Prospective randomised phase II study of gemcitabine at standard or fixed dose rate schedule in unresectable hepatocellular carcinoma
2003

Study of Gemcitabine for Liver Cancer

Sample size: 50 publication Evidence: low

Author Information

Author(s): Guan Z, Wang Y, Maoleekoonpairoj S, Chen Z, Kim W S, Ratanatharathorn V, Reece W H H, Kim T W, Lehnert M

Primary Institution: Tumor Hospital of Sun Yat-Sen University

Hypothesis

Can gemcitabine administered at a fixed dose rate achieve higher activity in hepatocellular carcinoma compared to the standard schedule?

Conclusion

Both schedules of gemcitabine were found to be safe and manageable, but gemcitabine was not more effective than other treatments for advanced liver cancer.

Supporting Evidence

  • The overall response rate was only 2.1%, with one partial response observed.
  • The median survival time for patients was 97 days.
  • Toxicity was manageable with no drug-related deaths reported.

Takeaway

This study tested a cancer drug called gemcitabine to see if giving it in a special way would work better for patients with liver cancer, but it didn't help them more than the usual way.

Methodology

Patients with unresectable hepatocellular carcinoma were randomly assigned to receive gemcitabine either at a standard schedule or a fixed dose rate, and their responses were evaluated.

Limitations

The study was stopped early due to low activity observed, and the sample size was small.

Participant Demographics

The study included 50 patients, predominantly male, with a median age of approximately 49 years, from China, Thailand, South Korea, and Hong Kong.

Statistical Information

Confidence Interval

95% CI: 0.05–11.1%

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601369

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication