Ye H, et al. Three vs 6 Cycles of Chemotherapy for High-Risk Retinoblastoma: A Randomized Clinical Trial. JAMA. 2024;332:1634-1641. PMID 39432296

One-paragraph summary

Two Chinese eye centres randomized 187 enucleated unilateral high-risk patients to three or six CEV cycles.

Key findings

• Five-year DFS was 90.4% versus 89.2%; difference 1.2% (95% CI −7.5 to 9.8), meeting a 12% noninferiority margin.
• Six cycles caused more adverse events, greater quality-of-life reduction and higher costs.

Limitations

• The margin and defined pathology population limit extrapolation to different high-risk combinations or extraocular disease.

Why it matters

The trial provides direct evidence that more chemotherapy is not automatically better after enucleation.

Cited by wiki pages

• enucleation and high risk pathology
• systemic chemotherapy
• clinical trials landscape