Table 1.
Parameters | Scenario 1 |
Scenario 2 |
|||
---|---|---|---|---|---|
Classic mode | values | Cure mode | values | ||
Full population | PFS: chemotherapy | Log-logistic | Shape = 2.339 Scale = 9.146 |
Log-logistic mixture cure | theta = 0.0426 shape = 2.5569 scale = 8.6537 |
PFS: sacituzumab govitecan | Log-normal | Meanlog = 2.9889 Sdlog = 1.0169 |
Log-normal mixture cure | theta = 0.0569 meanlog = 2.8824 sdlog = 0.9411 |
|
OS: chemotherapy | Log-logistic | Shape = 1.904 Scale = 28.350 |
Log-logistic non-mixture cure | theta = 0.0243 shape = 1.74 scale = 67 |
|
OS: sacituzumab govitecan | Weibull | Shape = 1.424 Scale = 67.278 |
Weibull mixture cure | theta = 0.1174 shape = 1.5381 scale = 57.0151 |
|
BMN population | PFS: Chemotherapy | Log-logistic | Shape = 2.569 Scale = 8.972 |
Log-logis mixture cure | theta = 0.00241 shape = 2.59 scale = 8.95 |
PFS: sacituzumab govitecan | Log-logistic | Shape = 1.770 Scale = 22.097 |
Weibull mixture cure | theta = 0.0721 shape = 1.4158 scale = 27.8427 |
|
OS: chemotherapy | Log-logistic | Shape = 1.839 Scale = 28.903 |
Log-logistic mixture cure | theta = 0.00415 shape = 1.85 scale = 28.8 |
|
OS: sacituzumab govitecan | Weibull | Shape = 1.411 Scale = 72.222 |
Gompertz non-mixture cure | theta = 0.24201 shape = 0.03646 rate = 0.00385 |
|
Grade 3 or 4 AEs in the chemotherapy arm | Incidence | Range | Distribution | ||
Fatigue | 5.40% | (4.05%–6.75%) | Beta | ||
Leukopenia | 5.40% | (4.05%–6.75%) | Beta | ||
Anemia | 4.90% | (3.68%–6.13%) | Beta | ||
Neutropenia | 33% | (24.75%–41.25%) | Beta | ||
Diarrhea | 0.40% | (0.3%–0.5%) | Beta | ||
Febrile neutropenia | 2.20% | (1.65%–2.75%) | Beta | ||
Grade 3 or 4 AEs in the sacituzumab govitecan arm | |||||
Fatigue | 3.10% | (2.33%–3.88%) | Beta | ||
Leukopenia | 10.10% | (7.58%–12.63%) | Beta | ||
Anemia | 7.80% | (5.85%–9.75%) | Beta | ||
Neutropenia | 51.20% | (38.4%–64%) | Beta | ||
Diarrhea | 10.50% | (7.88%–13.13%) | Beta | ||
Febrile neutropenia | 5.80% | (4.35%–7.25%) | Beta | ||
PFS progression-free survival. OS overall survival. BMN brain metastatic-negative. AEs adverse events. |