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- Posted Wednesday October 16, 2013
Pancreatic cancer patient survival is 'significantly higher' with nab-paclitaxel, in study led by TGen and Scottsdale Healthcare
NEJM today publishes findings of international trial resulting in recent FDA approval of Abraxane (nab-paclitaxel) for patients with advanced pancreatic cancer
SCOTTSDALE, Ariz. - Oct. 16, 2013 - By all
measures, the addition of nab-paclitaxel for the treatment of
patients with advanced pancreatic cancer was superior to the
survival for patients who received only gemcitabine, according to
the results of a study led by the Translational Genomics Research
Institute (TGen) and Scottsdale Healthcare, published today
by The New England Journal of Medicine.
The study of 861 patients, conducted at 151 community and academic
centers in 11 nations, found that the 431 patients assigned
nab-paclitaxel - in addition to the standard-of-care gemcitabine -
had significantly improved overall survival, progression-free
survival, and drug response rates than for the 430 assigned to
gemcitabine alone.
"This large, randomized, international, phase 3 study showed that
the nab-paclitaxel plus gemcitabine led to a significant
improvement in survival at all time points," said Dr. Daniel D. Von
Hoff, TGen Distinguished Professor and Physician-In-Chief, and
Chief Scientific Officer for the Virginia G. Piper Cancer Center
Clinical Trials at Scottsdale Healthcare, a partnership with
TGen.
"The rate of survival was significantly higher in the
nab-paclitaxel-gemcitabine group than in the gemcitabine group,"
said Dr. Von Hoff, lead author among the study's 23 co-authors and
more than 130 researchers. He served as Principal Investigator of
MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), which
included sites in North America, Europe and Australia.
Dr. Von Hoff, considered among the nation's leading authorities on
pancreatic cancer, also was the principal investigator for the
first clinical trial of gemcitabine, the first therapy to show
improvement in survival for patients with pancreatic cancer. The
FDA approved gemcitabine in 1996.
On Sept. 6, the U.S. Food and Drug Administration (FDA) approved
nab-paclitaxel (produced by Celgene Corporation under the brand
name Abraxane) for use in advanced pancreatic cancer patients.
Abraxane previously was approved by the FDA for use in the
treatment of metastatic breast cancer (2005) and advanced lung
cancer (2012).
While it is still uncertain exactly how Abraxane works, Abraxane
wraps traditional chemotherapy, paclitaxel, in near-nano sized
shells of albumin, a protein that the tumor could recognize as
food. Once inside the tumor, the Abraxane may act like a "Trojan
Horse" to release chemotherapy and kill the cancer cells.
Participants treated with Abraxane plus gemcitabine lived, on
average, 1.8 months longer than those treated with gemcitabine
alone, and they experienced a delay in tumor growth
(progression-free survival) that was, on average, 1.8 months later
than the participants who only received gemcitabine.
Of note, 35 percent of patients who also received Abraxane
survived more than 1 year, a 59 percent increase over the 22
percent of those receiving only gemcitabine who survived more than
1 year. Also, more than twice as many patients (9 percent) who also
received Abraxane survived more than 2 years, compared to those (4
percent) who only received gemcitabine.
"This a major breakthrough, but there is more work to be done.
Building on these results, we are evaluating new targeted agents in
combination with the Abraxane/gemcitabine regimen," said Dr. Ramesh
Ramanathan, Medical Director of the Virginia G. Cancer Center
Clinical Trials at Scottsdale Healthcare, and MPACT principal
investigator for the United States.
The most significant side effect from the addition of
nab-paclitaxel was peripheral neuropathy, such as numbness in the
hands and feet, although this occurred in only a small proportion
of patients and was "rapidly reversible in most patients" by
temporarily halting the drug and subsequently reducing its dosage.
None of the patients experienced severe (grade 4) neuropathy.
The pancreas is a glandular organ behind the stomach that secretes
enzymes to help digestion, and produces hormones, including
insulin, which helps regulate blood-sugar metabolism.
"We are very grateful to the Seena Magowitz Foundation and to the
Bedding Industry, which supported the research, leading to this
important new survival-improving combination therapy," said Dr. Von
Hoff. "We also appreciate the support of Stand Up To
Cancer."
For information about eligibility to participate in clinical
trials at the Virginia G. Piper Cancer Center at Scottsdale
Healthcare, contact the cancer care coordinator at 480-323-1339;
toll free at 1-877-273-3713 or via email at [email protected].
The New England Journal of Medicine article is available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1304369.
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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 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]