Adjuvant statin therapy for oesophageal adenocarcinoma: the STAT‐ROC feasibility study
| Autor: | S. M. Dresner, Simon L. Parsons, H. Warren, Yoon K. Loke, Edward Cheong, Matthew Hammond, Megan Jones, Ann Marie Swart, Erika J. Sims, Leo Alexandre, S. S. Kadirkamanathan, Michael P. Lewis, Andrew Hart, S. Walton, Allan Clark, Bhaskar Kumar, Marcus Flather |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
0301 basic medicine Simvastatin medicine.medical_specialty Esophageal Neoplasms lcsh:Surgery Adenocarcinoma Placebo Medication Adherence law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Quality of life Randomized controlled trial law Internal medicine Diabetes mellitus medicine Upper GI Humans Adverse effect Aged Aspirin business.industry Cholesterol LDL General Medicine lcsh:RD1-811 Middle Aged medicine.disease Combined Modality Therapy United Kingdom Esophagectomy Randomized Clinical Trials Treatment Outcome 030104 developmental biology Chemotherapy Adjuvant 030220 oncology & carcinogenesis Randomized Clinical Trial Quality of Life Feasibility Studies Female Observational study Hydroxymethylglutaryl-CoA Reductase Inhibitors business medicine.drug |
| Zdroj: | BJS Open, Vol 4, Iss 1, Pp 59-70 (2020) BJS Open |
| Popis: | 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 (http://www.isrctn/com). After oesophagectomy for oesophageal adenocarcinoma (OAC), the 5‐year survival rate is currently only 30 per cent. There is strong observational evidence that statin use is associated with reduced all‐cause and cancer‐specific mortality in patients with OAC. This multicentre, double‐blind, parallel‐group, randomized, placebo‐controlled trial has established the feasibility of a future phase III trial of adjuvant statin therapy in patients treated with curative intent for invasive OAC. Justification for a full trial |
| Databáze: | OpenAIRE |
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