The Lynx Group

Statin Therapy Improves Survival in Patients with Cancer

November 2012, Vol 3, No 8

It is well understood that cancer-cell proliferation encourages tumor growth and metastasis. It is also known that the use of statins blocks the production of cholesterol, and endogenous cholesterol is crucial for human cell proliferation. Linking these 2 disparate mechanisms, researchers in Denmark set out to investigate whether statin therapy can help to reduce cancer-related mortality by limiting cancer-cell proliferation in patients who have used statins before they were diagnosed with cancer (Nielsen SF, et al. N Engl J Med. 2012;367:1792-1802).

Using data from the Danish Cancer Registry between 1995 and 2007, which includes cancer data for the en­tire patient population in Denmark, the investigators compared mortality among patients with cancer (aged ≥40 years) who had used statins before their cancer diagnosis and patients with cancer who had never used statin therapy. During the study period, 18,721 patients with cancer had used statins regularly before being diagnosed with cancer, and 277,204 patients with cancer had never used statins. The follow-up continued until the end of 2009 (median, 2.6 years; range, 0-15). Other national registries were also used to incorporate mortal­ity data and the various causes of death.

During the 1,072,503 person-years of follow-up, a total of 195,594 patients died—162,067 from cancer, 14,489 from cardiovascular disease, and 19,038 from other causes. The multivariable-adjusted hazard ratios (HRs) for death from any cause for patients using statins compared with those who have never used statins were 0.85 (95% confidence interval [CI], 0.83-0.87; P <.001) and 0.85 (95% CI, 0.82-0.87; P <.001) for death from cancer.

Adjusted HRs for death from cancer according to the daily statin dose (the assumed average maintenance daily dose) were 0.83 (95% CI, 0.81-0.86; P <.001), for a defined daily dose of 0.01 to 0.75; 0.87 (95% CI, 0.83-0.91; P <.001), for a defined daily dose of 0.76 to 1.50; and 0.87 (95% CI, 0.81-0.92; P <.001), for a defined daily dose of 1.50. This lack of a statin dose and cancer-related mortality indicates that the use of any statin dose will help to reduce mortality in patients with cancer.

Furthermore, the reduction in cancer-related mortality was seen in all 13 types of cancer that were investigated. These results are supported by evidence from previous studies showing a reduction in mortality in patients with advanced prostate cancer who have used statins and a reduced rate of cancer recurrence in patients with prostate or breast cancer who have used statins.

This new study clearly shows a need for clinical trials to investigate the potential role of statin therapy in patients with cancer. This study was not designed to investigate the role of statins for the prevention of cancer.

Survival Trends in Myelofibrosis Improving at a Slow Pace

Primary myelofibrosis (PMF) is associated with a significant risk for mortality. Advances in the treatment of PMF have nevertheless failed to significantly affect survival, which re­mains a challenge, and life expectancy has not increased significantly in the past decades, in part because of a lack of breakthroughs in treatment. Approx­imately 20% of patients with PMF progress to acute leukemia. A recent international study evaluated the current survival status of patients with PMF in 4 countries in Europe (Cervantes F, et al. J Clin Oncol. 2012; 30:2981-2987).

Median survival of patients with PMF in the 1970s, 1980s, and early and mid-1990s ranged from 3.5 years to 5 years, with no evidence of improved survival for patients who were diagnosed between 1985 and 1997 compared with those diagnosed in the previous decade (1970-1984). However, the landscape for patients with PMF may be incrementally changing in recent years.

This new study included data of 802 patients with PMF in France, Italy, Spain, and the United Kingdom who were divided into 2 groups based on the period of their PMF diagnosis—434 patients were diagnosed between 1980 and 1995, and 368 patients were diagnosed between 1996 and May 2007. By the time of this analysis, 83% of patients from the earlier period and approximately 50% of the patients diagnosed in the later period had died.

A comparison of the survival patterns among the 2 period groups showed a survival increase of almost 2 years for patients diagnosed between 1996 and 2007 (median survival, 6.5 years; 95% CI, 5.5-7.4) compared with those diagnosed a decade earlier (median survival, 4.6 years; 95% CI, 4.0-5.1). Furthermore, the increase in survival persisted after applying the data from other survival studies and adjusting for increased life expectancy in the general population, as well as other demographic factors.

Of note, the increase in survival in the later decade compared with the early decade was greater among women (mean survival, 10.6 vs 4.7, respectively) compared with the survival among men (median survival, 5.3 vs 4.4, respectively).

Direct-to-Consumer Advertising Positively Affects Prescriptions for Breast Cancer Therapy

It is safe to assume that direct-to-consumer advertising (DTCA) has a positive impact on increasing the number of prescriptions, which can be evidenced from the continuation of this practice by pharmaceutical companies. How­ever, it has often been suggested that DTCA might result in patients placing inappropriate pressure on physicians to prescribe therapies that may not always be appropriate for a particular patient. A new study has now shown that DTCA has a positive effect on the prescription patterns of aromatase inhib­itors (AIs) for women with breast cancer, by increasing the number of appropriate prescriptions; surprisingly, the study has also shown that DTCA does not lead to an increase in inappropriate use of these agents for this patient population (Abel GA, et al. Cancer. 6 Nov 2012. Epub ahead of print).

Because AIs have been particularly targeted for DTCA, and because they are indicated only for postmeno­pausal women, the investigators believed that this drug class was a good way to investigate the cancer-related impact of DTCA, and that age was a surrogate marker of appropriate use.

They combined national data on DTCA spending (from TNS Media Intelli­gence) and prescription data for hormonal therapy use (from IMS Health) between October 2005 and September 2007. Prescriptions for women aged ≤40 years (assumed premenopausal) were considered inappropriate and for women aged ≥40 years, appropriate.

The main target of DTCA for AIs was in national magazines, and to a lesser degree in Sunday newspapers. During the study period, the highest spending ($22,019,660) on AI-related DTCA was in October 2005 and the lowest ($118,600) was in January 2007, reflecting a great variation over time. The results were also compared with a second analysis of the impact of AI advertising in the Journal of Clinical Oncology on physicians during the same period.

Overall, every $1 million spent on AI-related DTCA was associated with a 0.15% increase in new prescriptions for AI 3 months later for all ages (P <.001) and a 0.18% increase for women aged >60 years (P <.001), but with no significant change for women aged <40 years up to 6 months later.

This finding suggests that DTCA has a positive impact on the appro­priate use of certain types of cancer-related drugs and does not lead to increased inappropriate prescription use. It is not clear whether this conclusion can be extended to all drug classes, but it may suggest that, when it comes to cancer drugs, DTCA does not have a negative impact.

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