Phase II Study of Temozolomide and Thalidomide in Patients with Unresectable or Metastatic Leiomyosarcoma
2008

Temozolomide and Thalidomide for Advanced Leiomyosarcoma

Sample size: 24 publication Evidence: low

Author Information

Author(s): Michelle S. Boyar, Mary Hesdorffer, Mary Louise Keohan, Zhezhen Jin, Robert N. Taub

Primary Institution: Columbia University Medical Center

Hypothesis

Temozolomide is the active agent in this regimen and should be further studied.

Conclusion

The combination of temozolomide and thalidomide provided disease stabilization in a subset of patients with advanced leiomyosarcoma.

Supporting Evidence

  • Two patients (10%) had partial responses.
  • Five patients (24%) had stable disease for at least six months.
  • The median overall survival was 9.5 months.

Takeaway

Doctors tested a combination of two medicines on patients with a type of cancer called leiomyosarcoma. Some patients felt better for a while, but not everyone got better.

Methodology

This was a phase II single-institution trial where patients received temozolomide and thalidomide until disease progression or unacceptable toxicity.

Limitations

The study was limited to a small number of patients and had a low overall response rate.

Participant Demographics

Median age was 60 years, with 92% female and 8% male participants.

Statistical Information

Confidence Interval

95% CI 7–28 months for overall survival

Digital Object Identifier (DOI)

10.1155/2008/412503

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