- German Study Results Published in Journal of Clinical Oncology -
GOTTINGEN, Germany, Sept. 21 /PRNewswire/ -- The University of Gottingen
today announced that the results of a five-year study conducted at this German
university's Departments of General Surgery and Nuclear Medicine were
published in the September 20th issue of The Journal of Clinical Oncology, a
publication of the American Society of Clinical Oncology. The authors
reported that they treated 23 colorectal cancer patients with a radioactive,
humanized, antibody against carcinoembryonic antigen (CEA), which is expressed
by more than 90% of colorectal cancers, after the patients had complete
resection of their liver metastases by these surgeons. The investigators
found that those treated after surgery with one injection of this 131I-labeled
labetuzumab antibody, developed by Immunomedics, Inc. (Nasdaq: IMMU), survived
twice as long (68 months median survival) than either historical controls or a
contemporaneous control group of patients receiving either chemotherapy or no
therapy (31 months median survival) at this hospital. The median follow-up
time in this trial was a little over 5 years (64 months). In the evaluable
population of 19 patients, the five-year survival rate was 51.3%. The major
adverse event was transient myelosuppression, mostly in a drop in white blood
cells and/or platelets.
The study's principal investigators, Dr. Torsten Liersch (Department of
General Surgery) and Dr. Johannes Meller (head of the Department of Nuclear
Medicine of the University of Gottingen), commented: "These are the best
results we know so far for the adjuvant, or post-operative treatment, of
patients having their liver metastases of colorectal cancer resected. In most
other trials reported, the median survival after resection of these
metastases, even with post-operative chemotherapy, is between 28 and 41
months, when about 25%-37% of the patients survive five years. These initial
trial results with radiolabeled labetuzumab confirm animal and earlier
clinical studies showing a benefit for this treatment in the setting of
micrometastatic disease, which we presume is present in patients having their
liver metastases removed, since over two-thirds usually relapse between 2 and
5 years later."
"These striking results encourage us to proceed to a randomized trial,
comparing 131I-labetuzumab to post-operative chemotherapy or to the
combination of radioimmunotherapy and chemotherapy in colorectal cancer
patients having resection of their liver metastases," added Professor Heinz
Becker, M.D., Director of the Department of General Surgery, and a
co-investigator of this study.
Reference:
T. Liersch, J. Meller, B. Kulle, T.M. Behr, P. Markus, C. Langer, B.M.
Ghadimi, W.A. Wegener, J. Kovacs, I.D. Horak, H. Becker, and D.M. Goldenberg.
Phase II Trial of Carcinoembryonic Antigen Radioimmunotherapy With 131I-
labetuzumab After Salvage Resection of Colorectal Metastases in the Liver:
Five-Year Safety and Efficacy Results. J Clin Oncol 2005; 23(27): 6763-6770.
About Colorectal Cancer
Colorectal cancer is responsible for more than 15% of all malignancies in
the United States and Europe, afflicting about 147,000 Americans and killing
approximately 57,000 in 2004; it is the third most frequent cancer killer in
our society. The liver is the most common site of distant spread, or
metastasis, affecting up to 60% of colorectal cancer patients (at least
50,000 is the USA). The five-year survival rate, irrespective of any form of
therapy other than surgery, is close to zero in patients with liver
metastases, and after resection of liver tumors in patients who are amenable
to complete surgical removal of metastatic liver disease, the 5-year survival
rate has been reported to be between 25% and 37% at specialized centers, but
with tumor relapse occurring in the majority of patients. Since about
two-thirds of resected colorectal cancer patients eventually relapse, with
more than half first experiencing a recurrence in the liver, current thought
is that clusters of tumor cells are trapped selectively in the liver, where
they then expand to form liver metastases. Therefore, methods to selectively
and timely destroy these clusters of cancer cells are needed, so that surgical
efforts can be more successful.
About 131I-labetuzumab
Labetuzumab is Immunomedics' proprietary, humanized, monoclonal antibody
targeting a specific site on carcinoembryonic antigen (CEA) that is associated
with over 90% of colorectal cancers, even when they spread to the liver and
other organs. The antibody, labeled with a therapeutic radioisotope, iodine-
131, is able to target and destroy clusters of CEA-expressing cancer cells, as
demonstrated previously in preclinical studies involving human colonic cancers
grafted to immunosuppressed mice, where cures were achieved after giving the
therapeutic to mice with disseminated, or metastatic, disease. Since the
radioactivity passes through the blood as the antibody distributes throughout
the body, compartments rich in blood, such as the bone marrow, received
radioactivity, but at lower doses than to cancer cells. This results in the
transient hematological depression observed in patients at the radiation doses
delivered. Studies are now in progress to assess the safety and efficacy of
repeated doses of this radioactive antibody following resection of liver
metastases in colorectal cancer patients.
Contact person at University of Gottingen:
Dr. Stefan Weller, stefan.weller@med.uni-goettingen.de, +49-551-3999-59
SOURCE University of Gottingen
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Related links:
http://www.Immunomedics.com
Company News On-Call:
http://www.prnewswire.com/comp/113121.html
CONTACT:
Dr. Stefan Weller, +49-551-3999-59, or
stefan.weller@med.uni-goettingen.de
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