Abstract 325P
Background
More patients are receiving immune checkpoint inhibitors (ICI) for advanced hepatocellular carcinoma (HCC). We aim to explore whether an association exists between the presence of irAE and the efficacy of ICI in advanced HCC.
Methods
We conducted a retrospective review of patients with advanced HCC who received ICIs between May 2015 - Nov 2018 at our centre. IrAE were graded according to the Common Terminology Criteria for Adverse Events v4.0. Response to ICI was evaluated based on RECIST v1.1 criteria.
Results
Of the 114 patients studied, median age was 67.3yrs (23.5-84.9) and 78 (89.7%) were male. 68.4% experienced irAE of any grade (n = 78), with 21.8% being grade 3-4 (n = 17). None were grade 5. Patients in the any-irAE group had comparable ORR and significantly higher DCR than the no-irAE group (23.4 vs 10.0%, p = 0.118 and 64.9 vs 30.0%, p = 0.001). Median PFS and OS in the any-irAE group were significantly longer than the no-irAE group (4.0 vs 1.4mths, p < 0.001 and 16.4 vs 3.3mths, p < 0.001, respectively). Comparing against the no-irAE group, the G1/2-irAE and G3/4-irAE groups had significantly longer median PFS (G1/2 (3.7mths) vs no irAE (1.4mths), p < 0.001; G3/4 (11.6mths) vs. no irAE (1.4mths), p = 0.001) and OS (G1/2 (14.5mths) vs no irAE (3.3mths), p < 0.001; G3/4 (20.9mths) vs. no irAE (3.3mths), p < 0.001). Multivariate analysis showed that the presence of irAE was associated with longer median PFS [HR: 0.52 (95% CI 0.31-0.90), p = 0.018] and OS [HR: 0.38 (95% CI 0.20-0.71), p = 0.003]. Table:
325P Cox regression analysis of the association between irAE and survival outcomes
Univariate hazard ratio (95% CI) | p-value | Multivariate hazard ratio* (95% CI) | p-value | |
---|---|---|---|---|
PFS | ||||
Any | 0.37 (0.23-0.59) | <0.001 | 0.52 (0.31-0.90) | 0.018 |
Hepatobiliary irAE | 0.75 (0.44-1.26) | 0.28 | ||
Skin irAE | 0.29 (0.18-0.46) | <0.001 | 0.32 (0.20-0.52) | <0.001 |
Gastrointestinal irAE | 0.76 (0.45-1.27) | 0.29 | ||
Endocrine irAE | 0.27 (0.08-0.91) | 0.035 | 0.34 (0.10-1.18) | 0.091 |
Lung irAE | 0.24 (0.06-0.97) | 0.046 | 0.29 (0.07-1.20) | 0.087 |
OS | ||||
Any | 0.27 (0.16-0.47) | <0.001 | 0.38 (0.20-0.71) | 0.003 |
Hepatobiliary irAE | 0.56 (0.28-1.12) | 0.10 | ||
Skin irAE | 0.28 (0.16-0.49) | <0.001 | 0.35 (0.19-0.64) | 0.001 |
Gastrointestinal irAE | 0.58 (0.29-1.15) | 0.12 | ||
Endocrine irAE | 0.36 (0.11-1.24) | 0.11 | ||
Lung irAE | 0.38 (0.09-1.61) | 0.19 |
Significant covariables in univariate analysis were included; for PFS: age category, bilirubin category; for OS: age category, albumin category, bilirubin category.
Conclusions
The presence of irAE in advanced HCC patients treated with ICI could possibly predict better response and survival outcomes.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
S.P. Choo: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (self): Sirtex Medical; Advisory / Consultancy, Speaker Bureau / Expert testimony: Lily; Advisory / Consultancy: Novartis; Advisory / Consultancy: Eisai; Advisory / Consultancy: Bayer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Ipsen. D. Tai: Research grant / Funding (self): Bristol-Myers Squibb; Advisory / Consultancy: Merck Sharp & Dohme; Advisory / Consultancy: Eisai; Honoraria (self), Advisory / Consultancy: Bayer; Advisory / Consultancy: Ipsen; Research grant / Funding (self): Sirtex. J. Lee: Advisory / Consultancy: Ipsen; Research grant / Funding (self): Bayer. All other authors have declared no conflicts of interest.
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