A Single Arm, Phase II Study of Simvastatin Plus XELOX and Bevacizumab as First-Line Chemotherapy in Metastatic Colorectal Cancer Patients.

Authors:
Youjin Kim
Youjin Kim
Florida State University
United States
Tae Won Kim
Tae Won Kim
Asan Medical Center
South Korea
Sae Won Han
Sae Won Han
Seoul National University Hospital
South Korea
Joong Bae Ahn
Joong Bae Ahn
Yonsei Cancer Center
Houston | United States
Seung Tae Kim
Seung Tae Kim
Samsung Medical Center
South Korea
Jeeyun Lee
Jeeyun Lee
Samsung Medical Center
South Korea
Joon Oh Park
Joon Oh Park
Samsung Medical Center
South Korea
Young Suk Park
Young Suk Park
Samsung Medical Center
South Korea

Cancer Res Treat 2018 Nov 21. Epub 2018 Nov 21.

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Purpose: Simvastatin has demonstrated anti-tumor activity in preclinical studies via tumor cell senescence, apoptosis, and anti-angiogenesis. This phase II trial evaluated the efficacy and toxicity profile of conventional XELOX and bevacizumab chemotherapy plus simvastatin in metastatic colorectal cancer patients (MCRC).

Materials And Methods: Patients with MCRC received first-line XELOX in 3-week treatment cycles of intravenous oxaliplatin 130 mg/m2 plus bevacizumab 7.5 mg/kg (day 1), followed by oral capecitabine 1,000 mg/m2 twice daily (day 1-14). Simvastatin 80 mg tablets were taken orally once daily every day during the period of chemotherapy. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, duration of response, overall survival (OS), time to progression, and toxicity.

Results: From January 2014 to April 2015, 60 patients were enrolled and 55 patients were evaluable for tumor response. The median follow-up duration was 30.1 months (range, 28.5 to 31.7 months). The median PFS was 10.4 months (95% confidence interval [CI], 9.6 to 11.1). The median OS of all patients was 19.0 months (95% CI, 11.9 to 26.0). The disease-control rate and overall response rate were 88.3% (95% CI, 74 to 96) and 58.3% (95% CI, 44 to 77), respectively, by intent-to-treat protocol analysis. There was 1 complete response and 34 partial responses. One patient experienced grade 3 creatine kinase elevation and liver enzyme elevation.

Conclusion: Based on the current study, the addition of 80mg simvastatin to XELOX and bevacizumab showed comparable clinical efficacy in patients with MCRC as first-line chemotherapy and did not increase toxicity.

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Source
http://www.e-crt.org/journal/view.php?doi=10.4143/crt.2018.3
Publisher Site
http://dx.doi.org/10.4143/crt.2018.379DOI Listing
November 2018
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