Gemcitabine with or without continuous infusion 5-FU in advanced pancreatic cancer
Author Information
Author(s): Di Costanzo F, Carlini P, Doni L, Massidda B, Mattioli R, Iop A, Barletta E, Moscetti L, Recchia F, Tralongo P, Gasperoni S
Primary Institution: Azienda Ospedaliera Careggi, Florence, Italy
Hypothesis
Does adding continuous infusion of 5-FU to gemcitabine improve outcomes in advanced pancreatic cancer?
Conclusion
The study found that adding continuous infusion 5-FU to gemcitabine does not significantly improve response rates, progression-free survival, or overall survival in advanced pancreatic cancer.
Supporting Evidence
- The overall response rate was 8% for gemcitabine alone and 11% for the combination with 5-FU.
- The median progression-free survival was 14 weeks for gemcitabine alone and 18 weeks for the combination.
- The median overall survival was 31 weeks for the combination and 30 weeks for gemcitabine alone.
Takeaway
This study looked at whether adding a drug called 5-FU to another drug called gemcitabine helps people with advanced pancreatic cancer. It found that it doesn't really make things better.
Methodology
Patients were randomized to receive either gemcitabine alone or in combination with continuous infusion 5-FU, and their responses were evaluated over time.
Limitations
The study was not powered for formal comparisons of efficacy outcomes, and the evaluation of tumor response was challenging due to the nature of pancreatic cancer.
Participant Demographics
Median age was 63 years, with 68% having a Karnofsky performance status of 80 or greater.
Statistical Information
P-Value
p=0.09
Confidence Interval
95% confidence interval: 0.5–16% for gemcitabine alone and 2–22% for the combination.
Digital Object Identifier (DOI)
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