Abstract 4338
Background
The most recent ESMO (2018) and EASL Clinical Practice Guidelines (2018) for the treatment of hepatocellular carcinoma (HCC) recommend considering liver function and tumour burden when selecting patients for intra-arterial therapy, such as selective internal radiation therapy (SIRT). The SARAH randomised trial did not show a statistically significant benefit of SIRT using yttrium-90 (Y-90) resin microspheres over sorafenib 400mg bid in terms of overall survival (OS) in the overall trial population of European patients with HCC. In this post-hoc analsis we explored the comparative effectivenes of these treatments in a subgroup of patients with low tumour burden (≤25% of total liver volume) and good liver function (ALBI grade 1).
Methods
A Cox proportional hazards survival regression was conducted in the intention to treat (ITT) population of the SARAH trial to explore treatment effect modification including low tumour burden/good liver function as an interaction effect with treatment.
Results
Among the ITT population, 37 (16%) patients in the SIRT arm and 48 (22%) patients in the sorafenib arm had a tumour burden ≤25% and an ALBI grade of 1. The interaction effect estimate from the Cox regression was 0.609 (95% CI: 0.344 to 1.079, p = 0.089) indicating that SIRT was relatively more effective in this subgroup. In the low tumour burden/good liver function subgroup the HR for SIRT vs sorafenib was 0.73 (95% CI: 0.44 to 1.21). Median OS was 21.9 months (95% CI: 15.2 to 32.5) for SIRT vs 17.0 months (95% CI: 11.6 to 20.8) for sorafenib. Subsequent curative therapy was more frequent after SIRT than sorafenib (14% vs 2%). The drop-out rate from randomisation to SIRT treatment was lower in the subgroup than in the overall ITT population (8% vs 22%).
Conclusions
The analysis suggests that it may be possible to select patients with HCC and a low tumour burden/good liver function, who would derive a meaningful benefit from treatment with SIRT compared to sorafenib. Further prospective validation is required.
Clinical trial identification
NCT01482442.
Editorial acknowledgement
Legal entity responsible for the study
Sirtex Medical UK Ltd.
Funding
Sirtex Medical UK Ltd.
Disclosure
D.H. Palmer: Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Eisai; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self), Travel / Accommodation / Expenses: Sirtex. N.S. Hawkins: Research grant / Funding (institution), Travel / Accommodation / Expenses: Sirtex. V. Vilgrain: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Sirtex. P.J. Ross: Honoraria (self), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Bayer; Advisory / Consultancy: Celgene; Honoraria (self), Advisory / Consultancy: Pierre Fabre; Honoraria (self): Roche; Honoraria (self), Advisory / Consultancy: Shire; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sirtex; Honoraria (self), Travel / Accommodation / Expenses: Servier; Research grant / Funding (institution): Sanofi. All other authors have declared no conflicts of interest.
Resources from the same session
4732 - Progesterone Receptor Isoform Ratio Dictates Antiprogestins/Progestins Effects on Metastatic Breast Cancer Models
Presenter: Maria Abascal
Session: Poster Display session 2
Resources:
Abstract
5737 - PAM50 and CGH-array genomic characterization of HER2-Equivocal Breast Cancers defined by the 2018 ASCO/CAP recommendations.
Presenter: Carine Ngo
Session: Poster Display session 2
Resources:
Abstract
1096 - OncotypeDX® predictive nomogram for recurrence score output: a machine learning system based on quantitative immunochemistry analysis - ADAPTED01
Presenter: Fabio Marazzi
Session: Poster Display session 2
Resources:
Abstract
5426 - Geriatric parameters predict both disease-related and patient-reported outcomes in older patients with breast cancer
Presenter: Willeke van der Plas-Krijgsman
Session: Poster Display session 2
Resources:
Abstract
5865 - Patients with a 21-gene assay in South East London differ from the TAILORx trial population
Presenter: Charalampos Gousis
Session: Poster Display session 2
Resources:
Abstract
1312 - Predictive tools in adjuvant breast cancer – what is the standard of evidence supporting their utility? A literature review examining validation of Adjuvant!, Cancermath and NHS Predict
Presenter: Alice Loft
Session: Poster Display session 2
Resources:
Abstract
2445 - Oncologic outcome of invasive lobular carcinoma: Is it different from that of invasive ductal carcinoma?
Presenter: Hee Jun Choi
Session: Poster Display session 2
Resources:
Abstract
2476 - Pathologic response and survival efficacy in patients with initial nodal involvement after neoadjuvant chemotherapy in early breast cancer
Presenter: SERAFIN MORALES Murillo
Session: Poster Display session 2
Resources:
Abstract
3761 - Chemotherapy-induced amenorrhea: prognostic impact on premenopausal Egyptian patients with breast cancer
Presenter: Khaled Abdel Karim
Session: Poster Display session 2
Resources:
Abstract
4687 - Predicting the presence of breast cancer using circulating small RNA in the serum
Presenter: Yumiko Koi
Session: Poster Display session 2
Resources:
Abstract