Table 1_Real-world clinical outcomes and safety of anlotinib-containing regimens in pediatric solid tumors: a retrospective cohort study at a Chinese center.xlsx

Patients with other solid tumors (n=21) had an ORR of 19.0%, a DCR of 57.1%, and a median PFS of 9.4 months, compared with 0%, 25.0%, and 3.0 months, respectively, among patients with sarcomas (n=24). The observed DCR was 80.0% among patients without metastatic or recurrent disease (n=10) and 28.6% among those with metastatic or recurrent disease (n=35). DCRs were 33.3%, 48.0%, and 0% in the usual-dose (n=18), low-dose (n=25), and high-dose (n=2) groups, respectively; exploratory analyses did not detect statistically significant differences in DCR (p=0.393) or PFS distributions (p=0.395) across the three groups.

Exploratory analyses did not detect statistically significant differences across the treatment-regimen groups in ORR (p=0.133), DCR (p=0.454), or PFS distributions (p=0.480). TEAEs were documented in 97.8% of patients, with grade 3–4 TEAEs observed in 84.4%. Hematologic TEAEs were the most frequently documented category (91.1%).

Frequent non-hematologic events included pyrexia (62.2%), proteinuria (35.6%), hypokalemia (33.3%), and hypoalbuminemia (33.3%).</p>Conclusion<p>In this small, heterogeneous, single-center Chinese pediatric cohort, patients receiving anlotinib-containing regimens had limited objective response and a high incidence of grade 3–4 TEAEs, predominantly involving hematologic events. Subgroup findings were exploratory and may reflect selection bias, confounding by indication, tumor heterogeneity, and concomitant therapies.

Larger prospective studies are required before comparative treatment or dosing conclusions can be made.</p>