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Statement

Treatment of early-stage HCC with SIRT is aimed at bridging to transplant, resection or RFA.

References: SIRT with resin microspheres in Asian regions

Article

Yang et al. Yttrium-90 transarterial radioembolization versus conventional transarterial chemoembolization for patients with hepatocellular carcinoma: a systematic review and meta-analysis. Cancer Biol Med. 2018;15(3):299-310. doi: 10.20892/j.issn.2095-3941.2017.0177

Grade

B-NR

Key Points

  • Meta-analysis of 2 RCTs and 9 observational studies conducted in Germany, Spain, China, Egypt, Turkey, USA: 1652 patients with unresectable HCC treated with SIRT (resin and/or glass)
  • HBV: 14.1% in TACE, 12.9% in SIRT; HCV: 32.1% in TACE, 40.7% in SIRT
  • Liver function was assessed and reported for each paper; no differences were found in patient characteristics among the trials
  • 1-year and 2-year survival rates were analyzed based on observational or RCT study design; 1-year rates were similar, but 2-year rates were higher for SIRT than TACE treated patients
  • Tumor responses were assessed using either WHO (n=4) or mRECIST (n=5), the significant differences varied depending on type of analysis used (mRECIST)
  • Serious AEs (≥grade 3) were rare and did not differ between treatments
Woo et al. Effect of yttrium-90 radioembolization on outcomes in Asian patients with early to advanced stage hepatocellular carcinoma. Hepatol Res. 2017 Apr;47(5):387-397. doi: 10.1111/hepr.12759

B-NR

  • Retrospective multi-center (South Korea) case series of HCC patients (n=50), BCLC stages A—C (20% HCV, 66% HBV), treated with SIRT (resin)
  • Study aim was to specifically evaluate safety, efficacy, and outcomes of SIRT treatment in a population of Asian patients (treated in South Korea), a majority of whom had chronic HBV infections
  • 40% of patients showed a response to treatment while 46% achieved stable disease. BCLC stage was significantly associated with overall response rate (ORR) (p=0.003)
  • Median overall survival (OS) for the entire cohort was 40.9 months (95% CI, 10.2–71.6 months). For patients with BCLC stage A, median survival was not reached, but the mean survival time was 39.4 months. For patients with BCLC stage B, median OS was 42.4 months (95% CI, 22.9–86 months), and for patients with BCLC stage C, median OS was 17.9 months (95% CI, 11.2–24.7 months)
  • In univariate analysis, BCLC stage, Child-Pugh Score, PVT, and tumor response were significantly associated with survival
  • Median time-to-progression (TTP) for the group overall was 5.9 months (range 0.9—46.1 months)
  • Follow-up treatments were conducted in 31 patients due to remnant HCC or HCC progression; these follow-up treatments included TACE, RFA, surgery, radiation treatment, and combination treatments
  • SIRT treatment appears to be well tolerated and effective in Asian patients with early to intermediate stage BCLC, and follow-up treatments post-SIRT were safely provided in this population
Kwok et al. Survival benefit of radioembolization for inoperable hepatocellular carcinoma using yttrium-90 microspheres. J Gastroenterol Hepatol. 2014 Nov;29(11):1897-904. doi: 10.1111/jgh.12621

C-LD

  • Retrospective single-center (Hong Kong) study of outcomes in patients with inoperable HCC who received SIRT treatment (n=30) (resin) compared to those who did not (n=16)
  • HCV/HBV infection rates of patients were not specified
  • MAA assessment was performed in both groups and survival time was calculated from that date
  • Median overall survival (OS) was >31.9 months for patients with BCLC A stage disease, 14.5 months for patients with BCLC B, and 5.2 months for patients with BCLC C
  • Among patients with BCLC C, SIRT treatment was associated with significantly longer median OS (5.2 months vs 3.8 months, p=0.047.
  • SIRT was also significantly associated with longer OS among patients with PVT (5.2 months vs 3.8 months, p=0.04) and patients who had less than 3 nodules (10.6 months vs 3.3 months, p=0.004)
  • Multivariate analysis identified independent factors for survival as Child-Pugh class, tumor diameter sum, BCLC stage, and SIRT treatment
  • Radioembolization-induced liver disease (REILD) was reported in 13% of patients
  • SIRT may improve survival for certain subgroups of patients with inoperable HCC, but caution should be taken for the possible complication of REILD

Pardo et al. The Post-SIR-Spheres Surgery Study (P4S): Retrospective analysis of safety following hepatic resection or transplantation in patients previously treated with selective internal radiation therapy with yttrium-90 resin microspheres. Ann Surg Oncol. 2017;24(9):2465-2473. doi: 10.1245/s10434-017-5950-z

C-LD

  • Retrospective multi-center case series (Asia-Pacific, Europe, USA) of patients with HCC (or other malignancies) receiving SIRT with resin microspheres, followed by liver transplantation or resection
  • Patient characteristics included bilobar (n=44), cirrhosis (n=41), total bilirubin grade ≥1 (n=28)
  • Intent of SIRT was bridge (n=9) downstaging or palliative (n=84) or not available (n=7)
  • Median IQR total SIRT activity was 1.5 GBq
  • Median time to LT was 10.1 months and to surgery, 5.7 months
  • Complete resection was achieved in 54 patients, R1 in 15, and R2 in 2
  • 25 resected patients had exposure of the FLR to SIRT, 3 had partial exposure of the FLR to SIRT; 32 had whole liver SIRT
  • 78 patients did not have post-SIRT chemotherapy