Table 2.
Efficacy measurements | Adult (n =24) | Children (n = 12) |
---|---|---|
Response at 12 weeks | ||
Complete response | 1 (4.2%) | 4 (33.3%) |
Confirmed partial response a | 14 (58.3%) | 6 (50.0%) |
Stable disease | 2 (8.3%) | 0 (0.0%) |
Progressive disease | 6 (25.0%) | 2 (16.7%) |
ORR at 12 weeks | 62.5% | 83.3% |
ITT failure‐free survival | ||
KM median, months (95% CI) | 10.2 (6.0, 14.2) | 8.7 (5.1, 14.4) |
ITT overall survival | ||
KM median | NR | NR |
Patients' status at last follow‐up | ||
NED | 3 (12.5%) | 3 (25.0%) |
AWD | 12 (50.0%) | 5 (41.7%) |
DOD | 9 (37.5%) | 4 (33.3%) |
One patient received only two cycles of AVI and was evaluated as unconfirmed PR.
Abbreviations: AVI, anlotinib, vincristine, and irinotecan; AWD, alive with disease; CI, confidence interval; DOD, died of disease; ITT, intention‐to‐treat population; KM, Kaplan‐Meier; NED, no evidence of disease; NR, not reached; ORR, overall response rate.