Katzenstein HM, Malogolowkin MH, Krailo MD, Piao J, Towbin AJ, McCarville MB, Tiao GM, Dunn SP, Langham MR, McGahren ED, Finegold MJ, Ranganathan S, Weldon CB, Thompson PA, Trobaugh-Lotrario AD, O’Neill AF, Furman WL, Chung N, Randazzo J, Rodriguez-Galindo C, Meyers RL. Doxorubicin in combination with cisplatin, 5-flourouracil, and vincristine is feasible and effective in unresectable hepatoblastoma: A Children’s Oncology Group study. Cancer. 2022 Mar 1;128(5):1057-1065. doi: 10.1002/cncr.34014. Epub 2021 Nov 11. PubMed PMID: 34762296; PubMed Central PMCID: PMC9066555.
Study ID Citation
Abstract
The Children’s Oncology Group (COG) adopted cisplatin/5FU/vincristine (C5V) as standard therapy after legacy study INT-0098 showed statistically equivalent survival, but less toxicity, when compared to cisplatin/doxorubicin (CD). Subsequent experience demonstrated doxorubicin to be effective in patients with recurrent disease after C5V, suggesting that it could be incorporated to intensify therapy for patients with advanced disease. In this COG non-randomized, phase 3 trial, we aimed to primarily explore the feasibility and toxicity of the novel therapeutic C5VD regimen with the addition of doxorubicin to C5V for patients considered to be intermediate-risk (IR). Patients were eligible if they had unresectable, non-metastatic disease. Patients with a complete resection at diagnosis with local pathologic evidence of small cell undifferentiated histology were also eligible for assessment of feasibility.