Prolonged fixed dose rate infusion of gemcitabine with autologous haemopoietic support in advanced pancreatic adenocarcinoma
2005

Gemcitabine Infusion in Pancreatic Cancer

Sample size: 23 publication Evidence: moderate

Author Information

Author(s): Bengala C, Guarneri V, Giovannetti E, Lencioni M, Fontana E, Mey V, Fontana A, Boggi U, Del Chiaro M, Danesi R, Ricci S, Mosca F, Del Tacca M, Conte P F

Primary Institution: University of Modena and Reggio Emilia

Hypothesis

To define the maximum-tolerated dose (MTD) of fixed dose rate (FDR) of gemcitabine infusion with circulating haemopoietic progenitor support and to evaluate the activity of the treatment.

Conclusion

The study found that the maximum-tolerated dose of gemcitabine was 6500 mg/m², but the treatment's effectiveness was not superior to less intensive schedules.

Supporting Evidence

  • The overall response rate was 22.2%.
  • The MTD was established at 6500 mg/m².
  • Median time to progression was 4.8 months.
  • Median overall survival was 7.0 months.
  • Patients with higher CdA expression had shorter overall survival.

Takeaway

Doctors tested a new way to give a cancer medicine called gemcitabine to help patients with pancreatic cancer, but it didn't work better than older methods.

Methodology

Patients received escalating doses of gemcitabine every 2 weeks with circulating haemopoietic progenitor support, and the study measured pharmacokinetics and treatment response.

Limitations

The study had a small sample size and the treatment's effectiveness was lower than expected.

Participant Demographics

Median age was 56 years, with 13 males and 10 females; 3 had locally advanced disease and 20 had metastatic disease.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI 1.7–7.9 for TTP; 95% CI 4.9–9.1 for OS

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602673

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