Table 3.
Proportion of patients with an objective tumor response
| Objective tumor response (OTR) |
Median time to OTRa | OTR sustained ≥24 weeks | Tumor control sustained ≥24 weeks | ||
|---|---|---|---|---|---|
| Crude incidence n/N1 (%) |
95% CIb | Months (95% CI) | n/N2 (%) | n/N2 (%) | |
| Based on best response | 15/17 (88) | 64–99 | 3.0 (2.9–3.1) | 13/15 (87) | 15/15 (100) |
| Modified RECIST ver.1.1 | 6/17 (35) | 14–62 | NE (8.5–NE) | 3/15 (20) | 15/15 (100) |
| Modified EORTC (18F-FDG–PET) | 14/17 (82) | 57–96 | 3.1 (2.9–8.6) | 8/15 (53) | 14/15 (93) |
| Modified inverse Choi (density/size) | 12/17 (71) | 44–90 | 3.1 (2.9–NE) | 10/15 (67) | 15/15 (100) |
N1 is the number of patients with at least one evaluable time point assessment using the respective tumor response criterion. N2 is the number of subjects with at least two evaluable time point assessments that were at least 24 weeks apart using the respective tumor response criteria.
aKaplan–Meier estimate.
bExact confidence interval.
NE, not estimable; OTR, objective tumor response = CR + PR; tumor control = CR + PR + SD.