Pancreatic cancer is the fourth leading cause of cancer-related death in the United States. Pancreatic cancer is usually diagnosed at an advanced stage. The course of disease is usually rapid, and the mortality rate is high.
In a clinical trial sponsored by the National Cancer Institute and NCCAM, researchers at Columbia University compared gemcitabine-based chemotherapy with an alternative regimen that combined pancreatic proteolytic enzymes, nutritional supplements, detoxification, and an organic diet* in a group of patients with inoperable pancreatic cancer. The study was originally designed in 1998 as a randomized controlled trial, but because most patients and physicians uncomfortable with random assignment, researchers changed the design in 2001 to allow patients to choose which therapy they received. Of 55 patients, 23 received chemotherapy and 32 received the enzyme regimen. The primary outcome for the study was survival time; the secondary outcome was quality of life.
When the study ended in October 2005, median survival was more than three times longer for the chemotherapy group (14 months) than the enzyme regimen group (4.3 months). At 1 year, 56 percent of the chemotherapy patients were alive, compared with 16 percent of the enzyme regimen group. Quality-of-life ratings over 12 months were greater for the chemotherapy group than the enzyme regimen group.
*This regimen has also been referred to as the Gonzalez regimen.
Chabot JA, Tsai W-Y, Fine RL, et al. Pancreatic proteolytic enzyme therapy compared with gemcitabine-based chemotherapy for the treatment of pancreatic cancer. Journal of Clinical Oncology.;28(12):2058–2063.2010