JENA, Germany, December 2, 2013 /PRNewswire/ --
5-year results of international TARGIT-A clinical trial
support targeted intraoperative radiotherapy (TARGIT) delivered
with the ZEISS INTRABEAM as non-inferior to external
beam radiotherapy (EBRT) for selected early stage breast
cancer patients.
Results of
the TARGIT-A clinical trial
published in The Lancet
A new clinical trial for breast cancer, published in The
Lancet, one of the world's leading medical journal, shows that
a single fraction of targeted intraoperative radiotherapy (TARGIT)
delivered with the ZEISS INTRABEAM® at time of
lumpectomy is non-inferior to traditional external beam radiation
(EBRT) delivered over three to six weeks after breast conserving
surgery, for a select group of patients.
"The most important benefit of TARGIT for a woman with
breast cancer is that it allows her to complete her entire local
treatment at the time of her operation, with lower toxicity to the
breast, the heart and other organs. Our research supports the use
of TARGIT concurrent with lumpectomy, provided patients are
selected carefully, and should allow patients and their clinicians
to make a more informed choice about individualizing their
treatment, saving time, money, breasts, and lives," according to
Professor Jayant S. Vaidya, FRCS MD,
PhD from the international TARGIT investigators group, in the
accompanying press release on the Lancet publication of the
research study.
Since 1998, the international TARGIT research group has
investigated whether radiotherapy targeted to the tumour bed at the
time of surgery can reduce the risk of recurrence in early breast
cancer as effectively as the traditional three to six week
EBRT.
Traditionally, whole-breast EBRT is given after lumpectomy
(breast conserving surgery) to reduce the risk of recurrence of
cancer in the breast and of breast cancer mortality. EBRT typically
is given over a course of three to six weeks requiring patients to
receive treatment at radiotherapy centers for 20-30 days. In some
cases, women suitable for breast conserving surgery, but living far
from a radiotherapy center and unable to attend daily post-surgical
treatments may even undergo mastectomy as an alternate.
In the TARGIT approach, during surgery after removal of the
tumor, the affected tissue in the tumor bed is irradiated from
within the breast using the ZEISS INTRABEAM. The TARGIT study
results show that targeted intraoperative radiotherapy delivered
with ZEISS INTRABEAM can reduce the risk of recurrence of the
cancer as effectively as a traditional 3- to 6-week course of whole
breast irradiation in selected women with invasive ductal
carcinoma.
The TARGIT-A trial has been to date the largest multicenter
randomized clinical trial for intraoperative radiotherapy (IORT) in
the field of partial breast irradiation, with 3451 patients in 33
international centers from Europe,
the United States, and
Australia. The TARGIT-A trial
followed an individualized risk-adapted approach, meaning, that
patients who had received TARGIT at the time of surgery showed in
the final pathology additional unforeseen risk factors, received
supplemental EBRT, which occurred for about 15% of the patients.
The 5-year results for local recurrence and the first analysis of
overall survival of the TARGIT-A trial have now been reported.
Comparing TARGIT with EBRT the difference in 5-year local
recurrence between the two treatments was less than 2.5% and
therefore considered "non-inferior" to standard EBRT (daily doses
for 3-6 weeks) in treating the cancer. Overall mortality was 3.9%
with TARGIT and 5.3% with EBRT, due to fewer deaths from
cardiovascular causes and other cancers.
Based on statistical comparison of breast cancer recurrence,
number of deaths and side effects of TARGIT versus EBRT the authors
conclude: "TARGIT concurrent with lumpectomy within a risk-adapted
approach should be considered as an option for eligible patients
with breast cancer carefully selected as per the TARGIT-A trial
protocol."
"We commend the international TARGIT group pioneered by
Professor Jayant Vaidya and
Professor Michael Baum for this
outstanding research on this new treatment option that can benefit
many breast cancer patients. The TARGIT group's research will
further enhance adoption by radiation oncologists and breast
surgeons worldwide and will broaden the application of our ZEISS
INTRABEAM for this new option in the fight against cancer," says
Dr. Ludwin Monz President and CEO of
Carl Zeiss Meditec AG.
The Lancet publication of the results of the TARGIT-A study can
be found at http://press.thelancet.com/TARGIT.pdf
http://www.meditec.zeiss.de/presse
Carl Zeiss Meditec AG
Carl Zeiss Meditec AG (ISIN: DE0005313704) is one of the
world's leading medical technology companies. The company supplies
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portfolio of Carl Zeiss Meditec is rounded off by promising
future-oriented technologies such as intraoperative radiotherapy.
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