The August 28th edition of the New England Journal of Medicine includes data from Dr. Jesus San Miguel describing the benefits of combining bortezomib (Velcade) with melphalan and prednisone (MP), compared to MP alone. The study, known as the VISTA trial, has been widely discussed at both the ASH and ASCO conferences.
How do individual studies apply to patient care?
In his editorial, Dr. Durie says that the statistics from the VISTA trial leave no doubt that combination therapy with bortezomib is superior to MP alone. However, he raises the issue, “how does this clear-cut evidence inform treatment decisions?”
Dr. Durie says that, going forward to effectively make cross-study comparisons that are applicable to patients, “prospective trials must carefully assess and compare efficacy, tolerability, and quality-of-life issues.”
He explains that, “results need to be examined in the larger context of other emerging treatments.” For example, how does bortezomib compare to recent trials with thalidomide and lenalidomide? Do these positive results pave the way for additional combinations of successful drugs, such as the trial of bortezomib plus lenalidomide now underway?
In evaluating a treatment, physicians need to take into account more than just outcome. They need to examine which specific criteria (secondary endpoints) are used.
Beyond efficacy, toxicities also play an important role in evaluating if and when a treatment should be used. This is especially important in myeloma where sequential treatments are required, and one does want to use two drugs with the same side-effects back-to-back.
Dr. Durie concludes, “we are fortunate to have so many options both in the clinic and in development.” Our challenge will be to assess what is best for each individual patient.
Click here to view a PDF of the slides from Dr. Jesus San Miguel's presentation on VISTA at the American Society of Hematology (ASH) meeting in 2007.