Resected Tumor Outcome and Recurrence (RESTORE) Index for Hepatocellular Carcinoma Recurrence after Resection
Abstract
:Simple Summary
Abstract: Importance
1. Introduction
2. Methods
2.1. Study Design and Patient Population
2.2. Data Source and Variables
2.3. Statistical Analysis and Generation of the RESTORE Index
2.4. Evaluation of Risk Score Performance
3. Results
3.1. Baseline Characteristics of Study Cohort
3.2. Post-Resection Outcomes
3.3. Recurrence Prediction
3.4. Construction of RESTORE Index and Recurrence Estimation
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Variables [n, % of Patients Experiencing Outcome] | Overall (n = 179) | No Recurrence (n = 86) | Recurrence (n = 93) |
---|---|---|---|
Age, years [median (IQR)] | 63 (57–67) | 61 (55–67) | 63 (57–67) |
Age at surgery <50 | 22 (12.3%) | 13 (15.1%) | 9 (9.7%) |
Age at surgery ≥50 | 157 (87.7%) | 73 (84.9%) | 84 (90.3%) |
Sex | |||
Female | 50 (27.1%) | 27 (31.4%) | 23 (24.7%) |
Male | 129 (72.9%) | 59 (68.6%) | 70 (75.3%) |
Race | |||
White | 74 (41.8%) | 26 (30.2%) | 48 (51.6%) |
Asian | 67 (37.9%) | 41 (47.7%) | 26 (28%) |
Black or AA | 22 (12.4%) | 11 (12.8%) | 11 (11.8%) |
Other | 14 (7.9%) | 6 (7%) | 8 (8.6%) |
Underlying Liver Disease | |||
HBV | 60 (33.5%) | 30 (34.9%) | 30 (32.3%) |
HCV | 61 (34.1%) | 30 (34.9%) | 31 (33.3%) |
Cryptogenic | 32 (17.9%) | 12 (14%) | 20 (21.5%) |
Unknown/Missing | 26 (14.5%) | 14 (16.3%) | 12 (12.9%) |
AFP, ng/mL [median (IQR)] | 12.3 (3.7, 183.7) | 5.3 (2.6, 59.9) | 41 (5.8, 397.5) |
≤20 | 94 (52.5%) | 55 (64%) | 39 (41.9%) |
21–99 | 27 (15.1%) | 12 (14%) | 15 (16%) |
100–999 | 29 (16.2%) | 9 (10.5%) | 20 (21.5%) |
1000+ | 29 (16.2%) | 10 (11.6%) | 19 (20.4%) |
Bilirubin, mg/dL [median (IQR)] | 0.80 (0.60, 1.10) | 0.80 (0.60, 1.20) | 0.80 (0.60, 1) |
Albumin, g/dL [median (IQR)] | 3.90 (3.30, 4.15) | 4.00 (3.42, 4.20) | 3.80 (3.10, 4.10) |
ALBI Score | −2.57 (−2.82, −2.05) | −2.66 (−2.86, −2.12) | −2.48 (−2.74, −2.02) |
ALBI Grade 1 | 86 (48%) | 48 (56%) | 38 (41%) |
ALBI Grade 2 | 85 (47%) | 33 (38%) | 52 (56%) |
ALBI Grade 3 | 8 (4.5%) | 5 (5.8%) | 3 (3.2%) |
Pre-Operative LRT | 35 (19.6%) | 15 (17.4%) | 20 (21.5%) |
Pre-Operative TACE | 26 (14.5%) | 10 (11.6%) | 16 (17.2%) |
Pre-Operative Y-90 | 5 (2.8%) | 3 (3.5%) | 2 (2.2%) |
Pre-Operative RFA | 2 (1.1%) | 1 (1.2%) | 1 (1.1%) |
Pre-Operative Bland Embolization | 2 (1.1%) | 1 (1.2%) | 1 (1.1%) |
Radiologic Findings | |||
Number of Nodules | |||
1 | 147 (82.1%) | 74 (86.09%) | 73 (78.5%) |
2 | 19 (10.6%) | 6 (7%) | 13 (14%) |
3 | 8 (4.5%) | 4 (4.7%) | 4 (4.3%) |
4+ | 4 (2.2%) | 1 (1.2%) | 3 (3.2%) |
