Contract Research & Services
Clinical Trials

New drug cuts hearing loss in children by 50% after cancer treatment

PBR Staff Writer Published 22 June 2018

A clinical trial, funded by Cancer Research UK, has shown that administering sodium thiosulphate (STS) after chemotherapy ‘cisplatin’ for the treatment of childhood liver cancer hepatoblastoma reduces hearing loss in children by almost 50%.

Hepatoblastoma is a rare type of primary liver cancer that affects young children and is often diagnosed in children under two.

During the SIOPEL-6 clinical trial led by researchers at Great Ormond Street Hospital, 109 children were either given cisplatin alone or cisplatin followed by STS six hours later.

While 63% of children who were given cisplatin suffered some hearing loss, only one-third (33%) of children who were also administered STS along with cisplatin suffered hearing loss – a 48% reduction in this side-effect.

The latest findings are expected to pave the way for reducing the number of children who suffer from debilitating side-effects as a result of cancer treatment.

Prof Pam Kearns of Cancer Research UK said: “Hearing is precious and we’re delighted to see that we can safeguard the future development of more children, without compromising the chance of curing their cancer.”

Moreover, the researchers also found that the three-year overall survival for the group given cisplatin was 92.3% and the group that was given cisplatin plus STS had a survival rate of 98.2%. It was found that three-year event-free survival for both groups were 78.8% and 81.2% respectively.

After pre-clinical and clinical research conducted earlier by Ed Neuwelt and his team at Oregon Health and Science University found that STS could prevent hearing loss caused by cisplatin, scientists determined when to administer STS to avoid interference with cisplatin’s effect on the tumor.

They are now examining whether STS could work for other cancers in children where cisplatin is used for the treatment.

The researchers intend to secure marketing authorization from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA has already designated this as a breakthrough therapy and it will be filed under a Pediatric Use Marketing Application in the EU.

The findings of the trial have been published in the New England Journal of Medicine.

Patients from 52 centers in 12 countries were recruited for the SIOPEL-6 trial for which Fennec Pharmaceuticals provided STS free of charge.