A Phase II Nonrandomised Open-Label Study of Liposomal Daunorubicin (DaunoXome) in Advanced Soft Tissue Sarcoma
2006

Study of Liposomal Daunorubicin in Advanced Soft Tissue Sarcoma

Sample size: 34 publication Evidence: low

Author Information

Author(s): Anne McTiernan, Jeremy Whelan, Michael Leahy, Penella J. Woll, Ian Judson

Primary Institution: Meyerstein Institute of Oncology, University College London Hospitals (UCLH)

Hypothesis

The study aims to assess the therapeutic activity of DaunoXome as first-line treatment in advanced soft tissue sarcoma of adults.

Conclusion

DaunoXome at this dose and schedule is well tolerated in patients with advanced soft tissue sarcoma, but is not associated with significant activity.

Supporting Evidence

  • Thirty-four patients with advanced soft tissue sarcoma were treated with DaunoXome.
  • Grade 3-4 neutropenia was seen in 20 patients (60.6%).
  • One patient had a partial response, giving a response rate of 3.13%.
  • Seven patients (21.9%) had stable disease.
  • The median time to progression for all patients was 42 days.

Takeaway

Doctors tested a new medicine called DaunoXome on patients with a type of cancer called soft tissue sarcoma, but it didn't work very well.

Methodology

Patients with advanced soft tissue sarcoma were treated with DaunoXome 100mg/m2 every 3 weeks, and their responses and toxicities were evaluated.

Potential Biases

There may have been selection bias in choosing patients who were less likely to respond to treatment.

Limitations

The study had a small sample size and a low response rate, which may limit the generalizability of the findings.

Participant Demographics

The study included 34 patients, with a median age of 59 years, and a mix of male and female participants.

Statistical Information

Confidence Interval

95% CI, 0.08–16.22%

Digital Object Identifier (DOI)

10.1155/SRCM/2006/41080

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