Sodium thiosulfate: Phase III data

Preliminary data from 104 evaluable patients ages 1-18 years old receiving cisplatin for newly diagnosed cancer in the open-label, international Phase III ACCL0431 trial showed that 16 g/m 2 IV STS given after each cisplatin dose significantly reduced the proportion of patients with hearing loss 4 weeks after the final cisplatin dose - the primary endpoint - vs. untreated controls (28.6% vs. 56.4%, p=0.004). On secondary endpoints at a median post-enrollment follow-up of 2.9 years for all 126 patients enrolled, STS led to an EFS rate of 61.2% vs. 69.9% for untreated controls (p=0.31) and an OS rate of 77% vs. 88.9% for controls (p=0.029). A post hoc analysis of 78 patients with localized disease showed an EFS rate of 72.5% for STS vs. 68.3% for controls (p=0.94) and an OS rate of 89% for STS vs. 89.5% for controls (p=0.48). A post hoc analysis of 47 patients with metastatic disease showed an EFS rate of 41.6% for STS vs. 72.5% for controls (p=0.085) and an OS rate of 55.9% for STS vs. 88.1% for controls (p=0.011). The trial was sponsored by the Children's Oncology Group. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...