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Results From Study 2
(SIOPEL 6)
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Not actual patient.
PEDMARK significantly reduced the relative risk of hearing loss by 42% in the International Childhood Liver Tumor Strategy Group study (SIOPEL 6) compared with cisplatin alone1
Study Design: A multicenter, randomized, controlled, open-label study conducted by the International Childhood Liver Tumor Strategy Group (SIOPEL) to assess the efficacy and safety of sodium thiosulfate (STS) in reducing ototoxicity in children receiving cisplatin (CIS) chemotherapy for standard risk hepatoblastoma (SR-HB). Eligible study participants were children aged 1 month to 18 years with histologically confirmed newly diagnosed SR-HB. Children were randomized 1:1 to receive STS after each CIS dose (CIS + STS arm) or CIS without subsequent STS (CIS Alone arm).1
Percentage of patients with hearing loss (ITT population) in SIOPEL 6 (n=114)1
6 patients in the PEDMARK + cisplatin arm and 7 patients in the cisplatin alone arm did not have hearing data available for evaluation and were assumed to have hearing loss in the analysis.1
ITT=intent-to-treat.
PEDMARK has a demonstrated safety profile in patients with standard risk hepatoblastoma1
Adverse reactions occurring in ≥10% of patients who received PEDMARK, with a difference of >5% compared to cisplatin alone in SIOPEL 61
| Adverse Reaction | PEDMARK + cisplatin (n=53) | Cisplatin alone (n=56) | ||
|---|---|---|---|---|
| All grades (%) |
Grade 3 or 4 (%) |
All grades (%) |
Grade 3 or 4 (%) |
|
| Gastrointestinal disorders | ||||
| Vomiting | 85 | 8 | 54 | 3.6 |
| Nausea | 40 | 3.8 | 30 | 5 |
| Investigations | ||||
| Decreased hemoglobin | 34 | 19 | 29 | 16 |
| Metabolism and nutrition disorders | ||||
| Hypernatremia | 26 | 1.9 | 3.6 | 0 |
| Hypokalemia | 15 | 9 | 1.8 | 0 |
| Hypophosphatemia | 15 | 9 | 1.8 | 0 |
| Hypermagnesemia | 11 | 9 | 5 | 3.6 |
| General disorders | ||||
| Pyrexia | 15 | 0 | 9 | 0 |
Patients who received PEDMARK were treated for a median of 6 cycles (range: 2 to 8 cycles) over a
median of 94 days of chemotherapy.1
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IMPORTANT SAFETY INFORMATION
- PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.
- Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.
- PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.
- Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.
- Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73 m2.
- Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.
- The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.
Please see full Prescribing Information for PEDMARK.
INDICATIONS AND USAGE
PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non‑metastatic solid tumors.
Limitations of Use
The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.