Breast Cancer Clinical Trial of Laser Ablation Treatment Shows Promising Results for Patients

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Groundbreaking Novilase Research Led by Rose Medical Center’s Dr.
Barbara Schwartzberg Is Presented at San Antonio Breast Cancer Symposium

DENVER–(BUSINESS WIRE)–A laser treatment called Novilase® Breast Therapy shows promise as a way
to successfully treat small breast cancers, according to research that
was led by principal investigator Barbara Schwartzberg, M.D. of Rose
Medical Center.

Results of the multi-center international BR-002
Novilase Clinical Trial
were presented today by Dr. Schwartzberg in
a scientific poster at the prestigious 2015 San Antonio Breast Cancer
Symposium (SABCS).

Laser ablation treatment places small probes in the center of the cancer
and subsequently uses heat to destroy tumors. Laser ablation could be a
viable option for small lesions and might allow some women to forgo
surgery in the future.

The trial results showed that Novilase Breast Therapy achieved 91
percent complete tumor ablation when treatment guidelines were followed.
The trial also demonstrated that MRI can be used to determine
effectiveness of tumor ablation. As such, MR imaging may potentially be
used to assess effectiveness, as pathology is used today after surgery.

The research trial, headed by Dr. Schwartzberg, is part of the process
of determining whether Novilase Breast Therapy will be approved by the
U.S. Food & Drug Administration (FDA) as an effective alternative to
lumpectomy surgery for the treatment of small, early-stage breast
cancers.

All patients in the study received standard-of-care, adjuvant and
radiation therapy as indicated. The ablated tissue was excised with
surgery 4 weeks after the laser treatment to allow investigators to
analyze the pathology of the targeted lesion. Researchers used that data
to correlate imaging to pathology in evaluating disease status after the
procedure.

The Novilase laser treatment, developed by Novian Health, is a minimally
invasive alternative to lumpectomy that targets the lesion using
ultrasound guidance. The trial results point to a possible future in
which women could get common breast cancers treated with less physical
damage and disruption to their daily lives. The novel Novilase laser
ablation therapy is already FDA-cleared as an alternative to surgery for
the treatment of benign breast tumors (fibroadenomas).

“We learned more from this research study than we anticipated, so I’m
very pleased with the results,” said Dr. Schwartzberg. “We saw multiple
advantages of using laser therapy to not only destroy the cancer tumor,
but to do so with only local anesthetic and less cosmetic damage than
traditional lumpectomy. Patients benefit from quicker recovery and are
less likely to need additional treatments than with surgery.”

Even when retreatment is needed, the consequences are far less with the
laser than with a lumpectomy, Dr. Schwartzberg said: “A retreatment with
the laser is still a minimally invasive procedure that causes no
substantial change to the look and feel of the breast and otherwise
poses few risks for the patient. By comparison when a second surgery is
needed, the situation is completely different. You’re probably worsening
the cosmetic impact already caused by the first operation. Plus you’re
re-exposing patients to the other risks and stresses of surgery.”

The clinical trial, which included Rose Medical Center and its breast
program, was conducted at 11 different sites – eight in the U.S. and
three in Britain – with both radiologists and breast surgeons as
investigators. A total of 61 patients with 64 tumors (61 primary and
three satellite) were enrolled in the study. Notable results included:

  • High rate of successful treatment. In 91 percent of cases where
    Novilase Breast Therapy was performed according to technical
    guidelines, the tumor was completely ablated. In all cases, there was
    84 percent complete tumor ablation.
  • Positive health-related quality of life scores. Patients reported
    better symptom-related scores and higher functional status scores
    following Novilase than has been reported for surgery.
  • No serious adverse events. There were no serious adverse events
    related to Novilase therapy at any of the trial sites.
  • Correlation between MRI and pathology. The trial demonstrated a
    high rate of correlation between MRI and pathology in determining
    effectiveness of laser ablation of breast cancer (a negative
    predictive value of 92 percent in correlating with pathology). In
    other words, the research showed that an MRI may be effective means of
    determining if a patient’s treatment was successful.

“The radiology aspects of the trial were very encouraging,” said Rose
Medical Center radiologist John Lewin, M.D., a co-author of the poster
presented at the San Antonio conference. “When targeted appropriately
using the image-guidance technology, the laser treatment achieved
complete ablation of the tumor a very large percentage of the time. The
tight correlation between MRI and pathology was also impressive. Using
imaging instead of pathology to analyze treatment outcomes is almost as
pioneering and important as using a laser instead of surgery.”

If the trial results help lead Novilase Breast Therapy to becoming
approved as a breast cancer treatment option, women could benefit in
several ways. Rather than requiring a surgical incision, the laser
device is inserted through the skin into the tumor. The incisions are so
small that they are closed with a bandage after the procedure. Laser
treatment causes little or no scarring or change in the breast’s shape
and feel – in contrast to the substantial cosmetic and tactile impact
that can result from a lumpectomy.

Laser treatment requires only local anesthesia instead of the general
anesthesia or IV sedation used for breast cancer lumpectomy or surgery.
Laser patients can generally return to normal activities in a day or
less, while recovery from surgery may take up to a week. Finally, there
is also less risk of complications with Novilase Breast Therapy.

“The difference between the laser and my two lumpectomies was day and
night,” said Kathryn Lawrence, 51, a graphic designer and property
investor in Brighton, Colo. She participated in the clinical trial at
Rose Medical Center and has had lumpectomies for cancers in both of her
breasts.

“The laser was almost pain-free with no scars and no deformity. I was
able to attend a business meeting on the same day as my treatment,” she
said. “I hope my participation in the trial helps to make this option
available to women like me in the future. I was excited to be one of the
first to access this technology for my diagnosis of breast cancer and
look forward to the day when any one who is diagnosed can take advantage
of this incredible treatment option.”

A follow-up pivotal clinical trial of the Novilase technology is planned
for 2016. It will expand upon the findings from the recent BR-002 study,
as part of the process to make the laser treatment more widely available
for women with breast cancer.

About Rose Medical Center

Well known as a Denver institution and a 9th Avenue landmark for more
than 60 years, Rose Medical Center has earned its reputation as Denver’s
“Baby Hospital” while becoming a leader in comprehensive women’s,
surgical and endoscopy services, heart and vascular, orthopedics, total
joint replacement, bariatrics, and sports, internal and aesthetic
medicine. With origins in Jewish teachings, traditions and community,
Rose’s founders built this hospital to “serve the need of every creed.”
By offering a high level of expertise and service across all
disciplines, Rose has become a destination hospital, attracting patients
from throughout Colorado and around the world. Learn more at www.RoseMed.com.

Contacts

Rose Medical Center
Abigail Kesner, 303-320-2819
abigail.kesner@healthonecares.com
or
Dowling
& Dennis Public Relations
Liz Dowling, 415-388-2794
liz@dowlingdennis.net