Experts Praise Drug Trial for Creating a Realistic Study Population
A German study of a new drug therapy for chronic lymphocytic leukemia (CLL) was lauded for including elderly persons who had other, coexisting health issues in its study population. An accompanying editorial noted that the study population more accurately represented patients with CLL than most trials in this area.
CLL is one of the most common forms of blood cancers, usually affecting those later in life. The editorial was written by Kanti Rai, MD, chief of CLL Research and Treatment Program for the North Shore-Long Island Jewish (LIJ) Cancer Institute in Lake Success, New York, and Jacqueline Barrientos, MD, a research hematologist on staff at the CLL Program, also at North Shore-LIJ. These two physicians' research in CLL is world-renowned.
They pointed out that an important factor in the study is that most of the nearly 800 participants are elderly with other, coexisting health issues.
Until now, researchers have skipped this population in favor of younger and healthier participants, the doctors explained. However, the average age at diagnosis of CLL is 72 years, and most patients usually have other health problems. The editorial appeared in the New England Journal of Medicine (2014; doi:10.1056/NEJMe1400599).
The study focused on the use of obinutuzumab, an antibody that binds to the protein CD20, in subjects with previously untreated CLL and coexisting conditions. Most cases of CLL start in white blood cells that have CD20 on their surface.
Researchers compared the benefits of obinutuzumab with that of another antibody rituximab, which also attacks CD20. Both drugs were combined with the chemotherapy drug chlorambucil. They found that subjects receiving obinutuzumab-chlorambucil had an average of 26.7 months progression-free of the disorder compared to 16.3 for those given rituximab-chlorambucil. The study was also published in the New England Journal of Medicine (2014;370:1101-1110).
Findings of the study will have an important impact on future CLL research, explained Rai. "The researchers' work will encourage future use of obinutuzumab in combination with other drugs and help shape the clinical landscape of CLL in the next decade."
The editorial explained that “the largest population of patients enrolled was elderly with a considerable number of coexisting conditions.” They went on to explain that the new therapy was offered to the typical aging population with CLL. They also mentioned that findings in CLL can affect several other diseases.