A phase I/II multicentric trial of gemcitabine and epirubicin in patients with advanced pancreatic carcinoma
2006

Gemcitabine and Epirubicin in Pancreatic Cancer

Sample size: 40 publication Evidence: moderate

Author Information

Author(s): Eickhoff A, Martin W, Hartmann D, Eickhoff J C, Möhler M, Galle P R, Riemann J F, Jakobs R

Primary Institution: Klinikum Ludwigshafen gGmbH

Hypothesis

The study aimed to find the maximum-tolerated dose of epirubicin in combination with gemcitabine in pancreatic carcinoma and evaluate the antitumour activity and clinical benefit of this combination.

Conclusion

The combination of gemcitabine and epirubicin is well tolerated and shows promising clinical activity in patients with advanced pancreatic cancer.

Supporting Evidence

  • The maximum-tolerated dose was found to be GEM 1000 mg/m² and EPI 45 mg/m².
  • The median time to progression was 5.1 months and median survival time was 7.4 months.
  • Overall response rate was 23% based on partial responses in 9 out of 40 patients.
  • Median overall survival time for patients with tumor response was 12.6 months.

Takeaway

This study tested a new combination of two cancer drugs to see if they work better together for people with pancreatic cancer, and it looks like they do.

Methodology

The study was a phase I/II trial that involved dose escalation to determine the maximum-tolerated dose and assess safety and efficacy.

Limitations

The study had a small sample size and was limited to patients with unresectable pancreatic carcinoma.

Participant Demographics

{"age":"67.5 years (range 43–75)","gender":"40% female, 60% male","performance_status":{"≥60":"20%","70–80":"62.5%","90–100":"17.5%"},"disease_stage":{"stage III":"32%","stage IV":"68%"}}

Statistical Information

P-Value

0.01

Confidence Interval

95% CI: 5.1–9.9

Statistical Significance

p=0.01

Digital Object Identifier (DOI)

10.1038/sj.bjc.6603174

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