Results
suggest that the same two-drug regimen given every other week — rather
than weekly — can reduce the toxic side effects of treatment without
changing the treatment’s effectiveness.
OSUCCC – James clinician-scientists report these findings in San Francisco at the 2015 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium on Jan. 16, 2015.
In 2013,
the FDA approved the combination of gemcitabine (pronounced
“jem-SITE-a-bean”, marketed as Gemzar) and nab-paclitaxel (pronounced
“nab PAK-li-TAX-el”, marketed as Abraxane) given three times during a
28-day cycle for the treatment of metastatic pancreatic cancer.
“The combination of gemcitabine and nab-paclitaxel in pancreatic
cancer is one of the most recent advances in pancreatic cancer treatment
and has been shown to improve survival when compared to gemcitabine
alone,” says Kavya Krishna,
MD, a hematology oncology fellow at The OSUCCC – James and first author
of the ASCO GI abstract. “But this improved survival comes with
increased toxic side effects that can affect quality of life. We sought
an alternative regimen that would prolong treatment effectiveness and
reduce side effects.”
Based on institutional experience and previously published phase-3 data,
The OSUCCC – James team adopted a modified regimen of this two-drug
combination for metastatic pancreatic cancer patients treated in
Columbus, Ohio. The approach was developed and recommended by an expert
panel made up of gastrointestinal (GI) medical oncologists and specialty
pharmacists at The OSUCCC – James.
Study Design and Results
For this study, the OSUCCC – James GI team identified 69 patients
with pancreatic cancer who received the modified regimen of gemcitabine
and nab-paclitaxel. Forty nine had previously untreated metastatic
pancreatic cancer and the remaining 20 patients had either failed other
chemotherapy treatments or had locally advanced or borderline resectable
disease. With a median age of 65, all of the patients were given
gemcitabine and nab-paclitaxel on days 1 and 15 of a 28 day treatment
cycle.
Overall, less than two percent of patients experienced severe
neurological toxicities (compared with 17 percent in the previous phase 3
study); 10 percent experienced severe low white blood cell counts
(compared with 38 percent in the phase 3 study); and 8 percent required
growth factor injections the day after chemotherapy treatment to boost
production of white blood cells (compared with 26 percent in the
previous phase 3 study.)
“Shifting this treatment to every other week gives the immune
system time to recover between chemotherapy sessions and less overall
toxicity. It also means fewer visits to the infusion center to receive
chemotherapy,” says Tanios Bekaii-Saab,
MD, associate professor and OSUCCC – James gastrointestinal oncology
section chief. “This less-intense, every-other-week treatment approach
seems to be effective in treating our patients with metastatic
pancreatic cancer while significantly reducing side effects that impact
quality of life.”
Median overall survival of patients treated with the modified
regimen was approximately 11 months and progression-free survival was
4.8 months, confirming treatment was effective. In addition, the
modified treatment regimen reduced patient medical costs by $5,500 per
month.
“Pancreatic cancer is an especially difficult diagnosis, so
weighing the survival benefit of available treatments against how
treatment side effects will impact a patient’s remaining life is a
critically important part of the treatment planning process,” Krishna
adds.
About The OSUCCC – James
The Ohio State University Comprehensive Cancer Center – Arthur G.
James Cancer Hospital and Richard J. Solove Research Institute strives
to create a cancer-free world by integrating scientific research with
excellence in education and patient-centered care, a strategy that leads
to better methods of prevention, detection and treatment. Ohio State is
one of only 41 National Cancer Institute (NCI)-designated Comprehensive
Cancer Centers and one of only four centers funded by the NCI to
conduct both phase I and phase II clinical trials. The NCI recently
rated Ohio State’s cancer program as “exceptional,” the highest rating
given by NCI survey teams. As the cancer program’s adult patient-care
component, The James is a “Top Hospital” as named by the Leapfrog Group
and one of the top cancer hospitals in the nation as ranked by U.S.News
& World Report.