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- Posted Wednesday July 17, 2013
TGen-TD2-Scottsdale Healthcare breast cancer pilot study shows value of molecular profiling and proteomic mapping
Patients benefit from treatments tailored specifically for their tumor types; stage set for larger study
SCOTTSDALE, Ariz. - July 17, 2013 - The Side-Out
Foundation's breast cancer pilot study, led by the Translational
Genomics Research Institute (TGen), Translational Drug Development
(TD2) and Scottsdale Healthcare, has shown that cancer patients do
better when their treatment is guided by molecular profiling.
Specifically, 52 percent of patients with advanced breast cancer
received clinical benefit - meaning their disease was controlled
for a longer time - when their cancer was treated based on
addressing the abnormal proteins in their tumor, according to the
study conducted at the Virginia G. Piper Cancer Center Clinical
Trials, a partnership of Scottsdale Healthcare and TGen.
Each patient's treatment was "personalized," meaning that the
therapy they received was based on their individual tumor
biology.
"This study demonstrates the feasibility of personalized cancer
treatment, and shows that this approach merits further
investigation in future studies," said Gayle Jameson, Nurse
Practitioner at Scottsdale Healthcare's Virginia G. Piper Cancer
Center Clinical Trials and the study's Principal
Investigator.
"The success of this pilot study will lead to a larger study and
hopefully greater clinical benefit for more patients with advanced
breast cancer," said Jameson, who presented the results of the
study in June at the 2013 American Society of Clinical Oncology
(ASCO) in Chicago.
Due to the overwhelmingly positive results, a new study
incorporating additional technology for tumor analysis, Side-Out
II, will open at the Virginia G. Piper Cancer Center Clinical
Trials in the near future for patients with advanced breast
cancer.
"The success of our pilot proof-of-concept study has established a
firm launching pad for the upcoming Side-Out II study, which
involves a more in-depth investigation of tumor biology with an
expanded repertoire of tests to direct personalized treatment,"
said Dr. Jasgit Sachdev, M.D., a breast cancer specialist and
Associate Professor at the Virginia G. Piper Cancer Center Clinical
Trials.
"By showing the significant advantages of molecular profiling,
this pilot study has enabled us to move forward with a project that
should strengthen the evidence for using this approach in routine
clinical care."
The recent pilot study built on previous studies by Scottsdale
Healthcare and TGen that showed the value of guiding treatment
based on molecular profiling, in which each patient's tumor was
analyzed for protein abnormalities that may "drive" the cancer's
growth. The results pointed investigators toward specific genetic
changes that might be addressed by specific medications.
Beyond molecular profiling, the pilot study also included mapping
proteomic pathways within the tumor tissue so each patient could
receive a highly targeted regimen designed to impede their cancer
growth.
All of the patients in the recent study had advanced breast cancer
that had progressed following multiple previous chemotherapy
treatments. Of the 25 patients, 13 received clinical benefit as a
result of molecular profiling. For all 25 patients, the therapy
selected based on their tumor analysis was different than what they
would have received in their next planned treatment, if they had
not participated in the study.
The Virginia G. Piper Cancer Center at Scottsdale Healthcare was
the lead site in the 2-½ year pilot study. In addition, patients in
the study were treated at Virginia Cancer Specialists, US Oncology,
in Fairfax, Vir.; and at Evergreen Hematology & Oncology in
Spokane, Wash.
Translational Drug Development (TD2), a TGen company, managed the
pilot clinical trial, and will also oversee the follow-on study,
Side-Out II.
"This was an exciting study for TD2," said Linda Vocila, BSN, RN,
Director of Clinical Operations at TD2 and co-author of the study.
"It demonstrates that close collaboration between physicians and
scientists leads to greater clinical benefit for patients with
cancer."
Two labs analyzed tissue: the Center for Applied Proteomics and
Molecular Medicine (CAPMM) at George Mason University in Manassas,
Vir.; and Caris Life Sciences in Phoenix.
The Side-Out Foundation of Fairfax, Vir., sponsored the
study.
To participate in a clinical trial at the Virginia G. Piper Cancer
Center, please contact Patient Care Coordinator Joyce Schaffer at
480-323-1339 or [email protected].
# # #
About TGen
Translational Genomics Research Institute (TGen) is a Phoenix,
Arizona-based non-profit organization dedicated to conducting
groundbreaking research with life changing results. TGen is focused
on helping patients with cancer, neurological disorders and
diabetes, through cutting edge translational research (the process
of rapidly moving research towards patient benefit). TGen
physicians and scientists work to unravel the genetic components of
both common and rare complex diseases in adults and children.
