A Single Arm, Phase II Study of Simvastatin Plus XELOX and Bevacizumab as First-Line Chemotherapy in Metastatic Colorectal Cancer Patients / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment
;
: 1128-1134, 2019.
Article
in English
| WPRIM
| ID: wpr-763167
ABSTRACT
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 ANDMETHODS:
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 one 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 80 mg simvastatin to XELOX and bevacizumab showed comparable clinical efficacy in patients with MCRC as first-line chemotherapy and did not increase toxicity.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Arm
/
Tablets
/
Colorectal Neoplasms
/
Follow-Up Studies
/
Treatment Outcome
/
Cellular Senescence
/
Apoptosis
/
Disease-Free Survival
/
Simvastatin
/
Creatine Kinase
Type of study:
Practice guideline
/
Observational study
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
Cancer Research and Treatment
Year:
2019
Type:
Article
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