Maximal Dose of Radiotherapy with Gemcitabine for Pancreatic Cancer
Author Information
Author(s): Budiharto Tom, Haustermans Karin, Van Cutsem Eric, Van Steenbergen Werner, Topal Baki, Aerts Raymond, Ectors Nadine, Bielen Didier, Vanbeckevoort Dirk, Goethals Laurence, Verslype Chris
Primary Institution: University Hospitals Leuven, Leuven, Belgium
Hypothesis
What is the maximum tolerated dose of radiotherapy when combined with gemcitabine in patients with locally advanced pancreatic adenocarcinoma?
Conclusion
A total dose of 54 Gy with gemcitabine was not feasible due to gastrointestinal toxicity being the dose-limiting factor.
Supporting Evidence
- Three of six patients experienced acute dose limiting toxicity at the 54 Gy dose level.
- Patients treated at the 45 Gy dose level tolerated therapy without dose limiting toxicity.
- There was a significant difference in percentage weight loss between the two dose levels.
Takeaway
Doctors wanted to find out how much radiation they could safely give to patients with pancreatic cancer while also giving them a medicine called gemcitabine. They found that giving too much radiation caused too many side effects.
Methodology
Thirteen patients received escalating doses of radiotherapy (starting at 45 Gy) with a fixed dose of gemcitabine (300 mg/m2/week) and were monitored for toxicity.
Potential Biases
Potential selection bias due to the non-randomized design.
Limitations
The study had a small sample size and was not randomized.
Participant Demographics
Median age was 58 years, with 7 men and 6 women.
Statistical Information
P-Value
0.006
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website