Table 1.
Differences of the assessment criteria applied in the original versus adapted ESMO-MCBS (based on15)
| Adapted ESMO-MCBS | Original ESMO-MCBS v1.1 |
|---|---|
| Generation of scores | |
| Point estimate of the HR | Lower limit of the 95% CI of the HR |
| Applicable study designs | |
| Comparative studies (Form 1-2c) | Comparative (Form 1-2c) and non-comparative studies (Form 3) |
| Score adjustments | |
| Downgrades due to a negative median OS despite scored endpoint showing a statistically significant, positive difference (Form 2a, b and c) | Not implicated |
| Downgrades OR upgrades due to positive or negative differences, respectively, of at least 10% in any grade ≥3 AEs (Form 2a and b) | Upgrades due to statistically significantly less grade 3-4 toxicities impacting on daily well-being (Form 2a and b) Downgrades due to one or more statistically significantly increased incremental toxicities (Form 2b) |
| Downgrades OR upgrades due to positive or negative differences, respectively, of at least 10% in the discontinuation rates (Form 2a and b) | Not implicated |
| Downgrades due to no difference in QoL OR no QoL assessment carried out AND only PFS showing an improvement (Form 2b) | Downgrades due to no difference in QoL AND only PFS showing an improvement (Form 2b) |
| Downgrades OR upgrades due to statistically significant negative or positive differences (respectively) in QoL (Form 2a and b) | Upgrades due to statistically significant positive differences in QoL (Form 2a and b) |
AE, adverse event; CI, confidence interval; HR, hazard ratio; OS, overall survival; PFS, progression-free survival; QoL, quality of life.