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No link between statin use, increased OS in colorectal cancer
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Statin use was not linked to a greater survival rate in patients with colorectal cancer, according to study results.
Previous studies that have demonstrated an association between statin use and lower colorectal cancer mortality may not have adequately adjusted for disease stage at diagnosis and other factors associated with statin use, the researchers wrote.
“In contrast to studies on colorectal cancer risk, only few studies have investigated the use of statins on survival and recurrence after a diagnosis of colorectal cancer,” Michael Hoffmeister, PhD, of the division of clinical epidemiology and aging research at the German Cancer Research Center, and colleagues wrote. “The objective of the present study was to provide more detailed results from a large population-based cohort of colorectal cancer patients and to analyze associations of statin use with overall, colorectal cancer-specific survival and [RFS] according to clinical and pathological patient characteristics, active ingredient and duration of use.”
Hoffmeister and colleagues evaluated data from 2,697 patients in southern Germany who were diagnosed with colorectal cancer between 2003 and 2009. The mean age of the population was 68 years, and 40% of the patients were women.
Researchers evaluated whether patients used statins at the time of colorectal cancer diagnosis. Other factors included in the follow-up assessment included therapy details, recurrence, vital status and cause of death, if applicable.
Median follow-up was 3.4 years after diagnosis of colorectal cancer.
Overall, 15% (n = 412) of the patients used statins and 29% (n = 769) of patients died during follow-up. Statin use was more common in older patients, men and patients with a low cancer stage, higher BMI, higher incidence of smoking and frequent use of NSAIDs. Patients using statins also displayed an increased history of diabetes, myocardial infarction, stroke and heart failure compared with nonusers (88% vs. 21%).
Multivariate analyses adjusted for major clinical and epidemiological factors indicated the use of statins was not associated with prolonged OS (HR = 1.1; 95% CI, 0.85-1.41), disease-specific survival (HR = 1.11; 95% CI, 0.82-1.5) or RFS (HR = 0.9; 95% CI, 0.63-1.27).
There was no risk reduction in analyses adjusted for active ingredient, duration of use, age or sex.
However, researchers observed an association between statin use and RFS for stage I and stage II carcinomas (HR = 0.5; 95% CI, 0.26-0.95).
The researchers said information related to patients who discontinued statin use in the years before diagnosis were not considered. Because statin use was self-reported, the potential risk for miscalculation existed. The researchers also determined that their study size was not large enough to distinguish weak effects of statins use.
“Our finding of better [RFS] associated with use of statins in early-stage patients may be because of chance and needs to be confirmed,” Hoffmeister and colleagues concluded. “Before results from a first ongoing randomized trial become available, additional large observational cohort studies with prospective, comprehensive clinical and epidemiological assessment are required to clarify the currently uncertain effect of statins on survival of colorectal cancer patients and to inform future planning of clinical trials.” – by Cameron Kelsall
Disclosure: The researchers report no relevant financial disclosures.
Perspective
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David H. Ilson, MD, PhD
With the increasingly ubiquitous use of statins to treat hyperlipidemia and to potentially reduce complications of cardiovascular disease, large retrospective population-based studies have reported a potential protective effect of statin therapy on cancer incidence. Statin-mediated inhibition of the enzyme HMG-CoA reductase involved in cholesterol biosynthesis could potentially impact proliferative and inflammatory processes involved in tumorigenesis. Although early analyses suggested that statin use may correlate with a reduced risk for the development of colorectal cancer, a pooled meta-analysis of these trials failed to indicate a preventive benefit for statin therapy.There are a paucity of data for the impact of statin use on survival and recurrence after a diagnosis of colorectal cancer. Hoffmeister and colleagues now report the results of a contemporary German database of newly diagnosed patients with colorectal cancer treated from 2003 to 2009. The study evaluated a prospective patient cohort from Southwest Germany, and involved standardized questionnaires and face-to-face patient interviews at intake. Of the nearly 2,700 patients studied, nearly half had tumor tissue analysis for molecular profiling, including KRAS mutation status, presence of microsatellite instability, and CpG island methylator phenotype. Data analysis included disease stage at diagnosis, therapy delivered, baseline lifestyle habits, presence or absence of physical activity, use of other medications and aspirin, and comorbid medical conditions.
In the 15% of patients who were statin users, there was no reported difference in OS, colorectal cancer-specific survival or RFS. There also was no association with statin use and prevalence of any colorectal cancer molecular subtype. The relative short median duration of follow-up of 3.4 years would not be expected to impact the study outcome, as the endpoints of freedom from cancer recurrence and cancer-specific survival are likely to declare themselves within 2 to 4 years of cancer diagnosis. The observation of a potential reduced risk for recurrence with statin use in the patients with stage I or II cancers — in the absence, however, of any survival benefit — is hypothesis generating.
Results from this well-conducted prospective study raise further skepticism about the cancer preventive benefits of statin therapy. An ongoing randomized trial led by the National Surgical Adjuvant Breast and Bowel Project evaluating statin use after colon cancer resection hopefully will shed further light on this question. All retrospective, population-based studies need to be viewed as primarily hypothesis generating, given the negative experiences from many prospective cancer prevention trials that were engendered from initially encouraging retrospective series.
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