Table 4.
Demographic data and clinical outcomes of Y-90 SIRT for HCC treatment in previously published studies and the current study.
| Sangro et al.20 | Salem et al.22 | Mantry et al.32 | Bhangoo et al.31 | Hilgard etal.19 | Mazzaferro et al.21 | Khor et al.34 | Lee et al.29 | Woo et al.33 | Floridi et al.30 | The current study | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment year | 2003–2009 | 2004–2008 | 2004–2013 | 2005–2014 | 2006–2009 | 2007–2009 | 2008–2012 | 2009–2013 | 2009–2011 | 2009–2015 | 2014–2019 |
| Study design | Retrospective real-world cohort | Prospective real-world cohort | Retrospective real-world cohort | Retrospective real-world cohort | Retrospective real-world cohort | Prospective phase 2 study | Retrospective real-world cohort | Retrospective real-world cohort | Retrospective real-world cohort | Retrospective real-world cohort | Retrospective real-world cohort |
| Country | Europe (multicenter) | USA | USA | USA | Germany | Italy | Singapore | China | Korea (Two centers) | Italy | Thailand |
| Number | 325 | 291 | 111 | 17 | 108 | 52 | 103 | 30 | 50 | 43 | 52 |
| Age (years)a | 65 ± 11 | 65 (26–90) | 66 ± 10 | 68 (50–83) | 65 ± 12 | 64 (27–82) | 62 ± 10 | 63 (36–84) | 66 (33–91) | 66 ± 10 | 65 ± 11 |
| Male (%) | 82 | 77 | 77 | 100 | 80 | 94 | 75 | 87 | 80 | 86 | 81 |
| ECOG 0, 1 (%) | 54, 33 | 56, 36 | 90, 8 | N/A | 51, 44 | 60, 40 | 40, 53 | N/A | N/A | N/A | 50, 48 |
| Multifocal (%) | 76 | 73 | N/A | 82 | N/A | 69 | 81 | 100 | 7 | 79 | 71 |
| Bilobar (%) | 53 | 48 | 50 | 47 | N/A | 6 | 58 | N/A | 8 | 63 | 48 |
| CP A, B (%) | 83, 18 | 45, 52 | 74, 23 | 53, 41 | 77, 22 | 83, 17 | 59, 38 | 80, 20 | 96, 4 | 86, 9 | 86, 14 |
| BCLC | |||||||||||
| A (%) | 16 | 17 | 34 | 6 | 2 | 0 | 1 | 0 | 40 | 12 | 0 |
| B (%) | 27 | 28 | 46 | 65 | 47 | 33 | 27.2 | 60 | 24 | 74 | 29 |
| C (%) | 56 | 52 | 20 | 24 | 51 | 7 | 69 | 40 | 36 | 14 | 71 |
| PVT (%) | 23 | 43 | 15 | 24 | 31 | 67 | 31 | 40 | 30 | 14 | 63 |
| Prior treatment (%) |
55 |
13 |
N/A |
53 |
37 |
29 |
36 |
40 |
6 |
47 |
58 |
| Response rate by mRECIST criteria | Not assessed | CR 23%, PR 34%b |
CR 11%, PR 14%, stable disease 20%, PD 7%c |
CR 0%, PR 24%, stable disease 24%, PD 35%, no data 18% |
CR 6%, PR 35%, stable disease 48%, PD 10%c |
CR 10%, PR 31%, stable disease 38%, PD 21%b |
CR 0%, PR 21%, stable disease 39%, PD 40%c |
CR 3%, PR 27%, stable disease 20%, PD 50% |
CR 20%, PR 38%, stable disease 27%, PD 8% |
CR 8%, PR 8%, stable disease 42%, PD 36% |
CR 2%, PR 33%, stable disease 19%, PD 46% |
| OS (median (95% CI), months) | 12.8 (10.9–15.7) | N/A | 13.1 (10.3–18.4) | 8.4 (1.3–21.1) | 16.4 (12.1–∞) | 15.0 (12.0–18.0) | 14.4 (11.0–22.2) | 13.2 | 40.9 (10.2–71.6) | 27.7 (15.8–27.7) | 11.0 (7.8–14.3) |
| PFS (median (95% CI), months) | N/A | 7.9 (6.0–10.3) | 9.8 (6.8–14.8) | N/A | 10.0 (6.1–16.4) | 11.0 (6–NC) | 5.3 (4.1–10.0) | 3.3 | 5.8 (0.9–46.1) | 16.8 (11.1–22.4) | 2.4 (1.0–3.9) |
Abbreviations: BCLC, Barcelona Clinic Liver Cancer; CI, confidence interval; CP, Child-Pugh class; CR, complete response; EASL, European Association for the Study of the Liver; ECOG, Eastern Cooperative Oncology Group; mRECIST, modified Response Evaluation Criteria in Solid Tumors; N/A, not available; NC, not calculable; OS, overall survival; PD, progressive disease; PFS, progression free survival; PR, partial response; PVT, portal vein thrombosis; USA, United States of America.
a
Age was expressed as the mean ± standard deviation or median (range).
b
EASL
c
RECIST.