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Assessment of treatment with sorafenib plus doxorubicin vs sorafenib alone in patients with advanced hepatocellular carcinoma: Phase 3 CALGB 80802 randomized clinical trial

JAMA Nov 26, 2019

Abou-Alfa GK, Shi Q, Knox JJ, et al. - In this unblinded randomized phase 3 clinical trial involving 356 individuals [mean (SD) age was 62 (10.1) years] with advanced hepatocellular carcinoma, experts aspired to explore whether doxorubicin added to sorafenib therapy improves overall survival (OS), with stratification for locally advanced and metastatic disease. In the doxorubicin plus sorafenib arm, median OS was 9.3 months and in the sorafenib arm alone was 9.4 months. In the doxorubicin plus sorafenib arm, the median progression-free survival was 4.0 months, and in the sorafenib alone arm was 3.7 months. According to findings, adding doxorubicin to sorafenib therapy has not improved OS and has resulted in increased toxicity. It should not be used to treat advanced hepatocellular cancer by combining doxorubicin and sorafenib. Reported adverse events were grade 3 or 4 neutropenia and thrombocytopenia.
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