Adjuvant statin therapy for oesophageal adenocarcinoma: the STAT‐ROC feasibility study

Alexandre, L., Clark, A. B. ORCID: https://orcid.org/0000-0003-2965-8941, Walton, S., Lewis, M. P., Kumar, B., Cheong, E. C., Warren, H., Kadirkamanathan, S. S., Parsons, S. L., Dresner, S. M., Sims, E. ORCID: https://orcid.org/0000-0002-7898-0331, Jones, M., Hammond, M. ORCID: https://orcid.org/0000-0002-0739-3412, Flather, M., Loke, Y. K., Swart, A. M. ORCID: https://orcid.org/0000-0002-9359-6995 and Hart, A. R. (2020) Adjuvant statin therapy for oesophageal adenocarcinoma: the STAT‐ROC feasibility study. BJS Open, 4 (1). pp. 59-70. ISSN 2474-9842

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Abstract

Background: Statins inhibit proliferative signalling in oesophageal adenocarcinoma (OAC) and their use is associated with better survival in observational studies. The present study was undertaken to examine the feasibility of assessing adjuvant statin therapy in patients with operable OAC in a phase III RCT. Methods: For this multicentre, double‐blind, parallel‐group, randomized, placebo‐controlled feasibility trial, adults with OAC (including Siewert I–II lesions) who had undergone oesophagectomy were centrally allocated (1 : 1) to simvastatin 40 mg or matching placebo by block randomization, stratified by centre. Participants, clinicians and investigators were blinded to treatment allocation. Patients received treatment for up to 1 year. Feasibility outcomes were recruitment, retention, drug absorption, adherence, safety, quality of life, generalizability and survival. Results: A total of 120 patients were assessed for eligibility at four centres, of whom 32 (26·7 per cent) were randomized, 16 in each group. Seven patients withdrew. Participants allocated to simvastatin had lower low‐density lipoprotein cholesterol levels by 3 months (adjusted mean difference −0·83 (95 per cent c.i. −1·4 to −0·22) mmol/l; P = 0·009). Median adherence to medication was greater than 90 per cent between 3 and 12 months' follow‐up. Adverse events were similar between the groups. Quality‐of‐life data were complete for 98·3 per cent of questionnaire items. Cardiovascular disease, diabetes and aspirin use were more prevalent in the non‐randomized group, whereas tumour site, stage and grade were similar between groups. Survival estimates were imprecise. Conclusion: This RCT supports the conduct and informs the design considerations for a future phase III trial of adjuvant statin therapy in patients with OAC. Registration number: ISRCTN98060456 (www.isrctn/com).

Item Type: Article
Uncontrolled Keywords: cancer,chemotherapy,double-blind,ldl cholesterol,open-label,plus simvastatin,previously treated patients,randomized phase-ii,survival,trial,sdg 3 - good health and well-being ,/dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Gastroenterology and Gut Biology
Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023)
Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit
Faculty of Medicine and Health Sciences > Research Groups > Health Services and Primary Care
Faculty of Medicine and Health Sciences > Research Groups > Epidemiology and Public Health
Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health
Faculty of Science > Research Groups > Norwich Epidemiology Centre
Faculty of Medicine and Health Sciences > Research Groups > Norwich Epidemiology Centre
Faculty of Medicine and Health Sciences > Research Centres > Population Health
Faculty of Medicine and Health Sciences > Research Centres > Lifespan Health
Faculty of Medicine and Health Sciences > Research Centres > Metabolic Health
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Depositing User: LivePure Connector
Date Deposited: 17 Dec 2019 03:31
Last Modified: 26 Jun 2024 11:31
URI: https://ueaeprints.uea.ac.uk/id/eprint/73384
DOI: 10.1002/bjs5.50239

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