A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer
- Authors
- Lim, S.H.; Kim, T.W.; Hong, Y.S.; Han, S.-W.; Lee, K.-H.; Kang, H.J.; Hwang, I.G.; Lee, J.; Kim, H.S.; Kim, S.T.; Lee, J.; Park, J.O.; Park, S.H.; Park, Y.S.; Lim, H.Y.; Jung, S.-H.; Kang, W.K.
- Issue Date
- Nov-2015
- Publisher
- Nature Publishing Group
- Keywords
- Colorectal cancer; simvastatin; XELIRI/FOLFIRI chemotherapy
- Citation
- British Journal of Cancer, v.113, no.10, pp 1421 - 1426
- Pages
- 6
- Journal Title
- British Journal of Cancer
- Volume
- 113
- Number
- 10
- Start Page
- 1421
- End Page
- 1426
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/11343
- DOI
- 10.1038/bjc.2015.371
- ISSN
- 0007-0920
1532-1827
- Abstract
- Background:The purpose of this randomised phase III trial was to evaluate whether the addition of simvastatin, a synthetic 3-hydroxy-3methyglutaryl coenzyme A reductase inhibitor, to XELIRI/FOLFIRI chemotherapy regimens confers a clinical benefit to patients with previously treated metastatic colorectal cancer.Methods:We undertook a double-blind, placebo-controlled phase III trial of 269 patients previously treated for metastatic colorectal cancer and enrolled in 5 centres in South Korea. Patients were randomly assigned (1: 1) to one of the following groups: FOLFIRI/XELIRI plus simvastatin (40 mg) or FOLFIRI/XELIRI plus placebo. The FOLFIRI regimen consisted of irinotecan at 180 mg m -2 as a 90-min infusion, leucovorin at 200 mg m -2 as a 2-h infusion, and a bolus injection of 5-FU 400 mg m -2 followed by a 46-h continuous infusion of 5-FU at 2400 mg m -2. The XELIRI regimen consisted of irinotecan at 250 mg m -2 as a 90-min infusion with capecitabine 1000 mg m -2 twice daily for 14 days. The primary end point was progression-free survival (PFS). Secondary end points included response rate, duration of response, overall survival (OS), time to progression, and toxicity.Results:Between April 2010 and July 2013, 269 patients were enrolled and assigned to treatment groups (134 simvastatin, 135 placebo). The median PFS was 5.9 months (95% CI, 4.5-7.3) in the XELIRI/FOLFIRI plus simvastatin group and 7.0 months (95% CI, 5.4-8.6) in the XELIRI/FOLFIRI plus placebo group (P=0.937). No significant difference was observed between the two groups with respect to OS (median, 15.9 months (simvastatin) vs 19.9 months (placebo), P=0.826). Grade ≥3 nausea and anorexia were noted slightly more often in patients in the simvastatin arm compared with with the placebo arm (4.5% vs 0.7%, 3.0% vs 0%, respectively).Conclusions:The addition of 40 mg simvastatin to the XELIRI/FOLFIRI regimens did not improve PFS in patients with previously treated metastatic colorectal cancer nor did it increase toxicity. © 2015 Cancer Research UK. All rights reserved.
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