Page 35 - ARNM-1-1

Advances in Radiotherapy
& Nuclear Medicine SIR-spheres Y-90 resin microspheres for HCC treatment

last study day. Laboratory values, including liver function that was not classified as either a CR, PR, or PD was
(total bilirubin, alanine transaminase [ALT], aspartate considered a stable disease (SD).
transaminase [AST], albumin, creatinine, γ-glutamyl
transpeptidase [GGT], and alkaline phosphatase levels), 2.5. Safety
hematology (hemoglobin level, hematocrit, and red blood Safety endpoints of AEs and SAEs were chosen for their
cell and white blood cell counts), and the tumor marker feasibility without requiring long-term follow-up in the
α-fetoprotein (AFP) were assessed between 0 and 7 days HCC population. Grading of AEs was assessed using
before SIRT, and at 6 weeks and 3 and 6 months after SIRT. Common Terminology Criteria for AEs v4.03 and the
Patients were followed for 6 months for safety, tumor investigators’ clinical judgment. AEs and SAEs within
response, and changes in clinical presentation. The study 6 months of the SIRT procedure were documented.
population included all enrolled patients who received According to Vietnam regulations, disease progression was
SIRT and had at least one measurement after treatment. considered an SAE.
2.3. SIRT protocol 2.6. Statistical methods
In Vietnam, the Ministry of Health has approved the Baseline characteristics were described using frequencies
SIRT procedure as a standard of care in the treatment of for categorical variables and medians (ranges) or means
patients with HCC. Patients were evaluated for suitability (standard deviations) for continuous variables. Paired
for SIRT by a tumor review board at each institution, t-tests or Wilcoxon signed-rank tests were used to assess
and the treating oncologists coordinated with nuclear changes from baseline to 6 months in laboratory values
medicine physicians and interventional radiologists for and tumors. Missing data were not imputed; P < 0.05 was
SIRT delivery. Concomitant treatments were prescribed considered statistically significant. Data were analyzed
at the discretion of the treating physician. Patients who using SAS 9.4 (SAS Institute Inc).
underwent treatment planning were assessed using
technetium-99m-labeled macroaggregated albumin scans 3. Results
up to 7 days before the procedure. SIRT dose and dosing 3.1. Patients and demographics
schedule were determined by the treating physician based
on disease status. Dosimetry was calculated using the body Of the 46 patients screened between May 2017 and
surface area (BSA) method or partition model. SIRT with November 2018 to receive SIRT for unresectable HCC,
SIR-Spheres® Y-90 resin microspheres was performed 30 patients were enrolled from either the Military
[12]
according to a standard protocol . Central Hospital (n = 18) or Bach Mai Hospital (n = 12)
in Vietnam. Eight patients were without CT or MRI
2.4. Survival and tumor response assessments at the end of the study: 2 patients were
not assessable because they underwent liver resection,
Primary outcomes were tumor response, changes in 2 patients could not undergo the final MRI/CT procedure
liver function tests, and AEs. The secondary outcome
was 6-month OS. Additional endpoints included because they had artificial cardiac pacemakers, and 4
changes from baseline for ECOG performance status were lost to follow-up.
and Child-Pugh class 6 months after SIRT. Duration All patients were Vietnamese, and their median age
of follow-up was estimated from the date of SIRT if the was 60 years (range 44–87 years) (Table 1). At baseline, all
patient received SIRT only once and from the date of patients were Child-Pugh class A, and most had an ECOG
the last SIRT if the patient received SIRT more than performance status of 0. Chronic hepatitis B and D were
once. Tumor response was assessed using computed common, and 10 patients had cirrhosis at baseline.
tomography (CT) or magnetic resonance imaging (MRI) Previous surgical interventions were reported for
(positron electron tomography was optional) at screening 17 patients; because electronic medical records were not
and at 3 and 6 months after SIRT and evaluated using available, the types of procedures were self-reported by
modified Response Evaluation Criteria in Solid Tumors
[13]
(mRECIST) . The disappearance of any intratumoral only 4 of these patients: segmentectomy (n = 2), lobectomy
arterial enhancement in all target lesions was considered (n = 1), or wedge resection (n = 1). Prior medications
a complete response (CR). A decrease of at least 30% in included tenofovir 300 mg and silymarin, and 1 patient
received sorafenib as a targeted therapy.
the sum of the diameter of the viable target lesions was
considered a partial response (PR). An increase of at least At screening, no patients had extrahepatic metastases
20% in the sum of the diameters of viable target lesions or ascites, and 3 patients had hepatic vein invasion. The
was considered a progressive disease (PD). Any response mean diameter (SD) of the tumors was 8.6 (2.3) cm, and the

Volume 1 Issue 1 (2023) 3 https://doi.org/10.36922/arnm.0385