Seniors with Chronic Lymphocytic Leukemia Do Poorly
on Therapy Designed for Younger Patients
People who develop chronic lymphocytic leukemia (CLL)
are typically age 65 and older, but participants in CLL clinical trials
are usually several years younger
12, 2012 – Although most people are age 65 or older – senior citizens –
when they develop chronic lymphocytic leukemia (CLL), most of the
clinical trials use younger participants. And, age is not usually
considered when treatment is determined. A new study says this is a
mistake – the therapies should be different for older CLL patients and
younger ones, although the disease is incurable.
This study, led by researchers at the Ohio State
University Comprehensive Cancer Center – Arthur G. James Cancer Hospital
and Richard J. Solove Research Institute (OSUCCC – James), indicates
that older people with CLL may not respond as well to the therapy used
for most patients.
It was published
Dec. 10 in the Journal of Clinical Oncology.
“Our analysis shows that optimal therapy for
younger and older patients with chronic lymphocytic leukemia is likely
to be different, at least when using current treatments,” says first
author Dr. Jennifer Woyach, assistant professor of hematology at the
OSUCCC – James.
“We hope this study will shape future research by
highlighting the importance of enrolling older patients on clinical
trials and of developing trials that specifically target older
Doctors diagnose about 15,000 new cases of chronic
lymphocytic leukemia (CLL)
annually in the United States, making it the most common form of
leukemia. It remains incurable, and about 4,400 Americans die of the
malignancy each year. CLL most often occurs in people older than age 65;
the average age at diagnosis is 72. Yet, most CLL clinical-trial
participants are in their early 60s.
“Our findings apply to both routine care of CLL
patients 70 years and older and to future CLL trials,” says principal
investigator Dr. John Byrd, a CLL specialist and professor of medicine,
of medicinal chemistry and of veterinary biosciences at the OSUCCC –
“The study suggests that chlorambucil is superior
to fludarabine in older patients, and that
antibody therapies such as rituximab are beneficial as front-line
therapy for all CLL patients, regardless of age,” says Byrd, who is the
D. Warren Brown Designated Chair in Leukemia Research.
is cancer of the white blood cells. White blood cells help your
body fight infection. Your blood cells form in your bone marrow.
In leukemia, however, the bone marrow produces abnormal white
These cells crowd out the healthy blood cells,
making it hard for blood to do its work. In chronic lymphocytic
leukemia (CLL), there are too many of a specific type of white
blood cell called a lymphocyte.
CLL is the second most common form of leukemia in adults. It
often occurs during or after middle age and rarely occurs in
From 2005-2009, the median age at diagnosis for chronic
lymphocytic leukemia was 72 years of age.
Approximately 0.0% were diagnosed under age 20; 0.2% between 20
and 34; 1.6% between 35 and 44; 9.0% between 45 and 54; 20.9%
between 55 and 64; 26.5% between 65 and 74; 27.8% between 75 and
84; and 14.0% 85+ years of age.
The age-adjusted incidence rate was 4.2 per 100,000 men and
women per year.
From 2005-2009, the median age at death for chronic lymphocytic
leukemia was 79 years of age. Approximately
0.0% died under age 20; 0.1% between 20 and 34; 0.4% between 35
and 44; 2.9% between 45 and 54; 10.7% between 55 and 64; 20.8%
between 65 and 74; 35.1% between 75 and 84; and 29.9% 85+ years
The 4 Common Types of Leukemia
lymphocytic leukemia (or chronic lymphoblastic leukemia, CLL)
accounts for about 7,000 new cases of leukemia each year. Most
often, people diagnosed with the disease are over age 55. It
almost never affects children.
leukemia (or acute lymphoblastic leukemia, ALL) accounts for
about 3,800 new cases of leukemia each year. It is the most
common type of leukemia in young children. It also affects
leukemia (or chronic myelogenous leukemia, CML) accounts for
about 4,400 new cases of leukemia each year. It affects mainly
leukemia (or acute myelogenous leukemia, AML) accounts for
about 10,600 new cases of leukemia each year. It occurs in both
adults and children.
“These data also show that future treatment trials
for older adults with CLL should build on CD20 antibody therapies such
as rituximab and ofatumumab, but not on fludarabine or alemtuzumab.”
Byrd, Woyach and their colleagues reviewed 663 CLL
patients who were enrolled in four sequential CLL clinical trials
evaluating front-line therapies. The researchers looked for differences
in treatment outcomes between older and younger patients to identify the
most effective therapy for older adults.
The four trials, all sponsored by the Cancer and
Leukemia Group B (CALGB) clinical cooperative group, compared these
treatments: chlorambucil versus fludarabine, fludarabine plus rituximab
versus fludarabine, fludarabine with consolidation alemtuzumab, and
fludarabine plus rituximab with consolidation alemtuzumab.
Key conclusions include:
● Fludarabine versus chlorambucil: Fludarabine
improved progression-free survival and overall survival among patients
younger than age 70 but chlorambucil tended to produce higher overall
survival in patients older than 70.
● Rituximab combined with fludarabine, versus
fludarabine alone, improves progression-free and overall survival in
both younger and older patients.
● Alemtuzumab consolidation therapy after
chemotherapy or chemoimmunotherapy does not improve progression-free or
overall survival in either younger or older patients.
Funding from the NIH/National Cancer Institute
(grants CA31946, CA33601 and CA140158), the Leukemia and Lymphoma
Society, the Harry Mangurian Foundation and the D. Warren Brown Family
Foundation supported this research.
Other researchers involved in this study were Amy
S. Ruppert and Susan Geyer of Ohio State; Kanti Rai and Jonathan Kolitz
of North Shore-Long Island Jewish Medical System; Martin S. Tallman,
Memorial Sloan-Kettering Cancer Center; Thomas S. Lin, GlaxoSmithKline;
Frederick R. Appelbaum, Fred Hutchinson Cancer Research Center; Andrew
R. Belch, Cross Cancer Institute, Edmonton, Alberta, Canada; Vicki A.
Morrison, University of Minnesota and Veterans Affairs Medical Center;
and Richard A. Larson, University of Chicago.
The Ohio State
University Comprehensive Cancer Center – Arthur G. James Cancer Hospital
and Richard J. Solove Research Institute strives to create a
cancer-free world by integrating scientific research with excellence in
education and patient-centered care, a strategy that leads to better
methods of prevention, detection and treatment. Ohio State is one of
Institute (NCI)-designated Comprehensive Cancer Centers and
one of only seven centers funded by the NCI to conduct both phase I and
phase II clinical trials. The NCI recently rated Ohio State’s cancer
program as “exceptional,” the highest rating given by NCI survey teams.
As the cancer program’s 210-bed adult patient-care component, The James
is a “Top Hospital” as named by the Leapfrog Group and one of the top
cancer hospitals in the nation as ranked by U.S. News & World Report.
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