2+ | 31 (17.3%) | 11 (12.8%) | 20 (21.5%) |
Largest Nodule Size (cm) (mean, 95% CI) | 6.07 (5.41, 6.73) | 5.35 (4.36, 6.34) | 6.74 (5.85, 7.62) |
Aggregate Nodule Size (cm) (mean, 95% CI) | 6.44 (5.73, 7.14) | 5.54 (4.49, 6.58) | 7.25 (6.32, 8.18) |
Liver Pathology | |||
Cirrhosis | 65 (36.3%) | 28 (32.6%) | 37 (39.8%) |
Fibrosis (missing = 0) | |||
0 | 47 (26.3%) | 18 (20.9%) | 29 (31.2%) |
1 | 17 (9.5%) | 14 (16.3%) | 3 (3.2%) |
2 | 19 (10.6%) | 9 (10.5%) | 10 (10.8%) |
3 | 31 (17.3%) | 17 (19.8%) | 14 (15.1%) |
4 | 65 (36.3%) | 28 (32.6%) | 37 (39.8%) |
Steatosis (missing = 15) | |||
0 | 104 (58.1%) | 52 (60.5%) | 52 (55.9%) |
1 | 49 (27.4%) | 25 (29.1%) | 24 (25.8%) |
2/3 | 11 (6.1%) | 8 (9.3%) | 3 (3.2%) |
Inflammation (missing = 12) | |||
0 | 54 (30.2%) | 27 (31.4%) | 27 (29%) |
1 | 60 (33.5%) | 31 (36%) | 29 (31.2%) |
2/3 | 53 (29.6%) | 27 (31.4%) | 26 (28%) |
Tumor Pathology | |||
Differentiation | |||
Well | 26 (14.7%) | 15 (17.4%) | 11 (11.8%) |
Well-Moderate | 19 (10.7%) | 10 (11.6%) | 9 (9.7%) |
Moderate | 86 (48.6%) | 37 (43%) | 49 (52.7%) |
Moderate-Poor | 29 (16.4%) | 15 (17.4%) | 14 (15.1%) |
Poor | 17 (9.6%) | 7 (8.1%) | 10 (10.8%) |
Number of Nodules | |||
1 | 147 (82.1%) | 82 (95.3%) | 65 (69.9%) |
2 | 21 (11.8%) | 4 (4.7%) | 17 (18.3%) |
3 | 5 (2.8%) | 0 (0%) | 5 (5.4%) |
4+ | 6 (3.4%) | 0 (0%) | 6 (6.5%) |
2+ | 32 (18%) | 4 (4.7%) | 28 (30.1%) |
Largest Nodule Size (cm) (mean, 95% CI) | 6.26 (5.54–6.98) | 5.38 (4.27–6.49) | 7.07 (6.15–8) |
Aggregate Nodule Size (cm) (mean, 95% CI) | 6.74 (5.96, 7.51) | 5.43 (4.33, 6.54) | 7.93 (6.89, 8.98) |
Vascular Invasion | |||
No | 128 (71.9%) | 77 (89.5%) | 51 (54.8%) |
Yes | 50 (28.1%) | 8 (9.3%) | 42 (45.2%) |
Capsular Involvement | 67 (38.5%) | 21 (24.4%) | 46 (49.5%) |
Margin Status | |||
R0 | 163 (91%) | 79 (91.9%) | 84 (90.3%) |
≥R1 | 16 (9%) | 7 (8.1%) | 9 (9.7%) |
Number of Nodes Examined (mean, 95% CI) | 0.33 (0.15–0.51) | 0.36 (0.04, 0.67) | 0.31 (0.12, 0.5) |
Variables [n, % of Patients Meeting Criteria] | Overall (n = 179) | No Recurrence (n = 86) | Recurrence (n = 93) |
---|---|---|---|
Radiologic Criteria | |||
Within Milan | 92 | 55 (59.8%) | 37 (40.2%) |
Outside Milan but within UCSF | 26 | 7 (26.9%) | 19 (73.1%) |
Outside UCSF | 61 | 24 (39.3%) | 37 (60.7%) |
Outside Milan | 87 | 41 (47.1%) | 56 (52.9%) |
Pathologic Criteria | |||
Within Milan | 87 | 60 (69%) | 27 (31%) |
Outside Milan but within UCSF | 23 | 8 (34.8%) | 15 (65.2%) |
Outside UCSF | 69 | 18 (26.1%) | 51 (73.9%) |
Outside Milan | 92 | 26 (28.3%) | 66 (71.7%) |
Variable | Comparison | Univariate HR (95% CI) | p Value | Multivariate HR (95% CI) | p Value |
