(RxWiki News) Good news on the pancreatic cancer front has been slow for some time now. But the situation may have changed, as a new study suggests that a combination of two medications may improve the outlook for patients whose pancreatic cancer has spread.
A recently completed clinical trial showed that the combination of nab-paclitaxel (brand name Abraxane) and gemcitabine (Gemzar) was superior to gemcitabine alone in treating advanced pancreatic cancer.
The dual therapy extended overall survival and progression-free survival (the period during which the cancer doesn’t progress), and offered better response rates than the single therapy, the trial found.
"Learn more about clinical trials."
Daniel D. Von Hoff, MD, from the Translational Genomics Research Institute in Phoenix and the Virginia G. Piper Cancer Center in Scottsdale, Arizona, led this research.
The trial evaluated the effectiveness and safety of nab-paclitaxel plus gemcitabine compared to gemcitabine alone in patients with metastatic (has spread) pancreatic cancer.
Pancreatic cancer, which is diagnosed in about 45,000 Americans each year, is often diagnosed after it has already spread to other organs.
Since 1997, patients with inoperable advanced pancreatic cancer have been treated with gemcitabine, the authors noted in the study introduction.
MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) was an international, multicenter phase lll trial.
Participants included 861 metastatic pancreatic cancer patients who had not previously received chemotherapy.
These patients were randomly assigned to receive either nab-paclitaxel plus gemcitabine (431 patients) or gemcitabine alone (430 patients).
Patients in the combined therapy group received infusion of nab-paclitaxel first, followed by infusion of gemcitabine during the same session.
The researchers analyzed tumor response every eight weeks by spiral CT (computed tomography) or magnetic resonance imaging (MRI).
The results showed that the combination therapy was significantly superior to the single therapy in survival and response rates.
Median overall survival for patients receiving both medications was 8.5 months compared to 6.7 months for patients receiving the single therapy.
At one year, 35 percent of the people in the nab-paclitaxel plus gemcitabine group were alive versus 22 percent of the patients who received only gemcitabine.
After two years, the survival rate was 9 percent in the combination therapy group and 4 percent in the single therapy group.
Progression-free survival was 5.5 months in the nab-paclitaxel-gemcitabine group compared to 3.7 months in the gemcitabine group.
The response rate was 23 percent among people receiving both therapies and 7 percent in the group receiving one medication.
The median time until the treatment stopped working was 5.1 months in the nab-paclitaxel-gemcitabine group and 3.6 months in the gemcitabine group.
Serious side effects were worse in the nab-paclitaxel/gemcitabine group and included neutropenia (low white blood cell count), fatigue and numbness/weakness/pain in the extremities (neuropathy).
The side effects, in most cases, appeared to be reversible, according to the authors.
“In patients with metastatic pancreatic adenocarcinoma, nab-paclitaxel plus gemcitabine significantly improved overall survival, progression-free survival, and response rate, but rates of peripheral neuropathy and myelosuppression were increased,” the study concluded.
"The additional benefit of adding nab-paclitaxel to gemcitabine in the treatment of patients with metastatic pancreatic cancer is welcome news, along with the other recent data showing the superiority of FOLFIRINOX compared with gemctiabine in the treatment of this disease," said James Farrell, MD, director of Interventional Endoscopy and Pancreatic Diseases at the Yale University School of Medicine in New Haven, CT.
FOLFIRINOX is a combination of five chemotherapy agents approved to treat metastatic pancreatic cancer.
"Over time, which patients should receive the nab-paclitaxel regimen and who should receive FOLFIRINOX treatment initially will have to be addressed both in terms of outcome and toxicity," Dr. Farrell told dailyRx News.
The findings from this research were the basis for the US Food and Drug Administration’s September 2013 approval of the use of Abraxane in combination with Gemzar for the treatment of advanced pancreatic cancer.
This study was published October 16 in The New England Journal of Medicine.
The research was funded by Celgene, the maker of Abraxane.