Message #14 From:
Stock News Bot Date: December 19, 2006 07:29:00 AM
IOPM News European Medical Studies: Shorter Treatment Cycles, Improved Tumor Control and Longer Life Expectancy for Cancer Patients Treated with IOERT
SUNNYVALE, Calif.--(BUSINESS WIRE)--IntraOp Medical Corporation (OTCBB: IOPM) today announced the
results of several cancer research studies that were presented at the
European Society of Surgical Oncology (ESSO) Conference, November 30 to
December 3 in Venice, Italy, by members of the International Society of
Intraoperative Radiation Therapy (ISIORT).
These studies examined the efficacy of intraoperative electron-beam
radiation therapy (IOERT) for the treatment of breast cancer, rectal
cancer, pancreatic cancer and sarcomas for patients treated at various
European centers. The results of individual studies were ‘pooled’
by ISIORT to provide greater statistical significance to the results of
individual studies with patients that were treated with identical
therapies. Some of the studies are still ongoing but preliminary results
show significant improvements in areas such as local tumor control,
shorter treatment cycles and longer life expectancy. The studies are
summarized below:
Breast Cancer: Two Minutes of IOERT to Replace Five Weeks of
Radiation Therapy
The European Institute of Oncology (EIO) is conducting a randomised
trial on IOERT for early stage breast cancer. The EIO is testing whether
for a select group of women with early stage breast cancer if the
conventional treatment of five to seven weeks of external beam
radiation, after the woman has healed from the surgical removal of the
tumor, can be replaced by a two minute treatment of IOERT. The study is
focusing on women over the age of 48 with small tumors and negative
nodes.
The report on this study was given by Dr. Giovanni Ivaldi, radiation
oncologist at the EIO. The study is expected to be completed by the end
of this year and the final results will be reported in about 24 months,
after the data has matured. Dr. Ivaldi reported on the results of 590
patients treated with IOERT as the sole radiation treatment for early
stage breast cancer at the EIO. The patients treated with IOERT and
surgery alone appeared to be doing as well as conventionally treated
patients but, it will be another 24 months before all of the answers
concerning this promising approach will be proven by the randomized
trial.
Dr. Umberto Veronesi, director of the EIO in Milan, Italy, said, “Intraoperative
radiotherapy is becoming a substantial component of the methods and
procedures for the treatment of cancer because of the new mobile linear
accelerators. They are very easy to use. Now, breast cancer, abdominal
tumors, rectal cancer, pancreatic cancer, cervical cancer and
gynecological tumors can be treated intraoperatively. This represents a
new course in therapy.”
Rectal Cancer: Five-Year Survival Rates Increase from 25% to 60% with
IOERT
At Catharina Hospital, in Eindhoven, The Netherlands, Dr. Harm Rutten,
surgical oncologist, is heading the pooled analysis study for patients
with locally advanced rectal cancer. This study showed that patients
treated with IOERT achieved a five-year local control of 87% and had a
five-year survival of over 60%. This is in marked contrast to
conventional treatment approaches without IOERT that typically achieve a
five-year local tumor control of less than 50% and survival of only
about 25%. Patients who fail to achieve local tumor control in rectal
cancer may require further surgery, additional hospitalization and
alternative treatments.
According to Dr. Rutten, the results of this study, which pooled the
data from four institutions and more than 600 patients, show the
important role that IOERT plays in both local control and in survival
for advanced rectal disease. “In The
Netherlands, we are already writing protocols which require IOERT to be
given to all Dutch patients who have rectal recurrences. Recurrent
rectal cancer is even a more difficult disease to treat than locally
advanced rectal cancer. With the new mobile IOERT technology available,
it is convenient and easy to deliver. It should not be long before all
major cancer centers can offer this critical treatment to their patients,”
said Dr. Rutten.
Breast Cancer: IOERT ‘Boost’
Achieves 99.6% Tumor Control
Dr. Felix Sedlmayer, professor and chairman of radiation oncology at the
University of Salzburg, Austria, presented pooled data for 1100 early
stage breast cancer patients from six European centers treated using
IOERT as a ‘boost’.
