Freezing Out Breast Cancer

First Reported Study Shows Encouraging Interventional Radiology Potential
Treatment for Breast Cancer With Cryotherapy, No Need to Undergo Surgery After
to Ensure Tumor Killed

TAMPA, Fla., March 16 /PRNewswire-USNewswire/ -- Interventional radiologists
have opened the door to an encouraging potential future treatment for the
nearly 200,000 women who are diagnosed with breast cancer in the United
States each year: image-guided, multiprobe cryotherapy. In the first reported
study, researchers were able to successfully freeze breast cancer in patients
who refused surgery; the women did not have to undergo surgery after treatment
to ensure that tumors had been killed, note researchers at the Society of
Interventional Radiology's 35th Annual Scientific Meeting in Tampa, Fla.

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"Minimally invasive cryotherapy opens the door for a potential new treatment
for breast cancer and needs to be further tested. When used for local control
and/or potential cure of breast cancer, it provided safe and effective breast
conservation with minimal discomfort for a group of women who refused invasive
surgery or had a local recurrence and needed additional management," noted
Peter J. Littrup, M.D., an interventional radiologist and director of imaging
research and image-guided therapy for the Barbara Ann Karmanos Cancer
Institute in Detroit, Mich. "This is the first reported study of
successfully freezing breast cancer without having to undergo surgery
afterward to prove that it was completely treated," he added. In the
13-patient study, no localized treatment recurrences were seen for up to five
years, no significant complications were noted and women were pleased with the
cosmetic outcomes, noted Littrup, who is also a professor of radiology,
urology and radiation oncology at Wayne State University in Detroit.
Cryotherapy was applied according to well-established freezing principles, and
biopsies at the margins of the cryotherapy site immediately after the
procedure and at the cryotherapy site in follow-up were all negative-showing
no cancer, said Littrup.

In the United States, a woman is diagnosed with breast cancer every three
minutes and one woman will die from the disease every 13 minutes. A woman has
about a 13 percent lifetime risk of developing breast cancer, with women 50
years of age and older accounting for approximately 80 percent of all breast
cancers. For these women, as well as the thousands of men diagnosed each year,
breast cancer treatments can be highly effective but often require invasive
treatment options such as surgery and chemotherapy. Surgery offers the best
chance for a cure. Until long-term data are available, interventional
treatments-such as cryotherapy, thermal ablation and laser therapy-are
reserved for women who cannot have-or have refused-surgery.

In this study's cryotherapy treatment, researchers used several needle-like
cryoprobes that were evenly spaced and that were inserted through the skin to
deliver extremely cold gas directly to the tumor to freeze it. This technique
has been used for many years by surgeons in the operating room; however, in
the last few years, the needles have become small enough to be used by
interventional radiologists through a small nick in the skin, without the need
for an operation. The "ice ball" that is created around the needle grows in
size and destroys the frozen tumor cells. The major benefits of cryotherapy
are its superb visualization of the ice treatment zone during the procedure,
its low pain profile in an outpatient setting and its excellent healing with
minimal scar, said Littrup. Breast imaging has markedly advanced by accurate
improvements in breast magnetic resonance imaging (MRI), allowing for
excellent treatment planning of tumor size and extent within the breast, as
well as showing zones of destruction thoroughly covering the tumor after
cryotherapy, he noted.

A major difference between this study and all prior uses of breast cryotherapy
is the confirmation of sufficient deadly temperatures when using two or more
cryoprobes, said Littrup. Prior breast cryotherapy studies had "inexplicably"
used only a single cryoprobe and suggested that tumors larger than 1.5
centimeters could not be adequately treated, he explained. "This is
incongruent with more than 10 years of treating an entire prostate, which is
approximately 5 centimeters, with more than six probes in order to generate
well-defined sufficient deadly temperatures throughout the whole gland. We
simply translated this concept to breast cancer in order to assure deadly
temperatures well beyond all apparent tumor margins in order to generate
successful use of cryotherapy in women," said Littrup. "This emphasizes the
important role of an interventional radiologist in pioneering image-guided
therapy by appropriately using established treatment technology-let alone
emerging ones-to deliver a sufficient treatment dose, rather than only relying
on the organ-specific expertise of other subspecialized physicians," said
Littrup. "An interventional radiologist can better focus on the image-guidance
similarities of nearly any treatment technology and thereby help lead the
effort of improved cancer treatments for many organ sites," added the
co-author of "Cryotherapy for a Spectrum of Breast Cancer: US and
CT-guidance."

