Skip to main content

A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer.

Publication ,  Journal Article
Lim, SH; Kim, TW; Hong, YS; Han, S-W; Lee, K-H; Kang, HJ; Hwang, IG; Lee, JY; Kim, HS; Kim, ST; Lee, J; Park, JO; Park, SH; Park, YS ...
Published in: Br J Cancer
November 17, 2015

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Br J Cancer

DOI

EISSN

1532-1827

Publication Date

November 17, 2015

Volume

113

Issue

10

Start / End Page

1421 / 1426

Location

England

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Simvastatin
  • Republic of Korea
  • Oncology & Carcinogenesis
  • Neoplasm Metastasis
  • Middle Aged
  • Male
  • Leucovorin
  • Irinotecan
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Lim, S. H., Kim, T. W., Hong, Y. S., Han, S.-W., Lee, K.-H., Kang, H. J., … Kang, W. K. (2015). A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer. Br J Cancer, 113(10), 1421–1426. https://doi.org/10.1038/bjc.2015.371
Lim, S. H., T. W. Kim, Y. S. Hong, S. -. W. Han, K. -. H. Lee, H. J. Kang, I. G. Hwang, et al. “A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer.Br J Cancer 113, no. 10 (November 17, 2015): 1421–26. https://doi.org/10.1038/bjc.2015.371.
Lim, S. H., et al. “A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer.Br J Cancer, vol. 113, no. 10, Nov. 2015, pp. 1421–26. Pubmed, doi:10.1038/bjc.2015.371.
Lim SH, Kim TW, Hong YS, Han S-W, Lee K-H, Kang HJ, Hwang IG, Lee JY, Kim HS, Kim ST, Lee J, Park JO, Park SH, Park YS, Lim HY, Jung S-H, Kang WK. A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer. Br J Cancer. 2015 Nov 17;113(10):1421–1426.

Published In

Br J Cancer

DOI

EISSN

1532-1827

Publication Date

November 17, 2015

Volume

113

Issue

10

Start / End Page

1421 / 1426

Location

England

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Simvastatin
  • Republic of Korea
  • Oncology & Carcinogenesis
  • Neoplasm Metastasis
  • Middle Aged
  • Male
  • Leucovorin
  • Irinotecan