Randomized Trials Analyzed as Observational Studies

Annals of internal medicine (Impact Factor: 16.1). 09/2013; 159(8). DOI: 10.7326/0003-4819-159-8-201310150-00709
Source: PubMed
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    ABSTRACT: Despite more than 40 years of extensive study it remains uncertain which persons, if any, with acute myelogenous leukemia (AML) in 1st remission should receive a blood cell or bone marrow transplant versus post-remission chemotherapy (or both). Nevertheless, there is a recent trend towards recommending more transplants in this setting. We consider four myths underlying this recommendation: (1) only persons achieving 2nd remission benefit from a transplant; (2) there is no effective therapy for relapse other than an allotransplant; (3) we can accurately predict which persons with AML in 1st remission need a transplant; and (4) detection of minimal residual disease in 1st remission will resolve this controversy. We discuss these misconceptions and suggest approaches to resolve this issue.Leukemia accepted article peview online, 14 April 2014. doi:10.1038/leu.2014.129.
    Leukemia: official journal of the Leukemia Society of America, Leukemia Research Fund, U.K 04/2014; 28(10). DOI:10.1038/leu.2014.129 · 10.16 Impact Factor
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    ABSTRACT: Much preclinical and epidemiological evidence supports the anticancer effects of statins. Epidemiological evidence does not suggest an association between statin use and reduced incidence of breast cancer, but does support a protective effect of statins-especially simvastatin-on breast cancer recurrence. Here, we argue that the existing evidence base is sufficient to justify a clinical trial of breast cancer adjuvant therapy with statins and we advocate for such a trial to be initiated without delay. If a protective effect of statins on breast cancer recurrence is supported by trial evidence, then the indications for a safe, well tolerated, and inexpensive treatment can be expanded to improve outcomes for breast cancer survivors. We discuss several trial design opportunities-including candidate predictive biomarkers of statin safety and efficacy-and offer solutions to the key challenges involved in the enrolment, follow-up, and analysis of such a trial.
    The Lancet Oncology 09/2014; 15(10):e461-8. DOI:10.1016/S1470-2045(14)70119-6 · 24.73 Impact Factor