Upfront Window Vincristine/Irinotecan Treatment of High-Risk Hepatoblastoma: A Report From The Children’s Oncology Group AHEP0731 Study Committee

Upfront Window Vincristine/Irinotecan Treatment of High-Risk Hepatoblastoma: A Report From The Children’s Oncology Group AHEP0731 Study Committee
This original article shows the result of the AHEP0731 study conducted by the COG. This study explores the efficacy of a new chemotherapy regimen (2 cycles of VI administered in an upfront window) for high risk hepatoblastoma by assessing the response rate and the outcome.
The study population included newly-diagnosed high risk hepatoblastoma. Patients received vincristine (V) on days 1 and 8 with irinotecan (I) on days 1 to 5. Response was assessed after 2 cycles and "response" was defined as either radiologic or decrease in AFP. Responders received 2 additional cycles of VI intermixed with 6 cycles of C5VD (cisplatin, 5-FU, vincristine and doxorubicine). Patients who were nonresponders received 6 cycles of C5VD without further VI. Two study radiologists used RECIST criteria to determine overall response for all patients.
32 patients were enrolled. 14/30 evaluable patients were responders (RECIST and AFP in 6 patients, RECIST only in 3 patients, and AFP only in 5 patients). However, an additional group of 15 patients had some decrease in AFP (7%-89%) in response to VI. The median AFP decline after 2 cycles of VI for the entire group was 85% of the initial AFP. The 3-year event-free and overall survival rates were 49% (95% CI, 30%-65%) and 62% (95% CI, 42%-77%), respectively.
- Small number of patients.
- The way they assess their primary outcome may have impacted their ability to demonstrate the efficacy of this new regimen. This underlines the importance of using the appropriate assessment tool (any AFP decline versus a real cut-off of 90% decline).
Although VI regimen did not meet predetermined criteria for demonstrating sufficient disease control, it appears to have a substantial activity in a large group of newly diagnosed patients with high-risk HB. Its role remains to be determined.

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