Clinical trial results show that sodium thiosulfate protects cisplatin-related hearing loss in children with liver cancer
The drug sodium thiosulfate can shield the hearing of youngsters with cancer that is being treated with the radiation treatment medicine cisplatin, according to a new study results program. The scientific trial engaged youngsters with liver cancer cells that had not spread (local cancer cells). And for whom cisplatin was the standard chemotherapy drug. Although cisplatin is very effective, it can also cause hearing loss in many children.
Participants in the trial, conducted primarily in Europe, were randomly assigned to receive either sodium thiosulfate or cisplatin alone 6 hours after each cisplatin treatment. The researchers reported that children in the sodium thiosulfate group were half as likely to develop permanent deafness as those in the group who received cisplatin alone. Importantly, sodium thiosulfate did not appear to reduce the efficacy of cisplatin: how many children in each treatment team lived 3 years after finishing treatment? The New England Journal of Medicine released the test outcomes on June 21.
The results mirror those of a similar trial performed last year in the United States, which checked sodium thiosulfate’s capability to avoid cisplatin-induced hearing loss in youngsters with various kinds of cancer cells.
” It’s encouraging that there are 2 studies showing that you can lower the risk of hearing loss in these children without lowering the performance of chemotherapy,” commented Dr. Lisa Cunningham., a researcher at the National Institute on Deafness and Various Other Interaction Problems that was not involved in either test.
Hearing loss influences advancement
Today, more than 80% of kids detected with cancer are alive at least 5 years after medical diagnosis, and many are thought about curable.
Researchers are now turning more attention to reducing the long-term side effects experienced by children from many widely used cancer treatments. Dr. Cunningham commented that these problems include heart or lung problems, cognitive impairment, infertility and hearing loss.
“Over the past decade or so, we have better understood how these drugs damage the inner ear.” For example, earlier this year, her lab published results showing that cisplatin remains in the inner ear for a long time, which may explain why its use causes hearing loss. Dr. Edward Neuwelt of Oregon Health and Science University said:
Hearing loss can have significant long-term effects in children undergoing cancer treatment, and he helped lead two recent trials. “Approximately 60% to 80% of children treated with cisplatin have serious hearing loss,” Dr. Neuwelt explained. He continued that the effects of hearing loss can be profound, including a significantly increased risk of missing school.
Dr. Cunningham added that the consequences can be more severe in very young children. “Hearing loss actually impacts their ability to develop normal speech and language skills, which… can cause serious developmental problems for the child,” she explains. It is believed to bind to unsafe molecules called responsive oxygen types produced in cisplatin cells. This combination prevents free radicals from damaging inner ear hair cells, which play a crucial role in hearing.
It’s also possible that sodium thiosulfate works by binding to cisplatin itself, preventing any remaining cisplatin from killing cells in the ear, Dr. Cunningham said.
Results from an NCI-supported Children’s Oncology Group-led trial published last year included children with multiple cancer types who received cisplatin as a treatment. [European trials require testing of cisplatin in other cancer types, including adults. Sodium sulfate was used for additional studies.
2023 on September 20, the FDA approved the marketing application for Fennec Pharmaceuticals’ sodium thiosulfate injection (Pedmark) to reduce the risk of cisplatin-related complications in pediatric patients 1 month old and older with local non-metastatic solid tumors. Hearing loss is becoming the first drug in this field.
This news affected Fennec Pharmaceuticals’ stock price, which rose 15.78%, with a total market value of US$199 million.
The approval was based on two multicenter, open-label, randomized, controlled Phase III clinical trials to evaluate the efficacy and security of the drug in pediatric patients receiving cisplatin.
The SIOPEL 6 study enrolled a total of 114 pediatric patients with hepatoblastoma who received 6 cycles of cisplatin-based chemotherapy. The results showed that only 39% of cisplatin + Pedmark group patients developed grade 1 or higher hearing loss. In comparison, the incidence of hearing loss in the cisplatin alone group was 68%, and the study met the primary endpoint.
Another COG ACCL0431 study included 125 pediatric patients with solid tumors who received chemotherapy. The results showed that the incidence of hearing loss in the Pedmark + cisplatin and the cisplatin alone groups were 44% and 58%, respectively. The two studies show that Pedmark significantly decreases the risk of hearing loss in patients with localized, non-metastatic solid tumors.
Overall, the drug was safe and well-tolerated, with the most common adverse reactions (≥25%) in both studies being vomiting, nausea, decreased hemoglobin, hyponatremia, and hypokalemia.
“The approval of Pedmark is a significant development for pediatric clients with local, non-metastatic solid growths who have hearing loss caused by cisplatin. Cisplatin is a key chemotherapy agent for many childhood malignancies; however, it may also induce permanent and ineffective Reversed bilateral hearing impairment.” “Thanks to Pedmark, physicians now have a new treatment option to meet the treatment needs of these patients and avoid the risk of ototoxicity,” said Rosty Raykov, CEO of Fennec Pharmaceuticals.
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The drug sodium thiosulfate can shield the hearing of youngsters with cancer that is being treated with the radiation treatment medicine cisplatin, according to a new study results program. The scientific trial engaged youngsters with liver cancer cells that had not spread (local cancer cells). And for whom cisplatin was the standard chemotherapy drug. Although…