Abstract 53P
Background
Glioblastoma is the one of most fast-growing primary brain tumor in adult and it carries the worst prognosis. Atorvastatin is an inhibitor of HMG-CoA reductase, a rate-limiting enzyme in the mevalonate pathway. Preclinical studies demonstrate encouraging anticancer activity of statins. The primary objective of the study was to evaluate the efficacy of Atorvastatin in addition to the standard therapy in patients with glioblastoma.
Methods
In this open-label, prospective, single-arm, phase II study, eligible patients received Atorvastatin in combination with standard therapy comprising radiotherapy and Temozolomide (TMZ). The primary endpoint is progression free survival (PFS) at 6 months. A minimum of 80% power required at least 32 eligible patients with planned final analysis after at least 1 year from last recruited patient.
Results
From January 2014 to December 2016, 36 evaluable patients were enrolled. Median age was 52 (20-69); 22% were ≥ 60 years of age and 62% were male. 97% of patients underwent resection. All patients have received Atorvastatin for a median of 6.2 (0.3 – 28 ) months duration, 80% of patients have discontinued this because of disease progression. At a median follow-up of 19 months, PFS-6 rate was 66% with median PFS of 7.6 months. Median overall survival was 19.9 months (4.8 – 42.5 months). Grades 3 and 4 hematological adverse events, including neutropenia and thrombocytopenia occurred in 7% and 12 % of patients respectively. On multivariate analysis, worse survival was associated in patients with baseline high LDL level (p = 0.046) and better survival was seen in patients received adjuvant TMZ (p = 0.001) and methylated tumors (p = 0.013).
Conclusions
This study did not meet its primary endpoint of PFS-6 compared to historical controls. However, this study proves the fact that high LDL level was found to be an important independent predictor of poor cancer-related outcome. Future clinical trials testing statins should aim to enroll patients with slow-growing tumors.
Clinical trial identification
clinical trial information: NCT02029573.
Editorial acknowledgement
Legal entity responsible for the study
King Fahad Medical City.
Funding
King Fahad Medical City.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
51P - Enhancing the anti-breast tumour activity of STING through a novel sting transcriptional regulator
Presenter: Hanchu Xiong
Session: Poster display session
Resources:
Abstract
52P - Reverse Warburg effect-related mitochondrial activity and 18F-FDG uptake in invasive ductal carcinoma
Presenter: Byung Wook Choi
Session: Poster display session
Resources:
Abstract
54P - Association between Parkinson’s disease and brain tumours: A nationwide population-based cohort study
Presenter: Joo-hyun Park
Session: Poster display session
Resources:
Abstract
55P - Toxicity profiles of treatment with modern fractionated radiotherapy, contemporary stereotactic radiosurgery, or transsphenoidal surgery in non-functioning pituitary macroadenoma
Presenter: Kevin Sheng-Po Yuan
Session: Poster display session
Resources:
Abstract
56P - Hippocampal avoidance in WBRT for metastases: Comparative neurocognitive and dosimetric assessment
Presenter: Vibhay Pareek
Session: Poster display session
Resources:
Abstract
57P - Multidisciplinary brain metastasis clinic: Is it effective and worthwhile?
Presenter: Annu Rajpurohit
Session: Poster display session
Resources:
Abstract
58P - Functional status as a determinant prognostic factor for overall survival in adult patients with medulloblastoma treated with chemotherapy and radiotherapy
Presenter: Juan Ayala Alvarez
Session: Poster display session
Resources:
Abstract
59P - Pattern of care in high-grade gliomas after recurrence
Presenter: Nandini Menon
Session: Poster display session
Resources:
Abstract
60P - Five fractions plus “SRS” boost combined with temozolamide for newly diagnosed and recurrent glioblastoma multiforme (GBM)
Presenter: Azhar Rashid
Session: Poster display session
Resources:
Abstract
64P - Entrectinib in locally advanced/metastatic ROS1 and NTRK fusion-positive non-small cell lung cancer (NSCLC): Updated integrated analysis of STARTRK-2, STARTRK-1 and ALKA-372-001
Presenter: Filippo de Braud
Session: Poster display session
Resources:
Abstract