Among patients with locally advanced metastatic pancreatic adenocarcinoma, gemcitabine has been shown to improve outcomes compared with fluorouracil.
Dr William Regine and colleagues from Canada determined if the addition of gemcitabine to adjuvant fluorouracil chemo radiation (chemotherapy plus radiation), improves survival for patients with resected pancreatic adenocarcinoma.
|The 3-year survival was 22% in the fluorouracil group|
|Journal of the American Medical Association|
The team performed a randomized controlled phase 3 trial of patients with complete gross total resection of pancreatic adenocarcinoma.
The patients had no prior radiation or chemotherapy and were enrolled between 1998 and 2002 with follow-up through 2006, at 164 US and Canadian institutions.
The team used chemotherapy with either fluorouracil in 230 patients or gemcitabine in 221 patients for 3 weeks prior to chemoradiation therapy and for 12 weeks after chemoradiation therapy.
The researchers reported that chemoradiation with a continuous infusion of fluorouracil was the same for all patients.
The team's primary end point was survival for all patients and survival for patients with pancreatic head tumors.
Secondary end points included toxicity.
The researchers randomized a total of 451 patients, of which 388 had pancreatic head tumors.
The team noted that the median survival was 21 months, and a 3-year survival of 31% in the gemcitabine group vs a median survival of 17 months.
The 3-year survival was 22% in the fluorouracil group.
The treatment effect was strengthened on multivariate analysis.
Grade 4 hematologic toxicity was 1% in the fluorouracil group, and 14% in the gemcitabine group without a difference in febrile neutropenia or infection.
The team found no differences in the ability to complete chemotherapy or radiation therapy.
Dr Regine's team concluded, "The addition of gemcitabine to adjuvant fluorouracil-based chemoradiation was associated with a survival benefit for patients with resected pancreatic cancer, although this improvement was not statistically significant."