Surgeons and radiation oncologists have long tried to provide at least a
1-centimeter margin of treatment surrounding all aspects of a localized breast
cancer, and it was important to ensure a similar "surgical margin" of lethal
temperatures beyond all tumor margins by cryotherapy in this study, said
Littrup. "The well-visualized ice margin by ultrasound CT or MR is actually
only the 0-degree Celsius line, or isotherm, which is not sufficiently
lethal to cancer cells, but has unfortunately been confused with the actual
treatment margin. We made sure that the lethal isotherm of approximately -30
degrees Celsius extended beyond all tumor margins," said Littrup.

After breast MRI and thorough consultation, patient consents were obtained for
institutional review board-approved breast cryotherapy. In 13 cryotherapy
sessions, 25 breast cancer foci were treated in 13 patients, stages 1-4, using
multiple 2.4-millimeter cryoprobes. Using only local anesthesia with mild
sedation, ultrasound guidance alone was used in six patients; seven patients
required both CT and ultrasound to better define ice margins. MR and/or
clinical follow-up were available for up to 65 months after cryotherapy.
Pretreatment breast tumor diameter was 1.7 + 1.2 centimeters (range, 0.5-5.8
centimeters) and an average of 3.3 cryoprobes produced ice diameters of 5.2 +
2.2 centimeters (range, 2-10 centimeters).

"With recent developments of powerful new cryotechnology, multiple directions
for breast cryotherapy can be pursued, including translating the current,
somewhat challenging, procedure done with ultrasound and/or CT guidance to a
more consistent and reproducible MR-guided approach," said Littrup.
Cryotechnology promises to be more MR-compatible and would also allow accurate
targeting of more difficult-to-see breast tumors. More importantly, larger
studies in multiple centers need to be done, following these basic cryobiology
principles of sufficient lethal temperatures generated by multiple cryoprobes
spaced evenly throughout a breast cancer region, he added.

More information about the Society of Interventional Radiology, interventional
radiologists and minimally invasive treatments for cancer can be found online
at www.SIRweb.org.

Abstract 158: "Cryotherapy for a Spectrum of Breast Cancer: US and
CT-guidance," P.J. Littrup, M. D'Agostini, B. Adam and D. Bouwman, Karmanos
Cancer Institute, Detroit, Mich., and B. Jallad and P. Chandiwala-Mody, both
at Wayne State University, Detroit, Mich., SIR 35th Annual Scientific
Meeting March 13-18, 2010, Tampa, Fla.. This abstract can be found at
www.SIRmeeting.org.

About the Society of Interventional Radiology

Interventional radiologists are physicians who specialize in minimally
invasive, targeted treatments. They offer the most in-depth knowledge of the
least invasive treatments available coupled with diagnostic and clinical
experience across all specialties. They use X-ray, MRI and other imaging to
advance a catheter in the body, such as in an artery, to treat at the source
of the disease internally. As the inventors of angioplasty and the
catheter-delivered stent, which were first used in the legs to treat
peripheral arterial disease, interventional radiologists pioneered minimally
invasive modern medicine. Today, interventional oncology is a growing
specialty area of interventional radiology. Interventional radiologists can
deliver treatments for cancer directly to the tumor without significant side
effects or damage to nearby normal tissue.

Many conditions that once required surgery can be treated less invasively by
interventional radiologists. Interventional radiology treatments offer less
risk, less pain and less recovery time compared to open surgery. Visit
www.SIRweb.org.

The Society of Interventional Radiology is holding its 35th Annual Scientific
Meeting March 13-18 in Tampa, Fla. The theme of the meeting is "IR
Innovation," celebrating the remarkable inventiveness of SIR members and
highlighting the contributions made to both creating the field of
interventional radiology and to improving patient care.

SOURCE Society of Interventional Radiology

Maryann Verrillo, +1-703-460-5572, Diane Shnitzler, +1-703-460-5582, Lisa
Tadje (March 11-12), +1-212-453-2137, Don Murphy (March 11-12),
+1-212-453-2462, Neil Hochman (March 11-12), +1-212-453-2067, Tampa Press Room
(March 13-18), +1-813-276-6905, +1-813-276-6906, +1-813-276-6912,
comm@SIRweb.org, all of the Society of Interventional Radiology