastro-oesophageal cancer | OS | 5.5 m | 2.2 m | 0.71 (0.59 to 0.85) | 11.1 m | 2.7 m | 0.74 (0.60 to 0.91) | NA | 3 | |
| ECX vs ECF and EOX vs EOF Cunningham et al67 |
Advanced first-line gastric or gastro-oesophageal cancer | Non-inferiority (OS) | – | – | – | 9.9 m 9.3 m |
0 m 1.9 m |
0.86 (0.80 to 0.99) 0.92 (0.80 to 1.1) |
Non-inferiority criteria were met | NA | NC |
| Ramucirumab vs placebo† (REGARD) Fuchs et al68 |
Second-line gastric or gastro-oesophageal cancer after cisplatin/5FU | OS | – | – | – | 3.2 m | 2.0 m | 0.78 (0.60 to 0.99) | 2 | NA | |
| Paclitaxel±ramucirumab (RAINBOW) Wilke et al69 |
Second-line gastric or gastro-oesophageal cancer after cisplatin/5FU | OS | – | – | – | 7.4 m | 2.2 m | 0.81 (0.68 to 0.96) | No difference in QOL | NA | 2 |
| Salvage chemotherapy vs best supportive care Kang et al70 |
Second-line or third-line gastric or gastro-oesophageal cancer after cisplatin/5FU | OS | – | – | – | 3.8 m | 1.5 m | 0.66 (0.49 to 0.89) | Treatment: docetaxel or irinotecan | NA | 2 |
*Calculated according to form 2c due to immature data.
†Adapted according to Cherny et al.8
CT, chemotherapy; DCF, docetaxel, cisplatin, fluorouracil; EP, end point; ECF, epirubicin, cisplatin, fluorouracil; ECX, epirubicin, cisplatin, capecitabine; EOF, epirubicin, oxaliplatin, fluorouracil; EOX, epirubicin, oxaliplatin, capecitabine; ESMO-MCBS, European Society for Medical Oncology Magnitude of Clinical Benefit Scale; FT, field testing; FOLFIRI, fluorouracil, irinotecan; m, months; NA, not applicable; NC, not calculated; OS, overall survival; PFS, progression-free survival; QOL, quality of life; TTF, time to treatment failure.