Patients with advanced pancreatic adenocarcinoma have a poor response, progression-free survival, and overall survival with standard treatment.
Dr Reni and colleagues aimed to assess whether a 4-drug regimen could improve 4-month progression-free survival compared with gemcitabine alone.
The investigators conducted a randomized multi-center phase III trial where 52 patients were randomly assigned to 4 drug treatment groups.
The researchers reported 40 mg/m2 cisplatin and 40 mg/m2 epirubicin were both given on day 1.
|1-year overall survival in the fluorouracil group was 39% versus 21% in the gemcitabine|
|The Lancet Oncology|
The team also stated that 600 mg/m2 gemcitabine was given intravenously over 1 hour on days 1 and 8.
200 mg/m2 fluorouracil a day was given by continuous infusion on days 1 to 28 of a 4 week cycle (PEFG regimen).
The team assigned 47 patients to 1000 mg/m2gemcitabine given intravenously over 30 min once a week for 7 of 8 consecutive weeks in cycle 1 and for 3 of 4 weeks thereafter.
The primary endpoint was 4-month progression-free survival.
The team also considered secondary endpoints including overall survival, objective response, safety, and quality of life with all analyses done by intention to treat.
The researchers found that 51 patients assigned fluorouracil (PEFG regimen)and 46 assigned gemcitabine alone had disease progression.
The research team observed that 49 patients in the fluorouracil (PEFG regimen) group, and 46 in the gemcitabine group died from progressive disease.
More patients allocated to fluorouracil (PEFG regimen) than gemcitabine alone were alive without progressive disease at 4 months.
The investigators noted that 1-year overall survival in the fluorouracil (PEFG regimen) group was 39%, and 21% in the gemcitabine group.
More patients assigned to fluorouracil (PEFG regimen) showed disease response than did those assigned gemcitabine.
In addition, the team found that more patients in the fluorouracil (PEFG regimen) group had grade 3 to 4 neutropenia and thrombocytopenia than in the gemcitabine group.
Dr Reni's team concludes, “The PEFG regimen consisting of 200 mg/m2 fluorouracil a day given by continuous infusion on days 1 to 28 of a 4 week cycle could be considered for treatment of advanced pancreatic adenocarcinoma.”