Table 2.
Study 19 | SOLO 2 | NOVA | ARIEL3 | ||||||
---|---|---|---|---|---|---|---|---|---|
ASCO NHB | gBRCA | wBRCA, HRD (−) | gBRCA | gBRCA | HRD | wBRCA, HRD (−) | gBRCA | HRD | wBRCA, HRD (−) |
Clinical Benefit | 66 | 36 | 56 | 58 | 50 | 34 | 62 | 45 | 34 |
Toxicity | (−)4 | (−)4 | (−)9 | (−)8 | (−)8 | (−)8 | (−)8 | (−)8 | (−)8 |
Tail of the curve | - | - | - | - | - | - | - | - | - |
Palliation of symptoms | - | - | - | - | - | - | - | - | - |
TFI | - | - | - | - | - | - | - | - | - |
QOL | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Final NHB score | 62 | 32 | 47 | 50 | 42 | 26 | 54 | 57 | 26 |
ESMO MCBS | |||||||||
Clinical Benefit | 3 | 2 | 3 | 3 | 3 | 2 | 3 | 3 | 2 |
Toxicity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
QOL | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Final adjustments | (+)1* | - | (+)1* | (+)1* | (+)1* | - | (+)1* | (+)1* | (+)1* |
Final MCBS grade | 4 | 2 | 4 | 4 | 4 | 2 | 4 | 4 | 3 |
ASCO = American Society of Clinical Oncology; NHB = Net Health Benefit; ESMO = European Society of Medical Oncology; MCBS = Magnitude of Clinical Benefit Scale; QOL = quality of life; TFI = treatment-free interval; HRD = homologous recombination deficiency; gBRCA = germline BRCA mutation; wBRCA = wild-type BRCA gene
Upgrade for long-term plateau in PFS and >10% improvement in PFS at 1 year.