Phase I/II trial of doxorubicin and fixed dose-rate infusion gemcitabine in advanced soft tissue sarcomas: a GEIS study
2006

Combining Doxorubicin and Gemcitabine for Soft Tissue Sarcomas

Sample size: 36 publication Evidence: low

Author Information

Author(s): López-Pousa A, Losa R, Martín J, Maurel J, Fra J, Sierra M, Casado A, García del Muro J, Poveda A, Balañá C, Martínez-Trufero J, Esteban E, Buesa J M

Primary Institution: Hospital Central de Asturias, Instituto Universitario de Oncología del Principado de Asturias (IUOPA)

Hypothesis

The study aimed to determine the dose-limiting toxicity and maximum tolerated dose of a first-line combination of doxorubicin and gemcitabine in adult patients with advanced soft tissue sarcomas.

Conclusion

The combination of doxorubicin and gemcitabine showed limited clinical activity and significant toxicity, which does not justify further studies with this administration schedule.

Supporting Evidence

  • Objective activity in 36 patients was 22%.
  • Grade 3–4 granulocytopenia occurred in 70% of patients.
  • 50% remission rate was noted in leiomyosarcomas.

Takeaway

Doctors tested a mix of two cancer drugs to see if they could help patients with a type of soft tissue cancer, but it turned out to be too risky and didn't work well enough.

Methodology

Patients received doxorubicin followed by gemcitabine every 3 weeks, with dose adjustments based on toxicity.

Limitations

The study had a small sample size and was limited by the high toxicity observed.

Participant Demographics

The study included 36 patients with advanced soft tissue sarcomas, with a median age of 59 years.

Statistical Information

P-Value

p=0.02

Confidence Interval

95% CI: 9–35%

Statistical Significance

p=0.02

Digital Object Identifier (DOI)

10.1038/sj.bjc.6603187

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