Working with collaborators in the scientific and medical
communities literally worldwide, TGen makes a substantial
contribution to help our patients through efficiency and
effectiveness of the translational process. For more information,
visit:www.tgen.org.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
602-343-8704
[email protected]
About Translational Drug Development (TD2)
Translational Drug Development (TD2) is an oncology drug
development organization and is wholly owned by the Translational
Genomics Research Institute (TGen). TD2 provides innovative
services for oncology focused biopharmaceutical companies using a
dedicated team of professionals with broad experience and
understanding in drug development. TD2 is uniquely positioned to
support the need for improved and accelerated development of new
chemical entities (NCE's) for life-threatening diseases. TD2 uses a
unique combination of experience gained through its contract
research organization business, and an integrated suite of
proprietary and non-proprietary tools, preclinical study execution,
regulatory affairs assistance, clinical trial design and
management, and drug development experts to successfully move
therapeutics towards regulatory approval. TD2 is dedicated to
reducing the risks and uncertainty inherent in the drug development
process. For more information about Translational Drug Development,
visit www.td2inc.com.
Press Contact:
Tara Franks
VP, Business Operations
602-358-8322
[email protected]
About the Virginia G. Piper Cancer Center at Scottsdale
Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare in
Scottsdale, Ariz. offers comprehensive cancer treatment and
research through clinical trials, diagnosis, treatment, prevention
and support services in collaboration with leading scientific
researchers and community oncologists. Scottsdale Healthcare is the
nonprofit parent organization of the Virginia G. Piper Cancer
Center at Scottsdale Healthcare, Scottsdale Healthcare Research
Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale
Healthcare Shea Medical Center and Scottsdale Healthcare Thompson
Peak Hospital. For more information, visit www.shc.org.
Press Contact:
Jamie Grim
Virginia G. Piper Cancer Center at Scottsdale Healthcare
480-323-1387
[email protected]
About Caris Life Sciences
Caris Life Sciences is a U.S. based biosciences company
specializing in the development and commercialization of
clinically-validated molecular diagnostics and anatomic pathology
services primarily in the fields of oncology, dermatopathology,
hematopathology and gastrointestinal pathology. The company
provides academic-caliber medical consults through its
industry-leading team of subspecialty fellowships and
expert-trained pathologists in gastrointestinal and liver
pathology, dermatopathology and hematopathology. Caris Life
Sciences also offers advanced molecular analyses of patient samples
through prognostic testing services and genomic and proteomic
profiling to assist physicians in their treatment of cancer and
other complex diseases. Additional information is available
at www.carislifesciences.com.
About Evergreen Hematology & Oncology
Evergreen Hematology & Oncology is a group of physicians,
nurses, and support staff committed to offering a new approach to
treating cancer in an environment that provides the utmost in
hospitality and caring - as well as the very latest in cutting-edge
cancer treatments. We believe we have both a moral and an ethical
obligation to participate in the search for a cure. We believe our
patients should have access to all options available to
successfully meet the challenges of cancer. And we believe that,
whether you're newly diagnosed or coping with recurrence, you
deserve more than just treatment. You deserve the best in
front-line therapy. You deserve hope. More information: evergreen4cure.com.
About Virginia Cancer Specialists
For more than thirty years, Virginia Cancer Specialists has
contributed greatly to the campaign against cancer and diseases of
the blood by offering advancements in technology, treatment, early
detection and clinical trials. For residents throughout
Northern Virginia this means the chances of beating cancer are
better than ever. Illustrating the outpatient emphasis of cancer
treatment, Virginia Cancer Specialists cancer care and blood
disorder experts work closely with you and your family to create an
individual treatment plan that provides for your physical and
emotional health, all in the familiar setting of your community. virginiacancerspecialists.com.
About George Mason University's Center for Applied
Proteomics and Molecular Medicine
The Center for Applied Proteomics and Molecular Medicine in
Manassas, Va., is a key element of the Life Sciences initiative in
theCollege of Science. Proteomics - the
study of proteins, how they communicate and interact, and how those
actions impact biology - is the new frontier in molecular medicine.
CAPMM Scientists, have invented the RPMA technology to provide the
unprecedented ability to measure the activity level of hundreds of
protein pathway biomarkers at once from a tiny needle biopsy. These
biomarkers can then be used to directly tailor treatment based on
the unique patient-specific information within the tumor itself.
The new classes of molecular targeted inhibitors that are just now
reaching the bedside act by modulating protein activity, not genes
and the RPMA technology was developed by the CAPMM to synergize
with these new compounds. Working with clinical investigators from
health care partners and industry collaborators, their goal is to
accelerate innovative laboratory discoveries into clinical research
at the bedside, which holds the promise of individually tailored
therapies and personalized disease management for patients, and the
discovery of biomarkers for early disease detection.
About the Side-Out Foundation
The Side-Out Foundation (Side-Out) was established in 2004 by a
group of individuals drawn together by their love of volleyball,
but who also share a similar passion to be a part of the war
against breast cancer. Side-Out's mission is to raise money for the
war against breast cancer through the sport of volleyball. www.side-out.org.
