WEDNESDAY, May 11, 2011 (HealthDay News) -- A four-drug chemotherapy regimen for deadly pancreatic cancer nearly doubled patients' survival time compared to standard chemotherapy, a new study suggests.
In late-stage trials, French researchers split a group of 342 patients with advanced pancreatic adenocarcinoma, the most common form of the disease, into two groups. Half received gemcitabine, the standard treatment, while the rest received FOLFIRINOX, a four-drug combination of oxaliplatin, irinotecan, leucovorin and fluorouracil.
The median survival time improved from 6.8 months for those in the gemcitabine group to 11.1 months in the FOLFIRINOX group, according to the study, which is published in the May 12 issue of the New England Journal of Medicine. Those in the combination group did suffer greater side effects from treatment, however.
"We explain to the patients the advantages and toxicities of both regimens," said study author Dr. Thierry Conroy, a professor of medical oncology at Nancy University and Centre Alexis Vautrin in Nancy, France. "The FOLFIRINOX regimen was able to stabilize patients longer with improved quality of life and delay degradation of quality of life. Unfortunately, it is still a palliative treatment but able to save months, and sometimes years of life."
Pancreatic adenocarcinoma was the fourth leading cause of cancer deaths in the United States in 2010, the study said, and the five-year survival rate is only 6 percent in both the United States and Europe.
Study participants, whose average age was 61, were still fully active and able to carry out daily activities, and sicker patients were not eligible. The trial was conducted at 15 centers in France during the second phase of the trial and expanded to 48 centers during the third phase of the trial.
Patients discontinued the study at their request or if they experienced unacceptable toxic effects -- which included diarrhea, low blood cell counts and sensory neuropathy -- or evidence of disease progression. One patient from each group died from treatment-related causes, and 273 of the 342 patients had died by the end of the median follow-up period of 26 months.
Dr. Alberto Montero, an assistant professor of medicine at Sylvester Comprehensive Care Center at University of Miami Miller School of Medicine, said the results were "remarkable" because the FOLFIRINOX group experienced such an improved survival rate.
Montero cautioned, however, that a small minority of patients with pancreatic adenocarcinoma match the condition of patients in the study, who were still conducting normal daily activities. Even newly diagnosed patients are often extremely ill, he said, and might not be able to tolerate the combination drugs' toxic effects.
"To see a doubling in survival is impressive," said Montero, also a medical oncologist. "For many reasons, this cancer is very resistant to chemotherapy. I think this trial is a first step."
The U.S. National Institutes of Health has more on pancreatic cancer.