In a boost treatment, IOERT is given during the time of surgery after
the removal of a cancerous tumor and additional external beam radiation
is given to the patient after healing from the initial surgery. The
advantage of the IOERT boost, also known as the ‘bio-boost’,
is that it can be given to all women who are candidates for breast
conserving therapy, irrespective of age or nodal status, size or even
grade of the tumor. More than half of the women in the pooled analysis
had one or more of these adverse factors. With a median follow-up of 53
months, there were no recurrences at the site of the IOERT boost and
only four in-breast recurrences resulting in in-breast tumor control of
99.6%. At the University of Salzburg, the bio-boost is already the
standard of care for early stage breast cancer patients.
Sarcomas: Shorter Treatment Cycles, Fewer Complications and Longer
Survival Rates with IOERT
Dr. Robert Krempien, professor and chairman of radiation oncology at the
University of Heidelberg, Germany, presented the results of a study on
255 patients with extremity sarcomas. In this study, radiation therapy
combined with surgery (to remove the tumor) was used to avoid surgical
amputation of the effected limb. Sarcomas are typically quite large and
while they can be treated with external beam radiation or brachytherapy,
IOERT has the advantage of being delivered at the time of surgery when
the boost dose is more effective, is very uniform and can reduce the
amount of external radiation therapy that is required. With a median
follow-up of 61 months, Dr. Krempien reported local control and survival
rate of 77% and 78% respectively. These results compare quite favorably
with conventional boost techniques.
Dr. Krempien also reported on the use of IOERT to treat 123
retroperitoneal sarcoma patients. These sarcomas are large tumors in the
abdomen. It is very difficult to achieve local control and long-term
survival in patients with this disease. Of the patients in the study,
two-thirds had recurrent tumors, 67% were high grade tumors (more
virulent) and more than half the patients had tumors larger than 10 cm.
Despite these unfavorable characteristics, the analysis showed a
five-year survival of 58%, which compares very favorably to conventional
approaches for this tumor type.
Pancreatic Cancer: 73% Five-Year Local Control Rates for Patients
Treated with Preoperative Chemoradiation Coupled with IOERT
Dr. Vincenzo Valentini, professor of radiation oncology at the Catholic
University in Rome, presented the pooled analysis for pancreatic cancer,
one of the most difficult cancers to treat effectively, by any method.
(In the United States, there are 30,000 cases of pancreatic cancer each
year and the annual death rate from this disease is approximately
29,100.) The 185 patients in the European study were treated by three
different IOERT techniques: IOERT alone; IOERT followed by
post-operative radiation therapy with or without chemotherapy, or
pre-operative chemoradiation therapy followed by IOERT. The five-year
local control for all patients was 23%, but increased to 58% for
patients who also received chemotherapy and was 73% for those who
received pre-operative chemoradiation therapy plus IOERT. In pancreatic
cancer, patients that achieve local control generally also have pain
relief for most of their lives. The five-year survival was 22% for
patients that received pre-operative chemoradiation therapy but only 6%
for those that had IOERT alone. The pooled analysis clearly demonstrates
that the preferred approach for treating pancreatic cancer is
preoperative chemoradiation therapy followed by IOERT.
More information on these studies can be found on the ISIORT website, www.isiort.org,
About IntraOp
IntraOp Medical Corporation provides innovative technology solutions for
the treatment and eradication of cancer. Founded in 1993, IntraOp is
committed to providing the tools doctors need to administer
intraoperative radiation therapy safely and effectively –
for all cancer patients. The company’s
flagship product, Mobetron, is the first fully portable, self-shielding
intraoperative electron radiation therapy device designed for use in any
operating room. Key Mobetron benefits include: increased survival rates,
better local tumor control, shorter treatment cycles, and fewer side
effects. Leading hospitals, from university research centers to
specialized cancer clinics in North America, Europe and Asia, use
Mobetron as a vital part of their comprehensive cancer program.
For more information on IntraOp Medical Corporation, please visit www.intraopmedical.com
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the meaning of Section 27A of the 1933 Securities Act and Section 21E of
the 1934 Securities Exchange Act. Actual results could differ
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for the company's products and services and the ability of the Company
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Company can give no assurances that transactions described in this press
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