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Statement

References: SIRT with resin microspheres in Asian regions

Article

Grade

Key Points

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

B-NR

  • 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

References: SIRT with resin microspheres in non-Asian regions

Article

Grade

Key Points

Kolligs et al. Pilot randomized trial of selective internal radiation therapy vs. chemoembolization in unresectable hepatocellular carcinoma. Liver Int. 2015;35(6):1715-21. doi: 10.1111/liv.12750

B-R

  • Multi-center open-label pilot RCT conducted in Germany on patients with unresectable HCC receiving SIRT with resin microspheres
  • Patients randomized to receive either SIRT (n=13) or TACE (n=15)
  • Patient characteristics included ECOG 0/1 (SIRT, n=10/3; TACE, n=12/3); Child Pugh 5/6/7 (SIRT, n=9/3/1; TACE, n=9/4/2); AFP mean (SIRT, 636 ng/dL; TACE, 2624.7 ng/dL); total bilirubin median IQR (SIRT 1; TACE 1.08); Albumin median IQR (SIRT 3.63; TACE 4.20); BCLC A/B/C (SIRT, n=5/5/3; TACE, n=4/8/3)
  • Median activity 1.6 GBq delivered to whole (n=7), lobe (n=5), or segment (n=1)
  • No difference in QoL measures were detected 12 weeks after treatment
  • Using RECIST 1.0, PR was 30.8% for SIRT and 13.3% for TACE; 2 patients in each group were downstaged for LT (n=3) or RFA (n=1)
  • Median PFS was 3.6 months for SIRT and 3.7 months for TACE
  • No differences in frequency of AE between groups; only GI events occur more frequently in SIRT group; SAE occurred in 7 and 5 patients, respectively

Oladeru et al. Conformal external beam radiation or selective internal radiation therapy-a comparison of treatment outcomes for hepatocellular carcinoma. J Gastrointest Oncol. 2016 Jun;7(3):433-40. doi: 10.21037/jgo.2015.10.04

B-NR

  • Retrospective SEER analysis of 189 patients (USA) with unresectable HCC who were treated with SIRT using resin microspheres (n=77) or treated with SBRT (n=112)
  • Etiology not specified
  • Median overall survival (OS) for SIRT-treated patients was 12 months (95% CI: 9–17) vs 14 months (95% CI: 10–18) for patients treated with SBRT
  • Disease-specific survival (DSS) for SIRT-treated patients was 14 months (95%
    CI: 10–22) vs 14 months (95% CI: 12–20) for patients treated with SBRT
  • After adjustment for confounding factors, no significant differences were seen between treatment groups for OS (hazard ratio (HR), 0.72; 95% CI, 0.49–1.07; p=0.1077) or DSS (HR, 0.70; 95% CI, 0.46–1.05; p=0.0880)
  • For both treatment groups, elevated AFP levels were significantly associated with higher risk of death (p=0.0459) and disease-specific risk of death (p=0.0233) 

Ettore et al. Yttrium-90 radioembolization for hepatocellular carcinoma prior to liver transplantation. World J Surg. 2017;41(1):241-249. doi: 10.1007/s00268-016-3682-z

C-LD

  • Retrospective single-center case series (Italy) of 22 patients with HCC undergoing liver transplant after SIRT with resin microspheres
  • Patient characteristics included hepatitis B/C (n= 2/17); BCLC A/B/C (n=3/15/4); before SIRT within Milan criteria (n=3); at LT within Milan criteria (n=18)
  • Using mRECIST, CR/PR/SD/PD was 9/9/1/2
  • Median activity delivered was 1.6 GBq
  • MELD score increased for 11 patients within 6 months after SIRT and remained stable for 11 patients
  • AFP decreased in all cases after SIRT
  • Downstaging occurred for 19 patients and 3 had successful bridge to LT
  • OS from SIRT was 43.9 months and from LT was 30.2 months