---|---|---|---|---|---|
Patient Characteristic | |||||
Asian Race | Vs. White Race | 0.46 (0.28–0.74) | <0.01 | 0.86 (0.49, 1.51) | 0.60 |
AFP | |||||
100–999 | Vs. ≤20 | 2.37 (1.38–4.08) | <0.01 | 2.01 (1.06, 3.80) | 0.03 |
≥1000 | Vs. ≤20 | 2.47 (1.42–4.28) | <0.01 | 2.02 (1.07, 3.82) | 0.03 |
Radiology | |||||
Aggregate Nodule Size (cm) | Per cm diameter | 1.05 (1.01-1.09) | 0.02 | 0.97 (0.85, 1.13) | 0.81 |
Beyond Milan but within UCSF | Vs. within Milan | 2.43 (1.39–4.24) | <0.01 | 1.82 (0.93, 3.53) | 0.08 |
Beyond UCSF | Vs. within Milan | 1.72 (1.09–2.71) | 0.02 | 1.36 (0.50. 3.69) | 0.54 |
Pathology | |||||
Fibrosis (Batts-Ludwig Criteria) | |||||
1 | vs. 0 | 0.19 (0.06–0.63) | 0.01 | 0.35 (0.09, 1.31) | 0.12 |
Tumor | |||||
Nodule # | |||||
2+ | vs. 1 | 3.11 (1.98–4.88) | <0.01 | 2.67 (1.623, 4.391) | <0.01 |
Largest Nodule Size (cm) | Per cm diameter | 1.04 (1.00–1.08) | 0.03 | 0.82 (0.67, 1.01) | 0.06 |
Aggregate Nodule Size (cm) | Per cm aggregate diameter | 1.05 (1.02–1.09) | <0.01 | 1.22 (1.02, 1.47) | 0.03 |
Vascular Invasion | Vs. None | 3.57 (2.35–5.40) | <0.01 | 2.25 (1.30, 3.89) | <0.01 |
Capsular Involvement | Vs. None | 1.81 (1.20–2.73) | <0.01 | 1.12 (0.67, 1.88) | 0.66 |
Transplant Criteria: Beyond Milan but within UCSF | vs. within Milan | 3.20 (1.68–6.08) | <0.01 | ** | |
Transplant Criteria: Beyond UCSF | vs. within Milan | 3.44 (2.14–5.53) | <0.01 | ** |
Variable | Hazard Ratio | p-Value | RESTORE Points |
---|---|---|---|
Pre-Op AFP | |||
≤20 | Ref | 0 | |
21–99 | 1.37 (0.79–2.26) | 0.35 | 1 |
≥100 | 1.78 (1.08–2.92\3) | 0.02 | 2 |
Vascular Invasion | |||
No | Ref | 0 | |
Yes | 2.77 (1.72–4.44) | <0.01 | 3 |
Lesion No. | |||
1 lesion w/in Milan | Ref | 0 | |
1 lesion outside Milan | 1.33 (0.79–2.26) | 0.29 | 1 |
2+ lesions | 3.39 (1.93–5.97) | <0.01 | 4 |
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Hoffman, D.; Shui, A.; Gill, R.; Syed, S.; Mehta, N. Resected Tumor Outcome and Recurrence (RESTORE) Index for Hepatocellular Carcinoma Recurrence after Resection. Cancers 2023, 15, 2433. https://doi.org/10.3390/cancers15092433
Hoffman D, Shui A, Gill R, Syed S, Mehta N. Resected Tumor Outcome and Recurrence (RESTORE) Index for Hepatocellular Carcinoma Recurrence after Resection. Cancers. 2023; 15(9):2433. https://doi.org/10.3390/cancers15092433
Chicago/Turabian StyleHoffman, Daniel, Amy Shui, Ryan Gill, Shareef Syed, and Neil Mehta. 2023. "Resected Tumor Outcome and Recurrence (RESTORE) Index for Hepatocellular Carcinoma Recurrence after Resection" Cancers 15, no. 9: 2433. https://doi.org/10.3390/cancers15092433