New breast cancer study results published in The Lancet compare targeted radiotherapy during surgery with ZEISS INTRABEAM to traditional post-surgical radiotherapy treatment

Geschrieben am 02-12-2013

Jena (ots) -

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

"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

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

Carl Zeiss Meditec AG

Carl Zeiss Meditec AG (ISIN: DE0005313704) is one of the world?s
leading medical technology companies. The company supplies innovative
technologies and application-oriented solutions designed to help
doctors improve the quality of life of their patients. It is a
provider of total solutions for the diagnosis and treatment of eye
diseases, including implants and consumables. The company creates
innovative visualization solutions in the field of microsurgery. The
medical technology portfolio of Carl Zeiss Meditec is rounded off by
promising future-oriented technologies such as intraoperative
radiotherapy. In fiscal year 2011/12 (ended 30 September) the 2,400
employees of the company generated revenue totaling EUR 862 million.
Carl Zeiss Meditec headquarters are located in Jena, Germany.

The company has subsidiaries in Germany and abroad; more than 50
percent of its employees are based in the USA, Japan, Spain and
France. The Center for Application and Research in India (CARIn) in
Bangalore, India, and the Carl Zeiss Innovation Center for Research
and Development in Shanghai, China, strengthen the company's presence
in these fast-growing countries. Around 35 percent of Carl Zeiss
Meditec shares are in free float. The remaining approx. 65% are held
by Carl Zeiss AG, one of the world?s leading groups in the optical
and optoelectronic industries. In the markets for Industrial
Solutions, Research Solutions, Medical Technology and Consumer
Optics, Carl Zeiss has contributed to technological progress for more
than 160 years and enhances the quality of life of many people around
the globe. Carl Zeiss AG, Oberkochen, is fully owned by the Carl
Zeiss Foundation.

For more information, please go to: www.meditec.zeiss.com

Contact for the press:
Jann Gerrit Ohlendorf, Group Communications,
Carl Zeiss Meditec AG
Phone +49 (0) 3641 220-331,
Email: press.meditec@zeiss.com

Alice Swinton, Group Communications,
Carl Zeiss Meditec, Inc.
Phone +1 925 557 4317,
Email: alice.swinton@zeiss.com

For investors:
Sebastian Frericks, Investor Relations,
Carl Zeiss Meditec AG
Phone +49 (0)3641 220-116,
Email: investors.meditec@zeiss.com


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