When I review results of clinical trials in oncology, I bear in mind that the typical reported end point is response rate, a parameter that provides a basic measure of treatment activity with certain limitations. Large clinical trials with longer follow-up may provide data on progression- free survival (PFS), perhaps a more significant parameter. However, for oncologists, the compelling outcome of improved overall survival (OS) is what we strive to achieve for our patients. Of course, the ultimate goal of any cancer treatment is cure.
San Diego, CA—The investigational proteasome inhibitor MLN9708 is the first oral drug in this class to enter clinical trials in multiple myeloma. Although development is still in the early stages, interest in this agent is very high.
A January 14, 2015, report published by the Institute of Medicine (IOM) walks a fine line between the competing clinical data sharing comfort zones of pharmaceutical companies, physician associations, patient groups, and other advocacy organizations.
Results of a recent meta-analysis have demonstrated that the addition of bortezomib (Velcade) to induction regimens in transplant-eligible patients results in improved overall response rate, progression-free survival (PFS), and overall survival (OS) compared with regimens that do not contain bortezomib.
“Pooled estimates of response and survival strongly favor including bortezomib in induction regimens,” commented lead investigator of the study, Ajay K. Nooka, MD, MPH, FACP, Winship Cancer Institute, Emory University, Atlanta, GA.
San Diego, CA—Impressive results from several clinical trials on pomalidomide—a novel immunomodulating drug for multiple myeloma—presented at the 2011 American Society of Hematology annual meeting continue to show promise for this drug.
Multiple myeloma (MM) is a progressive malignancy of the plasma cells in the bone marrow and is associated with an increased level of monoclonal protein (M-protein) in the blood and/or urine. The growth of myeloma cells causes skeletal destruction and bone marrow failure, whereas overproduction of M-protein causes suppression of normal immunoglobulin production and renal insufficiency.
Historically, Pharmacy and Therapeutics (P&T) Committee review of new cancer therapies was essentially an automatic placement of products on formulary, without any significant restrictions or barriers to access for patients and physicians. The rationale being that there was a lack of sufficient clinical data to differentiate between competing therapies, as well as a limited number of specific treatments for any one type of cancer.
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