Abstract 3379
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).
\r\nAll 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.