SIR-Spheres® Y-90 resin microspheres
Contraindications and Potential Adverse Events
Contraindications
SIR-Spheres® Y-90 resin microspheres are contraindicated in patients who have or are:
- had previous external beam radiation therapy to the liver
- ascites or are in clinical liver failure
- abnormal liver function tests (LFTs)
- total bilirubin > 2.0 mg/dL and/or albumin < 3.0 g/dL
- > 30 Gy absorbed radiation dose to the lungs, as estimated by the Technetium-99m macroaggregated-albumin (99mTc MAA) study
- pre-assessment angiogram that demonstrates potential pathways for deposition of microspheres to non-target organs such as the stomach, pancreas, or bowel that cannot be corrected (coiling)
- patients who are pregnant
Adverse Events
When the patient is treated with proper technique, without excessive radiation to any organ, the common adverse events after receiving the SIR-Spheres Y-90 resin microspheres are fever, transient decrease of haemoglobin, transient thrombocytopenia, mild to moderate abnormality of liver function tests (mild increase in aspartate aminotransferase, alkaline phosphatase, bilirubin), abdominal pain, nausea, vomiting, and diarrhea.
Potential Serious Adverse Events Due to High Radiation
Acute Pancreatitis: causes immediate severe abdominal pain. Verify by SPECT/CT or PET/CT of the abdomen and test for serum amylase.
Radiation Pneumonitis: causes excessive non‑productive cough. Verify by X-ray evidence of pneumonitis.
Acute Gastritis: causes abdominal pain. Verify by standard methods to diagnose gastric ulceration.
Acute Cholecystitis: causes significant upper abdominal pain and may require cholecystectomy for resolution. Verify by appropriate imaging studies.
Radioembolization induced liver disease (REILD): REILD is a rare complication following Selective Internal Radiation Therapy (SIRT). REILD is characterized by a well-defined constellation of temporal, clinical, biochemical, and histopathologic findings. It typically manifests approximately 4 to 8 weeks post-SIRT and is characterized clinically by jaundice and ascites in the absence of tumor progression or bile duct obstruction.
The typical biochemical picture of REILD is an elevated bilirubin (> 3 mg/dL) in almost all cases, elevated alkaline phosphatase (ALP) and gamma- glutamyl transpeptidase (GGT) in most cases, accompanied by virtually no change in the transaminases (AST and ALT). If liver biopsy is performed, the typical histological appearance is of sinusoidal obstruction that may resemble veno-occlusive disease.
REILD may occur in both non-cirrhotic and cirrhotic patients.
Prophylactic treatment with methylprednisolone and ursodeoxycholic acid starting on the day of SIRT and continued for two months may reduce the incidence of REILD.
In the treatment of REILD, low molecular weight heparin may also be considered but both corticosteroids and heparin may only be useful if commenced very early in the course of the disease.
SIR-Spheres® Y-90 resin microspheres are indicated for the treatment of:
- Unresectable hepatocellular carcinoma (HCC), or
- Unresectable metastatic liver tumors from primary colorectal cancer (mCRC) in patients refractory to or intolerant of chemotherapy, or
- Unresectable intrahepatic cholangiocarcinoma (iCCA), or
- Hepatic metastases by neuroendocrine tumours (mNET), or
- Other liver metastases