361P - Effect of silibinin nutraceutical supplementation in brain metastases of patients with advanced lung cancer

Date 10 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Non-Small-Cell Lung Cancer, Metastatic
Central Nervous System Malignancies
Presenter Joaquim Bosch-Barrera
Citation Annals of Oncology (2017) 28 (suppl_5): v109-v121. 10.1093/annonc/mdx366
Authors J. Bosch-Barrera1, E. Sais1, A. Izquierdo2, A. Hernández1, D. Roa1, E. Cuyas3, S. Pedraza4, N. Priego5, P. Ortuño4, G. Sánchez4, N. Cañete4, A. Roselló6, R. Soffietti7, J. Brunet1, M. Valiente5, J.A. Menendez3
  • 1Medical Oncology Department, Catalan Institute of Oncology, 17007 - Girona/ES
  • 2Medical Oncology Department, Catalan Institute of Oncology, Girona/ES
  • 3Metabolism And Cancer Group, Girona Biomedical Research Institute, 17007 - Girona/ES
  • 4Department Of Radiology, Diagnostic Imaging Institute, Doctor Josep Trueta University Hospital, 17007 - Girona/ES
  • 5Brain Metastasis Group, CNIO, Madrid/ES
  • 6Radiotherapy Department, Catalan Institute of Oncology, 17007 - Girona/ES
  • 7Department Of Neuro-oncology, University of Turin and City of Health and Science Hospital, Torino/IT

Abstract

Background

Silibinin is a bioactive flavonolignan extracted from milk thistle (Silybum marianum). We are currently evaluating the pre-clinical activity of silibinin on reactive astrocytes, a major component of the brain metastasis microenvironment shown to play important pro-metastatic functions.

Methods

We present data of patients with lung cancer and brain metastases that have received compassionate use of nutraceutical supplementation with Legasil®, a commercially available silibinin-based nutraceutical, in addition to standard oncologic treatment. We have compared our observed results with the brain GPA index of each patient calculated by Lung-molGPA tool (brain GPA Index).

Results

Eighteen patients have been treated: median age 62 y (range: 35–80); male: 11 (61%); median number of brain metastases: 4 (range: 1-20); median size of the bigger brain metastasis: 26 mm (range: 10-65 mm). Histology: Adenocarcinoma: 14, Large cell: 1, Small cell: 2, Squamous: 1. All patients have received whole brain radiotherapy. Observed overall survival (OS) was significantly superior compared with expected OS calculated by Lung-molGPA (median 22.2 months [95% CI 13.0-32.6] vs 6.9 months [4.2-9.5]; p = 0.001). Time to central nervous system treatment failure of silibinin was 26.9 months (95% CI 11.7-42.1 months). Brain tumor progression was observed in 6 patients (33%). Overall response rate at brain disease was 75% (Complete Response:3 patients (20%) and Partial Response: 10 patients (55%)). Only one patient presented brain tumor progression as best response. At data cutoff (May 1st, 2017), 6 (33%) patients remained alive.

Conclusions

These preliminary data suggest that silibinin supplementation contributes to the control of brain metastases in lung cancer patients. Further evaluation of the silibinin use in a phase II clinical trial is warranted.

Clinical trial identification

Legal entity responsible for the study

Joaquim Bosch-Barrera

Funding

None

Disclosure

J. Bosch-Barrera: Research grant of SEOM (Sociedad Española de Oncología Médica, Spain) and an Unrestricted Educational Research grant from Meda Pharma (Germany).

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All other authors have declared no conflicts of interest.

Disclosure

J. Bosch-Barrera: Research grant of SEOM (Sociedad Española de Oncología Médica, Spain) and an Unrestricted Educational Research grant from Meda Pharma (Germany).

All other authors have declared no conflicts of interest.